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Tribedoce (Thiamine Hydrochloride, Hydroxocobalamin, Pyridoxine Hydrochloride)

Active Ingredient: Thiamine Hydrochloride (B1), Hydroxocobalamin (B12), Pyridoxine Hydrochloride (B6)
Dosage: 100, 200 mcg
Route of Administration: Oral
Dosage Form: Soluble tablets
Quantity per package: 30, 60 per pack

Tribedoce belongs to a class of water-soluble vitamins. It ensures a high biological activity. This complex of vitamins is significant for normal hematopoiesis, it contributes to the maturation of erythrocytes. Tribedoce is involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. It has a beneficial effect on hepatic function and the nervous system condition. This vitamin complex activates the blood coagulation. When taken in high doses, it causes an increase in the thromboplastin and prothrombin activity.

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Indications

The drug is used to treat low back pain, cervicalgia, brachialgia, radiculitis, facial neuralgia, trigeminal neuralgia, intercostal neuralgia, herpetic neuralgia, alcoholic neuropathy, diabetic neuropathy, carpal duct syndrome, fibromyalgia, spondylitis.

Dosage and administration

Take 3 dragees a day, preferably after meals.

Contraindications

  • Hypersensitivity to the components of the formula;
  • Polycythemia vera;
  • Early Leber’s disease (hereditary optic nerve atrophy);
  • Gastroduodenal acid peptic ulcer;
  • Attacks of bronchial asthma, hives or acute rhinitis caused by acetylsalicylic acid or its derivatives;
  • A history of bleeding in the digestive tract;
  • Pregnancy, breastfeeding and children under 12 years;
  • Renal and/or hepatic impairment;
  • Severe arterial hypertension;
  • Cytopenias.

Side effects

Isolated reports of reactions by long-term parenteral administration of thiamine and vitamin B12 have been published. Thay may probably be due to rare cases of hypersensitivity. The administration of pyridoxine megadoses may produce certain sensory neuropathic syndromes. however, histopathological studies have not shown that such syndromes are related to some degree of neuronal degeneration. When pyridoxine is suspended, the neuronal diffusion gradually improves, until the patients recover completely. Hypersensitivity to any of the components of the formula can provoke skin rash and other reactions, polycythemia vera.

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Gastrointestinal system: abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia. Rare reactions: gastroduodenal hemorrhage, mane, hematemesis, ulceration, perforation, bloody diarrhea. Occasional: ulcerative colitis or Crohn’s proctocolitis, gingivostomatitis, esophageal lesions, glossitis, constipation.

Central nervous system: Vertigo, lightheadedness, headache, fatigue. Rare reactions: paraesthesia, sensitivity and vision disorders;, memory disorders, disorientation, tinnitus, insomnia, psychotic irritations, taste disturbances.

Skin (isolated cases): Vesicular eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, erythroderma (exfoliative dermatitis), alopecia, photosensitivity reactions, purpura.

Kidney (in rare cases): Hypotension, edema, anaphylactic reactions.

Overdose

There have been no reports of overdosing by thiamine or vitamin B12.

In cases of acute poisoning, symptomatic support measures should be applied. A specific antidote is unknown. The required measures: stomach washing and administration of activated carbon.

Interaction

It has been reported that thiamine may increase the effect of neuromuscular blocking agents.

Pyridoxal phosphate reinforces the peripheral decarboxylation of levodopa and reduces its effectiveness in the treatment of Parkinson’s disease.

Concomitant administration of carbidopa with levodopa prevents this effect of pyridoxine. Pyridoxine hydrochloride should not be administered in doses greater than 5 mg per day.

The administration of 200 mg per day of pyridoxine hydrochloride for one month causes a decrease in serum concentrations of phenobarbital and phenytoin up to 50%. Cycloserine and hydralazine are antagonists of vitamin B6 and the administration of pyridoxine reduces the neuronal side effects related to the use of these compounds. Prolonged use of penicillamine may cause vitamin B6 deficiency. When pyridoxine and cyclosporine are administered simultaneously, the latter’s plasma concentrations may decrease.

The absorption of vitamin B12 in the gastrointestinal system can be reduced by the administration of the following drugs: aminoglycosides, colchicine, preparations based on prolonged-release potassium, aminosalicylic acid and its salts, anticonvulsants (phenytoin, phenobarbital, primidone), irritation with cobalt in the small intestine and excessive alcohol intake for more than 2 weeks. Concomitant administration of neomycin and colchicine increases malabsorption of vitamin B12.

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Ascorbic acid can destroy significant amounts of vitamin B12 and intrinsic factor, in vitro conditions, so this possibility should be considered when large doses of ascorbic acid are administered concomitantly to vitamin B12. Prednisone has been reported to increase vitamin B12 absorption and intrinsic factor secretion in some patients with pernicious anemia but not in patients with partial or total gastrectomy.

The clinical importance of these observations is unknown. Concomitant administration of chloramphenicol and vitamin B12 may antagonize the hematopoietic response to the vitamin.

Simultaneous administration of diclofenac with lithium or digoxin-based preparations or with potassium-sparing diuretics may increase the plasma concentrations of these drugs.

Concomitant use of Tribedoce with other non-steroidal anti-inflammatory drugs may increase the risk of adverse side effects. Close monitoring should be practiced in patients treated with anticoagulants. Non-steroidal anti-inflammatory drugs should be suspended 24 hours before administering a methotrexate treatment, to avoid raising the plasma cytostatic concentration and causing toxic effects.