ATOVAQUONE AND PROGUANIL HYDROCHLORIDE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ATOVAQUONE (UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT), PROGUANIL HYDROCHLORIDE (UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V)

제공처:

Aidarex Pharmaceuticals LLC

INN (International Name):

ATOVAQUONE

구성:

ATOVAQUONE 250 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES ). Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or any component of the formulation. Rare cases of anaphylaxis following treatment with atovaquone/proguanil have been reported. Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) (see CLINICAL PHARM

제품 요약:

Atovaquone and proguanil hydrochloride tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride, are pinkish brown to brown colored, circular, biconvex beveled edge, film-coated tablets with ‘404’ debossed on one side and ‘G’ debossed on the other side. Atovaquone and proguanil hydrochloride tablets 250 mg/100 mg NDC 33261-900-01 unit dose pack of 24

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Atovaquone and proguanil hydrochloride is a fixed-dose combination of
the antimalarial agents
atovaquone and proguanil hydrochloride. The chemical name of
atovaquone is _trans_-2-[4-(4-
chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is
a yellow crystalline solid
that is practically insoluble in water. It has a molecular weight of
366.84 and the molecular formula
C
H ClO . The compound has the following structural formula:
The chemical name of proguanil hydrochloride USP is
1-(4-chlorophenyl)-5-isopropyl-biguanide
hydrochloride. Proguanil hydrochloride USP is a white crystalline
solid that is sparingly soluble in
water. It has a molecular weight of 290.22 and the molecular formula C
H ClN •HCl. The compound
has the following structural formula:
Atovaquone and proguanil hydrochloride tablets are for oral
administration. Each atovaquone and
proguanil hydrochloride tablet contains 250 mg of atovaquone and 100
mg of proguanil hydrochloride
USP. The inactive ingredients in the tablet are colloidal silicon
dioxide, ferric oxide red, hypromellose
2910, low substituted hydroxypropyl cellulose, magnesium stearate,
microcrystalline cellulose,
poloxamer 188, povidone K30, polyethylene glycol 400, polyethylene
glycol 8000, sodium starch
glycolate, titanium dioxide.
22
19
3
11
16
5
glycolate, titanium dioxide.
CLINICAL PHARMACOLOGY
MICROBIOLOGY:
Mechanism of Action:
The constituents of atovaquone and proguanil hydrochloride interfere
with 2 different pathways
involved in the biosynthesis of pyrimidines required for nucleic acid
replication. Atovaquone is a
selective inhibitor of parasite mitochondrial electron transport.
Proguanil hydrochloride primarily
exerts its effect by means of the metabolite cycloguanil, a
dihydrofolate reductase inhibitor. Inhibition
of dihydrofolate reductase in the malaria par