PYRIDOXINE HCI injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

HF Acquisition Co LLC, DBA HealthFirst

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 B6 dependent convulsions or vitamin B6 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 mg daily, followed by withdrawal.

Dettagli prodotto:

PYRIDOXINE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1410-1 PYRIDOXINE HCI INJECTION, USP 100mg per mL 1mL VIAL NDC 51662-1410-2 PYRIDOXINE HCI INJECTION, USP 100mg per mL 1mL VIAL, 1 VIAL PER POUCH NDC 51662-1410-3 PYRIDOXINE HCI INJECTION, USP 100mg per mL 1mL VIAL, 1 VIAL PER POUCH, 25 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PYRIDOXINE HCI- PYRIDOXINE HCI INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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PYRIDOXINE HCI INJECTION, USP 100MG PER ML 1ML VIAL
SPL UNCLASSIFIED
100 mg/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 B6 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 B6 are
pyridoxal phosphate
(codecarboxylase) and pyridoxamine phosphate. Riboflavin is required
for the
conversion of pyridoxine phosphate to pyridoxal phosphate.
Vitamin B6 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 B6 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 B6 deficiency by detecting
xanthinurea. The
average adult minimum daily requirement is about 1.25 mg. The
‘‘Recommended