Loxaprim Co-trimoxazole Trimethoprim and Sulphamethoxazole Tablets and Syrup Suspension

LOXAPRIM

Co-trimoxazole

ORAL PRESENTATIONS

TO THE MEDICAL AND PHARMACEUTICAL PROFESSIONS.

 

PRESENTATION AND COMPOSITION

Loxaprim 480mg tablet contains 80mg of Trimethoprim BP and 400mg Sulphamethoxazole BP.

Each 5ml of Flavoured syrup suspension contains 40mg Trimethoprim BP and 200mg Sulphamethoxazole BP.

 

INDICATIONS

1. Respiratory Tract Infections: Otitis media, acute exacerbations of chronic bronchitis, Pneumonitis Carnii (including prevention).

2. Urinary Tract Infections: Acute uncomplicated urinary tract infection.

3. Gastro-intestinal tract infections: Bacillary Dysentery, cholera, as adjunction to fluid and electrolyte replacement shigellosis traveller’s diarrhoea, nocardiosis, toxoplasmosis.

4. Protozoal Infections: Malaria due to P. Falciparum.

5. Skin and Soft Tissue: Furuncles, abscesses and infected wounds

6. Genital Tract Infections: Chancroid, Salpingitis, Gonorrhoea including oropharyngeal and ano-rectal, Granuloma inguinale (vancreum).

7. Other Bacterial Infections: Septicaemia due to sensitive organisms, mycetoma, acute and chronic osteomyelitis, brucellosis.

 

DOSAGE AND ADMINISTRATION

Loxaprim should be administered with food or drink. This is to reduce the possibilities of gastrointestinal disturbance.

AGE STANDARD DOSE
Children 6 weeks – 5 months 2.5ml (measure) every 12 hours
Children 6 months – 5 years 5ml (measure) every 12 hours
Children 6-12 years 10mI (measure) every 12 hours
Adults Two tablets every 12 hours

 

SPECIAL DOSAGE RECOMMENDATION

Gonorrhoea: In uncomplicated cases 4 tablets every 12hrs for 2 days or 5 tablets followed by a further 5 tablets 8 hours later or 10 tablets once daily for 3 days. With poor patient compliance a single dose of 8 tablets taken under supervision could be employed.

 

Pneumonitis Carnii

Treatment

20mg of trimethoprim and 100mg of sulphamethoxazole per kg body weight per day in two or more divided doses for two weeks.

 

Prevention

Adult

Standard dosage for the duration of the period at risk.

160mg trimethoprim/800mg sulphamethoxazole for7 days.

320mg trimethoprim/ 1600mg sulphamethoxazole per day in 2 divided doses 3 times on alternate days.

 

Acute Brucellosis

Treatment

A higher than standard dosage should be used initially and treatment continued for a period of at least 4 weeks and may be repeated.

 

Prophylaxis of recurrent or suppression of chronic infection

A nightly dose of 2mg trimethoprim and 10mg of sulphamethoxazole per kg of body weight. Treatment may continue for as long as appropriate.

 

Chanroid

Standard dosage should be taken for 10- 15 days.

 

Granuloma inguinale

Standard dosage should be taken for up to 2 weeks.

 

CONTRA-INDICATIONS

Co-trimoxazole is contra-indicated in infants under 6 weeks. It should not be given to patients with history of sulphonamides or trimethoprim hypersensitivity. It is also contra-indicated in patients showing marked liver parenchymal damage, hepatic or renal failure. Caution is advised in folate deficiency patients and patients receiving pyrimethamine or immunosuppressive therapy.

 

ADVERSE REACTION

Hypersensitivity reactions particularly involving the skin are among the most common adverse effects caused by Co-trimoxazole and are usually due to the sulphonamide component. The Steven-Johnsons syndrome have been reported in patients receiving Co-trimoxazole. Hypersensitivity reactions also include rashes, photosensitivity reactions, exfoliative dermatitis and nephrotoxic reactions, Lumbar pain, haematuria, oligouria and anuria may also occur due to crystallisation in the urine of sulphamethoxazole component of Co-trimaxazole or its less acetylated metabolite.

Blood disorders have occasionally occurred during co-trimoxazole administration and include agranulocytosis, aplastic anaemia, thrombocytopenia, leucopenia, hypoprothrombinaemia eosinophilia. Acute haemolytic anaemia is a rare complication which may be associated with glucose-6- phosphate dehydrogenase deficiency.

Other adverse effect include syndrome resembling serum sickness, hepatotoxic reactions, myocarditis, pancreatitis, pulmonary eosinophilia and vasculitis including polyarteritis nodosa. Other adverse reactions include optic neuropathy or transcient myopia, fever, hypothyroidism and neuroplogical reactions including ataxia, dizziness, fatigue, headache, insomnia, peripheral neuritis and vertigo. Pseudomembraneous colitis can occur in prolonged use of Co-trimoxazole.

 

DRUG INTERACTIONS

Concurrent use with rifampicin results in shortening of the plasma half-life of trimethoprim after a period of one week. Co-trimoxazole potentiates the anticoagulant activity of warfarin via stereo-selective inhibition of metabolism. Sulphamethoxazole may displace warfarin from plasma-albumin protein-binding sites in vitro.

Co-trimoxazole prolongs the half-life of phenytoin if administered concurrently and the physician should be alert for increased phenytoin effect. Patients treated with Co-trimoxazole and cyclosporin following transplantation could experience deterioration in renal function.

Patients receiving antifolate drugs such as methotrexate should receive folate supplement.

 

KEEP ALL MEDICINES OUT OF REACH OF THE CHILDREN.

 

PHARMACEUTICAL PRECAUTIONS AND RECOMMENDATIONS

Store below 25°C and protect from light.

Shake suspension thoroughly before use.

 

Manufactured by

May & Baker Nigeria Plc

1, May & Baker Avenue, Off Idiroko Road,

(Opposite Covenant University)

Ota, Ogun State, Nigeria.

www.may-baker.com

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