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Fansidar

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Fansidar

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Acute Malaria

Fansidar (sulfadoxine and pyrimethamine) 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 (sulfadoxine and pyrimethamine) , in which case alternative treatment should be administered.

Prevention of Malaria

Malaria prophylaxis with Fansidar (sulfadoxine and pyrimethamine) 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 (sulfadoxine and pyrimethamine) , 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 (sulfadoxine and pyrimethamine) .

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
(>2 months to 18 years)
The dosage for treatment of malaria in children is based upon body weight:
Weight (kg)
Number of Tablets Taken 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 (sulfadoxine and pyrimethamine) 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 (sulfadoxine and pyrimethamine) 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 Weekly Once Every 2 Weeks
Adults 1 tablet
2 tablets
Pediatric patients
(>2 months to 18 years)
The dosage for prevention of malaria in children is based upon body weight:
Weight (kg)
Number of Tablets Taken Once Weekly
>45
31 to 45 1
21 to 30 ¾
11 to 20 ½
5 to 10 ¼

Prophylaxis with Fansidar (sulfadoxine and pyrimethamine) 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 (sulfadoxine and pyrimethamine) ((ROCHE LOGO)) ROCHE.

Manufactured by: F. Hoffmann-La Roche Ltd. Basel, Switzerland. Distributed by: Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey, NJ 07110-1199. Revised: August 2004. FDA revision date: 2/26/2004

Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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