PYRIDOXINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following:      Inadequate dietary intake.      Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia. The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions.  It is also indicated when gastrointestinal absorption is impaired. A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication. Symptoms of dependence have been noted in adults given only 200

Product summary:

Pyridoxine Hydrochloride Injection, USP is supplied as: PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIDOXINE HYDROCHLORIDE- PYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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PYRIDOXINE HYDROCHLORIDE INJECTION, USP
100 MG PER ML
DESCRIPTION:
Pyridoxine Hydrochloride Injection, USP is a sterile solution of
pyridoxine hydrochloride in Water for
Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5%
chlorobutanol anhydrous
(chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0
to 3.8).
Pyridoxine hydrochloride is a colorless or white crystal or a white
crystalline powder. One gram
dissolves in 5 mL of water. It is stable in air and is slowly affected
by sunlight.
The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl)
pyridine hydrochloride.
The structural formula is:
CLINICAL PHARMACOLOGY:
Natural substances that have vitamin B
activity are pyridoxine in plants and pyridoxal or pyridoxamine
in animals. All 3 are converted to pyridoxal phosphate by the enzyme
pyridoxal kinase. The
physiologically active forms of vitamin B
are pyridoxal phosphate (codecarboxylase) and
pyridoxamine phosphate. Riboflavin is required for the conversion of
pyridoxine phosphate to
pyridoxal phosphate.
Vitamin B
acts as a coenzyme in the metabolism of protein, carbohydrate, and
fat. In protein
metabolism, it participates in the decarboxylation of amino acids,
conversion of tryptophan to niacin or
to serotonin (5-hydroxtryptamine), deamination, and transamination and
transulfuration of amino acids. In
carbohydrate metabolism, it is responsible for the breakdown of
glycogen to glucose-1-phosphate.
The total adult body pool consists of 16 to 25 mg of pyridoxine. Its
half-life appears to be 15 to 20
days. Vitamin B
is degraded to 4-pyridoxic acid in the liver. This metabolite is
excreted in the urine.
The need for pyridoxine increases with the amount of protein in the
diet. The tryptophan load test
appears to uncover early vitamin B
deficiency by detecting xanthinurea. The average adult minimum
daily requirement is about 1.25 mg. The ‘‘Recommended Dietary
Allowance’’