ZINC CHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Exela Pharma Sciences,LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Plastic Vial Rx Only 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. None known. None known.

Product summary:

Zinc Chloride Injection, USP, 1 mg/mL is supplied in 10 mL plastic vials. NDC Number Strength Packaged NDC 51754-0102-1 10 mg/10 mL (1 mg/mL) 10 mL vial NDC 51754-0102-4 10 mg/10 mL (1 mg/mL) 25 vials per carton Store at 20 to 25°C (6 8 to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: 1245 Blowing Rock Blvd Lenoir, NC 28645 Revised 05/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZINC CHLORIDE- ZINC CHLORIDE INJECTION
EXELA PHARMA SCIENCES,LLC
----------
ZINC CHLORIDE INJECTION, USP
FOR I.V. USE ONLY AFTER DILUTION
PLASTIC VIAL
RX ONLY
DESCRIPTION
Zinc Chloride Injection, USP, 1 mg/mL is a sterile, nonpyrogenic
solution intended for use
as an additive to intravenous solutions for total parenteral nutrition
(TPN). Each mL of
solution contains 2.09 mg zinc chloride and 9 mg sodium chloride. The
solution contains
no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0
(1.5 to 2.5); product
may contain hydrochloric acid and sodium hydroxide for pH adjustment.
The osmolarity
is 0.354 mOsmoL/mL (calc.).
Zinc Chloride, USP is chemically designated ZnCl
, a white crystalline compound freely
soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water.
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals
according to USP biological standards for plastic containers. The
small amount of water
vapor that can pass through the plastic container wall will not
significantly alter the drug
concentration.
CLINICAL PHARMACOLOGY
Zinc is an essential nutritional requirement and serves as a cofactor
for more than 70
different enzymes including carbonic anhydrase, alkaline phosphatase,
lactic
dehydrogenase, and both RNA and DNA polymerase. Zinc Chloride
Injection, USP
facilitates wound healing, helps maintain normal growth rates, normal
skin hydration,
and the senses of taste and smell.
Zinc Chloride Injection, USP resides in muscle, bone, skin, kidney,
liver, pancreas, retina,
prostate and particularly in the red and white blood cells. Zinc
Chloride Injection, USP
binds to plasma albumin, α -macroglobulin, and some plasma amino
acids including
histidine, cysteine, threonine, glycine, and asparagine. Ingested zinc
is excreted mainly in
the stool (approximately 90%), and to a lesser extent in the urine and
in