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- The only FDA-approved zinc acetate prescription drug for the maintenance treatment of Wilson’s disease
- FDA-approved based upon controlled clinical trials
- FDA-mandated compliance with Good Manufacturing Practices and subject to the FDA audit process
- Covered by many insurance providers
- Detailed prescribing information required for a prescription product
- Can effectively help control copper levels in patients with Wilson’s disease after initial treatment with a copper binding medication
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Galzin® (Zinc Acetate) therapy is indicated for maintenance treatment of patients
with Wilson’s disease who have been initially treated with a chelating agent, an
agent that binds to copper. Wilson’s disease results in a build-up of copper in
Galzin® is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
Galzin® is not recommended for the initial therapy of symptomatic patients because of the delay in time it takes for Zinc Acetate to become effective in reducing copper levels. Patients who are having symptoms should be treated initially with copper binding agents (chelating agents).
Galzin® can cause stomach irritation. It may cause elevations of liver and pancreatic enzymes that may last for weeks to months suggesting pancreatitis, an inflammation of the pancreas. The enzyme levels normally return to the high-normal range within the first one or two years of zinc therapy. There have been rare cases of death due to overdose of Zinc Acetate or use as initial therapy in patients with advanced liver disease.
Pregnancy Category: A. Studies in pregnant women have not shown that Zinc Acetate or zinc sulfate increases the risk of fetal abnormalities if administered during all trimesters of pregnancy. Zinc Acetate should be used during pregnancy only if clearly needed. Zinc does appear in breast milk and zinc-induced copper deficiency in the nursing baby may occur.
Therefore, it is not recommended to nurse while taking Galzin®. No patients below the age of 10 years have been studied.
Patients should take Galzin® on an empty stomach, at least one hour before or two to three hours after meals. Capsules should be swallowed whole, not opened or chewed. In the rare event of gastrointestinal intolerance, generally occurring with the morning dose, this dose may be taken between breakfast and lunch. Patients must be clinically monitored to determine if the zinc acetate therapy is adequate. People with Wilson’s disease should reduce their dietary copper intake. Patients must adhere strictly to their treatment regimen.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800.FDA.1088.