Label: MIDODRINE HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 27, 2023

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  • DESCRIPTION
    Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, monohydrochloride, (±)- ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Midodrine hydrochloride forms an active metabolite, desglymidodrine, that is an alpha1-agonist, and exerts its actions via activation of the alpha-adrenergic receptors of ...
  • Clinical Studies
    Midodrine has been studied in 3 principal controlled trials, one of 3-weeks duration and 2 of 1 to 2 days duration. All studies were randomized, double-blind and parallel-design trials in patients ...
  • 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 ...
  • CONTRAINDICATIONS
    Midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine ...
  • WARNINGS
    Supine Hypertension: The most potentially serious adverse reaction associated with midodrinehydrochloride 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 available for oral administration, containing 2.5 mg of midodrine hydrochloride, USP. The 2.5 mg tablets are white to off-white, uncoated round shaped ...
  • PRINCIPAL DISPLAY PANEL
    Midodrine Hcl 2.5 mg Tablet, #100
  • INGREDIENTS AND APPEARANCE
    Product Information