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Septra - Septrin - Bactrim - Sulfatrim: UK regulators advise use restrictions

This page is from a campaign by award-winning investigative journalist Brian Deer in The Sunday Times of London over risks and side-effects from this antibiotic, marketed under many names, such as Bactrim, Bactrim DS, Septra, Septra DS, Septrin, Sulfatrim, SMZ/TMP, Septran and co-trimoxazole | The investigation | Symptom searcher | Tell Brian & help others

At the conclusion of the campaign, the UK's Committee on Safety of Medicines and Medicines Control Agency announced in July 1995 a change in the drug's indications. This change was reflected in the "uses" section in its data sheet, set out below.

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BEFORE THE CAMPAIGN:

Uses. Septrin is an antibacterial agent. Septrin is effective in vitro against a wide range of Gram-positive and Gram-negative organisms. It is not active against Mycobacterium tuberculosis. Mycoplasma or Treponema pallidium. Pseudomonas aeruginosa is usually insensitive.

Septrin is of value in the treatment of the following:

Respiratory tract: Acute and chronic bronchitis, bronchiectasis, lobar and broncho-pneumonia, otitis media. sinusitis and prevention and treatment of Pneumocystis carinii pneumonitis.

Genito-urinary tract: Acute upper and lower urinary tract infections, bacterial prostatitis and male and female gonorrhoea.

Gastro-intestinal tract: Typhoid and paratyphoid fevers, chronic carriage of Salmonella typhi and paratyphi, cholera as an adjunct to fluid and electrolyte replacement and shigellosis.

Skin infections: Pyoderma, abcesses and wound infections.

Other bacterial infections: Acute and chronic osteomyelitis, acute brucellosis, septicaemias and other infections caused by sensitive organisms.

AFTER THE CAMPAIGN:

Uses. Septrin should only be used where, in the judgement of the physician, the benefits of treatment outweigh any possible risks; consideration should be given to the use of a single effective antibacterial agent.

The in vitro susceptibility of bacteria to antibiotics varies geographically and with time; the local situation should always be considered when selecting antibiotic therapy.

Treatment and prevention of Pneumocystis carinii pneumonitis (see Dosage and administration and Side- and adverse effects).

Treatment and prophylaxis of toxoplasmosis, treatment of nocardiosis.

Urinary tract infections; Acute uncomplicated urinary tract infections: Treatment of urinary tract infections where there is bacterial evidence of sensitivity to co-trimoxazole and good reason to prefer this combination to a single antibiotic.

Respiratory tract infections; Otitis media: Acute treatment of otitis media, where there is good reason to prefer co-trimoxazole to a single antibiotic.

Treatment of acute exacerbations of chronic bronchitis, where there is bacterial evidence of sensitivity to co-trimoxazole and good reason to prefer this combination to a single antibiotic.


Deer's Bactrim - Septra homepage

SEPTRIN BACTRIM SEPTRA BACTRIM DS SEPTRA DS COTRIM SEPTRIN FORTE SULFATRIM AP0-SULFATRIM SEPTRAN CO-TRIMOXAZOLE COTRIMOXAZOLE SULFAMTHOXAZOLE FORTE DS BRIAN DEER TMP-SMX SMZ/TMP SIDE-EFFECTS