PYRIDOXINE HCI
Drug Details
- Generic Name
- PYRIDOXINE HCI
- Brand Names
- PYRIDOXINE HCI
- Application Number
- ANDA080618
- Sponsor
- HF Acquisition Co LLC, DBA HealthFirst
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAMUSCULAR, INTRAVENOUS
- Active Ingredients
- PYRIDOXINE HYDROCHLORIDE
Indications and 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.
Warnings
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.