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Fansidar Indications, Dosage, Storage, Stability - Sulfadoxine and Pyrimethamine

Fansidar Indications, Dosage, Storage, Stability - Sulfadoxine and Pyrimethamine

INDICATIONS AND USAGE

Treatment of Acute Malaria

Fansidar is indicated for the treatment of acute, uncomplicated P. falciparum malaria for those patients in whom chloroquine resistance is suspected. However, strains of P. falciparum (see CLINICAL PHARMACOLOGY: Microbiology) may be encountered which have developed resistance to Fansidar, in which case alternative treatment should be administered.

Prevention of Malaria

Malaria prophylaxis with Fansidar is not routinely recommended and should only be considered for travelers to areas where chloroquine-resistant P. falciparum malaria is endemic and sensitive to Fansidar, and when alternative drugs are not available or are contraindicated (see CONTRAINDICATIONS). However, strains of P. falciparum may be encountered which have developed resistance to Fansidar.

DOSAGE AND ADMINISTRATION

(See INDICATIONS AND USAGE)

The dosage should be swallowed whole, and not chewed, with plenty of fluids after a meal.

Treatment of Acute Malaria

Adults

2 to 3 tablets taken as a single dose.

   

Pediatric patients

The dosage for treatment of malaria in

(>2 months to 18 years)

children is based upon body weight:

 

Number of Tablets Taken

Weight (kg)

as a Single Dose

>45

3

31 to 45

2

21 to 30

1 ½

11 to 20

1

5 to 10

½

Prevention of Malaria

The malaria risk must be carefully weighed against the risk of serious adverse drug reactions (see INDICATIONS AND USAGE). If Fansidar is prescribed for prophylaxis, it is important that the physician inquires about sulfonamide intolerance and points out the risk and the need for immediate drug withdrawal if skin reactions do occur. The first dose of Fansidar should be taken 1 or 2 days before arrival in an endemic area; administration should be continued during the stay and for 4 to 6 weeks after return.

   

Once Every

Once Weekly

2 Weeks

Adults

1 tablet

2 tablets

Pediatric patients

The dosage for prevention of malaria in

(>2 months to 18 years)

children is based upon body weight:

     

 

Number of Tablets Taken

Weight (kg)

Once Weekly

>45

1 ½

31 to 45

1

21 to 30

¾

11 to 20

½

5 to 10

¼

Prophylaxis with Fansidar should not be continued for more than two years, since no experience of more prolonged administration is available to date.

HOW SUPPLIED

Scored tablets, containing 500 mg sulfadoxine and 25 mg pyrimethamine — unit dose packages of 25 (NDC-0004-0161-03). Imprint on tablets: FANSIDAR ((ROCHE LOGO)) ROCHE.

Manufactured by: F. Hoffmann-La Roche Ltd. Basel, Switzerland Distributed by:XXXXXXXX , Revised: XXXX XXXX , Copyright 1996-200X by Roche Laboratories Inc. All rights reserved.

Updated Apr 19, 2004

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