Sancuso

Generic Name: granisetron (Transdermal route)

gra-NIS-e-tron

Commonly used brand name(s)

In the U.S.

• Sancuso

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Sancuso

Granisetron transdermal is used to prevent nausea and vomiting that may occur after treatment with cancer medicines (chemotherapy). Granisetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Before Using Sancuso

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 granisetron transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of granisetron transdermal have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related heart, liver, or kidney problems, which may require caution in patients receiving granisetron transdermal.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Apomorphine


• Cisapride


• Dronedarone


• Fluconazole


• Mesoridazine


• Pimozide


• Sparfloxacin


• Thioridazine

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.

• Alfuzosin


• Amiodarone


• Amoxapine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Gatifloxacin


• Gemifloxacin


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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.

• Phenobarbital

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel obstruction or


• Gastric distention (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems.

Proper Use of Sancuso

Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.

To use the skin patch:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.


• Wash the area of skin where you will apply the patch gently with soap and warm water. Rinse completely and dry with a clean dry towel.


• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.


• Apply the patch to a clean, dry, intact skin area on your upper outer arm. Do not put the patch over rashes, cuts, or irritated skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.


• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.


• Leave the patch in place for at least 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on how long you are receiving chemotherapy.


• Do not expose the patch to direct sunlight or sunlamps. This could destroy the medicine in the patch. If you will be exposed to direct sunlight or sunlamps, cover your skin with clothing where you have the patch. Keep the clothing on this area while you are wearing it and for 10 days after you remove it.

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.

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 transdermal dosage form (patch):
  
  • For nausea and vomiting:
    
    • Adults—One patch containing 34.3 milligrams (mg) at least 24 to 48 hours before chemotherapy.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

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

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.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Sancuso

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Serious skin reactions may occur while using the patch. Remove the patch and check with your doctor right away if you have a skin rash, itching, redness, or any skin irritation while you are wearing the patch.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or intestinal problem.

Sancuso 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

• Difficulty having a bowel movement (stool)

Rare

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• cough


• difficulty with swallowing


• dizziness


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


• fainting


• fast or irregular heartbeat


• headache


• hives or welts


• itching


• nausea


• nervousness


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• shortness of breath


• skin rash


• slow heartbeat


• sweating


• unusual tiredness or weakness


• wheezing

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chills


• diarrhea


• fear


• fever


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• sleepiness or unusual drowsiness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stomach pain


• swollen glands


• troubled breathing with exertion


• unusual bleeding or bruising


• vomiting

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:

Incidence not known

• Decreased appetite


• hair loss or thinning of the hair


• lack or loss of strength


• sleeplessness


• trouble sleeping


• unable to sleep

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: Sancuso side effects (in more detail)

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More Sancuso resources

• Sancuso Side Effects (in more detail)
• Sancuso Use in Pregnancy & Breastfeeding
• Sancuso Drug Interactions
• Sancuso Support Group
• 3 Reviews for Sancuso - Add your own review/rating

• Sancuso Prescribing Information (FDA)


• Sancuso Consumer Overview


• Sancuso MedFacts Consumer Leaflet (Wolters Kluwer)


• Granisetron MedFacts Consumer Leaflet (Wolters Kluwer)


• Granisetron Prescribing Information (FDA)


• Granisetron Hydrochloride Monograph (AHFS DI)


• Granisol Prescribing Information (FDA)


• Kytril Consumer Overview


• Kytril Prescribing Information (FDA)

Compare Sancuso with other medications

• Nausea/Vomiting, Chemotherapy Induced

Taclonex Ointment

Pronunciation: bay-ta-METH-a-sone/kal-si-POE-try-een
Generic Name: Betamethasone/Calcipotriene
Brand Name: Taclonex

Taclonex Ointment is used for:

Treating a certain type of psoriasis (psoriasis vulgaris). It may also be used for other conditions as determined by your doctor.

Taclonex Ointment is a combination topical corticosteroid and an agent that is similar to vitamin D. Exactly how it works to treat psoriasis is unknown.

Do NOT use Taclonex Ointment if:

• you are allergic to any ingredient in Taclonex Ointment


• you have a known or suspected calcium metabolism disorder, high levels of calcium or vitamin D in the blood, or high levels of calcium in the urine


• you have certain other types of psoriasis (erythrodermic, exfoliative, pustular)


• you have a viral infection; thin skin; or a bacterial, fungal, viral, or tuberculosis (TB) skin infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Taclonex Ointment:

Some medical conditions may interact with Taclonex Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems or kidney stones


• if you have any cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; have an infection; or have had a positive tuberculosis test


• if you are taking prednisone or a similar medicine or you are having any kind of phototherapy treatment for psoriasis

Some MEDICINES MAY INTERACT with Taclonex Ointment. Because little, if any, of Taclonex Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Taclonex Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Taclonex Ointment:

Use Taclonex Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Taclonex Ointment. Talk to your pharmacist if you have questions about this information.


• Wash your hands before and after using Taclonex Ointment, unless your hands are part of the treated area.


• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Taclonex Ointment, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Taclonex Ointment.

Important safety information:

• Taclonex Ointment is for external use only. Do not get Taclonex Ointment in the eyes, nose, mouth, or groin. If you get Taclonex Ointment in your eyes, rinse immediately with cool water.


• Do NOT take more than the recommended dose or use for longer than 4 weeks without checking with your doctor.


• Do not apply Taclonex Ointment over large areas of your body without first checking with your doctor.


• Do not use Taclonex Ointment on the face, under your arms, or on your groin.


• Talk with your doctor before you receive any vaccine while using Taclonex Ointment.


• Do not use Taclonex Ointment for other skin conditions at a later time.


• Taclonex Ointment may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Taclonex Ointment. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Taclonex Ointment has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Taclonex Ointment should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Taclonex Ointment.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Taclonex Ointment while you are pregnant. It is not known if Taclonex Ointment is found in breast milk. If you are or will be breast-feeding while you use Taclonex Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Taclonex Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; headache; itching; mild burning at the application site; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, redness, or peeling skin not present before you began using Taclonex Ointment; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Taclonex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Taclonex Ointment:

Store Taclonex Ointment at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Taclonex Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Taclonex Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Taclonex Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Taclonex Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Taclonex resources

• Taclonex Side Effects (in more detail)
• Taclonex Use in Pregnancy & Breastfeeding
• Taclonex Drug Interactions
• Taclonex Support Group
• 14 Reviews for Taclonex - Add your own review/rating

Compare Taclonex with other medications

• Psoriasis

Sodium Chloride Irrigation

0.45% Sodium Chloride Irrigation, USP

0.9% Sodium Chloride Irrigation, USP

For All General Irrigation, Washing, Rinsing and Dilution Purposes

Not For Injection By Usual Parenteral Routes

Flexible Irrigation Container

Semi-rigid Irrigation Container

Rx only

Sodium Chloride Irrigation Description

These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes.

Each 100 mL of 0.45% Sodium Chloride Irrigation, USP contains: Sodium chloride 450 mg; pH 5.6 (4.5 to 7.0). The solution is hypotonic (154 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 77; Cl− 77.

Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl− 154.

These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Sodium Chloride Irrigation - Clinical Pharmacology

Each of these irrigation solutions exert a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. Each also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.45% Sodium Chloride Irrigation, USP provides a hypotonic half-strength saline irrigation identical in composition with 0.45% Sodium Chloride Injection, USP.

0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline).

0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs; 0.45% Sodium Chloride Irrigation, USP may be used alone or combined with appropriate additives when 0.9% sodium chloride is considered too irritating for wounds or other altered structures.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Sodium Chloride Irrigation

Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Entry of a hypotonic solution into the circulation may cause hemolysis.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Do not heat container over 66°C (150°F).

Precautions

Do not use for irrigation that may result in absorption into the blood.

Caution should be observed when a hypotonic solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload.

Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.

When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Do not administer unless solution is clear, seal is intact and container is undamaged.

Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers:

Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman.

Pregnancy:

Teratogenic Effects.

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Irrigation, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Safety and effectiveness of Sodium Chloride Irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride Irrigation solution in the pediatric population is referenced in the medical literature. The Warnings, Precautions, and Adverse Reactions identified in the label should be observed in the pediatric population.

Geriatric Use:

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients.

This drug is known to be substantially secreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Sodium Chloride Irrigation Dosage and Administration

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer’s recommendations should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

How is Sodium Chloride Irrigation Supplied

0.45% Sodium Chloride Irrigation, USP:

Container Size	NDC
Single-dose 2000 mL flexible irrigation container	0409-7975-07

0.9% Sodium Chloride Irrigation, USP:

Container Size	NDC
Single-dose 500 mL semi-rigid irrigation container	0409-6138-03
Single-dose 250 mL semi-rigid irrigation container	0409-6138-22
Single-dose 1000 mL semi-rigid irrigation container	0409-7138-09
Single-dose 1500 mL semi-rigid irrigation container	0409-7138-36
Single-dose 1000 mL flexible irrigation container	0409-7972-05
Single-dose 2000 mL flexible irrigation container	0409-7972-07

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: May, 2009

Printed in USA	EN-2130
Hospira, Inc., Lake Forest, IL 60045 USA

IM-0687

IM-1153

RL-2095

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7138 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7138-09 12 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 1000 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-7138-09) 2 0409-7138-36 9 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 2 1500 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-7138-36)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017514	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6138 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6138-22 24 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 250 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-6138-22) 2 0409-6138-03 24 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 2 500 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (0409-6138-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017514	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7972 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7972-05 12 BAG In 1 CASE contains a BAG 1 1000 mL In 1 BAG This package is contained within the CASE (0409-7972-05) 2 0409-7972-07 6 BAG In 1 CASE contains a BAG 2 2000 mL In 1 BAG This package is contained within the CASE (0409-7972-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018314	05/17/2010

SODIUM CHLORIDE  sodium chloride  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7975 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 450 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-7975-07 6 BAG In 1 CASE contains a BAG 1 2000 mL In 1 BAG This package is contained within the CASE (0409-7975-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018380	05/17/2010

Labeler - Hospira, Inc. (141588017)

Revised: 01/2012Hospira, Inc.

Timentin injection

Generic Name: ticarcillin and clavulanate potassium (injection) (TYE kar SIL in KLAV ue la nate poe TAS ee um)

Brand Names: Timentin

What is ticarcillin and clavulanate potassium?

Ticarcillin is an antibiotic in a group of drugs called penicillins. Ticarcillin fights bacteria in the body.

Clavulanate potassium is a form of clavulanic acid, which is similar to penicillin. Clavulanate potassium fights bacteria that is often resistant to penicillins and other antibiotics.

The combination of ticarcillin and clavulanate potassium is used to treat many different infections caused by bacteria, such as urinary tract infections, bone and joint infections, severe vaginal infections, stomach infections, and skin infections.

Ticarcillin and clavulanate potassium may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ticarcillin and clavulanate potassium?

Do not use this medication if you are allergic to clavulanate potassium, ticarcillin or to any other penicillin antibiotic, such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), carbenicillin (Geocillin), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using ticarcillin and clavulanate potassium tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have kidney disease, a bleeding or blood clotting disorder, low levels of potassium in your blood, a history of any type of allergy, or if you are on a salt-restricted diet.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ticarcillin and clavulanate potassium will not treat a viral infection such as the common cold or flu.

Ticarcillin and clavulanate potassium can make birth control pills less effective. Use a second non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using ticarcillin and clavulanate potassium.

What should I discuss with my healthcare provider before using ticarcillin and clavulanate potassium?

Do not use this medication if you are allergic to clavulanate potassium, ticarcillin, or to any other penicillin antibiotic, such as:

• 
  

  amoxicillin (Amoxil, Augmentin);

  
  


• 
  

  ampicillin (Omnipen, Principen);

  
  


• 
  

  carbenicillin (Geocillin);

  
  


• 
  

  dicloxacillin (Dycill, Dynapen);

  
  


• 
  

  oxacillin (Bactocill); or

  
  


• 
  

  penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others).

  
  

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using ticarcillin and clavulanate potassium, tell your doctor if you are allergic to any drugs (especially cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others), or if you have:

• 
  

  kidney disease;

  
  


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  an electrolyte imbalance such as low levels of potassium in your blood;

  
  


• 
  

  a history of any type of allergy; or

  
  


• 
  

  if you are on a salt-restricted diet.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ticarcillin and clavulanate potassium can make birth control pills less effective. Use a second non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using ticarcillin and clavulanate potassium. It is not known whether ticarcillin and clavulanate potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use ticarcillin and clavulanate potassium?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Ticarcillin and clavulanate potassium is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Ticarcillin and clavulanate potassium must be mixed with a liquid (diluent) before injecting it. Do not mix the medicine until you are ready to give yourself an injection.

Ticarcillin and clavulanate potassium is usually given for 10 to 14 days, depending on the infection being treated. Follow your doctor's instructions.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ticarcillin and clavulanate potassium will not treat a viral infection such as the common cold or flu.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using ticarcillin and clavulanate potassium.

Store unmixed ticarcillin and clavulanate potassium, and the liquid diluent, at cool room temperature.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 drowsiness, hyperactivity, or seizure (convulsions).

What should I avoid while using ticarcillin and clavulanate potassium?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Ticarcillin and clavulanate potassium 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  blood in your urine, feeling an urgent need to urinate, painful or difficult urination;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  chest pain; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild diarrhea, gas, stomach pain;

  
  


• 
  

  nausea or vomiting;

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  headache;

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  pain, swelling, or burning where the injection was given; or

  
  


• 
  

  vaginal yeast infection (itching or discharge).

  
  

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 ticarcillin and clavulanate potassium?

There may be other drugs that can affect ticarcillin and clavulanate potassium. 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 Timentin resources

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

Compare Timentin with other medications

• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Deep Neck Infection
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Septicemia
• Skin Infection
• Urinary Tract Infection

Where can I get more information?

• Your doctor or pharmacist can provide more information about ticarcillin and clavulanate.

See also: Timentin side effects (in more detail)

Sultrin Triple Sulfa

Generic Name: triple sulfa vaginal (TRIH pull SUL fa)

Brand Names: Gyne Sulf, Sultrin Triple Sulfa, Trysul, V.V.S.

What is Sultrin Triple Sulfa (triple sulfa vaginal)?

Triple sulfa is an antibacterial medication. It fights bacteria in the body.

Triple sulfa vaginal is used to treat vaginal infections caused by the bacteria Gardnerella vaginalis.

Triple sulfa vaginal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sultrin Triple Sulfa (triple sulfa vaginal)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (such as pantyhose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Sultrin Triple Sulfa (triple sulfa vaginal)?

Do not use triple sulfa vaginal if you have ever had an allergic reaction to it or to another sulfa-based medicine.

Triple sulfa vaginal is in the FDA pregnancy category C. This means that it is not known whether triple sulfa vaginal will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. Triple sulfa passes into breast milk and may affect a nursing baby. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use Sultrin Triple Sulfa (triple sulfa vaginal)?

Use triple sulfa vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Insert the tablet or cream into the vagina using the applicator as directed. Triple sulfa vaginal is usually used twice a day, in the morning and evening.

Use this medication continuously for the prescribed amount of time, even during your menstrual period.

A sanitary napkin can be worn to prevent the medication from staining clothing but do not use a tampon.

If the infection does not clear up after one course of therapy has been finished, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth. Store triple sulfa vaginal at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose.

What happens if I overdose?

An overdose of triple sulfa vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that triple sulfa vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Sultrin Triple Sulfa (triple sulfa vaginal)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent spreading the infection to a sexual partner.

Sultrin Triple Sulfa (triple sulfa vaginal) side effects

Stop using triple sulfa vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Sultrin Triple Sulfa (triple sulfa vaginal)?

Avoid using other vaginal creams or douches during treatment with triple sulfa, unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with triple sulfa vaginal. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines, including herbal products.

More Sultrin Triple Sulfa resources

• Sultrin Triple Sulfa Support Group
• 0 Reviews for Sultrin Triple Sulfa - Add your own review/rating

Compare Sultrin Triple Sulfa with other medications

• Bacterial Vaginitis

Where can I get more information?

• Your pharmacist has additional information about triple sulfa vaginal written for health professionals that you may read.

What does my medication look like?

Triple sulfa vaginal is available with a prescription under several brand names. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 
  

  Sultrin Triple Sulfa vaginal tablets

  
  


• 
  

  Sultrin Triple Sulfa vaginal cream

  
  


• 
  

  Dayto Sulfa vaginal cream

  
  


• 
  

  Gyne-Sulf vaginal cream

  
  


• 
  

  Trysul vaginal cream

  
  


• 
  

  V.V.S. vaginal cream

  
  

Ketoprofen

Class: Other Nonsteroidal Anti-inflammatory Agents
Chemical Name: 3-Benzoyl-α-methylbenzeneacetic acid
Molecular Formula: C₁₆H₁₄O₃
CAS Number: 22071-15-4
Brands: Oruvail

• Cardiovascular Risk


• 
  

  Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).¹ Risk may increase with duration of use.¹ Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.¹ (See Cardiovascular Effects under Cautions.)

  
  


• 
  

  Contraindicated for the treatment of pain in the setting of CABG surgery.¹

  
  

• GI Risk


• 
  

  Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).¹ Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.¹ Geriatric individuals are at greater risk for serious GI events.¹ (See GI Effects under Cautions.)

  
  

Introduction

Prototypical NSAIA; propionic acid derivative.^{1 2 3 4 30 53 93 205}

Uses for Ketoprofen

Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.¹ Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.¹

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.^{1 36 96 97 98 99 100 101 102 103 104 105 106 107 108 131 132 134 135 136 137 138 139 147 148 150 153 154 158 205}

Has been used in the symptomatic treatment of ankylosing spondylitis†.^{97 104 105 106 108 109 138 142 143 144 146 175 205}

Pain

Relief of pain.^{1 121 160 166 171 173 174 235 236 238 239}

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.^{1 50 161 164 234}

Ketoprofen Dosage and Administration

General

• 
  

  Consider potential benefits and risks of ketoprofen therapy as well as alternative therapies before initiating therapy with the drug.¹

  
  

Administration

Oral Administration

Administer orally once daily as extended-release capsules or 3 or 4 times daily as conventional capsules.¹

Administration with antacids,^{1 97 102 115 116 142 149} food,^{1 104} or milk¹ may minimize adverse GI effects.

Ketoprofen extended-release capsules are not recommended for the management of acute pain because of slow onset of action.¹

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.¹ Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.¹

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Conventional capsules: Initially, 75 mg 3 times daily or 50 mg 4 times daily.¹ Base subsequent dosage on clinical response and tolerance.¹

Extended-release capsules: Initially, 200 mg once daily.¹ Base subsequent dosage on clinical response and tolerance.¹

Pain

Oral

Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.¹

Dysmenorrhea

Oral

Conventional capsules: Usual dosage is 25–50 mg every 6–8 hours as needed.¹

Prescribing Limits

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Conventional capsules: Maximum 300 mg daily.¹

Extended-release capsules: Maximum 200 mg daily.¹

Pain or Dysmenorrhea

Oral

Conventional capsules: Maximum 300 mg daily.¹

Special Populations

Hepatic Impairment

Maximum recommended initial total dosage is 100 mg daily in patients with hepatic impairment and serum albumin concentrations <3.5 g/dL.¹

Renal Impairment

Mild renal impairment: Maximum recommended dosage is 150 mg daily.¹

Severe renal impairment (GFR <25 mL/minute per 1.73 m² or end-stage renal impairment): Maximum recommended dosage is 100 mg daily.¹ (See Renal Impairment under Cautions.)

Geriatric Patients

Consider reduced initial dosage in patients >75 years of age.¹

Cautions for Ketoprofen

Contraindications

• 
  

  Known hypersensitivity to ketoprofen or any ingredient in the formulation.¹

  
  


• 
  

  History of asthma, urticaria, or other sensitivity reactions precipitated by aspirin or other NSAIAs.^{1 26 48 83 86 89 90 91 92 177}

  
  


• 
  

  Treatment of perioperative pain in the setting of CABG surgery.¹

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.²⁸⁴ Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.^{288 289 290} Information not available on risk associated with ketoprofen at this time.^{288 289 290}

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary. ¹

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).²⁸⁴

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.¹ (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.¹ Use with caution in patients with hypertension; monitor BP.¹ Impaired response to certain diuretics may occur.¹ (See Specific Drugs under Interactions.)

Fluid retention and edema reported.¹ Caution in patients with fluid retention or heart failure.¹

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;^{1 241 242 245} increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.^{1 233 270 281}

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;^{244 270 273 274} alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)^{244 270 273} or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).²⁷³

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.¹

Potential for overt renal decompensation.^{1 9 15 26 48 83 177 198} Increased risk of renal toxicity in patients with renal^{1 15 48 83 177 198} or hepatic^{1 15 26 48 83 177 198} impairment or heart failure,^{1 26 48 83 177 198} in geriatric patients,^{1 48 177} in patients with volume depletion,^{1 16 26 48 83 177 198 224} and in those receiving a diuretic,¹ ACE inhibitor,¹ or angiotensin II receptor antagonist.²⁸⁶ (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.¹

Immediate medical intervention and discontinuance for anaphylaxis.¹

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.¹

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported;^{1 142} can occur without warning.¹ Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).¹

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.¹

Elevations of serum ALT or AST reported.¹

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.¹ Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.^{1 209 210}

Hematologic Effects

Anemia reported rarely.^{1 141} Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.^{1 209 210}

May inhibit platelet aggregation and prolong bleeding time.^{1 34 40 41 47 54}

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.¹

May mask certain signs of infection.^{1 83 177 209 210}

Obtain CBC and chemistry profile periodically during long-term use.¹

Specific Populations

Pregnancy

Category C.¹ Avoid use in third trimester because of possible premature closure of the ductus arteriosus.¹

Lactation

Not known whether distributed into milk in humans.¹ Use not recommended.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

Caution advised.¹ Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.¹ Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.¹

Select dosage with caution because of age-related decreases in renal function.¹ Dosage adjustment recommended in geriatric patients >75 years of age.¹ May be useful to monitor renal function.¹

Hepatic Impairment

Monitor closely.¹ Reduced dosage may be necessary; use lowest effective dosage.¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.¹

Reduced maximum dosage recommended.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Dyspepsia,^{1 99 100 102 104 105 109 114 118 123 134 136 139 234} nausea,^{1 96 99 104 106 109 115 123 125 129 132 135 136 137 138 139 140 234} abdominal pain,^{1 104 115 127 135 136 137 138 140 234} diarrhea,^{1 102 104 105 107 114 127 132 133 234} constipation,^{1 99 104 105 107 109 118 132 135 143} flatulence,^{1 96 109 137 147 149 155} anorexia,^{1 107 109 135 137 147} vomiting,^{1 104 105 109 125 135 136 137 139} stomatitis,^{1 105 132 146 149} headache,^{1 99 102 104 105 106 109 118 123 127 129 234} dizziness,^{1 104 106 109 118 127 131 132 138 234} CNS depression,^{106 109 138 147 155 158 173 190} CNS excitation,^{1 104 105 132 150 155 161} tinnitus,^{1 118 119 164} visual disturbances,¹ rash,^{1 96 104 105 127 132 135 155 190} renal impairment.^{1 105 118 125 135 158 187 205 224}

Interactions for Ketoprofen

Protein-bound Drugs

Potential for ketoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs.^{52 78} Observe for adverse effects.^{209 210 211}

Specific Drugs

Drug	Interaction	Comments
ACE inhibitors	Reduced BP response to the ACE inhibitor1	Monitor BP1
Angiotensin II receptor antagonists	Reduced BP response to the angiotensin II receptor antagonist291	Monitor BP291
Antacids (magnesium- or aluminum-containing)	Conventional capsules: Pharmacokinetic interaction unlikely1
Anticoagulants (warfarin)	Possible bleeding complications1 Increased PT reported 240	Caution advised 1
Aspirin	Decreased ketoprofen protein binding1 52 Increased risk of GI ulceration or other complications 1 No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs284	Concomitant use not recommended1 Clinical importance of pharmacokinetic changes unknown1
Digoxin	Pharmacokinetic interaction unlikely1
Diuretics (furosemide, thiazides)	Reduced natriuretic effects1	Monitor for diuretic efficacy and renal failure1
Lithium	Increased plasma lithium concentrations1 209 229	Monitor for lithium toxicity1 209 229
Methotrexate	Possible increased and prolonged blood concentrations of methotrexate1 24 210 216 217 218 219 221 231	Use with caution1
Probenecid	Decreased clearance of ketoprofen and/or its conjugates78	Concomitant use not recommended1
Salicylates	Possible altered elimination of ketoprofen; no change in the pharmacokinetics of salicylate52	Clinical importance unknown52
Thrombolytic agents (streptokinase)	Possible bleeding complications39	Use with caution39

Ketoprofen Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration; bioavailability is about 90%.¹ Peak plasma concentration usually attained within 0.5–2 hours (conventional capsules) or 6–7 hours (extended-release capsules).^{1 58 60 61 62 64 66 69 71}

Food

Food delays time to peak plasma concentration by <1 hour or about 2 hours following administration as conventional capsules or extended-release capsules, respectively.¹

Distribution

Extent

Distributed into synovial fluid^{57 64 67 68 71 227} and the CNS.⁷⁵

Not known whether ketoprofen is distributed into human milk.¹

Plasma Protein Binding

>99% (mainly albumin).^{1 75}

Elimination

Metabolism

Rapidly and extensively metabolized in the liver; active metabolites not identified.^{1 2 45 59}

Elimination Route

Excreted principally in urine.^{1 57 59 60 61 62 70 72 80 228}

Half-life

Conventional capsules: 2–4 hours.¹

Extended-release capsules: 5.4 hours.¹

Special Populations

Renal Impairment: Half-life (when given as conventional capsules) prolonged to about 3 hours in patients with mild renal impairment and to about 5–9 hours in patients with moderate to severe renal impairment.¹

Stability

Storage

Oral

Conventional and Extended-release Capsules

Tight¹ , light resistant containers² at 25°C^{1 2} ; protect from direct light and excessive heat and humidity.¹

ActionsActions

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  Inhibits cyclooxygenase-1 (COX-1) and COX-2.^{264 265 266 267 268 269 270}

  
  


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  Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.^{1 31 34 42 43 205}

  
  

Advice to Patients

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  Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.¹

  
  


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  Risk of serious cardiovascular events with long-term use.¹

  
  


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  Risk of GI bleeding and ulceration.^{1 247 255}

  
  


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  Risk of serious skin reactions.¹ Risk of anaphylactoid and other sensitivity reactions.¹

  
  


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  Risk of hepatotoxicity.¹

  
  


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  Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.¹

  
  


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  Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.¹

  
  


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  Importance of discontinuing ketoprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.¹ Importance of seeking immediate medical attention if an anaphylactic reaction occurs.¹

  
  


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  Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.¹

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Importance of avoiding ketoprofen in late pregnancy (third trimester).¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.¹

  
  


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  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ketoprofen

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	50 mg*	Ketoprofen Capsules	Mylan, Teva
		75 mg*	Ketoprofen Capsules	Mylan, Teva
	Capsules, extended-release	200 mg*	Ketoprofen Capsules extended-release	Mylan
			Oruvail	Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ketoprofen 50MG Capsules (TEVA PHARMACEUTICALS USA): 90/$20.98 or 180/$31.98

Ketoprofen 75MG Capsules (TEVA PHARMACEUTICALS USA): 60/$14.99 or 180/$34.98

Ketoprofen CR 200MG 24-hr Capsules (MYLAN): 30/$89.99 or 90/$269.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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39. Hoechst-Roussel. Streptase prescribing information. Sommerville, NJ: 1982 Apr.

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