Proctofoam HC

DRUG 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-, (11?)-.

Hydrocortisone acetate structural formula illustration

Pramoxine hydrochloride

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

Pramoxine hydrochloride structural formula illustration

What are the possible side effects of hydrocortisone pramoxine topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • sleep problems (insomnia);
  • ongoing headache;
  • weight gain, puffiness in your face;
  • increased thirst or urination, weight loss,...

Read All Potential Side Effects and See Pictures of Proctofoam HC »

What are the precautions when taking hydrocortisone and pramoxine (Proctofoam HC)?

Before using this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to hydrocortisone; 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: diabetes, eye problems, infections (especially rectal sores/infections), liver disease, stomach/intestinal problems.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using...

Read All Potential Precautions of Proctofoam HC »


Proctofoam HC Consumer (continued)

SIDE EFFECTS: Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: rectal bleeding, change in skin appearance (e.g., color, thickness), skin redness/tenderness/pus or other signs of infection.

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 hydrocortisone; 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: diabetes, eye problems, infections (especially rectal sores/infections), liver disease, stomach/intestinal problems.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Caution is advised when using this drug in children. Do not use this product over a large area or use tight-fitting diapers/plastic pants unless directed by your doctor.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. It should not be used for long periods of time or in large amounts. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Proctofoam HC Patient Information Including Side Effects

Brand Names: Analpram E, Analpram-HC, Epifoam, HC Pramoxine, Hydropram, Novacort, Pramosone, Proctofoam HC, Rectocort HC, ZyPram

Generic Name: hydrocortisone and pramoxine topical (Pronunciation: HYE droe KOR ti sone and pra MOX een)

  • What is hydrocortisone and pramoxine topical (Proctofoam HC)?
  • What are the possible side effects of hydrocortisone pramoxine topical?
  • What is the most important information I should know about hydrocortisone and pramoxine topical?
  • What should I discuss with my health care provider before using hydrocortisone and pramoxine topical?
  • How should I use hydrocortisone and pramoxine topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using hydrocortisone and pramoxine topical?
  • What other drugs will affect hydrocortisone and pramoxine topical?
  • Where can I get more information?

What is hydrocortisone and pramoxine topical (Proctofoam HC)?

Pramoxine is an anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of hydrocortisone and pramoxine topical is used to treat pain, itching, or inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, psoriasis, insect bites, and minor burns or scrapes. This medication is also used on the rectal area to treat itching and inflammation caused by hemorrhoids, anal fissures, or other rectal irritation.

Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrocortisone pramoxine topical?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • sleep problems (insomnia);
  • ongoing headache;
  • weight gain, puffiness in your face;
  • increased thirst or urination, weight loss, unusual weakness;
  • fever, sore throat, tired feeling;
  • severe pain, burning, or irritation of treated skin;
  • rectal bleeding;
  • any new redness or swelling where the medicine was applied; or
  • itching, oozing, or other signs of infection.

Less serious side effects may include:

  • mild skin redness, burning, itching, dryness, or peeling;
  • acne;
  • changes in the color of treated skin;
  • thinning of your skin;
  • blistering skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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