Tri-B Tablet - Ampoule

Tri-B Tablet - Ampoule
Vitamin B-complex deficiency


Composition:-
- Active ingredients:
- Tablets:
Each tablet contains:
- Vitamin B1 ------ 125 mg.
- Vitamin B6 ------ 125 mg.
- Vitamin B12 ---- 125 mcg.
- Folic acid -------- 5 mg.
- Ampoules:
Each Ampoule 1 contains:
- Vitamin B1--------100 mg.
- Vitamin B6 ------- 40 mg.
- Ampoule 2 contains:
- Vitamin B12------ 1000 mcg.
- Inactive ingredients:
- Tablets: Saccharine sodium, PVP K25, vanillin, lactose, magnesium stearate, stearic acid, Talc, starch, PEG 6000, gelatin, ethyl alcohol.
- Ampoules: Thiourea, sodium phosphate dibasic anhydrous, methyl paraben, 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 B1, B6, B12 which are essential for the performance of the normal metabolism and proper functioning of the living cells. Vitamin B1 forms the co-enzyme co-carboxylase 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-B tablets in addition to vitamins B1, B6, B12 . contain folic acid which is necessary for the normal production of red blood cells including maturation of megaloblasts 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 absorbed 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 gastractomy 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.


Contra-indications:-



1- Not used to treat megaloblastic anaemia of pregnancy.
2- Patients with known sensitivity to any of the components.


Side Effects:-

Parenteral administration of thiamine hydrochloride solutions may cause allergic reactions.

Drug Interaction:-

- 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 gluconate with metformin.
- Biochemical interactions occur between pyridoxal phosphate and certain drugs as Isoniazid (increase urinary excretion of vitamin B6) Penicillamine
(prolonged use), cycloserine and hydralazine.
- Vitamin B6 enhances peripheral decarboxylation of levodopa and reduces its effectiveness thus must be avoided in patients receiving Ievodopa.
- 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 folic 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:-

Serious hypersensitivity reactions may occur.


Package and Storage:-

- Box of 6 double ampoules.
- Box of 3 double ampoules.
- Box of 2 strips x 10 tablets.
- Store in a dry place away from light.
- In a temperature below 25° C.
Instructions to Patients:-

- Keep out of reach of children