Klaron

Dosage Form: lotion
Klaron® (sodium sulfacetamide lotion) Lotion, 10%

Klaron Description

Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is N'-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Klaron - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Klaron Lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Klaron Lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Klaron Lotion excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

INDICATIONS

Klaron Lotion is indicated in the topical treatment of acne vulgaris.

Contraindications

Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Klaron Lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General

For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of the reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy – Category C

Animal reproduction studies have not been conducted with Klaron® Lotion. It is also not known whether Klaron Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Klaron Lotion should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Klaron Lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Klaron Lotion. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Klaron Lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

Klaron Dosage and Administration

Apply a thin film to affected areas twice daily.

How is Klaron Supplied

4 FL OZ (118mL) bottles (NDC 0066-7500-04).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

Shake well before using. Keep tightly closed.

Prescribing information as of July 2010.

Dermik Laboratories

a business of sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton

NDC 0066-7500-04

Klaron®

sodium

sulfacetamide

lotion

Lotion, 10%

FOR TOPICAL USE ONLY

One 4 fl oz (118mL) Bottle

DERMIK®

sanofi aventis

Klaron  sulfacetamide sodium  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0066-7500 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength water   propylene glycol   Lauric Diethanolamide   diethanolamine   polyethylene glycol 400   sodium chloride   sodium metabisulfite   methylparaben   xanthan gum   EDETIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0066-7500-04 118 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019931	12/23/1996

Labeler - Dermik Laboratories (824676584)

Establishment
Name	Address	ID/FEI	Operations
sanofi-aventis Canada Inc.		251046934	MANUFACTURE

Revised: 12/2011Dermik Laboratories

Tradjenta

Generic Name: linagliptin (Oral route)

lin-a-GLIP-tin

Commonly used brand name(s)

In the U.S.

• Tradjenta

Available Dosage Forms:

• Tablet

Pharmacologic Class: Dipeptidyl Peptidase IV Inhibitor

Uses For Tradjenta

Linagliptin is used together with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Linagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood.

Linagliptin does not help patients who have insulin-dependent or type 1 diabetes, because they do not produce insulin from the pancreas. The high blood sugar is best controlled with insulin injections in these patients.

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

Before Using Tradjenta

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of linagliptin in the elderly.

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 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.

• Carbamazepine


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin


• St John's Wort

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:

• Diabetic ketoacidosis (high ketones and acid in the blood) or


• Type 1 diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control. Your doctor may need to change your dose of linagliptin.

Proper Use of Tradjenta

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Linagliptin may be taken with or without food.

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 oral dosage form (tablets):
  
  • For type 2 diabetes:
    
    • Adults—5 milligrams (mg) once a day.
    
    
    • 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 Tradjenta

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

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take linagliptin with other diabetes medicine (e.g., glimepiride, glipizide, or glyburide). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.

The symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; a fast heartbeat; headaches that continue; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual.

The symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness (passed out); or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tradjenta 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

• Anxiety


• blurred vision


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• dizziness


• fast heartbeat


• headache


• increased hunger


• nausea


• nervousness


• nightmares


• seizures


• shakiness


• slurred speech


• unusual tiredness or weakness

Rare

• Bloating


• constipation


• darkened urine


• fever


• indigestion


• loss of appetite


• pains in the stomach, side, or abdomen, possibly radiating to the back


• vomiting


• yellow eyes or skin

Incidence not known

• Flaking and falling off of the skin


• hives or welts


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• redness of the skin


• skin rash

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

• Back pain


• difficulty with moving


• muscle aches


• muscle pain or stiffness


• pain in the joints


• sore throat


• stuffy or runny nose

Less common

• Cough


• weight gain

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: Tradjenta side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tradjenta resources

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

• Tradjenta Prescribing Information (FDA)


• Tradjenta MedFacts Consumer Leaflet (Wolters Kluwer)


• Tradjenta Consumer Overview


• Linagliptin Professional Patient Advice (Wolters Kluwer)

Compare Tradjenta with other medications

• Diabetes, Type 2

Soliris

Generic Name: eculizumab (E kue LIZ oo mab)

Brand Names: Soliris

What is eculizumab?

Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic (HEEM-oh-LIT-ik yoo-REEM-ik) uremic syndrome.

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

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

Do not shake the eculizumab vial (bottle) or you may ruin the medicine. Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. Call your doctor at once if you have a serious side effect such as severe headache, high fever, chills, stiffness in your neck or back, confusion, sensitivity to bright light, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions). With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms. You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

Before using eculizumab, tell your doctor if you have a fever or any type of infection.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

What should I discuss with my health care provider before taking eculizumab?

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a high fever (103 degrees or higher), chills, body aches, and other flu-like symptoms. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. It is best to stay current on all of your vaccinations while you are using eculizumab, and your doctor may recommend other vaccines before or during treatment. You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether eculizumab 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 is eculizumab given?

Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Eculizumab is usually given every 7 days for 5 weeks, and then once every 2 weeks thereafter. Follow your doctor's instructions. The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.

You may have a reaction to the infusion (when the medicine is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, and the infusion should not take more than 2 hours to complete. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.

Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication vial (bottle) or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. To reduce discomfort from your injection, allow the mixed medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.

Use a disposable needle only once. 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.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any scheduled visits to your doctor during this follow-up period.

Store in the refrigerator. Protect from light and do not freeze. Keep unopened eculizumab vials in their original carton. Throw away any unused vials after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking eculizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Eculizumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);

  
  


• 
  

  stiffness in your neck or back;

  
  


• 
  

  sensitivity to bright light;

  
  


• 
  

  high fever (103 degrees or higher), chills, body aches, flu symptoms;

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  any signs of a new illness or infection; or

  
  


• 
  

  signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

  
  

Less serious side effects may include:

• 
  

  nausea;

  
  


• 
  

  diarrhea;

  
  


• 
  

  mild headache;

  
  


• 
  

  runny nose, sore throat; or

  
  


• 
  

  back pain.

  
  

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 eculizumab?

There may be other drugs that can interact with eculizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Soliris resources

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

• Soliris Prescribing Information (FDA)


• Soliris Monograph (AHFS DI)


• Soliris Advanced Consumer (Micromedex) - Includes Dosage Information


• Soliris Consumer Overview


• Soliris MedFacts Consumer Leaflet (Wolters Kluwer)


• Eculizumab Professional Patient Advice (Wolters Kluwer)

Compare Soliris with other medications

• Hemolytic Uremic Syndrome
• Myasthenia Gravis
• Paroxysmal Nocturnal Hemoglobinuria

Where can I get more information?

• Your pharmacist can provide more information about eculizumab.

See also: Soliris side effects (in more detail)

Therapeutic

Generic Name: coal tar topical (KOL TAR TOP ik al)

Brand Names: Balnetar, Betatar Gel, Coal Tar, Cutar, Denorex, Denorex Dry Scalp, Denorex Extra Strength, Denorex Medicated Shampoo and Conditioner, DHS Tar Shampoo, Doak Tar, Doak Tar Oil, Elta Tar, Fototar, G-TAR, Ionil T, Ionil T Plus, MG 217 Psoriasis, MG217 Medicated Tar, Neutrogena T/Derm, Neutrogena T/Gel, Neutrogena T/Gel Extra Strength, Oxipor VHC, PC Tar, Pentrax, Pentrax Gold, Polytar, Psoriasin, Psorigel, T/Gel Conditioner, Tegrin Medicated, Tegrin Medicated Soap, Therapeutic, Theraplex T, Zetar

What is coal tar?

Coal tar is a by-product of coal processing.

Coal tar topical (for the skin) is used to treat the skin symptoms of psoriasis, including dryness, redness, flaking, scaling, and itching. Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

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

What is the most important information I should know about coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.

What should I discuss with my health care provider before using coal tar?

You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coal tar 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.

Coal tar products may contain lanolin, mineral oil, or other emulsifiers. Check the label of any coal tar product you are using. Talk with your doctor before using coal tar if you are allergic to any of the ingredients.

How should I use coal tar?

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

Apply coal tar cream, lotion, ointment, or solution according the directions on the medication label. Some forms of coal tar may be applied 1 to 4 times per day.

To use coal tar bath oil, pour 1 to 3 capfuls into a warm bath before bathing. The oil can make the bathtub slippery. Take care to avoid a fall.

Shake the coal tar shampoo well just before each use. Use enough shampoo to create a rich lather. Massage the shampoo into your scalp and rinse thoroughly. Apply the shampoo a second time and leave it on your scalp for 5 minutes. Rinse thoroughly. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.

Coal tar shampoo may discolor blond or colored hair. This effect is usually temporarily.

Some forms of coal tar can stain fabric or other surfaces.

Store coal tar at room temperature away from moisture and heat. Keep the medicine tightly closed with not in use.

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, wait until then to use the medicine and skip the missed 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.

Symptoms of a coal tar overdose are not known.

What should I avoid while using coal tar?

Avoid getting this medication in your eyes. If this does occur, rinse with water.

Do not use coal tar to treat the skin of your groin or rectal area.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result.

Coal tar 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 coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin.

Less serious side effects may include mild skin irritation or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect coal tar?

Do not use coal tar together with other psoriasis medications unless your doctor tells you to.

There may be other drugs that can interact with coal tar. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Therapeutic resources

• Therapeutic Use in Pregnancy & Breastfeeding
• Therapeutic Support Group
• 0 Reviews for Therapeutic - Add your own review/rating

• Betatar Gel Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Coal Tar Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Denorex Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Doak Tar Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Fototar Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• MG217 Medicated Tar Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Psoriasin Prescribing Information (FDA)

Compare Therapeutic with other medications

• Dermatitis
• Psoriasis
• Seborrheic Dermatitis

Where can I get more information?

• Your pharmacist can provide more information about coal tar.

Terbinafine topical

Generic Name: terbinafine topical (ter BIN a feen TOP i kal)

Brand names: Athlete's Foot Cream, LamISIL AT, LamISIL AT Athletes Foot, LamISIL AT Jock Itch, LamISIL Topical, Desenex Maximum

What is terbinafine topical?

Terbinafine is an antifungal medication. Terbinafine topical prevents fungus from growing on the skin.

Terbinafine topical (for the skin) is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections.

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

What is the most important information I should know about terbinafine topical?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

Avoid getting this medication in your mouth or eyes.

What should I discuss with my healthcare provider before using terbinafine topical?

You should not use this medication if you are allergic to it. It is not known whether terbinafine topical will be harmful to an unborn baby. Do not use terbinafine topical without first talking to your doctor if you are pregnant. It is not known whether terbinafine topical 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 terbinafine topical?

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

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the medication as directed.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to.

Store terbinafine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply 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.

An overdose of terbinafine topical is not likely to cause life-threatening symptoms.

What should I avoid while using terbinafine topical?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using other medications on the areas you treat with terbinafine topical unless your doctor has told you to.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Terbinafine topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terbinafine topical and call your doctor at once if you have a serious side effect such as severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Less serious side effects are more likely, and you may have none at all.

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.

Terbinafine topical Dosing Information

Usual Adult Dose for Tinea Corporis:

Cream, gel, spray: Apply to the affected area once a day.

Usual Adult Dose for Tinea Cruris:

Cream, gel, spray: Apply to the affected area once a day.

Usual Adult Dose for Tinea Pedis:

Cream, spray: Apply to the affected area twice a day.
Gel: Apply to the affected area once a day.

Usual Adult Dose for Tinea Versicolor:

Solution: Apply to the affected area twice a day.

Usual Pediatric Dose for Tinea Corporis:

12 years or older:
Cream, gel, spray: Apply to the affected area once a day.

Usual Pediatric Dose for Tinea Cruris:

12 years or older:
Cream, gel, spray: Apply to the affected area once a day.

Usual Pediatric Dose for Tinea Pedis:

12 years or older:
Cream, spray: Apply to the affected area twice a day.
Gel: Apply to the affected area once a day.

What other drugs will affect terbinafine topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied terbinafine topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More terbinafine topical resources

• Terbinafine topical Dosage
• Terbinafine topical Use in Pregnancy & Breastfeeding
• Terbinafine topical Support Group
• 5 Reviews for Terbinafine - Add your own review/rating

• Lamisil AT Prescribing Information (FDA)


• Lamisil AT Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lamisil AT Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamisil AT Jock Itch Prescribing Information (FDA)

Compare terbinafine topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about terbinafine topical written for health professionals that you may read.

Tenofovir

Generic Name: tenofovir (ten OF oh vir)

Brand Names: Viread

What is tenofovir?

Tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Tenofovir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Tenofovir is not a cure for HIV or AIDS. Tenofovir is also used to treat chronic hepatitis B.

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

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

Do not take other medicines that also contain tenofovir (such as Truvada). Some people develop lactic acidosis while taking tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Tenofovir can also cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using tenofovir. Visit your doctor regularly.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

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

Do not use this medication if you have ever had an allergic reaction to a medicine containing tenofovir, including Truvada.

You should not take tenofovir if you are also taking Truvada (emtricitabine/tenofovir) or adefovir (Hepsera).

To make sure you can safely take tenofovir, tell your doctor if you have any of these other conditions:

• liver disease (including hepatitis B);


• kidney disease; or


• 
  

  bone problems (such as osteopenia).

  
  

Some people develop a life-threatening condition called lactic acidosis while taking tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. Tenofovir can also cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tenofovir on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Tenofovir should not be given to a child unless your doctor has told you otherwise.

How should I take tenofovir?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take tenofovir with a full glass of water.

Tenofovir can be taken with or without food.

Use tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using tenofovir. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and direct light.

See also: Tenofovir dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tenofovir?

Avoid drinking alcohol. It may increase your risk of liver damage. Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Tenofovir 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. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Call your doctor at once if you have a serious side effect such as:

• 
  

  liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  kidney problems - increased thirst and urination, loss of appetite, weakness, constipation, urinating less than usual or not at all;

  
  


• 
  

  fever, chills, body aches, flu symptoms; or

  
  


• 
  

  any other signs of new infection.

  
  

Less serious side effects may include:

• 
  

  sleep problems (insomnia), strange dreams;

  
  


• 
  

  depression, headache, dizziness;

  
  


• 
  

  diarrhea, bloating, gas;

  
  


• 
  

  muscle or joint pain;

  
  


• 
  

  skin rash; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

  
  

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.

Tenofovir Dosing Information

Usual Adult Dose for HIV Infection:

300 mg orally once a day

Usual Adult Dose for Chronic Hepatitis B:

300 mg orally once a day
The optimum duration of treatment is not known.

Usual Adult Dose for Nonoccupational Exposure:

300 mg orally once a day plus efavirenz plus (emtricitabine or lamivudine)
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.
Duration: 28 days

Usual Pediatric Dose for HIV Infection:

12 years or older with body weight 35 kg or more: 300 mg orally once a day

What other drugs will affect tenofovir?

Tell your doctor about all other medicines you use, especially:

• 
  

  amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

  
  


• 
  

  pentamidine (Nebupent, Pentam);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as acyclovir (Zovirax), cidofovir (Vistide), foscarnet (Foscavir), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others;

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or

  
  


• 
  

  other HIV or AIDS medications such as atazanavir (Reyataz), didanosine (Videx), lopinavir and ritonavir (Kaletra).

  
  

This list is not complete and other drugs may interact with tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More tenofovir resources

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

• tenofovir Advanced Consumer (Micromedex) - Includes Dosage Information


• Tenofovir MedFacts Consumer Leaflet (Wolters Kluwer)


• Tenofovir Disoproxil Fumarate Monograph (AHFS DI)


• Viread Prescribing Information (FDA)


• Viread Consumer Overview

Compare tenofovir with other medications

• Hepatitis B
• HIV Infection
• Nonoccupational Exposure

Where can I get more information?

• Your pharmacist can provide more information about tenofovir.

See also: tenofovir side effects (in more detail)

Soothe & Cool Skin Paste

Generic Name: zinc oxide topical (ZINK OX ide)

Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Soothe & Cool Skin Paste (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Soothe & Cool Skin Paste (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Soothe & Cool Skin Paste (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I use Soothe & Cool Skin Paste (zinc oxide topical)?

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

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting.

What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Soothe & Cool Skin Paste (zinc oxide topical)?

Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Soothe & Cool Skin Paste (zinc oxide topical) 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 zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

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 Soothe & Cool Skin Paste (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Soothe & Cool Skin Paste resources

• Soothe & Cool Skin Paste Side Effects (in more detail)
• Soothe & Cool Skin Paste Use in Pregnancy & Breastfeeding
• 0 Reviews for Soothe & Cool Skin - Add your own review/rating

• Arcalyst Monograph (AHFS DI)


• Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Soothe & Cool Skin Paste with other medications

• Anal Itching
• Dermatologic Lesion
• Diaper Rash

Where can I get more information?

• Your pharmacist can provide more information about zinc oxide topical.

See also: Soothe & Cool Skin side effects (in more detail)

Synthetic Conjugated Estrogens, A vaginal

Generic Name: conjugated estrogens (vaginal) (KON joo gay ted ES troe jenz)

Brand Names: Premarin Vaginal, Synthetic Conjugated Estrogens, A

What are vaginal conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Vaginal conjugated estrogens are a mixture of estrogen hormones used to treat the vaginal symptoms of menopause such as dryness, burning, irritation, and painful sexual intercourse.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Vaginal conjugated estrogens may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vaginal conjugated estrogens?

This medication can cause birth defects in an unborn baby. Do not use vaginal conjugated estrogens if you are pregnant. Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer.

Long-term treatment with conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using vaginal conjugated estrogens.

Vaginal conjugated estrogens should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before using vaginal conjugated estrogens?

Do not use vaginal conjugated estrogens if you are pregnant, or if you have:

• 
  

  a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  
  


• 
  

  abnormal vaginal bleeding that a doctor has not checked;

  
  


• 
  

  liver disease; or

  
  


• 
  

  any type of breast, uterine, or hormone-dependent cancer.

  
  

Before using vaginal conjugated estrogens, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  high blood pressure, heart disease, or circulation problems;

  
  


• 
  

  a personal or family history of stroke;

  
  


• 
  

  endometriosis;

  
  


• liver or kidney disease;


• 
  

  asthma;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  migraines;

  
  


• 
  

  diabetes;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  high cholesterol or triglycerides;

  
  


• 
  

  high or low levels of calcium in your blood;

  
  


• 
  

  porphyria;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• 
  

  gallbladder disease; or

  
  


• 
  

  if you have had your uterus removed (hysterectomy).

  
  

Vaginal conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using vaginal conjugated estrogens.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using vaginal conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use vaginal conjugated estrogens if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. You should know that conjugated estrogens vaginal cream can weaken the latex of a condom, diaphragm, or cervical cap. Talk to your doctor about the best contraceptive methods to use. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not use this medication in anyone under 18 years old without the advice of a doctor.

How should I use vaginal conjugated estrogens?

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 directions on your prescription label.

Vaginal conjugated estrogens are usually prescribed for only a short time and are most often used in a cycle, such as 3 weeks on followed by 1 week off. Some conditions require daily use and others require use only twice a week during the treatment period. Follow the directions on your prescription label.

To apply this medication, use only the vaginal applicator provided. After each use, take the applicator apart and clean it with mild soap and warm water. Do not use hot or boiling water.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis if you are using vaginal conjugated estrogens long term.

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

This medication can affect the results of certain medical tests. Tell any doctor who treats you that you are using conjugated estrogens.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use your 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 nausea, vomiting, or vaginal bleeding.

What should I avoid while using vaginal conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by vaginal conjugated estrogens.

Vaginal conjugated estrogens 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:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  pain or swelling in your lower leg;

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  migraine headache;

  
  


• 
  

  pain, swelling, or tenderness in your stomach;

  
  


• 
  

  confusion, problems with memory or concentration;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  a breast lump.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

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 vaginal conjugated estrogens?

Before using conjugated estrogens, tell your doctor if you are using any of the following medicines:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  a thyroid medication such as levothyroxine (Synthroid);

  
  


• 
  

  insulin or diabetes medicine taken by mouth;

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  ketoconazole (Nizoral) or itraconazole (Sporanox);

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

  
  

This list is not complete and there may be other drugs that can interact with vaginal conjugated estrogens. 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 Synthetic Conjugated Estrogens, A resources

• Synthetic Conjugated Estrogens, A Side Effects (in more detail)
• Synthetic Conjugated Estrogens, A Use in Pregnancy & Breastfeeding
• Synthetic Conjugated Estrogens, A Drug Interactions
• 0 Reviews for Synthetic Conjugated Estrogens, A - Add your own review/rating

Compare Synthetic Conjugated Estrogens, A with other medications

• Atrophic Urethritis
• Atrophic Vaginitis
• Postmenopausal Symptoms

Where can I get more information?

• Your pharmacist can provide more information about vaginal conjugated estrogens.

See also: Synthetic Conjugated Estrogens, A side effects (in more detail)

Surmontil

Generic Name: trimipramine (Oral route)

trye-MIP-ra-meen

Oral route(Capsule)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Surmontil

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For Surmontil

Trimipramine is used to treat the symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA).

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

Before Using Surmontil

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

Geriatric

Although appropriate studies on the relationship of age to the effects of trimipramine 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 unwanted effects (e.g., confusion or unusual drowsiness) or age-related heart, liver, or kidney problems, which may require caution in patients receiving trimipramine.

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

• Bepridil


• Cisapride


• Clorgyline


• Dronedarone


• Grepafloxacin


• Isocarboxazid


• Levomethadyl


• Linezolid


• Mesoridazine


• Methylene Blue


• Moclobemide


• Phenelzine


• Pimozide


• Ranolazine


• Selegiline


• Sparfloxacin


• Terfenadine


• Thioridazine


• Tranylcypromine

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.

• Acecainide


• Alfuzosin


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Amprenavir


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Azimilide


• Azithromycin


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clonidine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Dextromethorphan


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Enflurane


• Epinephrine


• Erythromycin


• Etilefrine


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Ibutilide


• Iloperidone


• Indacaterol


• Iproniazid


• Isoflurane


• Isradipine


• Lapatinib


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mefloquine


• Methadone


• Methoxamine


• Midodrine


• Moricizine


• Moxifloxacin


• Nefopam


• Nialamide


• Nilotinib


• Norepinephrine


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxilofrine


• Paliperidone


• Pargyline


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Phenylephrine


• Posaconazole


• Procainamide


• Procarbazine


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Rasagiline


• Risperidone


• Saquinavir


• Sematilide


• Sertindole


• Sertraline


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tapentadol


• Tedisamil


• Telavancin


• Telithromycin


• Tetrabenazine


• Toloxatone


• Toremifene


• Tramadol


• Trazodone


• Trifluoperazine


• Trimethoprim


• Vandetanib


• Vardenafil


• Vasopressin


• Vemurafenib


• Venlafaxine


• Voriconazole


• Ziprasidone


• Zolmitriptan


• Zotepine

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.

• Acenocoumarol


• Arbutamine


• Atomoxetine


• Cannabis


• Dicumarol


• Paroxetine


• Phenprocoumon


• S-Adenosylmethionine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Heart attack, recent—Should not be used in patients with these conditions.

• Diabetes or


• Glaucoma, history of or


• Heart disease or


• Overactive thyroid or


• Schizophrenia or


• Seizures, history of or


• Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. May increase chance for serious side effects.

Proper Use of Surmontil

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Trimipramine can make you sleepy. Your doctor may tell you to take this medicine at bedtime.

This medicine comes with a medication guide. Read and follow the instructions in the guide carefully. Ask your doctor if you have any questions.

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 oral dosage form (capsules):
  
  • For depression:
    
    • Adults—At first, 75 milligrams (mg) in divided doses per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mg per day, unless you are in the hospital. Some hospitalized patients may need higher doses.
    
    
    • Teenagers and Older Adults—At first, 50 milligrams (mg) per day. Your doctor may increase your dose up to 100 mg per day.
    
    
    • 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 Surmontil

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Trimipramine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take trimipramine if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]) in the past two weeks. Do not start taking a MAO inhibitor within two weeks of stopping trimipramine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking trimipramine together with medicines used during surgery may increase the risk of side effects.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

Surmontil 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:

Incidence not known

• Abdominal or stomach pain


• actions that are out of control


• agitation


• anxiety


• black, tarry stools


• bleeding and bruising


• bleeding gums


• blood in urine or stools


• blurred vision


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


• chest pain or discomfort


• clay-colored stools


• cold sweats


• coma


• confusion about identity, place, and time


• continuing ringing, buzzing, or other unexplained noise in ears


• convulsions


• cool, pale skin


• cough or hoarseness


• dark urine


• decrease in frequency of urination


• decreased urine output or volume


• depression


• difficulty in passing urine (dribbling)


• difficulty in speaking


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


• double vision


• drooling


• dry mouth


• false beliefs that cannot be changed by facts


• fast, pounding, or irregular heartbeat or pulse


• fear or nervousness


• feeling of warmth


• feeling, seeing, or hearing things that are not there


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• fever with or without chills


• flushed, dry skin


• fruit-like breath odor


• general feeling of tiredness or weakness


• headache


• hearing loss


• hostility


• hyperventilation


• inability to move arms, legs, or facial muscles


• inability to speak


• increased hunger


• increased need to urinate


• increased thirst


• increased urination


• irritability


• itching


• lack of coordination


• lethargy


• loss of appetite


• loss of balance control


• lower back or side pain


• mood or mental changes


• muscle spasm or jerking of all extremities


• muscle trembling or stiffness


• muscle twitching


• nausea


• nightmares


• pain or discomfort in arms, jaw, back, or neck


• painful or difficult urination


• passing urine more often


• perspiration


• pinpoint red or purple spots on skin


• pounding in the ears


• rapid weight gain


• rash


• redness of the face, neck, arms, and occasionally, upper chest


• restlessness


• seizures


• shakiness and unsteady walk


• shortness of breath


• shuffling walk


• sleeplessness


• slow speech


• slurred speech


• sore throat


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


• stiffness of limbs


• stupor


• sudden loss of consciousness


• sweating


• swelling of face, ankles, legs, or hands


• swollen glands


• talking, feeling, and acting with excitement


• trouble in holding or releasing urine


• trouble sleeping


• twisting movements of body


• unable to sleep


• uncontrolled movements, especially of face, neck, and back


• unpleasant breath odor


• unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination


• unusual behavior


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood


• weakness in arms, hands, legs, or feet


• weight gain or loss


• yellow eyes or skin

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

Symptoms of Overdose

• Change in consciousness


• clumsiness


• decreased awareness or responsiveness


• difficulty sleeping


• disorientation


• disturbed concentration


• drowsiness to profound coma


• enlarged pupils


• extreme fatigue


• hallucination


• increased or excessive unconscious or jerking movements


• loss of consciousness


• low body temperature


• muscle aches


• muscle weakness


• pale skin


• severe sleepiness


• shivering


• weak or feeble pulse

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

• Abdominal cramps


• bigger, dilated, or enlarged pupils (black part of eye)


• black tongue


• bloating


• decreased interest in sexual intercourse


• diarrhea


• difficulty having a bowel movement (stool)


• disturbance of accommodation


• enlargement of the breast


• hair loss, thinning of hair


• heartburn


• hives or welts


• inability to have or keep an erection


• increased in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• increased sensitivity of eyes to light


• increased sensitivity of skin to sunlight


• loss in sexual ability, desire, drive, or performance


• pain or discomfort in chest, upper stomach, or throat


• peculiar taste


• redness or other discoloration of skin


• severe sunburn


• small red or purple spots on skin


• swelling of the breasts or breast soreness in both females and males


• swelling of the testicles


• swelling or inflammation of the mouth


• swollen, painful, or tender lymph glands on side of face or neck


• unexpected or excess milk flow from breasts

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: Surmontil side effects (in more detail)

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More Surmontil resources

• Surmontil Side Effects (in more detail)
• Surmontil Use in Pregnancy & Breastfeeding
• Drug Images
• Surmontil Drug Interactions
• Surmontil Support Group
• 1 Review for Surmontil - Add your own review/rating

• Surmontil Prescribing Information (FDA)


• Surmontil Concise Consumer Information (Cerner Multum)


• Surmontil Monograph (AHFS DI)


• Surmontil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Surmontil with other medications

• Depression