GENERIC NAME: DOXEPIN CREAM - TOPICAL (dox-EH-pin)
BRAND NAME(S): Zonalon
USES: This medication is used to relieve troublesome itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). It should be used only for a short time (no more than 8 days). Doxepin is a tricyclic antidepressant. It is not known how this medication decreases itching. Some medication is absorbed into the body when the cream is applied. This medication may work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. The decrease in itching may be a result of drowsiness or some other effect in the brain that causes you not to notice or be bothered by the itching.
HOW TO USE: Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Gently rub a small amount of the medication into the affected area in a thin layer, usually 4 times a day. Wait at least 3-4 hours between applications, or use as directed by your doctor. How often the medication is applied and for how long depends on your condition and response to treatment. Usually, this medication is for short-term use only (up to 8 days).Wash hands immediately after use unless the area being treated includes the hands. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, ears, mouth, or vaginal/anal area. If the medication gets in these areas, rinse immediately with clean water.Do not cover the area with plastic or waterproof bandages. Covering the treated area may increase the absorption of the medication through the skin and increase the risk of side effects.Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. Your condition will not improve faster and the risk for side effects will increase. Side effects may increase when you use the cream on a larger area of skin (e.g., more than 10 percent of your body surface). Tell your doctor if you have severe drowsiness while using this product. It may be a sign that you are absorbing too much of the medication. Your doctor may tell you to decrease how often you apply the medication, the amount of medication used, or how much skin to spread the medication over. Follow your doctor's directions carefully.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: Burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problem (narrow-angle glaucoma), problems urinating (e.g., due to enlarged prostate).Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., bronchitis, emphysema), long-term constipation, long-term heartburn, diabetes, eating disorders (e.g., bulimia), certain eye problem (open-angle glaucoma), heart problems (e.g., irregular heartbeat), kidney problems, liver problems, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (e.g., bipolar disorder, psychosis, suicide), seizures, conditions that may increase your risk of seizures (e.g., other brain disease, alcohol withdrawal).Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using doxepin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using doxepin safely.This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.To reduce dizziness and lower the risk of fainting, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist that you are using this medication.If you have diabetes, this drug may make your blood sugar levels harder to control. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high or low blood sugar such as fast heartbeat, increased thirst/urination, shakiness, unusual sweating, or hunger. Your anti-diabetic medication or diet may need to be adjusted.Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, difficulty urinating, and QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: arbutamine, cisapride, disopyramide, halofantrine.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine, belladonna alkaloids, scopolamine, drugs for Parkinson's disease such as benztropine), certain drugs for high blood pressure (e.g., clonidine, guanadrel, guanethidine, reserpine), digoxin, levodopa, lithium, thyroid medication, valproic acid, drugs affecting liver enzymes that remove doxepin from your body (e.g., alcohol, barbiturates such as phenobarbital, cimetidine, haloperidol, phenothiazines such as thioridazine, St. John's wort, terbinafine, certain drugs for heart rhythm such as flecainide/propafenone, certain HIV protease inhibitors such as fosamprenavir, certain anti-seizure drugs such as carbamazepine/phenytoin, antidepressants such as amitriptyline, duloxetine, fluvoxamine, paroxetine, sertraline, trazodone).Many drugs besides doxepin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, quinidine, procainamide, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Therefore, before using doxepin, report all medications you are currently using to your doctor or pharmacist.Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), theophylline, or tramadol, among others. Consult your doctor or pharmacist for details.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., levetiracetam), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, nefazodone).Check the labels on all your medicines (e.g., antacids, cough-and-cold products, diet aids) because they may contain cimetidine, ingredients that cause drowsiness, or decongestants/stimulants that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.
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OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose or swallowing may include: confusion, hallucinations, big/wide pupils, fast/irregular heartbeat, severe dizziness, fainting, seizures, loss of consciousness.
STORAGE: Store at room temperature at or below 80 degrees F (27 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.
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