FDA
Zinc Chloride
The FDA lists this product in 3 strengths and forms.
Indications
Zinc Chloride Injection, USP, 1 mg/mL is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
Contraindications
None known.
Warnings and precautions
Direct intramuscular or intravenous injection of Zinc Chloride Injection, USP, 1 mg/mL is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation. Severe kidney disease may make it necessary to reduce or omit chromium and zinc doses because these elements are primarily eliminated in the urine. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
Pregnancy and breastfeeding
Pregnancy Animal reproduction studies have not been conducted with zinc chloride. It is also not known whether zinc chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zinc chloride should be given to a pregnant woman only if clearly needed.
Adverse reactions
None known.
Composition
- Active ingredients
- ZINC CHLORIDE EQ 1MG ZINC/ML
Strengths and forms
At a glance
- Brand name
- Zinc Chloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Exela Pharma
- Status
- Prescription
- FDA approval
- 21 May 2021
- Application
- ANDA212007-001



