Proctofoam

What is Proctofoam used for?

Proctofoam is a prescription medicine that is used to treat signs of hemorrhoids or rectal irritation.

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.

Before taking Proctofoam, tell your doctor:

• If you are allergic to Proctofoam; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have rectal bleeding.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Proctofoam with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Proctofoam?

• Tell all of your health care providers that you take Proctofoam. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told by the doctor.
• This medicine may cause harm if swallowed. If Proctofoam is swallowed, call a doctor or poison control center right away.
• Do not use near an open flame or while smoking. It may burst.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Proctofoam while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Proctofoam best taken?

Use Proctofoam as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Proctofoam by mouth. Use on your skin only. Keep out of your mouth, nose, ears, and eyes (may burn).
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Do not put Proctofoam into the rectum by using your fingers or any type of applicator. Follow what the doctor has told you to do.
• Shake well before use.
• Do not put the applicator into the rectum.

What do I do if I miss a dose?

• If you use Proctofoam on a regular basis, put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.
• Many times Proctofoam is used on an as needed basis. Do not use more often than told by the doctor.

What are the side effects of Proctofoam that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Irritation where Proctofoam is used.
• Swelling, warmth, or redness of the skin.
• Bleeding from rectum or rectal pain.

What are some other side effects of Proctofoam?

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 you have any side effects that bother you or do not go away.

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 1-800-332-1088. You may also report side effects at https://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.

How do I store and/or throw out Proctofoam?

• Store at room temperature. Do not refrigerate or freeze.
• Store upright with the cap on.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 10 G

• NDC 0037-6822-10
  STORE UPRIGHT
• proctofoam® HC
• (hydrocortisone acetate 1% and
  pramoxine hydrochloride 1%)
  topical aerosol
• Rx Only
• 10 g net wt

SRC: NLM .