PRIMAQUINE PHOSPHATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals, LLC

INN (International Name):

PRIMAQUINE PHOSPHATE

Composition:

PRIMAQUINE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Primaquine Phosphate Tablets, USP are supplied as orange colored, round, biconvex, film-coated tablets of 26.3 mg (= 15 mg base), debossed with a "059" on one side and plain on the other side. Available in bottles of 100 (NDC 50742-191-01) and bottles of 500 (NDC 50742-191-05) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRIMAQUINE PHOSPHATE- PRIMAQUINE PHOSPHATE TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
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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:_ Hypromellose, Lactose Monohydrate, Magnesium
Stearate, Microcrystalline
Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset
Yellow FCF Aluminum Lake,
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 hemolytic anemia