Country: United States
Language: English
Source: NLM (National Library of Medicine)
PYRIMETHAMINE (UNII: Z3614QOX8W) (PYRIMETHAMINE - UNII:Z3614QOX8W)
Teva Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Treatment of Toxoplasmosis : Pyrimethamine tablets are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. Use of pyrimethamine tablets are contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. Use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.
Pyrimethamine Tablets, USP are available as following: 25 mg - White, round, scored tablets debossed with “2P” and “T” on one side and plain on the other side in bottles of 30 (NDC 0480-3720-56) and 100 (NDC 0480-3720-01). Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.
Abbreviated New Drug Application
PYRIMETHAMINE- PYRIMETHAMINE TABLET TEVA PHARMACEUTICALS, INC. ---------- PYRIMETHAMINE TABLETS, USP RX ONLY PRESCRIBING INFORMATION DESCRIPTION Pyrimethamine Tablets, USP are an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients pregelatinized corn starch, magnesium stearate and mannitol. Pyrimethamine, USP known chemically as 5-(4- chlorophenyl)-6-ethyl-2, 4- pyrimidinediamine, has the following structural formula: C H ClN Mol. Wt. 248.71 CLINICAL PHARMACOLOGY Pyrimethamine is well absorbed with peak levels occurring between 2 to 6 hours following administration. It is eliminated slowly and has a plasma half-life of approximately 96 hours. Pyrimethamine is 87% bound to human plasma proteins. MICROBIOLOGY: Pyrimethamine is a folic acid antagonist and the rationale for its therapeutic action is based on the differential requirement between host and parasite for nucleic acid precursors involved in growth. This activity is highly selective against _Toxoplasma gondii_. The action of pyrimethamine against _Toxoplasma gondii_ is greatly enhanced when used in conjunction with sulfonamides. This was demonstrated by Eyles and Coleman in the treatment of experimental toxoplasmosis in the mouse. Jacobs etal demonstrated that combination of the 2 drugs effectively prevented the development of severe uveitis in most rabbits following the inoculation of the anterior chamber of the eye with toxoplasma. 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 12 13 4 1 2 this combination. CONTRAINDICATIONS Use of pyrimethamine tablets are contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. Use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency. WARNINGS The dosage of pyrimethamine r Read the complete document