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Hydrocortisone acetate/ pramoxine foam

Generic Name: hydrocortisone acetate/pramoxine (hye-droe-KOR-ti-sone ASS-eh-tate/pra-MOX-een)
Brand Name: Proctofoam HC

Hydrocortisone acetate/ pramoxine foam is used for:

Treating inflammation and itching of the anal area due to certain skin conditions.

Hydrocortisone acetate/pramoxine foam is a combination topical corticosteroid and local anesthetic. It 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.

Do NOT use hydrocortisone acetate/ pramoxine foam if:

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

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

Before using hydrocortisone acetate/ pramoxine foam:

Some medical conditions may interact with hydrocortisone acetate/pramoxine foam. 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 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; 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 recent intestinal surgery or procedure

Some MEDICINES MAY INTERACT with hydrocortisone acetate/pramoxine foam. Because little, if any, of hydrocortisone acetate/pramoxine foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if hydrocortisone acetate/pramoxine foam 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 foam:

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

  • Hydrocortisone acetate/pramoxine foam is for use around the rectal area only.
  • Shake well for 5 to 10 seconds before each use.
  • Prime the container before the first use as directed. It usually requires 1 to 2 pumps for foam to appear.
  • Do not insert any part of the aerosol container directly into the anus. Apply to anus only with the applicator.
  • Fill applicator with foam from the container as directed. It usually requires 3 to 4 pumps for foam to reach the fill line. Remove applicator from the container cap.
  • Hold applicator firmly by the barrel. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. Do not insert any part of the applicator past the anus into the rectum.
  • After using, pull apart the applicator parts and thoroughly clean with warm water. Rinse the cap and tip of the container to prevent build-up of foam and possible blockage.
  • For use around the anus, apply a small amount of medicine to a tissue and rub in gently.
  • If you miss a dose of hydrocortisone acetate/pramoxine foam, apply 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 foam.

Important safety information:

  • Avoid getting hydrocortisone acetate/pramoxine foam in your eyes. If you get hydrocortisone acetate/pramoxine foam 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 foam for other rectal conditions at a later time.
  • Check with your doctor before having immunizations (vaccinations) while you are using hydrocortisone acetate/pramoxine foam.
  • The contents of this can are under pressure. Do not burn or puncture the container even if it appears to be empty.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use hydrocortisone acetate/pramoxine foam.
  • Caution is advised when using hydrocortisone acetate/pramoxine foam in CHILDREN; they may be more sensitive to its effects.
  • 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 foam while you are pregnant. It is not known if this medicine is found in breast milk after topical use. If you are or will be breast-feeding while you use hydrocortisone acetate/pramoxine foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of hydrocortisone acetate/ pramoxine foam:

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; itching.

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 foam; 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. Hydrocortisone acetate/pramoxine foam may be harmful if swallowed.

Proper storage of hydrocortisone acetate/pramoxine foam:

Store hydrocortisone acetate/pramoxine foam at room temperature, between 68 and 77 degrees F (20 and 20 degrees C), in an upright position. Store away from heat, moisture, and light. Do not refrigerate. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120 degrees F (49 degrees C). Do not store in the bathroom. Keep hydrocortisone acetate/pramoxine foam out of the reach of children and away from pets.

General information:

  • If you have any questions about hydrocortisone acetate/pramoxine foam, please talk with your doctor, pharmacist, or other health care provider.
  • Hydrocortisone acetate/pramoxine foam 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 foam 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 foam. 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 foam. 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 foam.

Review Date: August 8, 2016

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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