1. Disclaimer
This content is intended solely for educational and professional reference purposes and does not substitute for medical advice, diagnosis, or treatment. Injectable vitamin preparations should only be administered under medical supervision.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
Clinical decisions must always be based on current prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
2. Summary
VITA-3 Double Ampoules is a parenteral vitamin B-complex preparation containing thiamine (vitamin B1), pyridoxine (vitamin B6), and hydroxocobalamin (a vitamin B12 analog). It is supplied as a double-ampoule system that must be mixed immediately before intramuscular administration to preserve chemical stability.
The product is primarily used for the treatment of confirmed or strongly suspected deficiencies of these vitamins and as adjunctive therapy in certain neuropathic conditions where deficiency is documented or oral therapy is not feasible. Hydroxocobalamin provides longer systemic retention compared with cyanocobalamin.
3. Brand Name
VITA-3® Double Ampoules
4. Category
- Vitamin B-Complex
- Neurotropic Vitamins
- Injectable Vitamin Supplement
5. Active Ingredient
- Vitamin B1 (Thiamine hydrochloride)
- Vitamin B6 (Pyridoxine hydrochloride)
- Vitamin B12 (Hydroxocobalamin)
6. Pharmaceutical Form & Strength
Solution for intramuscular injection – double ampoule system
Ampoule (1), 1 mL contains:
- Thiamine (Vitamin B1) 100 mg
- Pyridoxine (Vitamin B6) 10 mg
Ampoule (2), 1 mL contains:
- Hydroxocobalamin (Vitamin B12) 500 micrograms
Both ampoules must be mixed immediately before administration.
7. Manufacturer & Marketing Authorization Holder
Misr Company for Pharmaceutical Industries S.A.E. (MISR Pharmaceuticals) Egypt
8. Mechanism of Action
- Thiamine (B1): Converted to thiamine pyrophosphate, a critical coenzyme in carbohydrate metabolism and neuronal energy production. Essential for normal nerve conduction.
- Pyridoxine (B6): Converted to pyridoxal-5-phosphate, a cofactor in amino acid metabolism, neurotransmitter synthesis, and hemoglobin production. Supports peripheral nerve function.
- Hydroxocobalamin (B12): Converted intracellularly to methylcobalamin and adenosylcobalamin, required for DNA synthesis, red blood cell formation, and myelin maintenance. Compared with cyanocobalamin, hydroxocobalamin shows greater protein binding and prolonged serum levels.
The combination provides synergistic neurotropic and hematopoietic effects.
9. Spectrum of Activity
Not applicable in antimicrobial terms. Therapeutic activity is limited to vitamin replacement and metabolic support.
10. Pharmacokinetics
Absorption: Complete systemic availability following intramuscular injection.
Distribution: Widely distributed in body tissues; hydroxocobalamin is highly protein-bound.
Metabolism:
- Thiamine and pyridoxine are converted to active coenzyme forms mainly in the liver.
- Hydroxocobalamin is converted to active cobalamin forms intracellularly.
Elimination:
- Excess B1 and B6 are excreted in urine.
- Hydroxocobalamin undergoes biliary and renal excretion with reduced urinary loss compared to cyanocobalamin.
11. Indications
VITA-3 is indicated for:
- Confirmed or suspected deficiency of vitamins B1, B6, and/or B12
- Peripheral neuropathy related to nutritional deficiency
- Alcohol-related neuropathy with documented deficiency
- Diabetic neuropathy as adjunctive therapy only
- Malabsorption states where oral supplementation is ineffective
- Hyperemesis gravidarum associated with vitamin deficiency
Historical indications such as trigeminal neuralgia, optic neuritis, radiation sickness, or nonspecific “poor growth” are not supported as standard therapy in modern evidence-based guidelines and require careful clinical justification.
12. Administration
- Route: Intramuscular injection only
- Dose: One mixed injection daily or every 2–3 days, according to clinical judgment
- Duration: Limited to correction of deficiency or until oral therapy becomes feasible
13. Method of Preparation
- Draw the contents of Ampoule (1) and Ampoule (2) into the same syringe
- Mix gently immediately before injection
- Use promptly; do not store after mixing
14. Contraindications
- Hypersensitivity to any component or to cobalt-containing compounds
- History of severe allergic reaction to parenteral B-vitamins
- Leber’s hereditary optic neuropathy (vitamin B12 may worsen optic nerve damage)
15. Warnings & Precautions
- Parenteral B-vitamins may rarely cause serious hypersensitivity reactions, including anaphylaxis
- Repeated injections increase the risk of sensitization
- Prolonged high-dose pyridoxine may cause sensory neuropathy
- Vitamin B12 may correct anemia while allowing neurological damage to progress if the underlying cause is not addressed
- Use only under medical supervision
16. Drug Interactions
- Levodopa: Pyridoxine reduces efficacy when used without a dopa-decarboxylase inhibitor
- Chloramphenicol: May blunt hematologic response to vitamin B12
- Alcohol: Impairs thiamine absorption and utilization
- Metformin and PPIs: Long-term use may reduce B12 status
17. Side Effects
Generally well tolerated. Possible adverse effects include:
- Injection-site pain or irritation
- Nausea, headache, dizziness
- Skin rash or pruritus
- Acneiform eruptions (associated with B12)
- Rare: hypersensitivity or anaphylactic reactions
18. Use in Special Populations
- Pregnancy: May be used when deficiency is documented or clinically justified
- Lactation: Compatible with breastfeeding
- Pediatrics: Use only if clearly indicated; dosing requires medical supervision
- Elderly: Commonly beneficial due to higher prevalence of deficiency
19. Storage Conditions
- Store below 25–30°C
- Protect from light
- Do not freeze
- Keep in original packaging and out of reach of children
20. Additional Sections
Clinical Consideration:
VITA-3 should not replace proper diagnostic evaluation of neuropathy. Routine parenteral vitamin therapy without documented deficiency is not recommended in modern practice.
21. Frequently Asked Questions (FAQ)
Q1: Why is VITA-3 supplied as double ampoules? To maintain chemical stability until the moment of use.
Q2: Is it superior to oral B-complex? Only when deficiency is severe, malabsorption exists, or oral therapy is not feasible.
Q3: Can it be used long-term? Long-term use requires monitoring and clear indication.
22. References
- Manufacturer’s Product Information – Misr Pharmaceuticals
- British National Formulary (BNF) – Vitamins Section
- Martindale: The Complete Drug Reference
- StatPearls (NCBI): Thiamine, Pyridoxine, Hydroxocobalamin
- Cochrane Database of Systematic Reviews – Vitamin B for neuropathy