Indications

1.Acute uncomplicated urinary tract infections

2.Acute otitis media

3.Acute exacerbation of chronic bronchitis

4.Treatment and prevention of Pneumocystis jiroveci.(P. carinii) pneumonitis

5.Treatment and prophylaxis of toxoplasmosis

6.Treatment of nocardiosis

Dosage and Administration

Usage: Oral

Dosage

Standard dosage recommendations for acute infections

Adults and children over 12 years:1 tablet every 12 hours.This dosage approximates to 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per 24 hours.

Precautions & Warning:

1. Life-threatening cutaneous reactions have been reported with the use of Sulfamethoxazole and Trimethoprim Tablets.

2. The administration of Sulfamethoxazole and Trimethoprim Tablets to patients known or suspected to be at risk ofacute porphyria should be avoided.

3. Fatalities, although very rare, have occurred due to severe reactions including Stevens- Johnson syndrome, Lyell's syndrome , fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract.

4. Antibiotic-associated colitis and pseudomembranous colitis have been reported with cotrimoxazole and with nearly all other anti-bacterial agents and may range from mild to life-threatening in severity.

5. Sulfamethoxazole and Trimethoprim Tablets should not be used in the treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci

Contraindications:

1. patients with a history of hypersensitivity to sulphonamides, trimethoprim, or any excipients of Sulfamethoxazole and Trimethoprim Tablets.

2. patients showing marked liver parenchymal damage.

3. patients with severe renal insufficiency where repeated measurements of the plasma concentration cannot be performed.

4. patients with porphyria.

Sulfamethoxazole and Trimethoprim Tablets should not be given to premature babies nor to full-term infants during the first 6 weeks of life except for the treatment/prophylaxis of PCP in infants 4 weeks of age or greater.(Please note however that Sulfamethoxazole and Trimethoprim Tablets are not appropriate for children under 12 years old and under.)

Adverse Reactions:

1. Infections and Infestations:Monilial overgrowth

2. Nervous system disorders:Headache;Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, dizziness

3. Gastrointestinal disorders:Nausea, diarrhoea;Vomiting; Glossitis, stomatitis, pseudomembranous colitis, pancreatitis

4. Skin and subcutaneous tissue disorders:Skin rashes;Photosensitivity, exfoliative dermatitis, fixed drug eruption, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis);

Drug interactions:

1.Trimethoprim may interfere with the estimation of serum/plasma creatinine when the alkaline picrate reaction is used.

2.In some situations, concomitant treatment with zidovudine may increase the risk of haematological adverse reactions to  Sulfamethoxazole and Trimethoprim Tablets

3.Concurrent use of rifampicin and  Sulfamethoxazole and Trimethoprim Tablets results in a shortening of the plasma half-life of trimethoprim after a period of about one week.

4.Sulfamethoxazole and Trimethoprim Tabletshas been shown to potentiate the anticoagulant activity of warfarin via stereo-selective inhibition of its metabolism.  

Storage instructions:

This medicinal product does not require any special storage conditions.