Falcipar Sulfadoxine and Pyrimethamine Tablets USP

Falcipar
Sulfadoxine & Pyrimethamine Tablets USP

 

For the use of Medical profession only

 

COMPOSITION

Each uncoated tablet contains:

Sulfadoxine USP 500mg

Pyrimethamine USP 25 mg

 

ACTIONS

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.

 

INDICATIONS

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.

 

PHARMACOKINETICS

Both Sulfadoxine and Pyrimethamine are absorbed orally and are excreted mainly by the kidney.

 

CONTRAINDICATIONS

Hypersensitivity to pyrimethamine & Sulphonamide or patients with marked impaired liver or kidney function.

Infants less than two months of age, during pregnancy & nursing period.

 

PRECAUTIONS

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.

 

SIDE EFFECTS

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.

 

INTERACTION

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.

 

DOSAGE ADMINISTRATION

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.

Prophylaxis
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.

Storage
Store below 30°C, Protect from light & moisture.

 

PRESENTATION

Strip of 3 Tablets packed in a carton with package insert.
Sole Agent

TRANSGLOBE

Pharmaceuticals Co. Ltd.

No. 6A Okoh Street, Off: P. H. Road,

Onitsha, Anambra State, Nigeria.

 

Manufactured by

SYNMEDIC LABORATORIES

106-107, HSIDC Indl. Estate, Sec-31,

Faridabad- 121003, Haryana, INDIA.

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