midodrine hydrochloride 5 MG Oral Tablet
INDICATIONS AND USAGE Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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, USP 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, USP 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, USP. After initiation of treatment, midodrine hydrochloride tablets, USP should be continued only for patients who report significant symptomatic improvement.
Par Pharmaceutical, Inc.
ROUND WHITE P 849
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HOW SUPPLIED
MIDODRINE HYDROCHLORIDE Tablets, USP are available for oral administration, containing 2.5 mg, 5 mg or 10 mg of
MIDODRINE HYDROCHLORIDE, USP. The 2.5 mg tablets are white to off-white, uncoated round shaped, flat-faced beveled edged tablets with “P” on one side and “814” debossed below the score line of other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-814-01 Bottles of 500 tablets NDC 49884-814-05 The 5 mg tablets are white to off-white, uncoated round shaped, flat-faced beveled edged tablets with “P” on one side and “849” debossed below the score line of other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-849-01 Bottles of 500 tablets NDC 49884-849-05 The 10 mg tablets are white to off-white, uncoated round shaped, flat-faced, beveled edged tablets with “P” above the score line on one side and “874” debossed other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-874-01 Bottles of 500 tablets NDC 49884-874-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg.Lic.No.: TN00002121 OS814-01-74-01 Issued: 05/2017
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