PRIMAQUINE PHOSPHATE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

PRIMAQUINE PHOSPHATE (UNII: H0982HF78B) (PRIMAQUINE - UNII:MVR3634GX1)

Disponible des:

PD-Rx Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

PRIMAQUINE PHOSPHATE

Composición:

PRIMAQUINE 15 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria. Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS). Pregnant women (see WARNINGS, Usage in Pregnancy). Primaquine phosphate is contraindicated in acutely ill patients suffering from systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus. The drug is also contraindicated in patients receiving concurrently other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow. Because quinacrine hydrochloride appears to potentiate the toxicity of antimalarial compounds which are structurally related to primaquine, the use of quinacrine in patients receiving primaquine is contraindicated. Similarly, primaquine should not be administered to patients who have received quinacrine recently, as toxicity is increased.

Resumen del producto:

Primaquine phosphate is supplied as pink, convex, discoid, film-coated tablets of 26.3 mg (= 15 mg base), printed with a "W" and "P97" on one side. Available in bottles of 14 (NDC 43063-225-14) Available in bottles of 28 (NDC 43063-225-28) Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature] Dispense in tight, light-resistant container as defined in the USP/NF.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

PRIMAQUINE PHOSPHATE- PRIMAQUINE PHOSPHATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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PRIMAQUINE
PHOSPHATE
TABLETS, USP
DESCRIPTION
Primaquine phosphate is
8-[(4-amino-1-methylbutyl)amino]-6-methoxyquinoline
phosphate, a synthetic compound with potent antimalarial activity.
Each tablet contains
26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine
base). The dosage
is customarily expressed in terms of the base.
_Inactive Ingredients: _Carnauba Wax, Hydroxypropyl Methylcellulose,
Lactose,
Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol
400, Polysorbate 80,
Pregelatinized Starch, Red Ferric Oxide, Talc, Titanium Dioxide.
CLINICAL PHARMACOLOGY
Primaquine phosphate is an 8-amino-quinoline compound which eliminates
tissue
(exoerythrocytic) infection. Thereby, it prevents the development of
the blood
(erythrocytic) forms of the parasite which are responsible for
relapses in vivax malaria.
Primaquine phosphate is also active against gametocytes of _Plasmodium
falciparum._
INDICATIONS AND USAGE
Primaquine phosphate is indicated for the radical cure (prevention of
relapse) of vivax
malaria.
CONTRAINDICATIONS
Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see
WARNINGS).
Pregnant women (see WARNINGS, Usage in Pregnancy).
Primaquine phosphate is contraindicated in acutely ill patients
suffering from systemic
disease manifested by tendency to granulocytopenia, such as rheumatoid
arthritis and
lupus erythematosus. The drug is also contraindicated in patients
receiving concurrently
other potentially hemolytic drugs or depressants of myeloid elements
of the bone
marrow.
Because quinacrine hydrochloride appears to potentiate the toxicity of
antimalarial
compounds which are structurally related to primaquine, the use of
quinacrine in
patients receiving primaquine is contraindicated. Similarly,
primaquine should not be
administered to patients who have received quinacrine recently, as
toxicity is increased.
WARNINGS
HEMOLYTIC ANEMIA AND G6PD DEFICIENCY
Due to the risk of