Re-B Forte

Re-B Forte

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Contents
Thiamine mononitrate, pyridoxine hydrochloride, cyanocobalamin.
Description
Each film coated tablet contains: Thiamine mononitrate (B1) 250 mg, pyridoxine (B6) hydrochloride 250 mg, cyanocobalamin (B12) 1,000 mcg.
Action
RE-B FORTE is a combination of the 3 essential neurotropic vitamin B group.
Pharmacology: Thiamine is involved in carbohydrate metabolism and in nerve transmission. Thiamine combines with adenosine triphosphate (ATP) to form a coenzyme, thiamine pyrophosphate (thiamine diphosphate, cocarboxylase), which is necessary for carbohydrate metabolism.
Pyridoxine is involved in amino acid metabolism and in protein metabolism. Pyridoxine is converted in erythrocytes to pyridoxal phosphate and to a lesser extent pyridoxamine phosphate which acts 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 influences hematopoiesis. It is involved in formation and metabolism of purities and pyrimidines and in the synthesis of nucleoproteins. Vitamin B12 acts as 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 is absorbed from the gastrointestinal tract and is widely distributed to most body tissues. It is not stored in the body and amounts in excess of the body's requirements are excreted in urine as uncharged thiamine or as its metabolite, pyrimidine. Pyridoxine is absorbed from the gastrointestinal tract and is converted to the active from: Pyridoxal phosphate. Pyridoxal phosphate is transformed to pyridoxic acid and excreted in the urine. Cyanocobalamin is absorbed from the gastrointestinal tract. In the blood, it is bound to plasma proteins and stored in the liver. It is excreted in the bile and undergoes some enterohepatic recycling, also excreted in urine.
Indications/Uses
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 nontoxic etiology); neuralgias e.g. lumbalgia, trigeminal neuralgia, shoulder-arm syndrome, herpes zoster, cervical syndrome, ischialgia, etc; diabetic neuropathy; metabolic and neurophatic changes due to pregnancy and oral contraceptives, convalescence.
Dosage/Direction for Use
Therapeutic dose: 2-3 tablet daily for 7-10 days. Maintenance dose: 1 tablet daily. RE-B FORTE should be swallowed whole, during or immediately after meals. Do not take the tablets on an empty stomach.
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
Past history of allergy to cobalamins. Known intolerance to thiamine. Known hypersensitivity to pyridoxine or any of the ingredients in the product.
Special Precautions
Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibly of masking symptoms of subacute degeneration of the spinal cord.
Cyanocobalamin is not 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 2 grams daily. Cyanocobalamin should not be used in megaloblastic anemia of pregnancy. Administration of doses greater than 10 microgram daily may produce a hematologival response in patients with folate deficiency.
Use In Pregnancy & Lactation
Taking excessive amounts of multivitamin and mineral supplement may be harmful to the mother and/or fetus and should be avoided cyanocobalamin is excreted in the breast milk.
Thiamine: Widely distributed to most body tissues and appears in breast milk.
Pyridoxal: Crosses the placenta and also appears in breast milk.
Adverse Reactions
Allergic hypersensitivity reactions have occurred rarely following the administration of cyanocobalamin compounds.
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, progressing 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 skin.
Drug Interactions
Pyridoxine decreases the effects of levodopa. Incompatibilities: Levodopa.
Chronic use of loop diuretics may result in thiamine deficiency. Concomitant intake of thiamine with food that contains sulfites may inactive thiamine.
Concomitant intake of thiamine with tea, coffee and decaffeinated coffee may inactive thiamine. This can reversed by taking supplements.
Pyridoxine reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given pyridoxine reduces the activity of altretamine. It has also been reported to decreased serum concentrations of phenobarbital and phenytoin. Many drugs may increase the requirement of pyridoxine, such drugs include hydralazine, isoniazid, penicillamine and oral contraceptives.
Absorption of vitamin B12 from the gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, histamine H2-antagonists, metformin, para-aminosalicylic acid, potassium chloride, colchicines and proton pump inhibitors (lansoprazole, omeprazole, pantoprazole, rabeprazole), cholestyramine and colestipol may decrease the enterohepatic reabsorption of vitamin B12. Inhalation of the anesthetic agent nitrous oxide can produce a functional vitamin B12 deficiency. The use of antibiotics may alter the intestinal microflora and may decrease the possible contribution of vitamin B12 by certain inhabitants of microflora to the body's requirement.
Storage
Store at temperature of not more than 30°C.
ATC Classification
A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.
Presentation/Packing
FC tab 10 x 10's.
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