DARAPRIM- pyrimethamine tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

PYRIMETHAMINE (UNII: Z3614QOX8W) (PYRIMETHAMINE - UNII:Z3614QOX8W)

متاح من:

Vyera Pharmaceuticals LLC

INN (الاسم الدولي):

PYRIMETHAMINE

تركيب:

PYRIMETHAMINE 25 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

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

الوضع إذن:

New Drug Application

خصائص المنتج

DARAPRIM- PYRIMETHAMINE TABLET
VYERA PHARMACEUTICALS LLC
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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.