ZINC SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO) (ZINC CATION - UNII:13S1S8SF37)

Available from:

American Regent, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Concentrated Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain plasma levels and to prevent depletion of endogenous stores. Concentrated Zinc Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.

Product summary:

Concentrated Zinc Sulfate Injection, USP, 5 mg zinc/mL NDC 0517-8105-25     5 mL Vials     Packed in a box of 25 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN8105 Rev. 1/09 MG #14229

Authorization status:

unapproved drug other

Summary of Product characteristics

ZINC SULFATE- ZINC SULFATE INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CONCENTRATED ZINC SULFATE INJECTION, USP
RX ONLY
STERILE, NONPYROGENIC TRACE ELEMENT ADDITIVE FOR INTRAVENOUS USE AFTER
DILUTION
(ZINC 5 MG/ML)
DESCRIPTION
Concentrated Zinc Sulfate Injection, USP is a sterile, non-pyrogenic
solution intended for use as an
additive to solutions for Total Parenteral Nutrition (TPN). Each mL
contains Zinc Sulfate (Anhydrous)
12.32 mg, Water for Injection q.s. pH adjusted with Sulfuric Acid. It
contains no preservatives. Discard
unused portion. It delivers elemental zinc 5 mg per mL.
CLINICAL PHARMACOLOGY
Zinc has been identified as a cofactor for over 70 different enzymes,
including 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.
Providing zinc during TPN prevents development of the following
deficiency symptoms: Parakeratosis,
hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth
retardation and
hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL,
dermatitis followed by alopecia has
been reported for TPN patients.
INDICATIONS AND USAGE
Concentrated Zinc Sulfate Injection, USP is indicated for use as a
supplement to intravenous solutions
given for TPN. Administration helps to maintain plasma levels and to
prevent depletion of endogenous
stores.
CONTRAINDICATIONS
Concentrated Zinc Sulfate Injection, USP should not be given undiluted
by direct injection into a
peripheral vein because of the likelihood of infusion phlebitis and
the potential to increase renal loss of
zinc from a bolus injection.
WARNINGS
This product contains aluminum that may be toxic. Aluminum may reach
toxic levels with prolonged
parenteral administration if kidney function is impaire