PRIMAQUINE PHOSPHATE tablet film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Ingenus Pharmaceuticals NJ, LLC

INN（国际名称）:

PRIMAQUINE PHOSPHATE

组成:

PRIMAQUINE 15 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

PRIMAQUINE PHOSPHATE- PRIMAQUINE PHOSPHATE TABLET, FILM COATED
INGENUS PHARMACEUTICALS NJ, 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 ane