Midodrine Hydrochloride midodrine hydrochloride 5 MG Oral 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'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. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.
Upsher-Smith Laboratories Inc.
ROUND PINK US 5 212
US 5 212 ROUND PINK
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Midodrine Hydrochloride midodrine hydrochloride 5 MG Oral Tablet
Upsher-Smith laboratories, LLC
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HOW SUPPLIED
MIDODRINE HYDROCHLORIDE tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. The 2.5 mg tablet is a white, round, uncoated tablet, scored on one side with "US" above and "2.5" below the score and "211" on the other side. They are supplied as follows: Bottles of 100 with child-resistant closure NDC 0245-0211-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0211-01 The 5 mg tablet is a pink, round, uncoated tablet, scored on one side with "US" above and "5" below the score and "212" on the other side. They are supplied as follows: Bottles of 100, with child-resistant closure NDC 0245-0212-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0212-01 The 10 mg tablet is a purple, round, uncoated tablet, scored on one side with "US" above and "10" below the score and "213" on the other side. They are supplied as follows: Bottles of 100 tablets NDC 0245-0213-11 Unit-Dose Cartons of 100 tablets (10 cards containing 10 tablets each) NDC 0245-0213-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Revised: 6/2024
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