البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)
HF Acquisition Co LLC, DBA HealthFirst
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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].
Abbreviated New Drug Application
PYRIDOXINE HCI- PYRIDOXINE HCI INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- 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 اقرأ الوثيقة كاملة