Entofoam Rectal foam (Hydrocortisone 10%)

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

COMMON
Application site irritation, itching or burning
Mental problems (such as depression, suicidal thoughts, mania, anxiety, confusion, difficulty in sleeping, loss of memory, or hallucinations)

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 mig

OTHERS

Before taking ENTOFOAM, inform your doctor if you have:

Severe depression or bipolar disorder
Endocrine problems
Stomach ulcers or other digestive problems
Osteoporosis (thinning of bones)
Myasthenia gravis (muscle weakness)
Glaucoma (increased pressure in the eyes)
Fungal infections
Tuberculosis or other bacterial infections
Amoebic dysentery or and strongyloidiasis (an infestation of gut worm)
Cerebral malaria
Got vaccinated recently or going to receive any vaccination
Chicken pox or shingles (viral infections)
Optic neuritis or ocular herpes simplex (viral eye infection)

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