Vitabion

Vitabion

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Contents
Thiamine mononitrate, pyridoxine hydrochloride, cyanocobalamin.
Description
Each film coated tablet contains: Thiamine mononitrate (Vitamin B1) 100 mg, pyridoxine hydrochloride (Vitamin B6) 200 mg, cyanocobalamin (Vitamin B12) 200 mcg.
Action
Pharmacology: Thiamine combines with adenosine triphosphate (ATP) to form a coenzyme, thiamine pyrophosphate (thiamine diphosphate, cocarboxylase), which is necessary for carbohydrate metabolism.
Pyridoxine is converted in erythrocytes to pyridoxal phosphate and to a lesser extent pyridoxamine phosphate, which act as coenzymes for various metabolic functions affecting protein, carbohydrate, and lipid utilization. Pyridoxine is involved in conversion of tryptophan to niacin or serotonin, breakdown of glycogen to glucose-1-phosphate, conversion of oxalate to glycine, synthesis of Gamma Aminobutyric Acid (GABA) within the CNS, and synthesis of heme. Cyanocobalamin acts as a coenzyme for various metabolic functions, including fat and carbohydrate metabolism and protein synthesis. It is necessary for growth, cell replication, hematopoiesis, and nucleoprotein and myelin synthesis, largely due to its effects on metabolism of methionine, folic acid, and malonic acid.
Pharmacokinetics: Thiamine: It is widely distributed to most body tissues and appears in breast milk. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body's requirements are excreted in the urine.
Pyridoxine: They are stored mainly in the liver and excreted in the urine. Pyridoxal crosses the placenta and appears in breast milk.
Cyanocobalamin: It is bound to specific plasma. They are stored in the liver, excreted in the bile and urine. It diffuses in the placenta and also in breast milk.
Indications/Uses
Mono-and polyneuropathies such as diabetic, alcoholic and toxic neuropathies, neuritis and neuralgia, especially cervical syndrome, shoulder-arm syndrome, lumbago, sciatica, root irritation due to degenerative changes of the vertebral column.
Deficiency or raised requirement of Vitamin B1, B6 and B12.
Dosage/Direction for Use
1 tablet three times daily or as directed by physician.
Overdosage
Since there is no specific antidote, treatment should be symptomatic and supportive and may include the following: To decrease absorption: Induction of emesis or use of gastric lavage to empty the stomach. Supportive care: Maintenance of adequate hydration. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Contraindications
Except under special circumstances, this medication should be not be used when the following medication problem exists: Cyanocobalamin: Leber's disease (optic nerve atrophy has occurred rapidly after administration; Cyanocobalamin concentrations are already elevated).
Risk-benefit should be considered when the following medication problems exist: Thiamine: Sensitivity to Thiamine; Wernicke's encephalopathy (intravenous glucose loading may precipitate or worse this condition in Thiamine-deficient patients; Thiamine should be administered prior to glucose).
Pyridoxine: Sensitivity to Pyridoxine.
Cyanocobalamin: Sensitivity to Cyanocobalamin or Hydroxocobalamin.
Special Precautions
Precaution to patient who are hypersensitivity to Thiamine, Cyanocobalamin, and Pyridoxine. Long term administration is associated with the development of severe peripheral neuropathies. This may occur with doses in excess of about 2 grams daily.
Cyanocobalamin should not be used in megaloblastic anemia of pregnancy, administration of doses greater than 10 microgams daily may produce hematological response in patients with folate deficiency.
Use In Pregnancy & Lactation
Thiamine: Widely distributed to most body tissues and appears in breast milk.
Pyridoxal and Cyanocobalamin: Crosses the placenta and also appears in breast milk.
Adverse Reactions
Incidence rare: Thiamine: Anaphylactic reaction (coughing: difficulty in swallowing; hives; itching of skin; swelling of face, lips or eyelids; wheezing or difficulty in breathing) usually after a large intravenous dose.
Pyridoxine: High doses taken for several months have caused severe sensory neuropathy, progression from unstable gait and numb feet to numbness to clumsiness of hands.
Cyanocobalamin: Anaphylactic reaction (skin, rash, itching, wheezing).
Incidence less frequent: Diarrhea; itching of the skin.
Drug Interactions
Pyridoxine: Cycloserine, ethionamide, hydralazine; immunosuppressants, such as: Azathioprine, Chlorambucil, corticosteroids, corticotrophin (ACTH), Cyclophosphamide, Cyclosporine, Mercaptopurine, Isoniazid and Penicillamine, Estrogen and contraceptives, Estrogen-containing, Levodopa.
Cyanocobalamin: Aminoglycosides; aminosalicylic acid; anticonvulsants, biguanides; chloramphenicol, cholestyramine, cimetidine, colchicine, potassium salts and methyldopa.
Storage
Store at temperature of not more than 30°C.
ATC Classification
A11D - VITAMIN B1, PLAIN AND IN COMBINATION WITH VITAMIN B6 AND B12 ; Used as dietary supplements.
Presentation/Packing
FC tab 50 x 10's.
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