Emtrim Cotrimoxazole Pediatric Suspension and Tablet

EMTRIMĀ®

BRAND OF CO-TRIMOXAZOLE B.P.

PAEDIATRIC SUSPENSION AND TABLET

 

COMPOSITION

EMTRIM is a brand of Co-trimoxazole B.P a mixture of 1 part Trimethoprim (2,4 diamino-5-(3,4,5-trimethonybenzyl) pyrimidine and 5 parts of Solphamethoxazole, (5- methyl-3 (Sulfanilamido-isoxazole).

 

PROPERTIES

The Two antibiotics in EMTRIM act synergistically to produce bactericidal or bacteriostatic action against a wide range of Gram-negative and Gram-positive organisms such as Streptococci, Pneumococci, Haemophilus cepacia, Pneumocystis carinni, Seratia marcescens, Yersinia norcardia. The active components interfere with the bacterial synthesis of tetrahydrofolic acid, an essential stage in the production of thymidine, purines and subsequent nucleic acid. Sulphamethoxazole inhibits the action of dihydrofolate reductase and prevents the synthesis of tetrahydrofolic acid.

 

INDICATIONS

I) Respiratory tract infections: Acute and Chronic bronchitis, Pneumonia, Pneumocytis carinni pneumonia, Pneumonitis, Pharyngitis, Tonsillitis, Otitis media.

II) Urinary tract infections: Acute and Chronic Cystitis, Pyelonephritis, Urethritis.

III) Gastrointestinal tract infections: These include Typhoid and Paratyphoid fever, Typhoid carrier state and bacillary dysentery and cholera.

IV) Skin and soft tissue infections: Pyoderma, Furuncles, abscesses and infected wounds

V) Bacterial infection: Acute and Chronic Osteomyelitis, acute brucellosis, septicaemia due to sensitive organisms, norcardiosis, mycetoma (except when caused by fungi) South American blastomycosis.

 

ABSORPTION AND EXCRETION

The two components of EMTRIM, Sulphamethoxazole and Trimethoprim, are readily absorbed from the gastrointestinal tract and peak plasma concentrations are reached within 4 hours after a dose is taken.

 

DOSAGE AND ADMINISTRATION

AGE/DOSAGE
Children: 6 weeks to 5 months – half teaspoonful twice daily

Children: 5 months to 5 years – 1 teaspoonful twice daily

Children: 6 years to 15 years – 2 teaspoonfuls twice daily or 1 tablet (double strength) twice daily

 

SIDE EFFECTS

At the recommended dosage, EMTRIM is usually well tolerated. Of the reported adverse effects, most are comprised of nausea (with or without vomiting) and drug rashes. Pseudomembraneous colitis has been reported rarely, while diarrhea and glossitis are uncommon and monilial overgrowth is very rare. Isolated cases of severe skin sensitivity reactions such as erythema mulliforme and toxic epidermal necrolysis-LYELLS Syndrome have been reported. Various haematological changes have been reported, the majority been mild and reversible when treatment is stopped. Although most changes are clinically asymptomatic, they may become severe in isolated cases especially in the elderly, those with hepatic or renal dysfunction and those with poor folate status. EMTRIM may induce haemolysis in certain susceptible Glocose-6-phosphate deficient patients. A high incidence of adverse effects has been reported in AIDS patients, desensitization may sometimes be considered.

 

PRECAUTIONS

In patients with impaired renal function, the dosage should be reduced or the interval between doses prolonged in order to prevent accumulation in the blood. Determination of plasma drug concentration is recommended is such patients. Regular blood counts are advisable whenever Emtrim is given for prolonged period especially in the elderly, with possibility of haematological changes indicative of folic acid deficiency; these are reversible by folic acid therapy. An adequate urinary output should be maintained at all times. Treatment must be discontinued immediately a skin rash appears.

 

CONTRAINDICATIONS

EMTRIM is contraindicated in patients with marked liver parenchymal damage. It is also contraindicated in patients with severe renal insufficiency when repeated determination of the plasma concentration cannot be made except in rare circumstances. EMTRIM should not be given to patients with serious haematological disorders. The combination has occasionally been administered to patients receiving cytotoxic agents for the treatment of leukuemia without evidence of any adverse effect on the bone marrow. Emtrim should not be administered to patients with a history of hypersensitivity to sulphonamides or trimethoprim. For safety reasons Emtrim is contraindicated for use in pregnancy. If pregnancy can not be excluded, possible risks should be balanced against the expected therapeutic benefit. Emtrim should not be given to premature newborn infants during the first few weeks of life.

 

STORAGE

Should be stored below 25oC and protected from light.

 

SUSPENSION

Each 5ml spoonful of EMTRIM suspension contains Trimethoprim BP 40mg and Sulphamethoxazole B.P 200 mg

 

TABLETS

Each tablet of Emtrim contains Trimethoprim BP 80mg and Sulphamethoxazole BP 400mg

 

DOUBLEĀ STRENGTH

Each double strength tablet contains Trimethoprim B.P 160mg and Sulphamethoxazole BP 800mg

 

PRESENTATION

50mI Suspension. 100ml Suspension, 2 x 10 tablet blisters, 1 x 1000s Secutainer, 10 x 10 blisters, 100 x 10 blisters

 

Manufactured by

EMZOR PHARMACEUTICAL INDUSTRIES LTD.

Plot 3C, Block A, Aswani Market Road, Isolo-Lagos, Nigeria.

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