Composition

Ciplin DS Tablets
Each tablet contains ....
Trimethoprim IP 160 mg and Sulphamethoxazole IP 800 mg

Description
Ciplin, a combination of trimethoprim and sulphamethoxazole (co trimoxazole) exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of bacterial folic acid. The synergy thus produced accounts for the high degree of bactericidal activity.

Indications
Urinary tract infections, Acute otitis media in paediatric patients, Acute exacerbations of chronic bronchitis in adults, Traveller's Diarrhoea in adults, Pneumocystitis carinii pneumonia.

Dosage and Administration
Ciplin should be taken with fluid, preferably after a meal. Adequate fluids should be taken when on Ciplin. The patient should notify the physician of skin rash, sore throat, fever or unusual bruising or bleeding.
Adults and children (above 12 years)
Contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in adults and pediatric patients and acute otitis media in pediatric patients.
Adults
The usual adult dosage in the treatment of urinary tract infections is 1 Ciplin DS tablet, or 4 teaspoonful Ciplin suspension every 12 hours for 10 to 14 days. An identical dosage is used for 5 days in the treatment of Shigellosis.

Acute Exacerbation of Chronic bronchitis
1.Ciplin DS, or 4 teaspoonful of Ciplin suspension every 12 hours for 14 days.

Travelers Diarrhoea
1 Ciplin DS tablet, or 4 teaspoonful of Ciplin suspension every 12 hours for 5 days.

Pediatric patients
The recommended dose for pediatric patients with urinary tract infections and acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg sulfamethoxazole per 24 hours, given in two divided doses every 2 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of Shigellosis. The following table is a guideline for the attainment of this dosage.
Paediatric Patients (Two months of age or older

Pneumocystitis carinii pneumonia: Treatment
Adults and Paediatric Patients
The recommended dosage for treatment of patients with documented Pneumocystis carinii pneumonia is 15 to 20 mg/kg trimethoprim and 75 to 100 mg/kg sulfamethoxazole per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.

PROPHYLAXIS
Adults
1.Ciplin DS tablet daily.

Paediatric patients

The recommended dose is 150 mg/m2/day trimethoprim with 750 mg/m2/day sulfamethoxazole given orally in equally divided doses twice a day, on 3 consecutive days per week.
The total daily dose should not exceed
320 mg trimethoprim and 1,600 mg sulfamethoxazole.

Contraindications
Marked liver parenchymal damage, blood dyscrasias, severe renal insufficiency and glucose 6 phosphate dehydrogenase deficiency, known hypersensitivity to sulphonamides and/or trimethoprim. Treatment must be discontinued on the appearance of a skin rash, or if any element of the blood count is reduced.

Warnings and Precautions
DRUG INTERACTIONS
Cyclosporin: A decrease in the therapeutic effect of cyclosporin and an increased risk of nephrotoxicity may occur on co administration of co trimoxazole.

Methotrexate: The bone marrow depressant effects of methotrexates may be potentiated by sulphamethoxazole.

Phenytoin: Hepatic clearance of phenytoin may be decreased and half life increased.

Diuretics: An increased incidence of thrombocytopenia with purpura has been observed in elderly patients concurrently receiving certain diuretics, primarily thiazides.

Hypoglycaemics: Care should be taken when giving Ciplin to patients receiving strongly serum protein bound drugs such as oral hypoglycaemic agents or coumarin anticoagulants as the action of these drugs may be increased. Ciplin may prolong the prothrombin time in patients receiving the anticoagulant, warfarin. This interaction should be borne in mind when Ciplin is given to patients already on anticoagulant therapy. In such cases, the coagulation time should be re determined.

PREGNANCY
Ciplin is not recommended for use in pregnant women.

NURSING MOTHERS
Ciplin is not recommended for use by nursing mothers.

PAEDIATRIC USE
Not recommended for premature babies and full term infants during the first six weeks of life.

Side Effects
The most common side effects are gastro-intestinal disturbances and allergic skin reactions. Hypersensitivity reactions have occasionally been reported.

Overdosage.
Treatment is symptomatic and may include gastric lavage and forced diuresis. Alkalinisation of the urine may aid the elimination of the sulphamethoxazole component but may decrease the elimination of the trimethoprim component.
Hypersensitivity reactions may require treatment with steroids. Calcium folinate, 3 to 6 mg intramuscularly for five to seven days, may be given to counteract the effects of trimethoprim on haemopoiesis

Presentation
Ciplin DS Blister pack of
10 tablets Ciplin DS
Suspension Bottle of 60 ml