Zinc Acetate

Prescription

Nomes comerciais: GALZIN

Forma Farmacêutica

Capsule

Via de Administração

ORAL

Fabricante

Eton Pharmaceuticals, Inc.

About This Medication

GALZIN® (Zinc Acetate) Capsules 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: Zinc acetate occurs as white crystals or granules, freely soluble in water and in boiling alcohol, and slightly soluble in alcohol. GALZIN® (Zinc Acetate) Capsules contain the equivalent of 25 or 50 mg of zinc, in addition to corn starch and magnesium stearate in gelatin capsules. The 25 mg capsule shells contain titanium dioxide and the 50 mg capsule shells contain titanium dioxide, methylparaben and propylparaben. The 25 mg capsule shells contain FD&C Blue #1; the 50 mg capsule shells contain FD&C Red #40, D&C Red #28, and D&C Yellow #10. Galzin Structural Formula

Princípios Ativos

Ingrediente	Concentração
Zinc Acetate	-

Indicações e Uso

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 ).

Posologia e Administração

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 .

Side Effects Overview

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 size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders: gastric irritation Investigations: elevations of serum alkaline phosphatase, amylase, and lipase lasting from weeks to months suggesting pancreatitis; the levels usually return to high normal within the first one or two years of zinc therapy.

Advertências e Precauções

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 copper deficiency. The cases reported the following complications of copper deficiency: anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy. If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc acetate, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels. Consider restarting zinc acetate treatment based on periodic monitoring of 24-hr urinary copper and NCC levels. Gastric Ulcer There have been postmarketing reports of gastric ulcers with long-term use of zinc acetate. The cases reported the complications of anemia and gastric ulcer perforation with peritonitis. In some cases, ulcers persisted after treatment until zinc acetate was discontinued. If a patient develops signs and/or symptoms of gastric ulcer during treatment with zinc acetate, discontinue zinc treatment. Most patients showed improvement after cessation of zinc treatment.

Contraindicações

CONTRAINDICATIONS Zinc Acetate Capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Frequently Asked Questions

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 …

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 copper deficiency. The cases reported the following complications of copper deficiency: anemia, granulocytopenia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and myeloneuropathy. If a patient develops signs and/or symptoms of copper deficiency during treatment with zinc acetate, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels. Consider restarting zinc …

CONTRAINDICATIONS Zinc Acetate Capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.

Zinc Acetate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Zinc Acetate drug label (National Library of Medicine)
• openFDA — Zinc Acetate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 199994 (NLM Normalized Drug Names)
• NDC Directory — Zinc Acetate (FDA National Drug Code)

Aviso Médico

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Fontes de dados: DailyMed (NLM), openFDA, MFDS