Label: GALZIN- zinc acetate capsule

  • NDC Code(s): 57844-208-52, 57844-215-52
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 30, 2024

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  • DESCRIPTION
    Zinc acetate as the dihydrate is a salt of zinc used to inhibit the absorption of copper in patients with Wilson's disease. Its structural formula is: C4H6O4Zn•2H2O    M.W. 219.51. Zinc acetate ...
  • CLINICAL PHARMACOLOGY
    Introduction - Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile, resulting in accumulation of excess copper ...
  • CLINICAL TRIALS
    In the single center United States trial, 60 patients with Wilson’s disease (31 male, 29 female) who had adequate detoxification of copper after initial chelation therapy were entered into a ...
  • INDICATIONS AND USAGE
    Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients).
  • CONTRAINDICATIONS
    Zinc Acetate Capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.
  • WARNINGS
    Copper Deficiency - Several post-marketing cases reported that zinc acetate taken over extended periods of time (i.e., months to years) may result in decreased enteral copper absorption and ...
  • PRECAUTIONS
    General - Zinc acetate is not recommended for the initial therapy of symptomatic patients because of the delay required for zinc-induced increase in enterocytic metallothionein and blockade of ...
  • ADVERSE REACTIONS
    The following adverse reactions associated with the use of zinc acetate were identified from postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain ...
  • OVERDOSAGE
    Acute oral overdosage with inorganic salts of zinc in humans is reported rarely. In the event of overdosage, the unabsorbed zinc salt should be removed from the stomach by lavage as quickly as ...
  • DOSAGE AND ADMINISTRATION
    The recommended adult dose is 50 mg as zinc three times daily (See CLINICAL TRIALS). Since 25 mg t.i.d. is also an effective dose in children 10 years of age or older or in women who are pregnant ...
  • HOW SUPPLIED
    GALZIN®, Zinc Acetate Capsules (25 mg zinc content) are #1 capsules with aqua blue opaque cap and body, imprinted "93-215." Packaged in bottles of 250 (NDC 57844-215-52). GALZIN® Zinc Acetate ...
  • Package/Label Display Panel
    NDC 57844-215-52 - GALZIN® 25 mg (zinc acetate) capsules - Rx only - Each aqua blue capsule contains: Zinc Acetate equivalent to 25 mg zinc. 250 CAPSULES - TEVA
  • Package/Label Display Panel
    NDC 57844-208-52 - GALZIN® 50 mg (zinc acetate) capsules - Rx only - Each orange capsule contains: Zinc Acetate equivalent to 50 mg zinc. 250 CAPSULES - TEVA
  • INGREDIENTS AND APPEARANCE
    Product Information