FDA approval for La Hydrochloro Thiazide - HydroDIURIL clinical trails
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FDA Approval for Hydrochloro Thiazide - Hydrodiuril

The manufacture, sale and distribution of Hydrochlorothiazide has been approved by the U. S. Food and Drug Administration-FDA as the supplemental new drug application-sNDA for the anti-hypertensive for initial use in patients with hypertension who are likely required multiple drugs for attaining their blood pressure goals and as the adjunctive therapy in edema associated with congestive heart failure – CHF, hepatic cirrhosis as well as corticosteroid and estrogen therapies.

The approval is based on the data from different clinical trials that involved over 1,200 patients with moderate or very high blood pressure disorders. In the first double-blind, active-controlled, seven week trial, the patients having very high hypertension with minimum bottom line of 172 / 113 mm Hg Systolic Blood Pressure-SBP / Diastolic Blood Pressure – DBP were randomly treated with Hydrochlorothiazide. After one week all the doses were doubled. After 5 weeks the patients demonstrated reduction in their mean blood pressure of 30.8 / 24.0 mm Hg versus 21.1 / 19.3 mm Hg of SBP / DBP.

Guidelines support initial combination therapy for very high hypertension based on the necessity of lowering blood pressure within weeks instead of months. Now with the help of Hydrochlorothiazide tablets the physicians have more therapeutic options for treating mild, moderate to very high hypertension cases. The drug is indicated for the treatment of hypertension and is also said to help slowing down the progression of nephropathy in type 2 diabetic hypertensive patients.

This drug may be used in treating the patients appropriately whose blood pressure is not sufficiently controlled on mono-therapy and now can be used as the initial therapy in appropriate patients who are supposed to require multiple medications for attaining their blood pressure targets.
 

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