zinc
Generic Name: (
Zinc Chloride)
Dosage Type: injection, solution Organization: Hospira, Inc.
FOR I.V. USE ONLY AFTER DILUTION
Plastic Vial
Rx Only
DESCRIPTION
Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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 m0smoL/mL (calc.).
Zinc Chloride, USP is
chemically designated ZnCl2, 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 facilitates wound healing, helps maintain normal growth rates, normal
skin hydration, and the senses of taste and smell.
Zinc
resides in muscle, bone, skin, kidney, liver, pancreas, retina, prostate and
particularly in the red and white blood cells. Zinc binds to plasma albumin,a2-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 perspiration.
Providing zinc helps prevent development
of deficiency symptoms such as: Parakeratosis, hypogeusia, anorexia, dysosmia,
geophagia, hypogonadism, growth retardation and hepatosplenomegaly.
The
initial manifestations of hypozincemia in TPN are diarrhea, apathy and depression.
At plasma levels below 20 mcg zinc/100 mL dermatitis followed by alopecia
has been reported for TPN patients. Normal zinc plasma levels are 100 ±
12 mcg/100 mL.
INDICATIONS AND USAGE
Zinc 1 mg/mL (Zinc Chloride Injection, USP) 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
Direct intramuscular or intravenous injection of Zinc 1 mg/mL
(Zinc Chloride Injection, USP) 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.
PRECAUTIONS
General
Do not use unless the solution is clear and the seal is intact.
Zinc
1 mg/mL (Zinc Chloride Injection, USP) should only be used in conjunction
with a pharmacy directed admixture program using aseptic technique in a laminar
flow environment; it should be used promptly and in a single operation without
any repeated penetrations. Solution contains no preservatives; discard unused
portion immediately after admixture procedure is completed.
Zinc
should not be given undiluted by direct injection into a peripheral vein because
of the likelihood of infusion phlebitis and the potential for increased excretory
loss of zinc from a bolus injection. Administration of zinc in the absence
of copper may cause a decrease in serum copper levels.
Laboratory Tests
Periodic determinations of serum copper as well as zinc are
suggested as a guideline for subsequent zinc administration.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential
of Zinc 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor
have studies been done to assess mutagenesis or impairment of fertility.
Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when Zinc 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing
woman.
Pediatric Use
See DOSAGE and ADMINISTRATION section.
Pregnancy Category C. 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.
Geriatric Use
An evaluation of current literature revealed no clinical
experience identifying differences in response between elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
ADVERSE REACTIONS
None known.
DRUG ABUSE AND DEPENDENCE
None known.
OVERDOSAGE
Single intravenous doses of 1 to 2 mg zinc/kg body weight
have been given to adult leukemic patients without toxic manifestations. However,
acute toxicity was reported in an adult when 10 mg zinc was infused over a
period of one hour on each of four consecutive days. Profuse sweating, decreased
level of consciousness, blurred vision, tachycardia (140/min), and marked
hypothermia (94.2° F) on the fourth day were accompanied by a serum zinc
concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia
may be a sign of impending zinc overdosage; patients receiving an inadvertent
overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day)
developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death
resulted from an overdosage in which 1683 mg zinc was delivered intravenously
over the course of 60 hours to a 72 year old patient.
Symptoms
of zinc toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea,
vomiting, jaundice, and oliguria, with a serum zinc level of 4184 mcg/dl.
Calcium
supplements may confer a protective effect against zinc toxicity.
DOSAGE AND ADMINISTRATION
Zinc 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg
zinc/mL and is administered intravenously only after dilution. The additive
should be diluted prior to administration in a volume of fluid not less than
100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous
dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day
(2
mL/day) is suggested for acute catabolic states. For the stable adult with
fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small
bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional
17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy
output) is recommended. Frequent monitoring of zinc blood levels is suggested
for patients receiving more than the usual maintenance dosage level of zinc.
For
full term infants and children up to 5 years of age, 100 mcg zinc/kg/day
(0.1
mL/kg/day) is recommended. For premature infants (birth weight less than 1500
g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS.
HOW SUPPLIED
Zinc 1 mg/mL (Zinc Chloride Injection, USP) is supplied in
10 mL Plastic Vials (List No. 4090).
Store at 20 to
25°C (68 to 77°F). [See USP Controlled Room Temperature.]
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©Hospira 2004
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EN-0488
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Printed in USA
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HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
Revised: 08/2006Hospira, Inc.