IV Dilution &
Medication Reference

PYRIDOXINE HYDROCHLORIDE injection

Usual Diluents Return to article top

May also be administered undiluted by direct injection.

Standard Dilutions [Amt of drug] [Infusion vol] [Infusion rate] Return to article top

Final concentration: 50 mg/mL. Protect from light.
*Depending on indication.

WARNINGS Return to article top

DESCRIPTION Return to article top

CLINICAL PHARMACOLOGY: Return to article top

CLINICAL PHARMACOLOGY:

INDICATIONS AND USAGE Return to article top

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.

CONTRAINDICATIONS Return to article top

A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.

PRECAUTIONS Return to article top

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.

Precautions:

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.

ADVERSE REACTIONS Return to article top

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.

Drug information

DOSAGE AND ADMINISTRATION Return to article top

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 B 6 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.

HOW SUPPLIED Return to article top

Pyridoxine Hydrochloride Injection, USP is supplied as:

Storage and Stability Return to article top

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].