Tri b Tablets ampoules Composition:
Each tablet contains:
Vitamin B1 125 mg.
Vitamin B6 125 mg.
Vitamin B12 125 mg
Folic acid 5 mg.
Ampoule 1 contains:
Vitamin B 1 100 mg.
Vitamin B6 40 mg.
Ampoule 2 contains:
Vitamin B12 1000 mcg
Tablets:Saccharine sodium, PVP 1>.:25, vanillin, lactose, magnesium stearate, stearic acid, Talc, maize starch, PEG 6000, gelatin, ethyl alcohol.
Thiourea, sodium phosphate dfbaslc anhydrous, methyl para ben, sodium acetate crystalline trihydrate,acetic acid, benzyl alcohol
Tri b Tablets ampoules Pharmaceutical form:
Tablets and ampoules.
Tri b Tablets ampoules Pharmacological actions:
Tri – B ampoules contain three factors of vitamin B complex BI, B6, Bl2 which are essential for the performance of the normal metabolism and proper functioning of the living cells. Vitamin B1 forms the co-enzyme decarboxylase which catalyses the decarboxylation of pyruvic acid and other keto-acids.
Vitamin B6 is a constituent of the enzyme system which is concerned with transamination and decarboxylation of amino-acids. Vitamin B12 in addition to its haematinic and anabolic functions fulfils an important role in the treatment of neurological disorders. Tri-R tablets, in addition to vitamins BI, B6, B12 , contain folic acid which is necessary for the normal production of red blood cells including maturation of megalobtasts into normoblasts.
Tri b Tablets ampoules Pharmacokinetics:
-After I.M. administration, it’s absorbed rapidly and completely, distributed widely into body tissues, metabolized in liver,
excreted in urine and small amounts from bile.
-After oral administration, it’s ahsorbed from GIT, metabolized and stored in liver and excreted in urine.
Tri b Tablets–ampoules Indications:
1- Painful neuropathies ,Trigeminal neuralgia, rheumatic pains.
2- Polyneuritis, Optic neuritis, Diabetic neuritis, Alcoholic neuritis.
3- Neuritis of pregnancy.
4- Vomiting of pregnancy.
5- Neuromuscular disorders, Tremors, Cramps.
6- Anaemia: nutritional macrocytic anaemia, megaloblastic anaemia of infancy, anaemia of pregnancy, pellagra and following gastrectomy and in pernicious anaemia.
Tri b Tablets–ampoules Dosage and administration:
Injection:– The contents of the ampoules 1 and 2 are mixed and injected intramuscularly daily or as directed by the physician.
Tablets :1- 2 tablets daily or as directed by the physician.
Tri b Tablets ampoules Contraindications:
1-Not used to treat megaloblastic anaemia of pregnancy,
2-Patients with known sensitivity to any of the components.
3-Pregnancy ,Nursing mothers &Pediatric use.Do not administer injections preserved with benzyl alcohol to nconates, infants below 13 years, pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse eventse; death, particularly in pediatric patients ( it may cause Gasping syndrome ).Injections preservative free should be used in these populations.
Tri b Tablets–ampoules Side effects:
Parenteral administration of thiamine hydrochloride solutions may cause allergic reactions.
Tri b Tablets–ampoules Drug Interactions:
– Colchicine may interfere with vitamin B12 absorption leading to megaloblastic anaemia.
– Reduced absorption of vitamin B12 was observed in case of patients receiving potassium citrate or calcium gtuccnare with metformin.
– Biochemical interactions occur between pyridoxal phosphate and certain drugs as Isoniazid (increase urinary excretion of vitamin B6) Penicillumine (prolonged use), cycloserine and hydralazine.
– Vitamin B6 enhances peripheral decarboxylation of levodopa and reduces its effectiveness thus must be avoided in patients receiving levodopa.
– The effect of folic acid may be diminished in patients receiving barbiturates, and co-trimoxazole.
– Folic acid should not be given to patients using anticonvulsants as Phenytoin, phenobarbitone or primodone since it reduces their blood levels.
– Sulphasalazine can Impair the absorption of folie acid in the gut.
Tri b Tablets–ampoules Pregnancy and lactation:
– Used if clearly needed in pregnancy.
– Vitamin B complex excreted in breast milk, so caution should be taken during lactation.
Tri b Tablets–ampoules Precautions and warnings:
Tri-B ampoule contains benzyl alcohol ,which may be fatal in neonates and infants
– Serious hypersensitivity reactions may occur
-Tri-B ampoule contains beuzyl alcohol which is potentially toxic when administered locally to neural tissue and is contraindicated for use in premature infants because the formulation contains benzyl alcohol.
Tri b Tablets – ampoules Package and storage:
-Box of 6 double ampoules.
-Box of 3 double ampoules.
-Box of 2 strips x to tablets.
-Storc in a dry place away from light.
– Store at temperature not exceeding 25<>C.
Tri b Tablets – ampoules Manufactured by:
The NILE Co. for Pharmaceuticals and
Chemical Industries – Cairo – A.R.E. R.C.C.