midodrine hydrochloride 5 MG Oral Tablet
INDICATIONS AND USAGE Midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride 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, 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 . After initiation of treatment, midodrine hydrochloride should be continued only for patients who report significant symptomatic improvement.
Apotex Corp
ROUND ORANGE APO MID 5
APO MID 5 ROUND ORANGE
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midodrine hydrochloride 5 MG Oral Tablet
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HOW SUPPLIED
MIDODRINE HYDROCHLORIDE tablets, USP 2.5 mg are available for oral administration as white, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "2.5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1320-3) Bottles of 100 (NDC 60505–1320-1) Bottles of 500 (NDC 60505-1320-5) Bottles of 1,000 (NDC 60505–1320-8).
MIDODRINE HYDROCHLORIDE tablets, USP 5 mg are available for oral administration as orange, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1321-3) Bottles of 100 (NDC 60505–1321-1) Bottles of 500 (NDC 60505-1321-5) Bottles of 1,000 (NDC 60505–1321-8).
MIDODRINE HYDROCHLORIDE tablets, USP 10 mg are available for oral administration as light blue, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "10" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1325-3) Bottles of 100 (NDC 60505-1325-1) Bottles of 500 (NDC 60505-1325-5) Bottles of 1,000 (NDC 60505-1325-8). Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC.
MIDODRINE HYDROCHLORIDE TABLETS , USP 2.5 mg, 5 mg and 10 mg Manufactured by Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for Apotex Corp. Weston, Florida 33326 Revised: February 2017 Rev. 2
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