Document 6431668
Transcription
Document 6431668
Incotim Tablet, Suspension & DS tablet Presentation Incotim tablet: Each tablet contains 80 mg Trimethoprim BP and 400 mg Sulphamethoxazole BP. Incotim DS: Each Incotim -DS tablet contains 160 mg Trimethoprim BP and 800 mg Sulphamethoxazole BP. Incotim suspension: Each 5 ml of Incotim suspension contains 40 mg Trimethoprim BP & 200 mg Sulphamethoxazole BP. Uses Incotim shows bactericidal activity in vitro against a wide range of Gram-positive and Gram-negative organisms, including Streptococcus, Staphylococcus, Pneumococcus, Neisseria, B. catarrhalis, E. coli, Klebsiella, Proteus spp., Haemophilus, Salmonella, Shigella, Vibrio Cholerae, Brucella, Pneumocystis carinii, Nocardia and Bordetella. A particular high degree exhibited against Haemophilus influenzae, E. coli and proteus spp, making Incotim particularly suitable for the treatment of chronic bronchitis and urinary tract infections. Incotim exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of folinic acid in the microorganisms. The synergy thus produced accounts for the high degree of bactericidal activity. Indications Incotim is indicated for the treatment of : Respiratory tract infections; including acute and chronic bronchitis (treatment and prophylaxis), also bronchiectasis, lung abscess, lobar and broncho-pneumonia, pneumocystis carinii, pneumonitis, sinusitis and otitis media. Genitourinary tract infections; including urethritis, acute and chronic cystitis, pyelitis, pyelonephritis and prostatitis, male and female gonorrhoea. Gastrointestinal infections; caused by Salmonella typhi and paratyphi, including the chronic carrier state. Other infections caused by a wide range of organisms confirmed to be susceptible to Incotim-DS tablet and where the therapeutic benefits are considered to outweigh the possible occurrence of adverse events. Such infections include acute and chronic osteomyelitis, acute brucellosis, skin infections including pyoderma, abscesses and wound infections, septicaemias, bacillary dysentery and cholerae (including liquid and electrolyte replenishment), nocardiosis and mycetoma. Dosage and Administration Incotim-DS tablet : Duration of therapy: In acute infections, apart from gonorrhoea, Incotim-DS tablet should be given for at least or until the patient has been symptom-free for 2 days .Treatment for prostatitis and acute brucellosis should be maintained for a period of at least 4 weeks, whilst nocardiasis and mycetoma, dosage guideline requires long term therapy. Dosage guideline Adults and children over 12 years Usual dosage: One Incotim-DS tablet twice daily. Severe infections: One and a half Incotim-DS tablet twice daily. Septicaemia and Uncomplicated gonorrhoea: Two Incotim-DS tablet 12 hourly over 2 days or two and a half IncotimDS tablet every 8-12 hourly. Minimum dosage and long term treatment (> 14 days): Half a Incotim-DS tablet twice daily. Incotim suspension Children: 6-12 years of age 2-5 years of age 2 years of age : : : 1-2 tea spoonful twice daily. /2 - 1 tea spoonful twice daily. /2 tea spoonful twice daily. 1 1 Contraindication Hypersensitivity to Trimethoprim or Sulphonamides. Patients with megaloblastic anaemia due to folate deficiency, liver parenchymal damage, blood dyscrasia, severe renal insufficiency, glucose 6-phosphate dehydrogenase deficiency. Pregnancy and Lactation : Although Co-trimoxazole has been used during pregnancy without deleterious sequelae, animal studies have indicated a risk of teratogenic effects. Co-trimoxazole may interfere with folic acid metabolism. The risk of hyperbilirubinemia and kernicterus has led to a recommendation that the drug should not be used in the pregnancy. As there are alternatives it is wise not to use the drug in pregnant women. Side effects Crystalluria, allergic reactions, haemolysis, thrombocytopenia, neutropenia, agranulocytosis have also been reported rarely. Other side effects: headache, nausea, vomiting. These are normally transient and no need to withdraw treatment. Precaution Prolonged full dose treatment with co-trimoxazole is associated with the risk of macrocytic anaemia due to drug interference in the conversion of folic acid into folinic acid and it can be reversed by giving folinic acid. In case of diabetic patients, under going treatment with sulfonyl urea, caution is to be observed as this drug may potentiate the effects of sulfonyl urea. Commercial pack Incotim tablet : Each box contains 10 blister strips of 10's tablets. Incotim-DS tablet : Each box contains 10 blister strips of 10's tablets. Incotim suspension : Each amber coloured bottle contains 60ml suspension. Manufactured by Incepta Pharmaceuticals Ltd. Dhaka, Bangladesh Registered Trademark PTG : 036/05-01/50000 FAC I 140501 SPD