PYRIMETHAMINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Pyrimethamine Tablets USP, 25 mg are white to off-white round shaped, biconvex, uncoated tablet, debossed with ‘L’ ‘25’ on one side and break line on other side. They are supplied as follows:             Bottles of 30                                NDC 59651-590-30             Bottles of 100                               NDC 59651-590-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in a dry place and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRIMETHAMINE - PYRIMETHAMINE TABLET
AUROBINDO PHARMA LIMITED
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PYRIMETHAMINE TABLETS, USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Pyrimethamine is an antiparasitic compound available in tablet form
for oral
administration. Each scored tablet contains 25 mg pyrimethamine USP
and the inactive
ingredients colloidal silicon dioxide, lactose monohydrate, magnesium
stearate and
pregelatinized starch (corn).
Pyrimethamine USP, known chemically as 5-(4- chlorophenyl)-6-ethyl-2,
4-
pyrimidinediamine, has the following structural formula:
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: Pyrimethamine tablets are indicated for
the treatment
of toxoplasmosis when used conjointly with a sulfonamide, since
synergism exists with
this combination.
1
2
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 req