Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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].; PRINCIPAL DISPLAY PANEL, VIAL LABEL VIAL PT1 VIAL PT 2 VIAL PT 3; PRINCIPAL DISPLAY PANEL, SERIALIZED LABELING SERIALIZED LABELING; PRINCIPAL DISPLAY PANEL - NDC 51662-1410-2 POUCH LABELING NDC 51662-1410-2 POUCH LABELING POUCH LABELING VIAL LABEL; PRINCIPAL DISPLAY PANEL - NDC 51662-1410-3 CASE LABELING NDC 51662-1410-3 CASE LABELING NDC 51662-1410-3 SERIALIZED RFID LABELING Case Labeling RFID Label
- HOW SUPPLIED 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].
- PRINCIPAL DISPLAY PANEL, VIAL LABEL VIAL PT1 VIAL PT 2 VIAL PT 3
- PRINCIPAL DISPLAY PANEL, SERIALIZED LABELING SERIALIZED LABELING
- PRINCIPAL DISPLAY PANEL - NDC 51662-1410-2 POUCH LABELING NDC 51662-1410-2 POUCH LABELING POUCH LABELING VIAL LABEL
- PRINCIPAL DISPLAY PANEL - NDC 51662-1410-3 CASE LABELING NDC 51662-1410-3 CASE LABELING NDC 51662-1410-3 SERIALIZED RFID LABELING Case Labeling RFID Label
Overview
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: STRUCTURE
Indications & Usage
INDICATIONS & USAGE 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.
Dosage & Administration
DOSAGE & ADMINISTRATION Pyridoxine Hydrochloride Injection may be administered intramuscularly or intravenously. In cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. Follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine. Poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed. The vitamin B6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life. In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily. In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given — 4 g intravenously followed by 1 g intramuscularly every 30 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
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 solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.
Adverse Reactions
Paresthesia, somnolence, and low serum folic acid levels have been reported.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.