General Information: Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group.
Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH.
Indications: 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.
Contraindications: Sensitivity to the ingredients listed.
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.
Precautions: The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously.
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.
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).
How supplied: Vitamin B-Complex 100 Injection is available in a 30 mL multiple-dose vial. Darkening of the solution may occur over time due to the riboflavin content. The color does not affect the safety or efficacy of the product.
Storage: Store this medication in a refrigerator at 36°F to 46°F (2°C to 8°C). Keep all medicines out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.