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news.Unichem laboratories (Unichem) has received ANDA approval from the FDA for Hydrochlorothiazide capsules in the strengths of 12.5mg. Hydrochlorothiazide is a thiazide diuretic used in the management of edema and hypertension. In hypertension, thiazide diuretics are often used as initial therapy, either alone or in combination with other agents.
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Hydrochlorothiazide capsules 12.5mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, and magnesium stearate.
In an 87 patient, four-week, double-blind, placebo-controlled, parallel group trial, patients who received hydrochlorothiazide had reductions in seated systolic and diastolic blood pressure, that were greater than those seen in patients who received placebo. In the published placebo-controlled trials, comparing 12.5mg of hydrochlorothiazide to 25mg, the 12.5mg dose preserved most of the placebo-corrected blood pressure reduction seen with 25 mg.
Hydrochlorothiazide’s innovator is Novartis-Global and appears world-wide under the brand names: Esidrix, HydroDIURIL, Microzide and Oretic.