Tabrol Suspension
Sulphamethoxazole 200mg + Trimethoprim 40mg/5ml
Aristo Pharmaceuticals Ltd.
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| Retail Price | 20.78 NPR |
Indications
Tabrol Suspension is used for:
Bacterial infections, Upper and lower respiratory tract infections, Gastrointestinal tract infections, Renal and urinary tract infections, Skin and wound infections, Septicaemias
Adult Dose
Intravenous
Acute exacerbations of chronic bronchitis ; Acute otitis media; Urinary tract infections
Adult: 960 mg bid. Severe infections: 2.88 g daily in 2 divided doses.
Pneumocystis (carinii) jiroveci pneumonia
Adult: 120 mg/kg daily in 2-4 divided doses by infusion over 60-90 min for 14-21 days.
Prophylaxis of Pneumocystis(carinii) jiroveci pneumonia
Adult: 960 mg once daily for 7 days; 960 mg once daily 3 times wkly on alternate days; or 960 mg bid 3 times wkly on alternate days. Doses are given by infusion over 60-90 min.
Hepatic impairment: Severe: Contraindicated.
Child Dose
Intravenous
Acute exacerbations of chronic bronchitis ; Acute otitis media; Urinary tract infections
Child: 18 mg/kg 12 hrly. Severe infections: Up to 27 mg/kg 12 hrly. Max: 1.44 g 12 hrly.
Pneumocystis (carinii) jiroveci pneumonia
Adult: Each ampoule contains sulfamethoxazole 400 mg and trimethoprim 80 mg in 5 mL:
Child: >4 wk 120 mg/kg daily in 2-4 divided doses by infusion over 60-90 min for 14-21 days.
Prophylaxis of Pneumocystis(carinii) jiroveci pneumonia
Child: >4 wk 15-30 mg/kg bid, by infusion over 60-90 min, 2-3 times wkly given on consecutive or alternate days.
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<15 Not recommended.
15-30 Half the standard dose.
Administration
Reconstitution: Dilute each 5 mL of concentrate in 125 mL of dextrose in water 5%. In patients w/ fluid restriction, each 5 mL of the concentrate may be diluted in 75 mL of dextrose 5%.
Contra Indications
Known hypersensitivity to trimethoprim or sulfonamides; severe hepatic failure or marked liver parenchymal damage, jaundice; serious haematological disorders and porphyria; severe renal insufficiency where repeated measurements of the plasma concentration cannot be performed; history of drug-induced immune thrombocytopenia w/ use of trimethoprim and/or sulfonamides; megaloblastic anaemia due to folate deficiency. Neonates <6 wk, except for the treatment/prophylaxis of P. jiroveci in infants >4 wk. Treatment of Group A β-haemolytic streptococcia. Pregnancy, esp in the period prior to birth. Concomitant use w/ clozapine. Concomitant use w/ leucovorin for the treatment of P. jiroveci in HIV positive patients.
Precautions
Known hypersensitivity to trimethoprim or sulfonamides; severe hepatic failure or marked liver parenchymal damage, jaundice; serious haematological disorders and porphyria; severe renal insufficiency where repeated measurements of the plasma concentration cannot be performed; history of drug-induced immune thrombocytopenia w/ use of trimethoprim and/or sulfonamides; megaloblastic anaemia due to folate deficiency. Neonates <6 wk, except for the treatment/prophylaxis of P. jiroveci in infants >4 wk. Treatment of Group A β-haemolytic streptococcia. Pregnancy, esp in the period prior to birth. Concomitant use w/ clozapine. Concomitant use w/ leucovorin for the treatment of P. jiroveci in HIV positive patients.
Pregnancy-Lactation
Interactions
May increase risk of hyperkalaemia w/ ACE inhibitors. Increased risk of methaemoglobinaemia w/ prilocaine. May increase risk of ventricular arrhythmias w/ amiodarone. May increase dofetilide-induced QT prolongation. May increase risk of dapsone toxicity. May increase risk of crystalluria w/ methenamine. May increase serum rifampicin levels. Enhanced effects of acenocoumarol and warfarin. Enhanced effect of sulfonylureas. May prolong the half-life of phenytoin.
May increase risk of megaloblastic anaemia w/ pyrimethamine given in doses of >25 mg wkly. May increase plasma concentrations of lamivudine, zidovudine and zalcitabine. Increased plasma concentrations w/ procainamide and/or amantadine. May increase risk of haematological toxicity w/ mercaptopurine and azathioprine. May increase digoxin levels. Increased risk of thrombocytopenia w/ diuretics. Potassium aminobenzoate may inhibit the effects of sulfonamides. Concomitant use w/ ciclosporin following renal transplantation may result to reversible deterioration of renal function.
Potentially Fatal: Increased risk of fatal agranulocytosis w/ clozapine. Concomitant use w/ leucovorin for the treatment of P. jiroveci in HIV positive patients may result to treatment failure and excess mortality.
Adverse Effects
Side effects of Sulphamethoxazole 200mg + Trimethoprim 40mg/5ml :
Allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalised allergic reactions, generalised skin eruptions, photosensitivity, conjunctival and scleral inj, pruritus, urticaria, rash, periarteritis nodosa, SLE; elevated serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhoea, anorexia; renal failure, interstitial nephritis, elevated BUN and serum creatinine, toxic nephrosis w/ oliguria and anuria; hyperkalaemia; aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache; hallucinations, depression, apathy, nervousness; dieresis, hypoglycaemia; arthralgia, myalgia; rhabdomyolysis; cough, shortness of breath, pulmonary infiltrates; weakness, fatigue, insomnia; QT prolongation, haemolysis, impaired phenylalanine metabolism.
Potentially Fatal: Severe skin, hepatic and blood disorders, aplastic anaemia, hypersensitivity of the resp tract; Stevens-Johnson syndrome, toxic epidermal necrolysis; Clostridium difficile-associated diarrhoea; severe and symptomatic hyponatraemia.
Mechanism of Action
Co-trimoxazole exhibits the synergistic actions of its components (sulfamethoxazole and trimethoprim) by 10-fold. Sulfamethoxazole inhibits dihydrofolic acid formation from PABA, thus interfering with synthesis and growth of bacterial folic acid. Trimethoprim inhibits enzymes folic acid pathway, preventing the reaction of the dihydrolic acid to tetrahydrofolate. Co-trimoxazole possesses bactericidal effects against E coli, Klebsiella spp, Enterobacter spp, M morganii, P mirabilis, P vulgaris, H influenzae, Strep pneumoniae, Pneumocystis (carinii) jiroveci, Cyclospora spp.
Note
Tabrol Suspension manufactured by Aristo Pharmaceuticals Ltd.. Its generic name is Sulphamethoxazole 200mg + Trimethoprim 40mg/5ml. Tabrol is availble in Nepal.
Farmaco Nepal drug index information on Tabrol Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.