Label: MIDODRINE HYDROCHLORIDE tablet
- NDC Code(s): 67046-1512-3
- Packager: Coupler LLC
- This is a repackaged label.
- Source NDC Code(s): 70756-049
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 1, 2025
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BOXED WARNING
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BOXED WARNING
Warning: Because midodrine hydrochloride can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to carry out activities of daily living, have not been verified.
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DESCRIPTIONName:Midodrine hydrochloride tablets, USP - Dosage Form:2.5 mg, 5 mg and 10 mg tablets for oral administration - Active Ingredient:Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg ...
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CLINICAL PHARMACOLOGYMechanism of Action - Midodrine hydrochloride forms an active metabolite, desglymidodrine, that is an alpha - 1-agonist, and exerts its actions via activation of the alpha-adrenergic receptors ...
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INDICATIONS AND USAGEMidodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood ...
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CONTRAINDICATIONSMidodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride ...
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WARNINGSSupine Hypertension: The most potentially serious adverse reaction associated with midodrine hydrochloride therapy is marked elevation of supine arterial blood pressure (supine hypertension) ...
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PRECAUTIONSGeneral - The potential for supine and sitting hypertension should be evaluated at the beginning of midodrine hydrochloride therapy. Supine hypertension can often be controlled by preventing the ...
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ADVERSE REACTIONSThe most frequent adverse reactions seen in controlled trials were supine and sitting hypertension; paresthesia and pruritus, mainly of the scalp; goosebumps; chills; urinary urge; urinary ...
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OVERDOSAGESymptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine hydrochloride ...
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DOSAGE AND ADMINISTRATIONThe recommended dose of midodrine hydrochloride tablets is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of ...
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HOW SUPPLIEDMidodrine hydrochloride tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. 2.5 mg tablets are white to off white, round tablets, scored on one side and debossed ...
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INGREDIENTS AND APPEARANCEProduct Information