FOLIC ACID- folic acid injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

FOLIC ACID

Composition:

FOLIC ACID 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.

Product summary:

Folic Acid Injection, USP 50 mg per 10 mL (5 mg per mL)  is available as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Retain vial in carton until contents are used.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID - FOLIC ACID INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
FOLIC ACID INJECTION, USP
Rx only
DESCRIPTION:
Folic Acid Injection, USP is a sterile, nonpyrogenic solution of
sodium folate (prepared by the addition
of sodium hydroxide to folic acid) in Water for Injection intended for
intramuscular (IM), intravenous
(IV) or subcutaneous (SC) use.
Folic Acid is a complex organic compound present in liver, yeast and
other substances, which may be
prepared synthetically. It is a yellow or yellowish orange, odorless
crystalline powder. It is very
slightly soluble in water, insoluble in alcohol, chloroform, ether;
readily dissolves in dilute solutions
of alkali hydroxides and carbonates. It is chemically designated as:
L-Glutamic acid, _N_-[4-[[(2-amino-1-
4-dihydro-4-oxo-6-pteridinyl) methyl] amino]benzoyl]-, and has the
following structural formula.
C
H
N
O M.W. 441.40
Each mL contains: Sodium folate (equivalent to 5 mg folic acid);
edetate disodium 2 mg; benzyl alcohol
15 mg (added as preservative); Water for Injection q.s. Hydrochloric
acid and/or sodium hydroxide for
pH adjustment (8.0 to 11.0).
CLINICAL PHARMACOLOGY:
In man, an exogenous source of folate is required for nucleoprotein
synthesis and maintenance of
normal erythropoiesis. Folic acid, whether given by mouth or
parenterally, stimulates specifically the
production of red blood cells, white blood cells and platelets in
persons suffering from certain
megaloblastic anemias.
INDICATIONS AND USAGE:
Folic Acid Injection, USP alone is effective in the treatment of
megaloblastic anemias due to a
deficiency of folic acid as may be seen in tropical or nontropical
sprue, in anemias of nutritional origin,
pregnancy, infancy or childhood.
WARNINGS:
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
soluti