midodrine 10 mg

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.

trupharma, llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] nausea` `[5] off label use` `[6] headache` `[7] arthralgia` `[8] dyspnoea` `[9] vomiting` `[10] diarrhoea`

6 months ago

ROUND WHITE A 042

6 months ago

A 042 ROUND WHITE

HOW SUPPLIED

MIDODRINE HYDROCHLORIDE Tablets, USP 2.5mg, 5mg and 10mg tablets for oral administration.

MIDODRINE HYDROCHLORIDE Tablets, USP 2.5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "040" on other side. Bottles of 100 tablets: NDC 52817-323-10

MIDODRINE HYDROCHLORIDE Tablets, USP 5mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "041" on other side. Bottles of 100 tablets: NDC 52817-324-10

MIDODRINE HYDROCHLORIDE Tablets, USP 10mg are white to off white, round beveled edge, scored tablets debossed with " ^ " above the score line on one side and "042" on other side. Bottles of 100 tablets: NDC 52817-325-10 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]. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed By TruPharma, LLC Tampa, FL 33609 Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Rx Only Rev.00, 09/2019

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trupharma, llc

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