CALCIUM GLUCONATE - calcium gluconate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31) (CALCIUM - UNII:SY7Q814VUP)

Available from:

American Regent, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcium gluconate is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy. It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage. Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs. In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity provided the patient is not receiving digitalis therapy. Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia. Intravenous administration of calcium is contraindicated when serum calcium levels are above normal. If neonates are required, or expected to require, trea

Product summary:

Calcium Gluconate Injection, USP 10% NDC 0517-3910-25    10%    10 mL Single Dose Vials packed in boxes of 25 NDC 0517-3950-25    10%    50 mL Single Dose Vials packed in boxes of 25 NDC 0517-3900-25    10%    100 mL Pharmacy Bulk Package packed in boxes of 25 Supersaturated solutions are prone to precipitation. NOTE: If crystallization has occurred, warming in a 60°C water bath for 15-30 minutes with occasional shaking, may dissolve the precipitate. Cool to body temperature before use. The injection must be clear at the time of use. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. No preservative added. Unused portion of vial should be discarded. Use only if solution is clear and seal intact. 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 IN3910 Rev. 7/11

Authorization status:

unapproved drug other

Summary of Product characteristics

CALCIUM GLUCONATE - CALCIUM GLUCONATE 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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CALCIUM GLUCONATE INJECTION, USP 10%
RX ONLY
STERILE, NONPYROGENIC
0.68 MOSMOI/ML 680 MOSMOL/L
CA 0.465 MEQ/ML PH (6.0-8.2)
100 ML PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION
CAUTION: For Intravenous Use. Not recommended for Intramuscular or
Subcutaneous use.
DESCRIPTION
Calcium Gluconate is the calcium salt of gluconic acid, an oxidation
product of glucose, and contains
9.3% calcium, which is about one-third of the calcium in strength of
calcium chloride USP. Since it is
soluble to the extent of only one part in 30 parts of cold water, the
10% solution is supersaturated and is
stabilized by the addition of calcium saccharate tetrahydrate 0.46%
w/v (which supplies calcium 6.2%).
Each mL contains 98 mg of calcium gluconate monohydrate, 4.6 mg of
calcium saccharate tetrahydrate,
and Water for Injection USP, q.s. Each mL provides 9.3 mg (0.465
milliequivalents) of calcium.
The 100 mL Pharmacy Bulk Package contains many single doses for use in
a pharmacy admixture
program in the preparation of parenteral fluids. See directions for
dispensing from the 100 mL
Pharmacy Bulk Package.
pH is adjusted with sodium hydroxide and/or hydrochloric acid.
The structural formula is:
CLINICAL PHARMACOLOGY
Calcium is the fifth most abundant element in the body and is
essential for maintenance of the functional
integrity of nervous, muscular and skeletal systems and cell membrane
and capillary permeability. It is
also an important activator in many enzymatic reactions and is
essential to a number of physiologic
processes including transmission of nerve impulses; contraction of
cardiac, smooth and skeletal
muscles; renal function; respiration and blood coagulation. Calcium
also plays regulatory roles in the
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release and storage of neurotransmitters and hormones