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Treatment of Toxoplasmosis: DARAPRIM (pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Treatment of Acute Malaria: DARAPRIM (pyrimethamine) is also indicated for the treatment of acute malaria. It should not be used alone to treat acute malaria. Fast-acting schizonticides such as chloroquine or quinine are indicated and preferable for the treatment of acute malaria. However, conjoint use of DARAPRIM (pyrimethamine) with a sulfonamide (e.g., sulfadoxine) will initiate transmission control and suppression of susceptible strains of plasmodia.
Chemoprophylaxis of Malaria: DARAPRIM (pyrimethamine) is indicated for the chemoprophylaxis of malaria due to susceptible strains of plasmodia. However, resistance to pyrimethamine is prevalent worldwide. It is not suitable as a prophylactic agent for travelers to most areas.
DOSAGE AND ADMINISTRATION
For Treatment of Toxoplasmosis: The dosage of DARAPRIM (pyrimethamine) for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.
The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g., sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks.
The pediatric dosage of DARAPRIM (pyrimethamine) is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM (pyrimethamine) .
For Treatment of Acute Malaria: DARAPRIM (pyrimethamine) is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, DARAPRIM (pyrimethamine) at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. DARAPRIM (pyrimethamine) is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein DARAPRIM (pyrimethamine) must be used alone in semi-immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.
For Chemoprophylaxis of Malaria:
Adults and pediatric patients over 10 years — 25 mg (1 tablet) once weekly
Children 4 through 10 years — 12.5 mg (1/2 tablet) once weekly
Infants and children under 4 years — 6.25 mg (1/4 tablet) once weekly
White, scored tablets containing 25 mg pyrimethamine, imprinted with “DARAPRIM (pyrimethamine) ” and “A3A” in bottles of 100 (NDC 0173-0201-55).
Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.
Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834 for GlaxoSmithKline, Research Triangle Park, NC 27709. March 2003. FDA Rev date: 11/18/2003
Last reviewed on RxList: 1/20/2009
This monograph has been modified to include the generic and brand name in many instances.
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