Entofoam 10 %

ENTOFOAM 10% Rectal Foam

Name:

• Brand Name: ENTOFOAM 10% Rectal Foam
• Common Name: Hydrocortisone Acetate Foam

Composition:

• Active Ingredients: Hydrocortisone Acetate 10% w/w Hydrocortisone is a corticosteroid.

Uses: ENTOFOAM 10% Rectal Foam is indicated for adjunctive therapy in the topical treatment of:

• Ulcerative proctitis (inflammation of the lining tissue of the inner rectum), a type of ulcerative colitis.
• Proctosigmoiditis (inflammation of the rectum and sigmoid colon). It works by inhibiting the production of certain chemical messengers in the body that cause redness, swelling, and itching, thereby reducing inflammation.

Dosage and Administration:

• The usual dose is one applicator-full of foam inserted into the rectum once or twice daily for 2 or 3 weeks.
• Thereafter, it may be administered every second day.
• Satisfactory response typically occurs within five to seven days.
• Shake the can vigorously before use.
• Hold the can upright and fill the applicator. Insert the applicator gently into the rectum while standing with one leg raised or lying on your side, then fully push the plunger to expel the foam.
• Avoid inserting any part of the aerosol container directly into the anus.
• After each use, the applicator parts should be thoroughly cleaned with warm water.

Side Effects:

• Common Side Effects: Application site reactions such as burning, irritation, itching, and redness, dry skin, hair follicle inflammation, hypertrichosis (excessive hair growth), acne-like rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infections, skin atrophy, stretch marks, and miliaria (sweat rash). Other common side effects include irregular periods, unexpected flattening of the neck, face, and body, dusky complexion with purple patches, or hair growth on the body in women.
• Serious Side Effects: Changes in eyesight, irregular heartbeats, or fits. Severe allergic reactions, severe chest pains, or broken bones. Long-term use in children may cause growth retardation, obesity, osteoporosis, or adrenal suppression.

Precautions:

• Do not use if allergic to Hydrocortisone or any other components of the product.
• Contraindicated in patients with viral (e.g., anal warts, herpes simplex, chickenpox, shingles) or fungal infections, bacterial infections, obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas, or sinus tracts.
• Use with caution in pregnant or breastfeeding women, and in elderly patients.
• Caution is advised in patients with kidney problems, liver problems, diabetes mellitus, severe ulcerative disease, heart problems, high blood pressure, or psychiatric disorders.
• Inform your doctor if you are scheduled for vaccination, especially live vaccines, as corticosteroids may suppress reactions to skin tests and live vaccines should not be taken while on treatment.
• Accidental oral ingestion could be harmful; seek immediate medical advice.
• ENTOFOAM is flammable; keep away from sources of ignition and do not expose to temperatures above 50°C.

Storage:

• Store in a cool and dry place, away from sunlight.
• Keep below 25°C; do not refrigerate.
• Keep out of reach and sight of children.
• The container is pressurized; protect from sunlight and do not expose to temperatures above 50°C. Do not spray on a naked flame or any incandescent material. Do not pierce or burn, even after use.

ENTOFOAM 10% by CIPLA LTD. is a rectal foam medicine containing Hydrocortisone Acetate, a corticosteroid used for its anti-inflammatory properties.

Here are some frequently asked questions about ENTOFOAM 10%:

What is ENTOFOAM 10% used for?

ENTOFOAM 10% is primarily used as an adjunctive therapy for the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients with ulcerative colitis and proctosigmoiditis. It helps to reduce inflammation, redness, swelling, and associated pain in the rectum.

How does ENTOFOAM 10% work?

ENTOFOAM 10% contains Hydrocortisone, which is a synthetic adrenocortical steroid. It works by inhibiting the production of certain chemical messengers in the body that cause inflammation, such as redness and swelling. This action helps to reduce the inflammatory response in the affected rectal area.

What is the usual dosage of ENTOFOAM 10%?

The usual recommended dose is one applicator-full of foam inserted into the rectum once or twice daily for approximately 2 to 3 weeks. Following this initial period, the dosage may be reduced to every second day. The exact dosage and duration of treatment will be determined by your doctor based on your condition and response.

What are the possible side effects of ENTOFOAM 10%?

Common side effects at the application site include burning, irritation, itching, and redness. More serious, but rare, side effects can include changes in eyesight, irregular heartbeats, or fits. Systemic side effects, which may occur with prolonged use or increased absorption, can include irregular periods, unexpected flattening of the neck, face, and body, dusky complexion with purple patches, or increased hair growth in women. Consult your doctor if any side effects persist or worsen.

Is ENTOFOAM 10% safe during pregnancy or breastfeeding?

ENTOFOAM 10% should be used with caution during pregnancy only if the potential benefit justifies the potential risk to the fetus, as corticosteroids have shown teratogenic effects in animal studies. It is generally not recommended for use in breastfeeding women because hydrocortisone may be excreted in breast milk and could potentially affect the infant. It is crucial to discuss the risks and benefits with your doctor if you are pregnant or breastfeeding.

Can ENTOFOAM 10% be taken with other medications?

ENTOFOAM 10% can interact with several other medications. Caution is advised when used concurrently with potassium-depleting agents (like diuretics or amphotericin B), macrolide antibiotics, NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), cardiac glycosides (e.g., Digoxin), antidiabetic medicines, and certain antiretroviral agents. Always inform your doctor about all other medications, supplements, or herbal products you are taking to avoid potential interactions.

What precautions should be taken while using ENTOFOAM 10%?

Do not insert any part of the aerosol container directly into the anus; use only the enclosed applicator. Avoid using the medication for longer periods than advised, especially in children, as prolonged use may lead to systemic effects such as growth retardation, obesity, or adrenal suppression. It should be used with caution in patients with pre-existing conditions like liver problems, kidney problems, diabetes mellitus, heart disease, severe ulcerative disease, or active infections. Live vaccines should not be administered while on corticosteroid therapy.

What happens if a dose of ENTOFOAM 10% is missed?

If you miss a dose, use it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one, as this may increase the risk of side effects.

How should ENTOFOAM 10% be stored?

ENTOFOAM 10% should be stored below 25°C and not refrigerated. It is a pressurized container, so it must be protected from sunlight and not exposed to temperatures above 50°C. Do not spray on a naked flame or any incandescent material, and keep it away from sources of ignition. Do not pierce or burn the container, even after use.