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Zinc Acetate

Pronunciation

(zink AS e tate)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Galzin: 25 mg, 50 mg

Brand Names: U.S.

  • Galzin

Pharmacologic Category

  • Chelating Agent, Oral

Pharmacology

Zinc induces production of the copper binding protein metallothionein in enterocytes. Copper binding within enterocytes results in an impairment of the intestinal absorption of dietary copper and reabsorption of endogenously secreted copper in saliva, bile, gastric acid. Following enterocyte desquamation, bound copper is eliminated in the feces.

Absorption

Small intestine (IOM 2001); impaired with food and beverages (other than water)

Distribution

Stored primarily in skeletal muscle and bone (IOM 2001)

Excretion

Feces and urine (IOM 2001)

Protein Binding

Primarily to albumin (IOM 2001)

Use: Labeled Indications

Wilson disease: Maintenance treatment of Wilson disease following chelation therapy.

Contraindications

Hypersensitivity to zinc acetate or any component of the formulation.

Dosing: Adult

Wilson disease: Oral: Note: Dose expressed in mg elemental zinc:

Usual dosage: 50 mg 3 times daily; may administer 25 mg 3 times daily if patient is compliant with therapy (increase dose to 50 mg 3 times daily if inadequate response to lower dose).

Pregnant females: 25 mg 3 times daily; may increase to 50 mg 3 times daily if inadequate response to lower dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Wilson disease: Oral: Note: Dose expressed in mg elemental zinc:

Children ≥10 years and Adolescents: 25 mg 3 times daily; may increase to 50 mg 3 times daily if inadequate response to lower dose.

American Association for the Study of Liver Diseases (AASLD) practice guideline recommendations (Roberts 2008):

Children <50 kg and >5 years: 75 mg/day in 3 divided doses

Children >50 kg: 150 mg/day in 3 divided doses

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer′s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer′s labeling.

Administration

Oral: Administer on empty stomach at least 1 hour before or 2 to 3 hours after meals, and at least 1 hour separated from beverages other than water. Gastric irritation is most commonly associated with morning dose; may administer morning dose between breakfast and lunch if gastric irritation occurs. Swallow capsule whole; do not chew or open.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

Ceftibuten: Zinc Salts may decrease the serum concentration of Ceftibuten. Management: Consider administering oral zinc salts at least 3 hours after ceftibuten. Consider therapy modification

Cephalexin: Zinc Salts may decrease the absorption of Cephalexin. Management: Consider administering oral zinc salts at least 3 hours after cephalexin. Consider therapy modification

Deferiprone: Zinc Salts may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Consider therapy modification

Dolutegravir: Zinc Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral zinc salts. Consider therapy modification

Eltrombopag: Zinc Salts may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any zinc-containing product. Consider therapy modification

Quinolone Antibiotics: Zinc Salts may decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Tetracycline Derivatives: Zinc Salts may decrease the absorption of Tetracycline Derivatives. Only a concern when both products are administered orally. Management: Consider doxycycline as a noninteracting tetracycline derivative. Separate dose administration of oral tetracycline derivative and oral zinc salts by at least 2 hours to minimize interaction. Exceptions: Doxycycline. Consider therapy modification

Trientine: May decrease the serum concentration of Zinc Salts. Zinc Salts may decrease the serum concentration of Trientine. Consider therapy modification

Adverse Reactions

Frequency not defined.

Central nervous system: Neurologic deterioration (uncommon)

Endocrine & metabolic: Amylase increased, lipase increased

Gastrointestinal: Gastric irritation

Hepatic: Alkaline phosphatase increased, hepatic function decreased (rare)

Warnings/Precautions

Concerns related to adverse effects:

• Central nervous system: Neurological deterioration may occur with initial therapy as copper stores are mobilized; effects are less common when compared to chelation therapy.

• GI effects: Gastric irritation/upset may occur with use and particularly with the morning dose.

Other warnings/precautions:

• Appropriate use: Not recommended for initial treatment of Wilson disease in symptomatic patients; may be used as maintenance therapy after patient has been stabilized on initial chelation therapy.

• Therapy management: Hepatic copper levels should not be used to manage therapy as they do not differentiate between potentially toxic free copper and safely bound copper.

Monitoring Parameters

Serum non-ceruloplasmin bound copper, 24-hour urinary copper excretion, 24-hour urinary zinc level; LFTs, neurologic evaluation including speech

Pregnancy Risk Factor

A

Pregnancy Considerations

Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. The risk of fetal harm appears remote with use of zinc acetate during pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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