GENERIC NAME: PRAMOXINE - TOPICAL (pram-OX-een)
BRAND NAME(S): Caladryl, Tronolane
USES: Pramoxine is used to temporarily relieve itching and pain caused by minor skin irritation such as minor burns/cuts/scrapes, sunburn, eczema, insect bites, cold sores, or rashes from poison ivy, poison oak, or poison sumac. Some products containing pramoxine are also used to temporarily relieve the itching and discomfort from hemorrhoids and certain other problems of the genital/anal area (such as anal fissures, itching around the vagina/rectum).Pramoxine belongs to a class of drugs known as local anesthetics. It works by numbing the skin to block the feelings of pain and itching.Do not use pramoxine for skin irritation in children younger than 2 years unless directed by the doctor.Do not use pramoxine for hemorrhoids or other genital/anal conditions in children younger than 12 years unless directed by the doctor.This product may also contain other ingredients including skin protectants (such as calamine, zinc acetate, zinc oxide). Read the product package for more information.If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)
HOW TO USE: This medication is for use only on the skin as directed by your doctor. Do not apply on severely broken skin areas such as open wounds, deep cuts, or serious burns. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.Gently clean and dry the affected area. If you are using a lotion or foam product, shake the container well before using as directed on the label. For skin irritation, apply to the affected area usually up to 3 to 4 times a day or as directed by your doctor. For hemorrhoids or other anal conditions, apply the medication to the affected area usually after each bowel movement or up to 4 to 5 times a day, or as directed by your doctor. Do not use this medication inside the rectum. Spray the foam onto a clean tissue and apply to the affected area. If you are using the hemorrhoidal cream, you may use the applicator that comes with it. Clean the applicator after each use.Wash your hands immediately after use, unless the area being treated includes the hands.Do not use this product on large areas of the body or use it more often than directed. Do not cover the area with waterproof bandages or plastic, or apply heat unless told to do so by your doctor. Your condition will not improve any faster, and your risk of side effects will increase.Do not get the product in your eyes, nose, ears, or mouth. If the medication gets in these areas, wipe it off and rinse immediately with water.Stop using this product and tell your doctor if your condition worsens, if symptoms do not improve within 7 days or persist after 7 days of treatment, or if symptoms clear up and return in a few days. If you think you may have a serious medical problem, seek immediate medical attention.
SIDE EFFECTS: Burning or stinging may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using the product do not have serious side effects.A very serious allergic reaction to this product 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 this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to any of the other ingredients listed on the product package; 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: deep/open/puncture wounds, broken/damaged/blistered skin, animal bites, serious burns.If you are using this product for hemorrhoids and bleeding from the rectum occurs, stop using it and consult your doctor promptly.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.
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.
MISSED DOSE: If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature. Different products have different storage needs. Check the product package for instructions on how to store it, or ask your pharmacist. Keep all medications 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 March 2013. Copyright(c) 2013 First Databank, Inc.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.