GALZIN- zinc acetate capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ZINC ACETATE

Sammensetning:

ZINC CATION 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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. Rev. 7/2020 Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 ©2020 Teva Pharmaceuticals USA, Inc. All rights reserved.

Autorisasjon status:

New Drug Application

Preparatomtale

GALZIN- ZINC ACETATE CAPSULE
TEVA PHARMACEUTICALS USA, INC.
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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:
C H O Zn•2H O
M.W. 219.51.
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.
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 in the liver, and
subsequently in other organs, including the brain, kidneys, eyes,
bone, and muscles. In this disease,
hepatocytes store excess copper, but when their capacity is exceeded
copper is released into the blood
and is taken up in extrahepatic sites, such as the brain, resulting in
motor disorders (ataxia, tremors,
speech difficulties) and psychiatric manifestations (irritability,
depression, deterioration of work
performance). Redistribution of excess copper in hepatocytes leads to
hepatocellular injury,
inflammation, necrosis, and eventual cirrhosis. Patients may present
clinically with predominantly
hepatic, neurologic, or psychiatric symptoms.
The disease has been treated by restricting copper in the diet, and
the use of chelating agents to bind
free copper to reduce its toxicity and facilitate its excretion. The
purpose of initial treatment of
symptomatic patients with a chelating agent is to detoxify copper.
Once the patient's symptoms have
stabilized clinically,