Label: AMANTADINE HYDROCHLORIDE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 4, 2024

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  • DESCRIPTION
    Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H17N.HCl. It has the following structural ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - Mechanism of Action - Antiviral - The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of ...
  • INDICATIONS AND USAGE
    Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride ...
  • CONTRAINDICATIONS(What is this?)
    Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine hydrochloride ...
  • WARNINGS
    Deaths - Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine ...
  • PRECAUTIONS
    Amantadine should not be discontinued abruptly in patients with Parkinson's disease since a few patients have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when ...
  • ADVERSE REACTIONS
    The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse ...
  • OVERDOSAGE
    Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine ...
  • DOSAGE AND ADMINISTRATION
    The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for ...
  • HOW SUPPLIED
    Amantadine hydrochloride capsules USP, 100 mg are available as swedish orange capsules, cap and body imprinted HP 362 in white ink. Each capsule is filled with white to off white powder. NDC ...
  • PRINCIPAL DISPLAY PANEL(What is this?)
    Amantadine HCl 100 mg Capsules #500
  • INGREDIENTS AND APPEARANCE
    Product Information