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Substance · official US FDA label

Pyridoxine (pyridoxine)

60 medicines listed on Vimpia contain it, alone or combined. Below, the official US FDA label for pyridoxine, unchanged.

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This is a US label.

The official US FDA label for pyridoxine (published as PYRIDOXINE HYDROCHLORIDE), effective October 15, 2024, describes products sold in the United States. The medicine sold in DR Congo may differ in strength, form or approved uses: ask a pharmacist or a doctor.

Official US FDA label for pyridoxine

Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. The full label on DailyMed.

Uses

INDICATIONS AND 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 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.

Dosage

US dosage, for products sold in the United States. For a medicine bought in DR Congo, follow its box, its leaflet or your pharmacist.

DOSAGE AND 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 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.

Warnings and 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.

Side effects

ADVERSE REACTIONS: 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.

Medicines that contain it

Names as they are sold. A medicine without an English page links to its French page.

Sources

  • ●Labels: U.S. Food and Drug Administration, openFDA (public domain). Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. DailyMed.
  • ●English names of substances: RxNorm, U.S. National Library of Medicine.
  • ●Marketing authorizations: register of the ACOREP, DR Congo.
  • ●Essential medicines: national list of essential medicines of DR Congo (LNME).
  • ●Composition: public medicines database of France (BDPM), ANSM, open licence.

Public information, for reference only: it does not replace the advice of a pharmacist or a doctor. Vimpia writes nothing about how to use a medicine and translates nothing: the label is the US FDA's, unchanged; names, composition and authorizations come from the official sources above.