Finished product reference
Biotin
Injection, Solution · Intramuscular · 5 mg/1mL · 1 mL
- List code
- 6536
- Pharmacologic class
- Vitamin (water-soluble B-complex vitamin, vitamin B7/H)
What it is and how it works
Biotin is a coenzyme for carboxylase enzymes (acetyl-CoA, pyruvate, propionyl-CoA and methylcrotonyl-CoA carboxylases) involved in fatty-acid synthesis, gluconeogenesis and amino-acid metabolism.
Indications
Prevention and treatment of biotin deficiency, including deficiency in long-term parenteral nutrition; inherited disorders of biotin metabolism such as biotinidase deficiency and holocarboxylase synthetase deficiency; also used in some hair, nail and skin conditions, although evidence is limited.
Dosage and administration (summary)
Dosing is individualised: physiological doses are used for deficiency, whereas much higher doses are given under specialist supervision for inherited metabolic disorders.
Contraindications
Hypersensitivity to biotin or any excipient.
Warnings and precautions
High-dose biotin interferes with streptavidin–biotin immunoassays, causing falsely high or low results (e.g. thyroid function tests, troponin, hormone assays); laboratories should be informed and biotin may need to be stopped before testing. It is generally well tolerated.
Pregnancy
Nutritional doses are considered safe in pregnancy.
Storage and supply
Store below 25 °C, protected from light and moisture.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.