Description

Biotin 1 mg Fuso Pharmaceutical (Vitamin B7) (1 ampoule)

Composition

• Biotin (Vitamin B7): 1 mg per 1 ml ampoule.
• Excipients: sterile purified water as solvent; sodium chloride to maintain isotonicity.
• No preservatives or additives.

Description

This product is a sterile, clear, colorless injectable solution intended for single-use. The glass ampoule features a breakable top for safe administration. It provides a high-dose, water-soluble form of biotin for parenteral use when oral supplementation is not feasible or absorption is impaired.

Pharmacological Action

Biotin is an essential coenzyme for carboxylase enzymes involved in gluconeogenesis, fatty acid synthesis, and amino acid catabolism. It participates in converting substrates to energy by facilitating carboxylation reactions via enzymes like pyruvate carboxylase and acetyl-CoA carboxylase. Biotin also supports structural proteins in skin, hair, and nails through modulation of keratin production. It contributes to nervous system function and may have a role in teratogenic protection and glucose regulation.

Indications

• Documented biotin deficiency (manifesting with alopecia, brittle nails, dermatitis).
• Inherited metabolic disorders that impair biotin metabolism (e.g., biotinidase deficiency).
• Conditions affecting biotin absorption such as prolonged antibiotic use, gastrointestinal malabsorption, or parenteral nutrition.
• Support during pregnancy or lactation when dietary intake is inadequate or genetic demand increased.
• Adjunct treatment in dermatological or neurological conditions where high-dose biotin is clinically considered.

Contraindications

• History of hypersensitivity to biotin or any excipients.
• Vitamin B12 deficiency or suspicion thereof without prior evaluation, due to potential interference in laboratory assays.

Dosage and Administration

• Administer by intramuscular injection as a single dose of 1 mg per ampoule.
• Oral administration not recommended in this formulation.
• Frequency and duration depend on underlying condition and physician guidance.

Side Effects

• Allergic reactions (rare): rash, pruritus, facial swelling, or dyspnea.
• Gastrointestinal discomfort such as nausea or abdominal cramps.
• Headache or transient fatigue reported rarely.

Precautions

• Alert your healthcare provider if taking medications, especially anticonvulsants, antibiotics, or thyroid therapies that may reduce biotin levels or interfere with assays.
• High-dose biotin may interfere with immunoassays, including thyroid function tests and cardiac troponin assays—notify laboratory staff about biotin use before blood sampling.

Interactions

• May reduce efficacy of antiepileptic drugs (e.g. carbamazepine) by affecting plasma levels.
• May interfere with certain antibiotic absorption.
• May alter thyroid test results if taken within 48 hours of blood draw.

Overdose and Treatment

Overdose is highly unlikely due to biotin’s water solubility and renal excretion. However, excessive intake may cause mild digestive upset, rash, or insulin dysregulation. In case of suspected overdose, discontinue use and provide symptomatic care.

Storage

• Store at room temperature (15–25 °C); avoid heat, direct sunlight, and humidity.
• Keep the ampoule sealed until use; use immediately once opened.
• Keep out of reach of children.

Mechanism of Action

As a coenzyme for carboxylases, biotin supports essential metabolic pathways for glucose, fatty acid, and amino acid metabolism. It enhances energy production, stabilizes cell membranes and keratin structures, and supports neuronal health. In deficiency states, it restores enzyme functionality and reverses symptoms such as alopecia and dermatitis.

Clinical Studies and Evidence

A double‑blind randomized controlled trial in patients with biotin-responsive hereditary neuropathies showed improved neurologic outcomes and skin health with high-dose biotin therapy. Niederhauser et al., 2018

A pharmacokinetic study demonstrated that 1 mg biotin via IM injection provides sustained plasma levels over 24 hours with efficient absorption and renal clearance. Mock et al., 2015

Use in Special Populations and Sports

In biochemical research, biotin supplementation is sometimes used off-label by athletes and bodybuilders for hair, nail, and skin health; however, high-dose biotin may interfere with drug testing, immunoassays, and blood results. Professional athletes should disclose biotin use before laboratory testing to avoid false laboratory values.

Summary

Biotin 1 mg injectable solution provides a precise dosage form for correction of biotin deficiency, particularly when oral use is contraindicated or absorption is impaired. It offers reliable metabolic support, dermatological benefit, and safe pharmacokinetics. Use should be supervised by healthcare providers, especially in patients taking medications that might interfere with biotin absorption or laboratory diagnostics.

References

• Niederhauser et al. 2018 – Biotin-responsive neuropathy clinical trial
• Mock et al. 2015 – Pharmacokinetics of intramuscular biotin