midodrine hydrochloride 10 mg
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’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 tabletsshould be continued only for patients who report significant symptomatic improvement.
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OVAL WHITE M 10 10
M 10 10 OVAL WHITE
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HOW SUPPLIED
MIDODRINE HYDROCHLORIDE 2.5 mg, 5 mg and 10 mg tablets for oral administration.
MIDODRINE HYDROCHLORIDE Tablets, USP 2.5 mg are white to off-white rectangle shaped, flat faced, beveled edge, scored tablets, debossed with “M” above the score and “2.5” below the score on one side of the tablet and “2.5” on the other side. Blistercards of 30 NDC 0615-8382-39
MIDODRINE HYDROCHLORIDE Tablets, USP 5 mg are white to off-white round shaped, flat faced, beveled edge, scored tablets, debossed with “M” above the score, “5” below the score on one side and “5” on the other side. Blistercards of 30 NDC 0615-8383-39
MIDODRINE HYDROCHLORIDE Tablets, USP 10 mg are white to off-white capsule shaped, flat faced, beveled edge, scored tablets, debossed with “M” on the left of the score and “10” on right of the score on one side of the tablet and “10” on the other side. Blistercards of 30 NDC 0615-8384-39 Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Issued: May 2020
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