Pyrimethamine
Generic: PYRIMETHAMINE
Basic Information
Manufacturer
Aurobindo Pharma Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
7aca002e-a538-4715-9121-a17bdb7f200c
Indications & Usage
INDICATIONS AND USAGE Treatment of Toxoplasmosis: Pyrimethamine tablets are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Warnings
WARNINGS The dosage of pyrimethamine required for the treatment of toxoplasmosis has a narrow therapeutic window.
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 Pyrimethamine 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.
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 Pyrimethamine 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.
Adverse Reactions
ADVERSE REACTIONS Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide.
Consult the complete prescribing information for the relevant sulfonamide for sulfonamide-associated adverse events.
With doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur.
Vomiting may be minimized by giving the medication with meals; it usually disappears promptly upon reduction of dosage.
Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm.
Hematologic effects, however, may also occur at low doses in certain individuals (see PRECAUTIONS ; General ).
Pulmonary eosinophilia has been reported rarely.
Consult the complete prescribing information for the relevant sulfonamide for sulfonamide-associated adverse events.
With doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur.
Vomiting may be minimized by giving the medication with meals; it usually disappears promptly upon reduction of dosage.
Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm.
Hematologic effects, however, may also occur at low doses in certain individuals (see PRECAUTIONS ; General ).
Pulmonary eosinophilia has been reported rarely.