Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
PYRIMETHAMINE (UNII: Z3614QOX8W) (PYRIMETHAMINE - UNII:Z3614QOX8W)
Vyera Pharmaceuticals LLC
PYRIMETHAMINE
PYRIMETHAMINE 25 mg
ORAL
PRESCRIPTION DRUG
Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. Use of DARAPRIM is 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.
White, scored tablets containing 25 mg pyrimethamine, imprinted with “DARAPRIM” and “A3A" in bottles of 100 (NDC 69413-330-10) and bottles of 30 (NDC 69413-330-30). Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light
New Drug Application
DARAPRIM- PYRIMETHAMINE TABLET VYERA PHARMACEUTICALS LLC ---------- DARAPRIM (PYRIMETHAMINE) DESCRIPTION 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: C H CIN 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 et al 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: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. CONTRAINDICATIONS Use of DARAPRIM is 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. ® 12 13 4 1 2 WARNINGS The dosage of pyrimethamine required for the treatment of toxoplasmosis has a narrow therapeutic window. Lugege kogu dokumenti