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Vitamin B Complex

RxNorm 801177· THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE· INTRAVENOUS

Mylan Institutional LLC

Indications and usage

INDICATIONS AND USAGE In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

Dosage and administration

DOSAGE AND ADMINISTRATION Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS .) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see HOW SUPPLIED ).

Warnings

WARNINGS Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.

Contraindications

CONTRAINDICATIONS Sensitivity to the ingredients listed.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • fatigue3,313
  • nausea2,215
  • diarrhoea2,179
  • headache2,072
  • pain1,759
  • drug ineffective1,635
  • dizziness1,632
  • dyspnoea1,493
  • arthralgia1,440
  • asthenia1,369
  • off label use1,279
  • fall1,262
  • weight decreased1,085
  • insomnia1,066
  • pain in extremity1,066
  • vomiting1,047

Adverse reactions (label)

ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (see WARNINGS ). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.

KR · 한국Products in Korea (188)

View more: Full FDA label on DailyMed →Label effective 20210915