Label: MIDODRINE HYDROCHLORIDE tablet

  • 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 (What is this?)

    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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  • DESCRIPTION
    Name: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 ...
  • CLINICAL PHARMACOLOGY
    Mechanism 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 ...
  • 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 ...
  • CONTRAINDICATIONS
    Midodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride ...
  • WARNINGS
    Supine Hypertension: The most potentially serious adverse reaction associated with midodrine hydrochloride therapy is marked elevation of supine arterial blood pressure (supine hypertension) ...
  • PRECAUTIONS
    General - 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 ...
  • ADVERSE REACTIONS
    The 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 ...
  • OVERDOSAGE
    Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine hydrochloride ...
  • DOSAGE AND ADMINISTRATION
    The 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 ...
  • HOW SUPPLIED
    Midodrine 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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