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Galzin (Zinc Acetate) - Indications and Dosage

 
 



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).

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, it may be advisable to use a dose of zinc to 25 mg three times a day, as long as the patient is compliant with therapy. The dose can be raised to 50 mg t.i.d. if monitoring indicates a lessening of control (see PRECAUTIONS: Monitoring Patients).

Patients should take zinc acetate on an empty stomach, at least one hour before or two to three hours after meals. For additional information, see PRECAUTIONS.

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 Capsules (50 mg zinc content) are #1 capsules with orange opaque cap and body, imprinted "93-208." Packaged in bottles of 250 (NDC 57844-208-52).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Rx only.

Manufactured For:
GATE PHARMACEUTICALS
Div. of Teva Pharmaceuticals USA
Sellersville, PA 18960

Manufactured By:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 11/2005

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