1. Disclaimer
The information provided in this report is intended solely for educational and professional reference purposes and is not a substitute for medical advice, diagnosis, or treatment. Clinical decisions must always be based on the official prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
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2. Summary
Thiotacid® is a thioctic acid (α-lipoic acid)–based pharmaceutical product widely used in the management of diabetic peripheral neuropathy and other neuropathic conditions associated with oxidative stress and metabolic dysfunction. Certain formulations (Thiotacid Compound / Plus) combine α-lipoic acid with benfotiamine (vitamin B1 derivative) and cyanocobalamin (vitamin B12) to provide synergistic neuroprotective, antioxidant, and metabolic benefits. The drug improves nerve blood flow, reduces oxidative damage, and supports nerve regeneration, making it a well-established option in neuropathic symptom control.
3. Brand Name
- Thiotacid® 300 mg
- Thiotacid® 600 mg
- Thiotacid® Compound
- Thiotacid® Plus XR
- Thiotacid® Ampoules
4. Category
- Antioxidant
- Neuroprotective agent
- Metabolic modulator
5. Active Ingredient
Depending on formulation:
- Thioctic Acid (Alpha-Lipoic Acid)
- Benfotiamine (Vitamin B1 derivative)
- Cyanocobalamin (Vitamin B12)
6. Pharmaceutical Form & Strength
- Film-coated tablets: 300 mg, 600 mg
- Capsules / caplets (Compound):
- Thioctic acid 300 mg
- Benfotiamine 40 mg
- Cyanocobalamin 250 mcg
- Extended-release tablets (XR): 600 mg
- IV ampoules: 300 mg / 10 mL
7. Manufacturer & Marketing Authorization Holder
EVA Pharma for Pharmaceuticals & Medical Appliances S.A.E.
Cairo, Egypt
8. Mechanism of Action
- Thioctic Acid acts as a mitochondrial coenzyme in oxidative decarboxylation, enhances glucose utilization, scavenges reactive oxygen species, regenerates endogenous antioxidants (glutathione, vitamins C & E), and improves endoneurial blood flow.
- Benfotiamine increases transketolase activity, diverting glucose metabolites away from harmful pathways (AGEs, PKC, hexosamine), thereby protecting nerves from hyperglycemia-induced damage.
- Cyanocobalamin is essential for myelin synthesis, DNA synthesis, and axonal regeneration, improving nerve conduction and repair.
9. Spectrum of Activity
Not applicable (non-antimicrobial agent).
10. Pharmacokinetics
- Absorption: Rapid; reduced by food intake
- Bioavailability: Approximately 20–40%
- Distribution: Wide; crosses blood-brain barrier
- Metabolism: Extensive hepatic metabolism
- Elimination: Primarily renal (as metabolites)
- Half-life: ~30 minutes (α-lipoic acid)
11. Indications
- Diabetic peripheral polyneuropathy
- Neuropathic pain, paresthesia, and numbness
- Alcoholic and nutritional neuropathies (adjunctive)
- Nerve inflammation and metabolic nerve disorders
- Vitamin B1/B12 deficiency–associated neuropathy (compound forms)
12. Administration
- Oral: Taken on an empty stomach, preferably 30 minutes before meals
- IV: Administered by slow intravenous infusion under medical supervision
13. Method of Preparation
- IV ampoules are diluted in 100–250 mL of 0.9% sodium chloride
- Infusion must be protected from light
- Administer over approximately 30 minutes
14. Contraindications
- Hypersensitivity to thioctic acid or any excipient
- Known allergy to B-vitamins (compound forms)
- Use in children unless explicitly prescribed
15. Warnings & Precautions
- Monitor blood glucose in diabetic patients (risk of hypoglycemia)
- Avoid alcohol consumption (reduces efficacy, worsens neuropathy)
- Use caution in thyroid disorders and severe hepatic disease
- IV administration requires monitoring for rare hypersensitivity reactions
16. Drug Interactions
- Antidiabetic agents: Enhanced hypoglycemic effect
- Cisplatin: Reduced chemotherapeutic efficacy
- Metal supplements (iron, calcium, magnesium): Reduced absorption if taken concurrently
- Alcohol: Decreases therapeutic benefit
17. Side Effects
Common:
- Nausea, vomiting, abdominal discomfort
- Headache, dizziness
- Metallic taste
Uncommon:
- Skin rash, pruritus
- Hypoglycemia (mainly in diabetics)
Rare:
- Allergic reactions
- Anaphylactoid reactions (IV form)
18. Use in Special Populations
- Pregnancy: Use only if benefit outweighs risk
- Lactation: Caution advised; insufficient data
- Elderly: No routine dose adjustment
- Renal/Hepatic impairment: Use with caution
19. Storage Conditions
- Store below 30°C
- Protect from light and moisture
- Keep in original packaging
- Keep out of reach of children
20. Additional Sections
Clinical Notes:
- Maximum benefit typically observed after 3–6 weeks
- IV therapy is often followed by oral maintenance
Overdose:
No specific antidote; manage symptomatically
21. Frequently Asked Questions (FAQ)
Q: Should Thiotacid be taken with food?
A: No. It should be taken on an empty stomach to maximize absorption.
Q: Can it cure diabetic neuropathy?
A: No. It relieves symptoms and may slow progression but does not cure the underlying disease.
Q: When will improvement be noticed?
A: Usually within 3–5 weeks of continuous use.
22. References
- EVA Pharma – Thiotacid® Product Monographs (EDA-approved)
- Ziegler D. et al., Diabetes Care – Alpha-lipoic acid in diabetic neuropathy
- European Medicines Agency (EMA) – Thioctic acid assessment reports
- NICE & ADA guidelines on neuropathic pain management