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B-cobal
Film-coated tablet
Description
A round, red film-coated tablet
with diameter about 12mm.
Composition
Each tablet contains active ingredients: mecobalamin 0.5 mg, vitamin B1 100
mg and Vitamin B6 200 mg
Actions
B-cobal is a combination of the 3 essential neurotropic vitamin B group.
Vitamin B1 is involved in carbohydrate metabolisme and in nerve
transmission. Vitamin B6 is involved in amino acid metabolism and in protein
metabolism. Mecobalamin is a B12-containing co-enzyme with an active methyl
base. It participates in transmethylation reactions and is the most active
of all B12 homologs in the body with respect to nucleic acid, protein and
lipid metabolism. Mecobalamin acts to repair damaged nerve tissue in nerve
disorders eg: axonal degeneration and demylination; and it is involved in
erythroblast maturation, promotion of erythroblast division, and heme
synthesis, thus acting to improve the status of the blood in megablastic
anemia.
Pharmacology
Mecobalamin promotes the metabolism of nucleic acids proteins and lipids. In
animal studies, mecobalamin acted as co-enzyme in methionine synthesis. In
particular, it was found to be involved in the synthesis of thymidine from
deoxyuridine and to accelerate the synthesis of DNA and RNA, and also found
to accelerate the synthesis of lecithin, a major component of the myelin
sheath.
Mecobalamin is efficiently
transferred to nervous tissue and improves metabolic disorder:
Mecobalamin is a CH3-vitamin B12 which is found in high concentration in
blood and cerebrospinal fluid. It also accelerated the synthesis of the
major structural component of the axon in sciatic nerve cell of rats with
experimental diabetes and returned the protein transport rate close to
normal, resulting in maintenance of axonal function.
Mecobalamin repairs nerve tissues in experimental nerve injury models.
Mecobalamin inhibits abnormal excitation transmission by nerve tissues.
Mecobalamin improves anemia by accelerating the maturation and division of
erythroblast.
Pharmacokinetics
Vitamin B1 is absorbed from the gastrointestinal tract and is widely
distributed to most bony tissues. it is not stored in the body and amounts
in excess of the body's requirements are excreted in urine as unchanged
thiamine or its metabolite, pyrimidine. Vitamin B6 is absorbed from the
gastrointestinal tract and is converted to the active form: Pyridoxal
phosphate. Pyridoxal phosphate is transformed to pyridoxic acid and excreted
in the urine . When mecobalamin administered by oral, peak plasma
concentration is achieved after 3 hrs and it is dose-related. The excretion
mainly through urine, approximately 40-80% of the total urine excretion is
excreted within first 8 hours.
Indications
For neurological and other disorders associated with disturbance of the
nerve cell metabolism in which high dose B-complex vitamins play a role.
These include: Polyneuritis (of toxic and non toxic etiology): neuralgias eg:
lumbago, sciatica, root irritation due to degenerative changes of the
vertebral column , shoulder-arm syndrome, herpes zoster, cervical syndrome,
ischialgia, etc: diabetic neuropathy; metabolic and neuropathic changes due
to pregnancy and oral contraceptives ; convalescence.
Megaloblastic anemia due to vitamin B12 deficiency.
Dosage
Usually for adults, orally
administer 1 tab 3 times a day.
The dosage should be adjusted according to age of patient and severity of
symptoms.
Side-effects
Gastrointestinal Symptoms, eg anorexia, nausea or diarrhea may occur
infrequently.
Dermatological: Skin rash may occur rarely.
Others: Prolonged use of larger doses of mecobalamin is not recommended to
patients whose occupation requires handling of mercury or its compounds.
PRECAUTIONS/WARNINGS
Cyanocobalamin should not be given before a diagnosis has been fully
established because of the possibility of masking symptoms of subacute
degeneration of the spinal cord. Cyanocobalamin is not a suitable form of
vitamin B12 for the treatment of optic neuropathies associated with raised
plasma concentrations of cyanocobalamin. Long term administration of large
doses of pyridoxine is associated with the development of severe peripheral
neuropathies. This may occur with doses in excess of about 2g daily.
Cyanocobalamin should not be used in megaloblastic anaemia of pregnancy.
Administration of doses greater than 10 microgram daily may produce a
haematological response in patients with folate deficiency.
CONTRAINDICATIONS
Patients with a history of
hypersensitive to vitamin B and mecobalamin
DRUG INTERACTIONS
Metformin, histamin H-2 receptor antagonists (cimetidine, ranitidine),
aminoglycosides, colchicines, aminosalicylic acid, anticonvulsants, neomycin
and alcohol may decrease the absorption of vitamin B12.
Antibiotics, Tetracycline - Vitamin B1 and Vitamin B12 should not be taken
at the same time as the antibiotic tetracycline because it interferes with
the absorption and effectiveness of this medication. B-cobal tablet should
be taken at different times from tetracycline.
Antidepressant Medications, Tricylic - Taking vitamin B1 supplements may improve treatment with
antidepressants such as nortriptyline, especially in elderly patients. Other
medications in this class of antidepressants include desimipramine and
imipramine.
Digoxin - Laboratory studies suggest that digoxin may reduce the ability of
heart cells to absorb and use vitamin B1. Diuretics particularly furosemide,
may reduce the levels of vitamin B1 in the body.
Vitamin B6 decreases the effects of the levodopa
Symptoms and treatment for overdosage
In case of overdose, treatment is
symptomatic and supportive.
Packing
Amber glass bottle of 15's, 30's,
60's and 90's.
Blister pack of 200's.
Store below 25°C in an airtight container.
Protect from light and moisture.
Shelf-life
Three years from the date of
manufacture.
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