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DOT Drotaverine DESCRIPTION DOT (Drotaverine Hydrochloride) is a benzylisoquinoline derivative. It is a new highly potent synthetic antispasmodic drug which is capable of relieving spasms of various organs. Drotaverine selectively inhibits the phosphodiesterase enzyme that leads to an increase of the cAMP level producing smooth muscle relaxation. Like papaverine, it acts directly on the smooth muscle fibers, exceeding however, the antispasmodic effect of the standard preparations. Drotaverine Hydrochlo-ride has rapid onset of action, which is very advantageous in cases of acute painful spastic conditions. In addition to its spasmolytic and vasodilatory actions Drotaverine Hydrochloride elicits a selective blockade of cardiac betareceptor. COMPOSITION Tablet: Each tablet contains Drotaverine Hydrochloride INN 40 mg. Injection: Each 2 ml ampoule contains Drotaverine Hydrochloride INN 40 mg. INDICATIONS ● Gastric, Intestinal or pyloric spasm, Irritable bowel syndrome, Spastic constipation, Tensmus in dysentery ● Cholelithiasis, Cholecystitis, Cholangitis Nephrolithiasis, Ureterolithiasis, Cystitis ● Spasm of the uterial orifice during delivery, Threatened abortion, Spastic dysmenorrhoea, Acute parametritis ● Cardio-spasm, Coronary insufficiency, Angina pectoris, Peripheral vascular disorder. DOSAGE AND ADMINISTRATION : Tablet Adult : The usual dose is 1 to 2 tablets, 3 times daily. Children : Children (1-6 years): 1/4 to 1/2 tablet, 1-2 times daily. Children (>6 years): 1/2 to 1 tablet, 1-2 times daily. In peptic ulcer, it is expedient to combine Drotaverine Hydrochloride with atropine or atropine like compounds. Injection Subcutaneously or intramuscularly - Usually 2 to 4 ml (1 - 2 ampoules) injection, 1-3 times daily. In case of acute stone colic, 2 to 4 ml (1 - 2 ampoules) may be given by slow intravenous injection. In case of peripheral arterial spasm or obstruction, it may be injected intra-arterially. SIDE EFFECTS Side effects of Drotaverine are usually mild. In rare cases, dryness of mouth, nausea and vomiting may occur. Arterial blood pressure may drop following too rapid intravenous injection. CONTRAINDICATIONS Drotaverine is contraindicated in patients who are hypersensitive to this drug. PRECAUTIONS Caution should be taken for those patients suffering from hepatic and renal impairment. Use in pregnancy Effect of Drotaverine Hydrochloride in pregnant women is still unknown. So caution should be taken in pregnancy. Use in lactation There is no sufficient data that Drotaverine is excreted in human milk. So caution should be exercised when Drotaverine is administered to a nursing mother. DRUG INTERACTIONS Effects of anti-parkinsonian drugs may be decreased. SUPPLY Tablet : Each box contains 10 X 10 tablets in blister pack. Injection: Each box contains 2 X 5 ampoules in blister pack. FOR HEALTH, VIGOUR AND HAPPINESS . Dhamrai, Dhaka, Bangladesh.