Prudoxin

Do not share this medication with others.

Use this medication only for the condition for which it was prescribed. Tell all your doctors you use this medication.

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not apply more to catch up.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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 as directed by your doctor, usually 4 times a day. Wait at least 3 to 4 hours between applications. 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 (such as 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.

Burning/stinging at the application site, drowsiness, dizziness, dry mouth, blurred vision, or changes in taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: heartburn that doesn't go away, mental/mood changes (such as agitation, confusion, depression), trouble urinating, swelling of the hands/feet.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, vision changes, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (such as 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems urinating (such as due to enlarged prostate), breathing problems (such as bronchitis, emphysema), glaucoma, heart problems (such as irregular heartbeat), kidney problems, liver problems, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis, suicide), seizures, conditions that may increase your risk of seizures (such as other brain disease, alcohol withdrawal).

Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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 blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have diabetes, this drug may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination or signs of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 (such as 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.

Some products that may interact with this drug are: certain drugs for high blood pressure (such as clonidine, guanadrel, guanethidine), thyroid medication.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, 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.

Other medications can affect the removal of doxepin from your body, which may affect how doxepin works. Examples include cimetidine, St. John's Wort, drugs to treat irregular heart rate (such as propafenone, flecainide), antidepressants (such as SSRIs including paroxetine, fluoxetine, fluvoxamine), drugs used to treat seizures (such as phenobarbital, phenytoin), among others.

Many drugs besides doxepin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, halofantrine, pimozide, quinidine, procainamide, sotalol, macrolide antibiotics (such as erythromycin), sparfloxacin, among others. Before using doxepin, report all medications you are currently using to your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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.