Midodrine HCl midodrine hydrochloride 10 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 tablet, USP'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, 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.
Eon Labs, Inc.
ROUND GREY E 149
E 149 ROUND GREY
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HOW SUPPLIED Midodrine Hydrochloride Tablets, USP, for oral administration, are available as 2.5 mg white, round, flat-faced, bevelled edge, debossed “ E ” over “40” on one side and bisected on the other side and supplied as: NDC 0185-0040-01 bottles of 100 NDC 0185-0040-05 bottles of 500 5 mg Reddish-orange, round, flat-faced, bevelled edge, debossed “ E ” over “43” on one side and bisected on the other side and supplied as: NDC 0185-0043-01 bottles of 100 NDC 0185-0043-05 bottles of 500 10 mg blue-grey, round, flat-faced, bevelled edge, debossed, “ E ” over “149” on one side and bisected on the other side and supplied as: NDC 0185-0149-01 bottles of 100 NDC 0185-0149-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc. Princeton, NJ 08540 OS8009 Rev. March 2017 MF0040REV03/17
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