A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Daraprim Indications, Dosage, Storage, Stability - Pyrimethamine
Daraprim Indications, Dosage, Storage, Stability - Pyrimethamine
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.
Treatment of Acute Malaria: DARAPRIM is also indicated
for the treatment of acute malaria. It should not be used alone to treat acute
malaria. Fast-acting schizonticides such as chloro-quine or quinine are indicated
and preferable for the treatment of acute malaria. However, conjoint use of
DARAPRIM with a sulfonamide (e.g., sulfadoxine) will initiate transmission control
and suppression of susceptible strains of plasmodia.
Chemoprophylaxis of Malaria: DARAPRIMis indicated for
the chemoprophylaxis of malaria due to susceptible strains of plasmodia. However,
resistance to pyrimethamine is prevalent worldwide. It is not suitable as a
prophylactic agent for travelers to most areas.
DOSAGE AND ADMINISTRATION
For Treatment of Toxoplasmosis: The dosage of DARAPRIM
for the treatment of toxoplasmosis must be carefully adjusted so as to provide
maximum therapeutic effect and a minimum of side effects. At the dosage required,
there is a marked variation in the tolerance to the drug. Young patients may
tolerate higher doses than older individuals. Concurrent administration of folinic
acid is strongly recommended in all patients.
The adult starting dose is 50 to 75 mg of the drug daily, together
with 1 to 4 g daily of a sulfonamide of the sulfa-pyrimidine type, e.g., sulfadoxine.
This dosage is ordinarily continued for 1 to 3 weeks, depending on the response
of the patient and tolerance to therapy. The dosage may then be reduced to about
one half that previously given for each drug and continued for an additional
4 to 5 weeks.
The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into
2 equal daily doses; after 2 to 4 days this dose may be reduced to one half
and continued for approximately 1 month. The usual pediatric sulfonamide dosage
is used in conjunction with DARAPRIM.
For Treatment of Acute Malaria: DARAPRIM is NOT recommended
alone in the treatment of acute malaria. Fast-acting schizonticides, such as
chloroquine or quinine, are indicated for treatment of acute malaria. However,
DARAPRIM at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate
transmission control and suppression of non-falciparum malaria. DARAPRIM is
only recommended for patients infected in areas where susceptible plasmodia
exist. Should circumstances arise wherein DARAPRIM must be used alone in semi-immune
persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4
through 10 years old may be given 25 mg daily for 2 days. In any event, clinical
cure should be followed by the once-weekly regimen described below for chemopro-phylaxis.
Regimens which include suppression should be extended through any characteristic
periods of early recrudescence and late relapse, i.e., for at least 10 weeks
in each case.
For Chemoprophylaxis of Malaria:
Adults and pediatric patients over 10 years — 25 mg (1 tablet)
once weekly Children 4 through 10 years — 12.5 mg (1/2 tablet)
once weekly Infants and children under 4 years — 6.25 mg (1/4
tablet) once weekly
HOW SUPPLIED
White, scored tablets containing 25 mg pyrimethamine, imprinted
with "DARAPRIM" and "A3A" in bottles of 100 (NDC 0173-0201-55).
Store at 15° to 25°C (59° to 77°F) in a dry place and protect
from light.
REFERENCES
1. Eyles DE, Coleman N. Synergistic effect of sulfadiazine
and Daraprim against experimental toxoplasmosis in the mouse. Antibiot Chemother.
1953;3:483-490.
2. Jacobs L, Melton ML, Kaufman HE. Treatment of experimental
ocular toxoplasmosis. Arch Ophthalmol. 1964;71: 111-118.
3. Jim RTS, Elizaga FV. Development of chronic granulocytic
leukemia in a patient treated with pyrimethamine. Hawaii Med J. 1977;36:173-176.
4. Sadoff L. Antimalarial drugs and Burkitt’s lymphoma. Lancet.
1973;2:1262-1263.
5. Bahna L. Pyrimethamine. LARC Monogr Eval Carcinog Risk Chem.
1977;13:233-242.
6. Clive D, Johnson KO, Spector JKS, et al. Validation and
characterization of the L5178Y/TK +/- mouse lymphoma mutagen assay system. Mut
Res. 1979;59:61-108.
Manufactured by: DSM Pharmaceuticals, Inc.
Greenville, NC 27834 for GlaxoSmithKline Research Triangle Park, NC 27709, ©2003,
GlaxoSmithKline. All rights reserved., March 2003 RL-1179
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