Hydrocortisone acetate/ pramoxine cream

Generic Name: hydrocortisone acetate/pramoxine (HYE-droe-KOR-ti-sone AS-e-tate/pram-OX-een and dye-OHS-mi-plex)
Brand Name: Analpram Advanced

Hydrocortisone acetate/ pramoxine cream is used for:

Treating inflammation and itching of the anal area due to certain skin conditions. The medical food is used for the dietary management of a condition called chronic venous insufficiency (CVI) that may contribute to hemorrhoids.

Hydrocortisone acetate/pramoxine cream is a combination topical corticosteroid and local anesthetic cream packaged with a medical food product. The cream works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not exactly understood. It also decreases pain in the affected area. The tablets work to restore certain body processes toward normal.

Do NOT use hydrocortisone acetate/ pramoxine cream if:

  • you are allergic to any ingredient in hydrocortisone acetate/pramoxine cream
  • you have a rectal obstruction, abscess, or perforation
  • you have a history of cancer

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

Slideshow: Hemorrhoids: A Common Ailment with Frequent Questions

Image Credit: U.S. FDA/Drugs.com

Before using hydrocortisone acetate/ pramoxine cream:

Some medical conditions may interact with hydrocortisone acetate/pramoxine cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin in the affected area
  • if you have a history of recurring hemorrhoid flares
  • if you have a parasitic, bacterial, fungal, or viral infection; diabetes; diarrhea; swelling of the esophagus; stomach or intestinal problems (eg, inflammation, blockage, ulcer, perforation, fistula, colostomy); inflammation of the lining of the abdomen; measles; tuberculosis (TB); a positive TB skin test; chickenpox; shingles; herpes infection of the eye; or kidney problems; or you have received a recent vaccination
  • if you have a history of congestive heart failure or heart attack
  • if you have had a recent intestinal surgery or procedure

Some MEDICINES MAY INTERACT with hydrocortisone acetate/pramoxine cream. Tell your health care provider if you are taking any other medicines, especially any of the following: Chlorzoxazone, diclofenac, or metronidazole because the risk of their side effects may be increased by hydrocortisone acetate/pramoxine cream

This may not be a complete list of all interactions that may occur. Ask your health care provider if hydrocortisone acetate/pramoxine cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use hydrocortisone acetate/ pramoxine cream:

Use hydrocortisone acetate/pramoxine cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • The cream is for use around the rectal area only.
  • Wash your hands immediately before and after using hydrocortisone acetate/pramoxine cream.
  • For use around the anus, apply a small amount of medicine to the affected area and rub in gently.
  • The tablets may be taken by mouth with or without food.
  • Continue to take the tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of hydrocortisone acetate/pramoxine cream, use it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use hydrocortisone acetate/pramoxine cream.

Important safety information:

  • Avoid getting hydrocortisone acetate/pramoxine cream in your eyes. If you get hydrocortisone acetate/pramoxine cream in your eyes, immediately flush them with cool tap water.
  • If your symptoms do not get better within 2 to 3 weeks or if they get worse, check with your doctor.
  • Do not use hydrocortisone acetate/pramoxine cream for other rectal conditions at a later time.
  • Check with your doctor before having vaccinations while you are using hydrocortisone acetate/pramoxine cream.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use hydrocortisone acetate/pramoxine cream.
  • Caution is advised when using hydrocortisone acetate/pramoxine cream in CHILDREN; they may be more sensitive to its effects. Safety and effectiveness of the tablets in CHILDREN has not been confirmed.
  • Serious side effects may occur if too much of hydrocortisone acetate/pramoxine cream is absorbed through the skin. This may be more likely to occur if you use hydrocortisone acetate/pramoxine cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply hydrocortisone acetate/pramoxine cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using hydrocortisone acetate/pramoxine cream while you are pregnant. It is not known if hydrocortisone acetate/pramoxine cream is found in breast milk after topical use. If you are or will be breast-feeding while you use hydrocortisone acetate/pramoxine cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of hydrocortisone acetate/ pramoxine cream:

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

Dry skin; headache; itching; stomach upset.

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

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

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

If OVERDOSE is suspected:

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

Proper storage of hydrocortisone acetate/pramoxine cream:

Store hydrocortisone acetate/pramoxine cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep hydrocortisone acetate/pramoxine cream out of the reach of children and away from pets.

General information:

  • If you have any questions about hydrocortisone acetate/pramoxine cream, please talk with your doctor, pharmacist, or other health care provider.
  • Hydrocortisone acetate/pramoxine cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take hydrocortisone acetate/pramoxine cream or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about hydrocortisone acetate/pramoxine cream. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydrocortisone acetate/pramoxine cream. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using hydrocortisone acetate/pramoxine cream.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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