Proctofoam HC

Name: Proctofoam HC

Description

Proctofoam®-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.

Proctofoam®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Hydrocortisone acetate

Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/100 mL. Chemical name: pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11β)-.

Pramoxine hydrochloride

Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water. Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.

Warnings

Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). If there is no evidence of clinical improvement within two or three weeks after starting Proctofoam®-HC therapy, or if the patient's condition worsens, discontinue the drug. Keep this and all medicines out of the reach of children.

What is the most important information i should know about hydrocortisone and pramoxine topical?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines."

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Do not use hydrocortisone and pramoxine topical for any condition that has not been checked by a doctor.

What should i discuss with my health care provider before using hydrocortisone and pramoxine topical?

You should not use this medication if you are allergic to hydrocortisone or pramoxine, or if you have chickenpox or measles.

Before using hydrocortisone and pramoxine topical, tell your doctor if you are allergic to any drugs or any other anesthetics or "numbing medicines." Also tell your doctor if you have:

  • liver disease;
  • diabetes;
  • problems with your eyes;
  • a stomach or intestinal disorder;
  • a rectal sore or infection; or
  • if you use any drugs that weaken the immune system, including steroids.

Hydrocortisone and pramoxine topical will not treat a bacterial, fungal, or viral skin infection. If you have a skin infection, you should not use this medication until your infection is treated and clears up.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using hydrocortisone and pramoxine topical, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether hydrocortisone and pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of topical hydrocortisone.

Side effects

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Read the entire FDA prescribing information for Proctofoam HC (Hydrocortisone and Pramoxine)

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Proctofoam-HC Overview

Proctofoam-HC is a brand name medication included in the following groups of medications: Anesthetics for topical use, Local anesthetics, Corticosteroids acting locally, Corticosteroids for local oral treatment, Antiinflammatory Corticosteroids, Corticosteroids, weak group I, Corticosteroids, weak, other combinations, Corticosteroids/antiinfectives/mydriatics in combination, Glucocorticoids. For more information about Proctofoam-HC see its generics Hydrocortisone, Pramocaine

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Irritation where Proctofoam HC is used.
  • Very bad bleeding from rectum or rectal pain.

What are some other side effects of Proctofoam HC?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry skin.
  • Burning.
  • Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Proctofoam HC or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Proctofoam HC. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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