CHLOROQUINE PHOSPHATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

CHLOROQUINE PHOSPHATE (UNII: 6E17K3343P) (CHLOROQUINE - UNII:886U3H6UFF)

Հասանելի է:

Rising Pharmaceuticals, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Chloroquine phosphate tablets are indicated for the: - Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax . - Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. - Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: - Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure). - Do not use chloroquine phosphate tablets for malaria prophylaxis in areas where chloroquine resistance occurs, Resistance to chloroquine phosphate tablets is widespread in P. falciparum, and is reported in P.vivax (see WARNINGS). - Concomitant therapy with an 8-aminoquinoline drug is necessary for treatment of the hypnozoite liver stag

Ապրանքի ամփոփագիր:

Tablets containing 500 mg chloroquine phosphate USP, equivalent to 300 mg of chloroquine base Bottle of 25                     (NDC 64980-178-02) Bottle of 100                   (NDC 64980-178-01) Bottle of 500                   (NDC 64980-178-05) Bottle of 1000                 (NDC 64980-178-10) White, round, biconvex film-coated tablets, with debossing of ‘CN 500’ on one side and plain surface on the other side. Dispense in tight, light-resistant container as defined in the USP/NF. Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F) [See USP Controlled Room Temperature]

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CHLOROQUINE PHOSPHATE - CHLOROQUINE PHOSPHATE TABLET
RISING PHARMACEUTICALS, INC.
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CHLOROQUINE PHOSPHATE TABLET, USP
DESCRIPTION
Chloroquine phosphate tablets, chloroquine phosphate, USP, is a
4-aminoquinoline compound for oral
administration. It is a white, odorless, bitter tasting, crystalline
substance, freely soluble inwater.
Chloroquine phosphate tablets are an antimalarial and amebicidal drug.
Chemically, it is
7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline phosphate
(1:2) andhas
the following structural formula:
C
H ClN .2H PO Molecular Weight: 515.87
Each tablet contains 500 mg of chloroquine phosphate USP, equivalent
to 300 mg chloroquine base.
_Inactive Ingredients:_ colloidal silicon dioxide, dibasic calcium
phosphate,
hydroxypropylmethylcellulose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polysorbate80, pregelatinized starch, sodium starch glycolate and
titanium dioxide.
CLINICAL PHARMACOLOGY
Chloroquine is rapidly and almost completely absorbed from the
gastrointestinal tract, and only a small
proportion of the administered dose is found in the stools.
Approximately 55% of the drug inthe plasma
is bound to nondiffusible plasma constituents. Excretion of
chloroquine is quite slow,but is increased
by acidification of the urine. Chloroquine is deposited in the tissues
in considerable amounts. In
animals, from 200 to 700 times the plasma concentration may be found
in the liver,spleen, kidney, and
lung; leukocytes also concentrate the drug. The brain and spinal cord,
in contrast, contain only 10 to 30
times the amount present in plasma.
Chloroquine undergoes appreciable degradation in the body. The main
metabolite is
desethylchloroquine, which accounts for one fourth of the total
material appearing in the
urine;bisdesethylchloroquine, a carboxylic acid derivative, and other
metabolic products as yet
uncharacterized are found in small amounts. Slightly more than half of
the urinary drug products can be
accounted for as unchanged chloroquine.
MICROBIOLOGY
Me