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Wednesday, May 9, 2012

Salicylate Oral, Rectal

Commonly used brand name(s)

In the U.S.

Amigesic

Asacol

Azulfidine

Azulfidine Entabs

Bayer

Canasa

Colazal

Dipentum

Doan's Extra Strength

Doan's Regular

Dolobid

Ecotrin

Kaopectate

Pepto Bismol

Salflex

Tricosal

Trilisate

In Canada

Alti-Sulfasalazine

Arthropan

Asacol 800

Bismuth Extra Strength

Bismuth Original Formula

Mesasal

Pentasa

Pepto-Bismol

Pms-Asa Suppository Adult

Pms-Asa Suppository Children

Salazopyrin

Salofalk

Available Dosage Forms:

Tablet, Enteric Coated

Tablet, Extended Release

Suppository

Tablet

Capsule

Tablet, Chewable

Tablet, Effervescent

Capsule, Delayed Release

Tablet, Delayed Release

Enema

Capsule, Extended Release

Liquid

Solution

Suspension

Uses For salicylate

Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.

Salicylates may also be used for other conditions as determined by your doctor.

The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.

Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.

Importance of Diet

Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.

Before Using salicylate

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.

Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.

Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

Geriatric

Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.

Pregnancy

Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.

Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast Feeding

Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).

Caffeine passes into the breast milk in small amounts.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Influenza Virus Vaccine, Live

Ketorolac

Pentoxifylline

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Acenocoumarol

Alteplase, Recombinant

Anisindione

Ardeparin

Argatroban

Beta Glucan

Bivalirudin

Certoparin

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Desvenlafaxine

Dicumarol

Dipyridamole

Duloxetine

Enoxaparin

Eptifibatide

Escitalopram

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Ginkgo

Heparin

Ketoprofen

Lepirudin

Methotrexate

Milnacipran

Nadroparin

Naproxen

Nefazodone

Parnaparin

Paroxetine

Pemetrexed

Phenindione

Phenprocoumon

Protein C

Reteplase, Recombinant

Reviparin

Riluzole

Rivaroxaban

Sertraline

Sibutramine

Tacrolimus

Ticlopidine

Tinzaparin

Tirofiban

Varicella Virus Vaccine

Venlafaxine

Vilazodone

Warfarin

Zimeldine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of salicylate

Take salicylate after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.

Take tablet or capsule forms of salicylate with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.

For patients taking aspirin (including buffered aspirin and/or products containing caffeine):

Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.

If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.

Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.

There are several different forms of aspirin or buffered aspirin tablets. If you are using:
- chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.
- delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.
- extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.

To use aspirin suppositories:

If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate) oral solution:

The liquid may be mixed with fruit juice just before taking.

Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:

The tablets must be swallowed whole. Do not crush them or break them up before taking.

Unless otherwise directed by your medical doctor or dentist:

Do not take more of salicylate than recommended on the label, to lessen the chance of side effects.

Children up to 12 years of age should not take salicylate more than 5 times a day.

When used for arthritis (rheumatism), salicylate must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of salicylate.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For aspirin

For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.
  - Children 11 to 12 years of age—320 to 480 mg every four hours as needed.
  - Children 9 to 11 years of age—320 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—320 to 325 mg every four hours as needed.
  - Children 4 to 6 years of age—240 mg every four hours as needed.
  - Children 2 to 4 years of age—160 mg every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (chewing gum):
- For pain:
  - Adults and teenagers—2 tablets every four hours as needed.
  - Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.
  - Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.
  - Children up to 3 years of age—Dose must be determined by your doctor.

For long-acting oral dosage form (extended-release tablets):
- For pain:
  - Adults and teenagers—1 or 2 tablets twice a day.
  - Children—The long-acting aspirin tablets are too strong for use in children.
- For arthritis:
  - Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.
  - Children—The long-acting aspirin tablets are too strong for use in children.

For rectal dosage form (suppositories):
- For pain or fever:
  - Adults and teenagers—325 to 650 mg every four hours as needed.
  - Children 11 to 12 years of age—325 to 480 mg every four hours as needed.
  - Children 9 to 11 years of age—325 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—325 mg every four hours as needed.
  - Children 4 to 6 years of age—240 mg every four hours as needed.
  - Children 2 to 4 years of age—160 mg every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

For aspirin and caffeine

For oral dosage forms (capsule):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
  - Children 6 to 9 years of age—325 mg every four hours as needed.
  - Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 9 to 12 years of age—325 to 400 mg every four hours as needed.
  - Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For buffered aspirin

For oral dosage forms (tablets):
- For pain or fever:
  - Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.
  - Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.
  - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
  - Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.
  - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
  - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For buffered aspirin and caffeine

For oral dosage form (tablets):
- For pain or fever:
  - Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.
  - Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.
  - Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.
  - Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.
  - Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.
  - Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.
- For preventing a heart attack, stroke, or other problems caused by blood clots:
  - Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.
  - Children—Use and dose must be determined by your doctor.

For choline salicylate

For oral dosage form (oral solution):
- For pain or fever:
  - Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.
  - Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
  - Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.
  - Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
  - Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.
  - Children up to 2 years of age—Dose must be determined by your doctor.
- For arthritis:
  - Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.
  - Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.

For choline and magnesium salicylates

For oral dosage forms (oral solution or tablets):
- For pain or fever:
  - Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.
  - Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.
  - Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.

For magnesium salicylate

For oral dosage form (tablets):
- For pain:
  - Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.
  - Children—Dose must be determined by your doctor.

For salsalate

For oral dosage forms (capsules or tablets):
- For arthritis:
  - Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.
  - Children—Dose must be determined by your doctor.

For sodium salicylate

For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
- For pain or fever:
  - Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.
  - Children 6 years of age and older—325 mg every four hours as needed.
  - Children up to 6 years of age—salicylate is too strong for use in children younger than 6 years of age.
- For arthritis:
  - Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.
  - Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.

Missed Dose

If you miss a dose of salicylate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using salicylate

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with salicylate may cause an overdose.

If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.

Serious side effects can occur during treatment with salicylate. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking salicylate and check with your doctor immediately if you notice any of these warning signs.

Check with your medical doctor or dentist:

If you are taking salicylate to relieve pain and the pain lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.

If you are taking salicylate to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

If you are taking salicylate for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

If you are taking salicylate regularly, as for arthritis (rheumatism), and you notice a ringing or buzzing in your ears or severe or continuing headaches. These are often the first signs that too much salicylate is being taken. Your doctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:

Take only the amount of aspirin ordered by your doctor. If you need a medicine to relieve pain, a fever, or arthritis, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

Do not stop taking salicylate for any reason without first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:

Acetaminophen (e.g., Tylenol)

Diclofenac (e.g., Voltaren)

Diflunisal (e.g., Dolobid)

Etodolac (e.g., Lodine)

Fenoprofen (e.g., Nalfon)

Floctafenine (e.g., Idarac)

Flurbiprofen, oral (e.g., Ansaid)

Ibuprofen (e.g., Motrin)

Indomethacin (e.g., Indocin)

Ketoprofen (e.g., Orudis)

Ketorolac (e.g., Toradol)

Meclofenamate (e.g., Meclomen)

Mefenamic acid (e.g., Ponstel)

Nabumetone (e.g., Relafen)

Naproxen (e.g., Naprosyn)

Oxaprozin (e.g., Daypro)

Phenylbutazone (e.g., Butazolidin)

Piroxicam (e.g., Feldene)

Sulindac (e.g., Clinoril)

Tenoxicam (e.g., Mobiflex)

Tiaprofenic acid (e.g., Surgam)

Tolmetin (e.g., Tolectin)

For diabetic patients:

False urine sugar test results may occur if you are regularly taking large amounts of salicylates, such as:
- Aspirin: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength), doses a day.
- Buffered aspirin or
- Sodium salicylate: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), doses a day.
- Choline salicylate: 4 or more teaspoonfuls (each teaspoonful containing 870 mg) a day.
- Choline and magnesium salicylates: 5 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-mg tablets, a day.
- Magnesium salicylate: 7 or more regular-strength, or 4 or more extra-strength, tablets a day.
- Salsalate: 4 or more 500-mg doses, or 3 or more 750-mg doses, a day.

Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
- you are not sure how much salicylate you are taking every day.
- you notice any change in your urine sugar test results.
- you have any other questions about this possible problem.

Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):

Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.

For patients taking salicylate by mouth:

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with salicylate, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:

Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.

For patients taking one of the products that contain caffeine:

Caffeine may interfere with the result of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

salicylate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

Symptoms of overdose in children

Changes in behavior

drowsiness or tiredness (severe)

fast or deep breathing

Any loss of hearing

bloody urine

confusion

convulsions (seizures)

diarrhea (severe or continuing)

difficulty in swallowing

dizziness, lightheadedness, or feeling faint (severe)

drowsiness (severe)

excitement or nervousness (severe)

fast or deep breathing

flushing, redness, or other change in skin color

hallucinations (seeing, hearing, or feeling things that are not there)

increased sweating

increased thirst

nausea or vomiting (severe or continuing)

shortness of breath, troubled breathing, tightness in chest, or wheezing

stomach pain (severe or continuing)

swelling of eyelids, face, or lips

unexplained fever

uncontrollable flapping movements of the hands (especially in elderly patients)

vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Abdominal or stomach pain, cramping, or burning (severe)

bloody or black, tarry stools

headache (severe or continuing)

ringing or buzzing in ears (continuing)

skin rash, hives, or itching

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach cramps, pain, or discomfort (mild to moderate)

heartburn or indigestion

nausea or vomiting

Less common

Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Sunday, May 6, 2012

Trandolapril and Verapamil

Dosage Form: tablet, film coated, extended release
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Trandolapril and Verapamil hydrochloride extended-release tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Trandolapril and Verapamil Description

Trandolapril and Verapamil hydrochloride extended-release tablets combine a slow release formulation of a calcium channel blocker, verapamil hydrochloride, and an immediate release formulation of an angiotensin converting enzyme inhibitor, trandolapril. The verapamil hydrochloride component of the formulation is designed for sustained release in the gastrointestinal tract.

Verapamil Component - Verapamil hydrochloride USP is chemically described as benzeneacetonitrile, α [3- [[2-(3,4- dimethoxyphenyl) ethyl] methylamino] propyl] -3,4-dimethoxy-α-( 1 -methylethyl) hydrochloride. Its empirical formula is C27H38N2O4 HCl and its structural formula is:

Verapamil hydrochloride USP is an almost white crystalline powder, with a molecular weight of 491.08. It is soluble in water, chloroform, and methanol. It is practically free of odor, with a bitter taste.

Trandolapril Component - Trandolapril USP is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. It is chemically described as (2S,3aR,7aS)-1- [(S)-N-[(S)-Carboxy-3-phenylpropyl] alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its empirical formula is C24H34N2O5 and its structural formula is:

Trandolapril USP is a colorless, crystalline substance with a molecular weight of 430.54. It is soluble (>100 mg/mL) in chloroform, dichloromethane, and methanol.

Trandolapril and Verapamil hydrochloride extended-release tablets are formulated for oral administration, containing verapamil hydrochloride USP as a controlled release formulation and trandolapril USP as an immediate release formulation. The tablet strengths are Trandolapril and Verapamil hydrochloride extended-release tablets 1 mg/240 mg , Trandolapril and Verapamil hydrochloride extended-release tablets 2 mg/180 mg, Trandolapril and Verapamil hydrochloride extended-release tablets 2 mg/240 mg, and Trandolapril and Verapamil hydrochloride extended-release tablets 4 mg/240 mg. The tablets also contain the following ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, ferric oxide red, hypromellose, lactose monohydrate, povidone, sodium alginate, sodium stearyl fumarate, magnesium stearate, microcrystalline cellulose and Opadry White 03B580006 (Trandolapril and Verapamil hydrochloride extended-release tablet 1 mg/240 mg) Opadry Pink 03B540030 (Trandolapril and Verapamil hydrochloride extended-release tablet 2 mg/180 mg), Opadry Green 03B510006 (Trandolapril and Verapamil hydrochloride extended-release tablet 2 mg/240 mg) and Opadry Brown 03B565020 (Trandolapril and Verapamil hydrochloride extended-release tablet 4 mg/240 mg).

Trandolapril and Verapamil - Clinical Pharmacology

Verapamil hydrochloride and trandolapril have been used individually and in combination for the treatment of hypertension. For the four dosing strengths, the antihypertensive effect of the combination is approximately additive to the individual components.

Verapamil Component - Verapamil is a calcium channel blocker that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. Verapamil exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia. During isometric or dynamic exercise, verapamil does not alter systolic cardiac function in patients with normal ventricular function. Verapamil does not alter total serum calcium levels.

Trandolapril Component - Trandolapril is de-esterified to its diacid metabolite, trandolaprilat. Both inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. Trandolaprilat is about 8 times more potent than trandolapril. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.

Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In controlled clinical trials, treatment with Trandolapril and Verapamil hydrochloride extended-release tablets resulted in mean increases in potassium of 0.1 mEq/L (see PRECAUTIONS). Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity (PRA).

ACE is identical to kininase II, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effect of Trandolapril and Verapamil hydrochloride extended-release tablets remains to be elucidated.

While the mechanism through which trandolapril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, trandolapril has an antihypertensive effect even in patients with low renin hypertension. Trandolapril is an effective antihypertensive in all races studied. Both black patients (usually a predominantly low renin group) and non-black patients respond to 2 to 4 mg of trandolapril.

Pharmacokinetics and Metabolism:

Trandolapril and Verapamil hydrochloride extended-release tablet

Following a single oral dose of Trandolapril and Verapamil hydrochloride extended-release tablets in healthy subjects, peak plasma concentrations are reached within 0.5-2 hours for trandolapril and within 4-15 hours for verapamil. Peak plasma concentrations of the active desmethyl metabolite of verapamil, norverapamil, are reached within 5-15 hours. Cleavage of the ester group converts trandolapril to its active diacid metabolite, trandolaprilat, which reaches peak plasma concentrations within 2-12 hours. The pharmacokinetics of trandolapril and trandolaprilat are not altered when trandolapril is administered in combination with verapamil, compared to monotherapy. The AUC and Cmax for both verapamil and norverapamil are increased when 240 mg of controlled release verapamil is administered concomitantly with 4 mg trandolapril. The increase in Cmax is 54 and 30% and the AUC is increased by 65 and 32% for verapamil and norverapamil, respectively. Administration of Trandolapril and Verapamil hydrochloride extended-release tablets 4 mg/240 mg (4 mg trandolapril and 240 mg verapamil hydrochloride extended-release) with a high-fat meal does not alter the bioavailability of trandolapril whereas verapamil peak concentrations and area under the curve (AUC) decrease 37% and 28%, respectively. Food thus decreases verapamil bioavailability and the time to peak plasma concentration for both verapamil and norverapamil are delayed by approximately 7 hours. Both optical isomers of verapamil are similarly affected.

Trandolaprilat has an effective elimination half-life of approximately 10 hours but like all ACE inhibitors, it has a prolonged terminal elimination half-life. The terminal half-life of verapamil is 6-11 hours. Steady-state plasma concentrations of the two components are achieved after about a week of once-daily dosing of Trandolapril and Verapamil hydrochloride extended-release tablets. At steady-state, plasma concentrations of verapamil and trandolaprilat are up to two-fold higher than those observed after a single oral Trandolapril and Verapamil hydrochloride extended-release tablet dose.

The pharmacokinetics of verapamil and trandolaprilat are significantly different in the elderly (≥ 65 years) than in younger subjects. The bioavailability of verapamil and norverapamil are increased by 87% and 77%, respectively, and that of trandolapril by approximately 35% in the elderly. AUCs are approximately 80% and 35% higher, respectively.

Verapamil Component

With the immediate release formulation, more than 90% of the orally administered dose is absorbed with peak plasma concentrations of verapamil observed 1 to 2 hours after dosing. A delayed rate but similar extent of absorption is observed for the sustained release formulation when compared to the immediate release formulation. Because of the rapid biotransformation of verapamil during its first pass through the portal circulation, absolute bioavailability ranges from 20% to 35%. A nonlinear correlation exists between verapamil dose and plasma concentrations.

In early dose titration with verapamil, a relationship exists between plasma concentrations of verapamil and prolongation of the PR interval. However, during chronic administration, this relationship may disappear. No relationship has been established between the plasma concentration of verapamil and reduction in blood pressure.

In healthy subjects, orally administered verapamil undergoes extensive metabolism in the liver. Twelve metabolites have been identified in plasma; all except norverapamil are present in trace amounts only. Approximately 70% of an administered dose is excreted as metabolites in the urine and 16% or more in the feces within 5 days. Urinary excretion of unchanged drug is about 3% to 4% of the dose. Verapamil is approximately 90% bound to plasma proteins.

In patients with hepatic insufficiency, verapamil clearance is decreased about 30% and the elimination half-life is prolonged up to 14 to 16 hours (see PRECAUTIONS). In patients with liver dysfunction, a dosage adjustment may be required. In the elderly (≥ 65 years), verapamil clearance is reduced resulting in increases in elimination half-life.

Trandolapril Component

Following oral administration of trandolapril, the absolute bioavailability of trandolapril is approximately 10% as trandolapril and 10% as trandolaprilat. Plasma concentrations of trandolaprilat but not trandolapril increase in proportion with dose. Plasma concentrations of trandolaprilat decline in a triphasic manner. The more prolonged terminal elimination phase probably represents a small fraction of dose saturably bound to ACE.

After an oral radiolabeled dose of trandolapril, excretion of trandolapril and metabolites account for 33% of the dose in the urine and about 66% in the feces. Less than 1% of the dose is excreted in the urine as unchanged drug. Serum protein binding of trandolapril is about 80%, and is independent of concentration. Binding of trandolaprilat is concentration-dependent, varying from 65% at 1000 ng/mL to 94% at 0.1 ng/mL, indicating saturation of binding with increasing concentration.

Compared to normal subjects, the plasma concentrations of trandolapril and trandolaprilat are approximately 2-fold greater and renal clearance is reduced by about 85% in patients with creatinine clearance below 30 mL/min and in patients on hemodialysis. Dosage adjustment is recommended in renally impaired patients. (See DOSAGE AND ADMINISTRATION).

Following oral administration in patients with mild to moderate alcoholic cirrhosis, plasma concentrations of trandolapril and trandolaprilat were, respectively, 9-fold and 2-fold greater than in normal subjects, but inhibition of ACE activity was not affected. Lower doses should be considered in patients with hepatic insufficiency. (see DOSAGE AND ADMINISTRATION).

Pharmacodynamics:

Trandolapril and Verapamil hydrochloride extended-release tablet

Verapamil does not interfere with ACE inhibition by trandolapril. Trandolapril does not alter the effect of verapamil on intra-cardiac conduction.

Verapamil Component

Verapamil dilates the main coronary arteries and coronary arterioles, both in normal and ischemic regions, and is a potent inhibitor of coronary artery spasm. This property increases myocardial oxygen delivery in patients with coronary artery spasm, and is responsible for the effectiveness of verapamil in vasospastic (Prinzmetal’s or variant) as well as unstable angina at rest.

Verapamil regularly reduces the total systemic resistance (afterload) by dilating peripheral arterioles. By decreasing the influx of calcium, verapamil prolongs the effective refractory period within the AV node and slows AV conduction in a rate- related manner.

Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil may interfere with sinus node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without preexisting conduction defects (see WARNINGS).

Verapamil does not alter the normal atrial action potential or intraventricular conduction time, but depresses amplitude, velocity of depolarization and conduction in depressed atrial fibers. Verapamil may shorten the antegrade effective refractory period of accessory bypass tracts. Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway following administration of verapamil (see WARNINGS).

Hemodynamics and Myocardial Metabolism:

Verapamil reduces afterload and myocardial contractility. Improved left ventricular diastolic function in patients with idiopathic hypertrophic subaortic stenosis (IHSS) and those with coronary heart disease has also been observed with verapamil therapy. In most patients, including those with organic cardiac disease, the negative inotropic action of verapamil is countered by a reduction of afterload and cardiac index is usually not reduced. However, in patients with severe left ventricular dysfunction (e.g., pulmonary wedge pressure about 20 mmHg or ejection fraction less than 30%), or in patients taking beta-adrenergic blocking agents or other cardio-depressant drugs, deterioration of ventricular function may occur (see DRUG INTERACTIONS).

Pulmonary Function:

Verapamil does not induce bronchoconstriction and hence, does not impair ventilatory function.

Trandolapril Component

After a single 2 mg dose of trandolapril, inhibition of ACE activity reaches a maximum (70-85%) at 4 hours with about 1% decline at 24 hours. Eight days after dosing, ACE inhibition is still 40%.

Four placebo-controlled dose response studies were conducted using once daily oral dosing of trandolapril in doses from 0.25 to 16 mg per day in 827 black and non-black patients with mild to moderate hypertension. The minimal effective once daily dose was 1.0 mg in non-black patients and 2.0 mg in black patients. Further decreases in trough supine diastolic blood pressure were obtained in non-black patients with higher doses, and no further response was seen with doses above 4 mg (up to 16 mg). The antihypertensive effect diminished somewhat at the end of the dosing interval.

During chronic therapy, the maximum reduction in blood pressure with any dose is achieved within one week. Following 6 weeks of monotherapy in placebo-controlled trials in patients with mild to moderate hypertension, once daily doses of 2 to 4 mg lowered supine or standing systolic/diastolic blood pressure 24 hours after dosing by an average 7-10/4-5 mmHg below placebo responses in non-black patients. Once daily doses of 2 to 4 mg lowered blood pressures 4-6/3-4 mmHg below placebo responses in black patients.

Clinical Studies

In controlled clinical trials, once daily doses of Trandolapril and Verapamil hydrochloride extended-release tablets, Trandolapril and Verapamil hydrochloride extended-release tablets 4 mg/240 mg or Trandolapril and Verapamil hydrochloride extended-release tablets 2 mg/180 mg, decreased placebo-corrected seated pressure (systolic/diastolic) 24 hours after dosing by about 7-12/6-8 mmHg. Each of the components of Trandolapril and Verapamil hydrochloride extended-release tablet added to the antihypertensive effect. Treatment effects were consistent across age groups (<65, ≥ 65 years), and gender (male, female).

Blood pressure reductions were significantly greater for the Trandolapril and Verapamil hydrochloride extended-release tablet 4 mg and 240 mg combination than for either of the components used alone.

The antihypertensive effects of Trandolapril and Verapamil hydrochloride extended-release tablets have continued during therapy for at least 1 year.

Indications and Usage for Trandolapril and Verapamil

Trandolapril and Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension.

This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE and ADMINISTRATION).

In using Trandolapril and Verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS: Neutropenia/Agranulocytosis).

Contraindications

Trandolapril and Verapamil hydrochloride extended-release tablets are contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil.

Because of the verapamil component, Trandolapril and Verapamil hydrochloride extended-release tablet is contraindicated in:

Severe left ventricular dysfunction (see WARNINGS).

Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock.

Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).

Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker).

Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see WARNINGS).

Because of the trandolapril component, Trandolapril and Verapamil hydrochloride extended-release tablets are contraindicated in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor.

Warnings

Heart Failure:

Verapamil Component

Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%, pulmonary wedge pressure above 20 mmHg, or severe symptoms of cardiac failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta adrenergic blocker (see DRUG INTERACTIONS). Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment (Note interactions with digoxin under: PRECAUTIONS).

Trandolapril Component

Trandolapril, as an ACE inhibitor, may cause excessive hypotension in patients with congestive heart failure (see WARNINGS, Hypotension).

Hypotension:

Verapamil Component

Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension.

Trandolapril Component

Trandolapril can cause symptomatic hypotension. Like other ACE inhibitors, trandolapril has only rarely been associated with symptomatic hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who are salt- or volume-depleted as a result of prolonged treatment with diuretics, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume and/or salt depletion should be corrected before initiating treatment with trandolapril (see PRECAUTIONS, Drug Interactions, and ADVERSE REACTIONS).

In controlled studies, hypotension was observed in 0.6% of patients receiving any combination of Trandolapril and Verapamil hydrochloride extended-release tablets.

In patients with concomitant congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or azotemia, and, rarely, with acute renal failure and death (see DOSAGE AND ADMINISTRATION).

If symptomatic hypotension occurs, the patient should be placed in the supine position and, if necessary, normal saline may be administered intravenously. A transient hypotensive response is not a contraindication to further doses; however, lower doses of verapamil hydrochloride extended-release tablets and/or trandolapril or reduced concomitant diuretic therapy should be considered.

Elevated Liver Enzymes/Hepatic Failure:

Verapamil Component

Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported. Such elevations have sometimes been transient and may disappear even in the face of continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain) in addition to elevations of SGOT, SGPT, and alkaline phosphatase.

Trandolapril Component

ACE inhibitors rarely have been associated with a syndrome of cholestatic jaundice, fulminant hepatic necrosis, and death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Liver abnormalities were noted in 3.2% of patients taking any of several combinations of Trandolapril and Verapamil doses. Periodic monitoring of liver function in patients taking Trandolapril and Verapamil hydrochloride extended-release tablets is therefore prudent.

Accessory Bypass Tract (Wolff-Parkinson-White or Lown-Ganong-Levine Syndromes):

Verapamil Component

Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated (see CONTRAINDICATIONS).

Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil.

Atrioventricular Block:

Verapamil Component

The effect of verapamil on AV conduction and the SA node may lead to asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms. PR interval prolongation is correlated with verapamil plasma concentrations, especially during the early titration phases of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed. Marked first-degree block or progressive development to second- or third-degree AV block requires a reduction in dosage or, in rare instances, discontinuation of verapamil hydrochloride and institution of appropriate therapy depending upon the clinical situation.

Patients with Hypertrophic Cardiomyopathy (IHSS):

Verapamil Component

In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (over 20 mmHg) capillary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients. Sinus bradycardia occurred in 11% of the patients, second-degree AV block in 4% and sinus arrest in 2%. It must be appreciated that this group of patients had a serious disease with a high mortality rate. Most adverse effects responded well to dose reduction and only rarely did verapamil have to be discontinued.

Anaphylactoid and Possibly Related Reactions:

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors, including trandolapril may be subject to a variety of adverse reactions, some of them serious.

Angioedema:

Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors including trandolapril. Symptoms suggestive of angioedema or facial edema occurred in 0.13% of trandolapril-treated patients. Two of the four cases were life-threatening and resolved without treatment or with medication (corticosteroids). Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue or glottis occurs, treatment with Trandolapril and Verapamil hydrochloride extended-release tablets should be discontinued immediately, the patient treated in accordance with accepted medical care and carefully observed until the swelling disappears. In instances where swelling is confined to the face and lips, the condition generally resolves without treatment; antihistamines may be useful in relieving symptoms. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, emergency therapy, including but not limited to subcutaneous epinephrine solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered. (seePRECAUTIONS: Information for Patientsand ADVERSE REACTIONS).

Anaphylactoid Reactions During Desensitization:

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions did not occur when ACE inhibitors were temporarily withheld, but they reappeared when the ACE inhibitors were inadvertently readministered.

Anaphylactoid Reactions During Membrane Exposure:

Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

Neutropenia/Agranulocytosis:

Trandolapril Component

Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Available data from clinical trials of trandolapril or Trandolapril and Verapamil hydrochloride extended-release tablets are insufficient to show that trandolapril does not cause agranulocytosis at similar rates. As with other ACE inhibitors, periodic monitoring of white blood cell counts in patients with collagen-vascular disease and/or renal disease should be considered.

Fetal/Neonatal Morbidity and Mortality:

Trandolapril Component

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.

The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.

These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of Trandolapril and Verapamil hydrochloride extended-release tablets as soon as possible.

Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment.

If oligohydramnios is observed, Trandolapril and Verapamil hydrochloride extended-release tablets should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

Trandolapril in doses of 0.8 mg/kg/day in rabbits, 100.0 mg/kg/day in rats, and 25 mg/kg/day in cynomolgus monkeys (10, 1250, and 312 times the maximum projected human dose, respectively, assuming a 50 kg woman) did not produce teratogenic effects.

Precautions

Use in Patients with Impaired Hepatic Function:

Trandolapril and Verapamil hydrochloride extended-release tablets have not been evaluated in subjects with impaired hepatic function.

Verapamil Component

Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients.

Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects (see OVERDOSAGE) should be carried out.

Trandolapril Component

Trandolapril and trandolaprilat concentrations increase in patients with impaired liver function.

Use in Patients with Impaired Renal Function:

Trandolapril and Verapamil hydrochloride extended-release tablets have not been evaluated in patients with impaired renal function.

Verapamil Component

About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by hemodialysis. Until further data are available, verapamil should be administered cautiously to patients with impaired renal function. These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage (see OVERDOSAGE).

Trandolapril Component

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including trandolapril, may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.

In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy.

Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when ACE inhibitors have been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of any diuretic and/or the ACE inhibitor may be required.

Evaluation of hypertensive patients should always include assessment of renal function (see DOSAGE AND ADMINISTRATION ).

Use in Patients with Attenuated (Decreased) Neuromuscular Transmission:

Verapamil Component

It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne’s muscular dystrophy, and that verapamil prolongs recovery from the neuromuscular blocking agent vecuronium. It may be necessary to decrease the dosage of verapamil when it is administered to patients with attenuated neuromuscular transmission. (See PRECAUTIONS - Surgery/Anesthesia.)

Hyperkalemia and potassium-sparing diuretics:

Trandolapril Component:

In clinical trials, hyperkalemia (serum potassium> 6.00 mEq/L) occurred in approximately 0.4 percent of hypertensive patients receiving trandolapril and in 0.8% of patients receiving a dose of trandolapril (0.5-8 mg) in combination with a dose of verapamil hydrochloride extended-release tablets (120-240 mg). In most cases, elevated serum potassium levels were isolated values, which resolved despite continued therapy. None of these patients were discontinued from the trials because of hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with trandolapril (see PRECAUTIONS, Drug Interactions).

Cough:

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. In controlled trials of trandolapril, cough was present in 2% of trandolapril patients and 0% of patients given placebo. There was no evidence of a relationship to dose.

Surgery/anesthesia:

Trandolapril Component

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, trandolapril will block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion. (See PRECAUTIONS — Use in Patients with Attenuated (Decreased) Neuromuscular Transmission.)

Drug Interactions

Digitalis:

Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. Chronic verapamil treatment can increase serum digoxin levels by 50 to 75% during the first week of therapy, and this can result in digoxin toxicity. In patients with hepatic cirrhosis, the influence of verapamil on digoxin kinetics is magnified. Verapamil may reduce total body clearance and extrarenal clearance of digitoxin by 27% and 29%, respectively. Maintenance digoxin doses should be reduced when verapamil is administered, and the patient should be carefully monitored to avoid over- or under-digitalization. Whenever overdigitalization is suspected, the daily dose of digoxin should be reduced or temporarily discontinued. Upon discontinuation of any verapamil-containing regime including Trandolapril and Verapamil hydrochloride extended-release tablets, the patient should be reassessed to avoid underdigitalization. Neither trandolapril nor its metabolites have been found to interact with digoxin.

Lithium:

Increased sensitivity to the effects of lithium (neurotoxicity) has been reported during concomitant verapamil-lithium therapy with either no change or an increase in serum lithium levels. Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. Trandolapril and Verapamil hydrochloride extended-release tablets and lithium should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

Clarithromycin:

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent clarithromycin.

Erythromycin:

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent erythromycin ethylsuccinate.

Cimetidine:

The interaction between cimetidine and chronically administered verapamil has not been studied. Variable results on clearance have been obtained in acute studies of healthy volunteers; clearance of verapamil was either reduced or unchanged. Neither trandolapril nor its metabolites have been found to interact with cimetidine.

Beta Blockers:

Verapamil Component

Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction, and/or cardiac contractility. The use of verapamil in combination with a beta-blocker should be used only with caution, and close monitoring.

Asymptomatic bradycardia (36 beats/mm) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.

Antiarrhythmic Agents:

Verapamil Component

Disopyramide

Data on possible interactions between verapamil and disopyramide phosphate are not available. Therefore, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration.

Flecainide

A study of healthy volunteers showed that the concomitant administration of flecainide and verapamil may have additive effects on myocardial contractility, AV conduction, and repolarization. Concomitant therapy with flecainide and verapamil may result in additive negative inotropic effect and prolongation of atrioventricular conduction.

Quinidine

In a small number of patients with hypertrophic cardiomyopathy (IHSS), concomitant use of verapamil and quinidine resulted in significant hypotension. Until further data are obtained, combined therapy of verapamil and quinidine in patients with hypertrophic cardiomyopathy should probably be avoided.

The electrophysiological effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.

Nitrates

Verapamil has been given concomitantly with short- and long-acting nitrates without any undesirable drug interactions. The pharmacologic profile of both drugs and the clinical experience suggest beneficial interactions.

Other:

Verapamil Component

Carbamazepine

Rifampin

Phenobarbital

Cyclosporin

Theophylline

Inhalation Anesthetics

Neuromuscular Blocking Agents

Concomitant diuretic therapy:

Trandolapril Component

As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Trandolapril and Verapamil hydrochloride extended-release tablets. The possibility of exacerbation of hypotensive effects with Trandolapril and Verapamil hydrochloride extended-release tablets may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with Trandolapril and Verapamil hydrochloride extended-release tablets. If it is not possible to discontinue the diuretic, the starting dose of Trandolapril and Verapamil hydrochloride extended-release tablets should be reduced (see DOSAGE AND ADMINISTRATION).

Friday, May 4, 2012

St. Joseph Aspirin Adult Chewable

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Aspirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aspirin?

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

a recent history of stomach or intestinal bleeding;

a bleeding disorder such as hemophilia; or

an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

asthma or seasonal allergies;

stomach ulcers;

liver disease;

kidney disease;

a bleeding or blood clotting disorder;

heart disease, high blood pressure, or congestive heart failure;

gout; or

nasal polyps.

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

severe nausea, vomiting, or stomach pain;

fever lasting longer than 3 days;

swelling, or pain lasting longer than 10 days; or

hearing problems, ringing in your ears.

Less serious side effects may include:

upset stomach, heartburn;

drowsiness; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin); or

another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

This list is not complete and there may be other drugs that can interact with aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More St. Joseph Aspirin Adult Chewable resources

St. Joseph Aspirin Adult Chewable Side Effects (in more detail)
St. Joseph Aspirin Adult Chewable Use in Pregnancy & Breastfeeding
St. Joseph Aspirin Adult Chewable Drug Interactions
0 Reviews for St. Joseph Aspirin Adult Chewable - Add your own review/rating

Aspirin Monograph (AHFS DI)

Aspirin Prescribing Information (FDA)

Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)

Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information

ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare St. Joseph Aspirin Adult Chewable with other medications

Angina
Angina Pectoris Prophylaxis
Heart Attack
Ischemic Stroke
Ischemic Stroke, Prophylaxis
Myocardial Infarction, Prophylaxis
Niacin Flush
Prevention of Thromboembolism in Atrial Fibrillation
Prosthetic Heart Valves
Prosthetic Heart Valves, Mechanical Valves
Revascularization Procedures, Prophylaxis
Thromboembolic Stroke Prophylaxis
Transient Ischemic Attack

Where can I get more information?

Your pharmacist can provide more information about aspirin.

See also: St. Joseph Aspirin Adult Chewable side effects (in more detail)

Tuesday, May 1, 2012

Kerlone

Generic Name: betaxolol (Oral route)

be-TAX-oh-lol

Commonly used brand name(s)

In the U.S.

Kerlone

Available Dosage Forms:

Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Cardioselective

Uses For Kerlone

Betaxolol is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

This medicine is available only with your doctor's prescription .

Before Using Kerlone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of betaxolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of betaxolol in the elderly. However, elderly patients may experience bradycardia (unusually slow heartbeat) more frequently than in younger adults, which may require caution and an adjustment of dosage in patients receiving betaxolol .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol

Arformoterol

Bambuterol

Bitolterol

Broxaterol

Clenbuterol

Colterol

Disopyramide

Dronedarone

Fenoldopam

Fenoterol

Formoterol

Hexoprenaline

Indacaterol

Isoetharine

Levalbuterol

Metaproterenol

Pirbuterol

Procaterol

Reproterol

Rimiterol

Ritodrine

Salmeterol

Terbutaline

Tretoquinol

Tulobuterol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac

Acemetacin

Alclofenac

Apazone

Benoxaprofen

Bromfenac

Bufexamac

Carprofen

Clometacin

Clonixin

Dexketoprofen

Diclofenac

Diflunisal

Dipyrone

Droxicam

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenoprofen

Fentiazac

Floctafenine

Flufenamic Acid

Flurbiprofen

Ibuprofen

Indomethacin

Indoprofen

Isoxicam

Ketoprofen

Ketorolac

Lornoxicam

Meclofenamate

Mefenamic Acid

Meloxicam

Nabumetone

Naproxen

Niflumic Acid

Nimesulide

Oxaprozin

Oxyphenbutazone

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Propyphenazone

Proquazone

St John's Wort

Sulindac

Suprofen

Tenidap

Tenoxicam

Tiaprofenic Acid

Tolmetin

Zomepirac

Interactions with Food/Tobacco/Alcohol

Proper Use of Kerlone

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablets):
- For high blood pressure:
  - Adults—At first, 10 milligrams (mg) once a day. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Kerlone

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Betaxolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking betaxolol .

Kerlone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain or discomfort

lightheadedness, dizziness, or fainting

shortness of breath

slow or irregular heartbeat

unusual tiredness

Less common

Cold arms, legs, hands, or feet

difficult or labored breathing

fast, pounding, or racing heartbeat or pulse

swelling of face, fingers, feet, or lower legs

tightness in the chest

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Anxiety

blurred vision

chills

cold sweats

coma

confusion

convulsions (seizures)

cool, pale skin

decreased urine output

depression

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

extreme fatigue

headache

increased hunger

irregular breathing

loss of consciousness

nervousness

nightmares

noisy breathing

shakiness

slurred speech

sweating

troubled breathing

weight gain

unusual tiredness or weakness

More common

Joint pain

nausea

Less common

Acid or sour stomach

belching

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

congestion

decreased interest in sexual intercourse

diarrhea

difficulty in moving

dryness or soreness of throat

fever

heartburn

hoarseness

inability to have or keep an erection

indigestion

loss in sexual ability, desire, drive, or performance

muscle pain or stiffness

rash

runny nose

sleeplessness

sneezing

stomach discomfort, upset, or pain

stuffy nose

tender, swollen glands in neck

trouble in swallowing

trouble sleeping

unable to sleep

unusual drowsiness, dullness, or feeling of sluggishness

unusual or strange dreams

voice changes

Rare

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

tiredness

trouble concentrating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Kerlone side effects (in more detail)

More Kerlone resources

Kerlone Side Effects (in more detail)
Kerlone Dosage
Kerlone Use in Pregnancy & Breastfeeding
Drug Images
Kerlone Drug Interactions
Kerlone Support Group
0 Reviews for Kerlone - Add your own review/rating

Kerlone Prescribing Information (FDA)

Kerlone MedFacts Consumer Leaflet (Wolters Kluwer)

Kerlone Concise Consumer Information (Cerner Multum)

Kerlone Monograph (AHFS DI)

Betaxolol Prescribing Information (FDA)

Compare Kerlone with other medications

Angina Pectoris Prophylaxis
High Blood Pressure

Wednesday, May 9, 2012

Salicylate Oral, Rectal

Commonly used brand name(s)

Uses For salicylate

Importance of Diet

Before Using salicylate

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of salicylate

Dosing

Missed Dose

Storage

Precautions While Using salicylate

salicylate Side Effects

Sunday, May 6, 2012

Trandolapril and Verapamil

Trandolapril and Verapamil - Clinical Pharmacology

Pharmacokinetics and Metabolism:

Pharmacodynamics:

Hemodynamics and Myocardial Metabolism:

Pulmonary Function:

Clinical Studies

Indications and Usage for Trandolapril and Verapamil

Contraindications

Warnings

Heart Failure:

Hypotension:

Elevated Liver Enzymes/Hepatic Failure:

Accessory Bypass Tract (Wolff-Parkinson-White or Lown-Ganong-Levine Syndromes):

Atrioventricular Block:

Patients with Hypertrophic Cardiomyopathy (IHSS):

Anaphylactoid and Possibly Related Reactions:

Angioedema:

Neutropenia/Agranulocytosis:

Fetal/Neonatal Morbidity and Mortality:

Precautions

Use in Patients with Impaired Hepatic Function:

Use in Patients with Impaired Renal Function:

Use in Patients with Attenuated (Decreased) Neuromuscular Transmission:

Hyperkalemia and potassium-sparing diuretics:

Cough:

Surgery/anesthesia:

Drug Interactions

Verapamil Component

Verapamil Component

Disopyramide

Flecainide

Quinidine

Nitrates

Other:

Verapamil Component

Carbamazepine

Rifampin

Phenobarbital

Cyclosporin

Theophylline

Inhalation Anesthetics

Neuromuscular Blocking Agents

Trandolapril Component

Friday, May 4, 2012

St. Joseph Aspirin Adult Chewable

What is aspirin?

What is the most important information I should know about aspirin?

What should I discuss with my healthcare provider before taking aspirin?

How should I take aspirin?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking aspirin?

Aspirin side effects

What other drugs will affect aspirin?

More St. Joseph Aspirin Adult Chewable resources

Compare St. Joseph Aspirin Adult Chewable with other medications

Where can I get more information?

Tuesday, May 1, 2012