Pharmaceutical Business review

Unichem Obtains ANDA Approval For Hydrochlorothiazide Capsules

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.