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:

Alvogen, Inc.

INN (International Name):

PRIMAQUINE PHOSPHATE

Composition:

PRIMAQUINE 26.3 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRIMAQUINE PHOSPHATE - PRIMAQUINE PHOSPHATE TABLET, FILM COATED
ALVOGEN, INC.
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BOXED WARNING
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE
COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PRIMAQUINE
PHOSPHATE.
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.
Molecular Formula C
H N O·2H PO Molecular Wt 455.34
Inactive Ingredients: Colloidal silicon dioxide, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, pregelatinized
starch, talc, titanium dioxide, FD&C
Yellow #5 aluminum lake, FD&C Yellow #6 aluminum lake, FD&C Blue #2
aluminum lake and FD&C
Red #40 aluminum Lake.
CLINICAL PHARMACOLOGY
Primaquine phosphate is an 8-aminoquinoline 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
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
15
21
3
3
4
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 receiv