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:

AvKARE

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 42291-510-01) 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
AVKARE
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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 in patients with G6PD