INTRODUCTION

ENTOFOAM contains Hydrocortisone acetate which belongs to the group of medicines called corticosteroids. It is used as an adjunctive therapy for the topical treatment of ulcerative colitis among patients who cannot retain hydrocortisone or other corticosteroid enemas. Ulcerative colitis is an inflammatory bowel disease which affects the lining of your large intestine (especially colon and rectum). Symptoms include rectal bleeding, stomach pain and bloody diarrhea.

Hydrocortisone works by inhibiting the synthesis of various chemical messengers and inflammatory mediators which are responsible for causing inflammation (redness and swelling), itching and bleeding in conditions such as ulcerative colitis. ENTOFOAM is meant for external use only. Always apply the foam to the anus only by using the enclosed applicator. Do not insert any part of aerosol foam container directly into the anus. Along with the treatment, eat less spicy food and drink plenty of water and fluids. Avoid smoking and alcohol consumption to enhance the chances of better healing.

This medicine is flammable in nature, so avoid going near naked flames after use. While using this medicine, inform your doctor immediately if you experience any signs of mental problems such as depression or suicidal thoughts. Your doctor might reduce your dose or suggest an alternative therapy. This medicine is generally safe and well tolerated. It may cause application site reactions such as irritation, itching or burning sensation in some individuals. Contact your doctor if they bother you.

Do not take this medicine if you have any bacterial, viral or fungal infections. Before taking this medicine inform your doctor if you have any liver, kidney, heart or stomach problems. Pregnant and breastfeeding women should inform their doctor before taking ENTOFOAM as a precaution. This medicine should be used with caution in children and adolescents under 18 years of age. Consult your doctor before taking.

USES OF ENTOFOAM

• Used as an adjunctive therapy for the topical treatment of ulcerative colitis

HOW ENTOFOAM WORKS

Hydrocortisone is a corticosteroid receptor agonist. It has anti-inflammatory, anti-pruritic and vasoconstrictive properties. Hydrocortisone applied around the anus (or rectum), dissolves through the cell membrane and binds to the receptor proteins. It blocks the synthesis of various chemical messengers and inflammatory mediators which are responsible for causing inflammation (redness and swelling), itching and bleeding in conditions such as ulcerative colitis.

DIRECTIONS FOR USE

Insert one full applicator (containing medicine) into the rectum, once or twice daily for 2-3 weeks and every second day thereafter or as directed by your physician. Shake the aerosol foam container for 5-10 seconds before each use. Hold the foam container only in an upright position while filling the applicator to allow a proper flow of medicine. Pull the plunger past the fill line marked on the applicator. Gently place the tip of the applicator into the tip of foam container (enclosed with a cap) and wait for 1-2 seconds.

Wait for 5-10 seconds and allow the foam to expand in the applicator. If required, repeat the steps until the foam is completely filled till the fill line of the applicator. Once filled completely, remove the applicator from the container cap and gently insert the applicator into the anus. Once fitted in position, push the plunger of the applicator, so that the foam gets expelled into the anus. Withdraw the applicator and wash the applicator parts in warm water.

It is for external use only. Do not insert any part of aerosol foam container directly into the anus. Always apply the foam to the anus only by using the enclosed applicator. Also wash the container cap and underlying tip thoroughly to prevent foam build-up and blockage. Continue to use this medicine, as long as your doctor tells you to do so, to obtain better results. Stay away from people having chickenpox, shingles or measles, because infections are easier to get and harder to spot while taking ENTOFOAM.

SIDE EFFECTS OF ENTOFOAM

HOW TO MANAGE SIDE EFFECTS

Application site reactions:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, consult your doctor.

Mental health problems:

This is a common side effect in both adults and in children and need to be monitored very carefully. Contact your doctor immediately if you experience any signs of mental problems such as depression or suicidal thoughts. Your doctor might reduce your dose or suggest an alternative therapy.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• aminoglutethimide (used to treat cancer)
• amphotericin B injection (used to treat systemic fungal infections)
• potassium depleting agents such as potassium sparging diuretics (e.g. aldosterone, spironolactone)
• macrolide antibiotics (used to treat bacterial infection) e.g. erythromycin
• anticholinesterases (used to prevent acetylcholine breakdown) e.g. rivastigmine, physostigmine
• medicines used for blood thinning (e.g. warfarin)
• medicines used to treat diabetes (e.g. insulin, metformin)
• isoniazid and rifampin (used to treat tuberculosis)
• cholestyramine (used to treat high blood cholesterol)
• ciclosporin (used to treat psoriasis or prevent graft rejection)
• digitalis (used to treat irregular heart rate and other heart problems)
• oral contraceptive pills (birth control pills)
• hormone replacement therapy
• medicines used to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine and primidone)
• barbiturates (used to reduce anxiety and induce sleep) e.g. phenobarbitone
• ketoconazole (used to treat fungal infections)
• aspirin (used to treat pain and blood clotting)
• live or live attenuated vaccines

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT ENTOFOAM

Can ENTOFOAM be used for rectal bleeding?

This medicine is intended to treat ulcerative colitis and its associated symptoms such as rectal bleeding, stomach pain and bloody diarrhea. However, consult your doctor before taking.

What should I avoid eating while taking ENTOFOAM?

Avoid eating spicy foods and drink plenty of water and fluids. Avoid smoking and alcohol consumption to enhance the chances of better healing.

Can ENTOFOAM be used in pregnant women?

No. Try to avoid using this medicine during pregnancy. This medicine should be taken by pregnant women only if the potential benefit justifies the risk. Consult your doctor for advice.

REFERENCES

1. KD. Tripathi. Corticosteroids. Essentials of medical pharmacology. Seventh edition. 2013. Page – 288 & 292.

2. Bernard P. Schimmer and John. W. Funder. ACTH, Adrenal steroids and Pharmacology of the Adrenal Cortex. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1356-1357.

3. Gerald G. Briggs and Roger K. Freeman. H. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1875-1886.

4. W S Ruddell, R J Dickinson, M F Dixon, A T Axon. Treatment of distal ulcerative colitis (proctosigmoiditis) in relapse: comparison of hydrocortisone enemas and rectal hydrocortisone foam. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. October 1980. [Accessed 5th January 2021] https://pubmed.ncbi.nlm.nih.gov/7002739/

5. Uma Mahadevan. Medical Treatment of Ulcerative Colitis. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2004. Accessed 5th January 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780076/

6. Cipla. Ltd. ENTOFOAM Rectal Foam (Hydrocortisone acetate). Ciplamed.com. [Revised on December 2016] [Accessed 5th January 2021] https://www.ciplamed.com/content/entofoam-rectal-foam

USEFUL DIAGNOSTIC TESTS

• Anti-Neutrophilic Cytoplasmic Antibody - P
• C- Reactive Protein Quantitative
• Erythrocyte Sedimentation Rate