Tri b
Tablets – ampoules
Vitamin B complex deficiency
Composition:
Active ingredients:
Tablets
Each tablet contains:
Vitamin 81 125 mg.
Vitamin 86 125 mg.
Vitamin B12 125 mcg
Folic acid 5 mg.
Ampoules
Ampoule 1 contains:
Vitamin B 1 100 mg.
Vitamin B6 40 mg.
Ampoule 2 contains:
Vitamin B12 1000 mcg
Inactive ingredients:
Tablets:Saccharine sodium, PVP 1>.:25, vanillin, lactose, magnesium stearate, stearic acid, Talc, maize starch, PEG 6000, gelatin, ethyl alcohol.
Ampoules:
Thiourea, sodium phosphate dfbaslc anhydrous, methyl para ben, sodium acetate crystalline trihydrate,acetic acid, benzyl alcohol,
Pharmaceutical form:
Tablets and ampoules.
Pharmacological actions:
Tri – B ampoules contain three factors of vitamin B complex BI, 86, Bl2 which are essential for the performance of the normal metabolism and proper functioning of the living cells. Vitamin 8t forms the co-enzymE.’ eo-carboxylase which catalyses the decarboxylation of pyruvic acid and other keto-acids.
Vitamin 86 is a constituent of the enzyme system which is concerned with transamination and decarboxylation of amino-acids. Vitamin 812 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 mcgatobtasts into normoblasts.
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.
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.
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.
Contraindications:
1-Not used to treat megaloblastic anaemia of pregnancy,
2-Pattents with known sensitivity to any of the components.
3-Pregnancv ,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 pedtatrtc yatients ( it may cause Gasping syndrome ).Injections preservative free should be used in these populations.
Side effects:
Parenteral administration of thiamine hydrochloride solutions may cause allergic reactions.
Drug Interactions:
– Colchicine may interfere with vitamin BI2 absorption leading to megaloblastic anaemia.
– Reduced absorption of vttamin Bl2 was observed in case of patients receiving potassium citrate or calcium gtuccnare with metfurmin.
– 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 ce- trtmoxazcle.
– 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.
Pregnancy and lactation:
– Used if clearly needed in pregnancy.
– Vitamin B complex excreted in breast milk, so caution should be taken during lactation.
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.
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.
Manufactured by:
The NILE Co. for Pharmaceuticals and
Chemical Industries – Cairo – A.R.E. R.C.C.
