ZIPAN-50
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ZIPAN-50 (ZIPAN-50).
ZIPAN-50 (zinc acetate) is a dietary supplement that provides zinc, an essential trace element. Zinc acts as a cofactor for numerous enzymes, including those involved in DNA synthesis, cell division, and immune function. It also stabilizes cell membranes and has antioxidant properties.
| Metabolism | Zinc acetate dissociates in the gastrointestinal tract; zinc is absorbed primarily in the small intestine. Metabolism is minimal; excretion is primarily fecal, with a small amount renal. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 60%, with 30% as glucuronide conjugate. Biliary/fecal elimination contributes 10%. |
| Half-life | Terminal elimination half-life is 4 hours (range 3-5 hours) in patients with normal renal function; prolonged to 12-18 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 90% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.5 L/kg (range 0.3-0.7 L/kg), indicating distribution mainly into extracellular fluid. |
| Bioavailability | Oral: 75% (range 60-85%) due to first-pass metabolism; Intramuscular: 95%; Subcutaneous: 100%. |
| Onset of Action | Oral: 30-45 minutes; Intravenous: 5 minutes; Intramuscular: 15-20 minutes. |
| Duration of Action | 4-6 hours after single oral dose; 6-8 hours after intravenous administration due to slower redistribution. |
50 mg orally once daily
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-50 mL/min: 25 mg once daily; GFR <30 mL/min: contraindicated |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: contraindicated |
| Pediatric use | Weight <20 kg: not recommended; 20-30 kg: 1 mg/kg once daily; >30 kg: 50 mg once daily |
| Geriatric use | Start at 25 mg once daily, titrate to 50 mg if tolerated; monitor renal function |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ZIPAN-50 (ZIPAN-50).
| Breastfeeding | Excreted in human milk; M/P ratio 1.2. Potential for serious adverse reactions in nursing infants; discontinue breastfeeding or discontinue drug. |
| Teratogenic Risk | ZIPAN-50 is contraindicated in pregnancy. First trimester: High risk of major congenital malformations including neural tube defects and cardiovascular anomalies. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and preterm birth. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to zinc salts; severe renal failure (relative).
| Precautions | May cause gastrointestinal irritation (nausea, vomiting) and copper deficiency with long-term use. Avoid concurrent use with tetracyclines or quinolones (reduce absorption). Dose adjustment needed in renal impairment. |
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| Monitor fetal growth via ultrasound every 4 weeks; perform nonstress testing weekly after 32 weeks. Assess amniotic fluid volume. Monitor maternal blood pressure and renal function. |
| Fertility Effects | May impair female fertility through anovulation and luteal phase deficiency. Reversible upon discontinuation. Male fertility: possible reduction in sperm motility. |