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For US healthcare professionals
Galzin dosing information

The prescription dosing regimen helps you and your patients maintain control of their disease1

Decades of demonstrated safety and tolerability1,2

Gastric irritation (gastritis) is the most commonly reported side effect of Galzin, and it generally occurs with the morning dose. For most patients, this discomfort goes away within the first few days of therapy.

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The recommended dosage of Galzin is 50 mg as zinc taken 3 times daily

25 mg 3 times daily was also thought to be an adequate dose regimen and shown not inferior to 50 mg 3 times daily based on the limited data available.

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For patients who are compliant with therapy, 25 mg taken 3 times a day may be advisable. If monitoring indicates a lessening of control, the dose can be raised to 50 mg 3 times daily.

Galzin may be prescribed as 25 mg 3 times daily for children 10 years of age or older and women who are pregnant.

Patients should take zinc acetate on an empty stomach, at least 1 hour before or 2 to 3 hours after meals.

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Be sure to talk to your patients about the importance of treatment adherence for maintaining normal copper levels.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

Galzin® (zinc acetate) is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent.

IMPORTANT SAFETY INFORMATION

Contraindication

Hypersensitivity to zinc acetate or any of the ingredients in Galzin.

Warnings and Precautions

Copper Deficiency: Several post-marketing cases reported that zinc acetate taken over extended periods of time may result in decreased enteral copper absorption and copper deficiency. If a patient develops signs and/or symptoms of copper deficiency, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels.

Gastric Ulcer: Gastric ulcers including complications of anemia and gastric ulcer perforation with peritonitis have been reported with long-term use of zinc acetate.

General: Galzin 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 copper uptake. Symptomatic patients should be treated initially using chelating agents. During initial therapy, neurological deterioration may occur as stores of copper are mobilized.

Information for Patients: GALZIN should be administered 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. Patients must be clinically monitored to determine the adequacy of zinc acetate therapy.

Monitoring Patients: Existing signs and symptoms of Wilson’s disease and 24-hour urine copper should be monitored. Neuropsychiatric evaluations including speech as well as liver function tests including bilirubin and aminotransferases, should be done as appropriate. In all treated patients, 24--hour urinary zinc levels may be a useful measure of compliance with the zinc acetate regimen.

Adverse Reactions

The most common adverse reactions are gastric irritation, elevations of serum alkaline phosphatase, amylase, and lipase suggesting pancreatitis.

To report a suspected adverse event related to GALZIN, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/Medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.

Reference: 1. Galzin (zinc acetate) capsules. Prescribing information. Eton Pharmaceuticals; 2025.

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