midodrine hydrochloride tablet
INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.
zydus pharmaceuticals (usa) inc.
ROUND WHITE 739
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HOW SUPPLIED
MIDODRINE HYDROCHLORIDE tablets USP, 2.5 mg, 5 mg and 10 mg for oral administration. The 2.5 mg tablet is white to off-white, round, flat uncoated tablets debossed with "737" on one side and break line on the other side. NDC 68382-737-01 in bottles of 100 tablets with child-resistant closure The 5 mg tablet is white to off-white, round, flat uncoated tablets debossed with "738" on one side and break line on the other side. NDC 68382-738-01 in bottles of 100 tablets with child-resistant closure The 10 mg is white to off-white, round, flat uncoated tablets debossed with "739" on one side and break line on the other side. NDC 68382-739-01 in bottles of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/22
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