Pyridoxine Hydrochloride

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.

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.

General Single deficiency, as of pyridoxine alone, is rare. Multiple vitamin deficiency is to be expected in any inadequate diet. Patients treated with levodopa should avoid supplemental vitamins that contain more than 5 mg pyridoxine in the daily dose. Women taking oral contraceptives may exhibit increased pyridoxine requirements. Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Pregnancy Pregnancy Category A —The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy. Nursing Mothers The need for pyridoxine is increased during lactation. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman. Usage in Children Safety and effectiveness in children have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Paresthesia, somnolence, and low serum folic acid levels have been reported.

Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Pregnancy Category A —The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy.

The need for pyridoxine is increased during lactation. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman.

Usage in Children Safety and effectiveness in children have not been established.