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COMIT 50 Tablets
Composition
Each Suppository contains
Sildenafil Citrate
equivalent to Sildenafil 50 mg
Description
Sildenafil Citrate is a selective inhibitor of cyclic guanosine monophosphate (CGMP) Specific phosphodiesterase type 5 (PDE5). Sildenafil Citrate Is designated chemically as 1-[ [3-(6,7 dihydro 1- methyl 7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrtmidin 5-yl)-4-ethoxypnenyO sulfonyl ]-4- methylpiperazlne citrate with a molecular weight of 666.7
Mechanism of Action
COMIT is a brand name of Sildenafil Tablets. Sildenafil is a unique medicine in the group that helps the erection of penis and stay rigid enough to complete the sexual activity on stimulation. It does not increase the desire to have sexual intercourse nor it induces fertility. The drug acts by enchancing the smooth muscle relaxant effects of Nitric Oxide that is normally released in response to stimulation. COMIT dilates the arteries in the penis and thus allows filling of blood into the sinusoids. As the penis hardens, the veins are compressed restricting the blood flow out of the penis; the filling of blood in the penis spaces causes erection.
Indication
COMIT is indicated for the treatment of Erectile Dysfunction.
Clinical Pharmacology
This drug is rapidly absorbed after oral administration, with absolute biovailbility of about 40%. It has a rapid onset of action usually within one hour of taking the dose. The rate of obsorption is reduced when Sildenafil is administered with food. Sildenafil is widely distributed into tissues and is approximately 96% bound to plasma proteins. It is metabolized predominately by hepatic metabolism and is converted to an active metabolite. Both Sildenafil and its metabolite have a plasma half-life of appromately 4 hours. Therefore it is not expected to accumulate when taken more than once daily. Sildenafil is excreted predminanty as metabolite in the faeces and to a lesser in the form of urine. Clearance may be reduced in the elderly and the severe renal or hepatic Impairment.
Contraindications
Hypersensitivity of the drugs or any its indredients, patients who are concurrently using organic nitrates in any form.
Precautions
The evaluation of Erectile Dyfunction should include a detemination of potentail underlying causes and the identifications of appropriate treatment following complete medical assessment. The cardiovascular risks of sexual activity may be advisable because of their underlying cardiovascular status. Caution is . required in patients with renal or hepatic impairment and dosage reduction may be be necessary. Care is also needed in patients with anatomical and hematological disorders, which may predipose them to priapism (painful erection than 6 hours in duration) and may be advisable in those with bleeding disorders or active peptic ulceration. The safety of Sildenafil is uncertain In patients with hypotension (BP < 90/95) or hypertension (BP>170/110) a recent history of stroke or myocardial infarction.

Prolonged erection greater than 4 hours and Priapism have been reported infrequently. In an event, an erection persists longer than 4 hours; the patient should seek medical assistance. If Priapus is not treated immediately, it could result in penile tissue damage and permanent loss of potency.
Side Effects
Low Blood Pressure, mild and ransient headache, flushing and dyspepsia and increased sensitivity to, light, urinary or respiratory tract infection, Priapism. Acute myocardial infarction after taking Sildenafil has been noted in US.
Overdose
In studies of healthy volunteers, single dose up to 800mg are well tolerated. In case of overdose, standard supportive should be adopted as required.
Dosage & Administration
The usual dose of Sildenafil Citrate is 50 mg to be taken one hour before sexual intercourse. The dose may be increased to 100 mg once a day to 25 mg in case of elderly patients and in those with severe renal or hepatic impairment and could later be increased to response if appropriate.
Storage
Store below 25° C in a dry place.
Presentation
COMIT 50 mg tablets in Aluminum blister of 4's.
 
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