Sulfadoxine & Pyrimethamine Tablets USP
For the use of Medical profession only
Each uncoated tablet contains:
Sulfadoxine USP 500mg
Pyrimethamine USP 25 mg
Falcipar acts by reciprocal potentiation of its two components achieved by a sequential blockade of two enzymes involved in the biosynthesis of Folinic acid within the parasite.
FALCIPAR is indicated for the treatment of cases of Malaria that are resistant to chloroquine. It is also indicated for prophylaxis use once or twice in a week regimen. Falcipar is indicated in all kind of malaria caused by plasmodium falciparum, plasmodium vivax, plasmodium Ovale and Plasmodium Malaria & in Chloroquine resistant Malaria also.
Both Sulfadoxine and Pyrimethamine are absorbed orally and are excreted mainly by the kidney.
Hypersensitivity to pyrimethamine & Sulphonamide or patients with marked impaired liver or kidney function.
Infants less than two months of age, during pregnancy & nursing period.
Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation. Should be given with caution to those with severe allergy or bronchial asthma. Periodic blood counts and analysis of urine for crystalluria are desirable during prolonged prophylaxis. Because Falcipar may interfere with folic acid metabolism, therapy should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
At the recommended dosage, side effects are uncommon and mild and rarely require discontinuance of the treatment. Minor effects encountered are nausea, vomiting, skin rashes and gastrointestinal disturbances.
Falcipar should be avoided with SuIfa/Trimethoprim combination & along with Chloroquine.
TREATMENT OF OVER DOSAGE
In case of over dosage or when toxic effects are severe the stomach should be emptied by aspiration and lavage. The elimination of Sulfadoxine in the urine may be assisted by alkalization. Convulsions should be cautiously controlled with a short acting barbiturate and injection of calcium folinate given to counter the effect of Pyrimethamine on hemopoiesis. Hypersensitivity reaction may require corticosteroids.
Treatment of Malaria
Adults 2 to 3 tablets
Children 9 to 14 yrs. 2 tablets; 4 to 8 yrs. 1 tablet; under 4 yrs. 1/2 tablet.
Adults 1 tablet once weekly
Children 9 to 14 yrs. 3/4 tablet once weekly; 4 to 8 yrs. 1/2 tablet once weekly; under 4 yrs. 1/4 tablet once weekly.
Store below 30°C, Protect from light & moisture.
Strip of 3 Tablets packed in a carton with package insert.
Pharmaceuticals Co. Ltd.
No. 6A Okoh Street, Off: P. H. Road,
Onitsha, Anambra State, Nigeria.
106-107, HSIDC Indl. Estate, Sec-31,
Faridabad- 121003, Haryana, INDIA.