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.

INN (International Name):

ZINC SULFATE ANHYDROUS

Composition:

ZINC CATION 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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:

Zinc Sulfate Injection, USP 1 mg/mL NDC 0517-6110-25                            10 mL SDV                            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 IN6110 Rev. 1/09

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._
----------
ZINC SULFATE INJECTION, USP
RX ONLY
(ZINC 1 MG/ML)
STERILE, PYROGEN FREE, TRACE ELEMENT ADDITIVE
FOR INTRAVENOUS USE AFTER DILUTION
DESCRIPTION
Zinc Sulfate Injection, USP is a sterile, nonpyrogenic solution
intended for use as an additive to
solutions for Total Parenteral Nutrition (TPN). Each mL contains Zinc
Sulfate (Anhydrous) 2.46 mg,
Water for Injection q.s. pH adjusted with Sulfuric Acid. It contains
no preservatives. Discard any unused
portion.
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
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
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 impaired. Premature
neonates are particularly at risk
because their kidneys are immature, and th