Daraprim

Daraprim

Daraprim Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

The dosage of pyrimethamine required for the treatment of toxoplasmosis is 10 to 20 times the recommended antimalaria dosage and approaches the toxic level. If signs of folate deficiency develop (see ADVERSE REACTIONS), reduce the dosage or discontinue the drug according to the response of the patient. Folinic acid (leucovorin) should be administered in a dosage of 5 to 15 mg daily (orally, IV, or IM) until normal hematopoiesis is restored.

Data in 2 humans indicate that pyrimethamine may be carcinogenic: a 51-year-old female who developed chronic granulocytic leukemia after taking pyrimethamine for 2 years for toxoplasmosis,3 and a 56-year-old patient who developed reticulum cell sarcoma after 14 months of pyrimethamine for toxoplasmosis.4

Pyrimethamine has been reported to produce a significant increase in the number of lung tumors in mice when given intraperitoneally at doses of 25 mg/kg.5

DARAPRIM should be kept out of the reach of infants and children as they are extremely susceptible to adverse effects from an overdose. Deaths in pediatric patients have been reported after accidental ingestion.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Treatment of Toxoplasmosis

DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Treatment of Acute Malaria

DARAPRIM 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 with a sulfonamide (e.g., sulfadoxine) will initiate transmission control and suppression of susceptible strains of plasmodia.

Chemoprophylaxis of Malaria

DARAPRIM 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.

History

There is currently no drug history available for this drug.

Other Information

DARAPRIM (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients corn and potato starch, lactose, and magnesium stearate.

Pyrimethamine, known chemically as 5-(4-chlorophenyl)-6-ethyl-2,4-pyrimidinediamine, has the following structural formula:

pyrimethamine chemical structure

C12H13ClN4                                                                                                                    Mol. Wt 248.71

Daraprim Manufacturers


  • Kaiser Foundation Hospitals
    Daraprim (Pyrimethamine) Tablet [Kaiser Foundation Hospitals]
  • Remedyrepack Inc.
    Daraprim (Pyrimethamine) Tablet [Remedyrepack Inc. ]
  • Amedra Pharmaceuticals Llc
    Daraprim (Pyrimethamine) Tablet [Amedra Pharmaceuticals Llc]
  • Turing Pharmaceuticals Llc
    Daraprim (Pyrimethamine) Tablet [Turing Pharmaceuticals Llc]

Login To Your Free Account