ATOVAQUONE AND PROGUANIL HCL- atovaquone and proguanil hydrochloride tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Bryant Ranch Prepack

Designación común internacional (DCI):

ATOVAQUONE

Composición:

ATOVAQUONE 250 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atovaquone and Proguanil Hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. Atovaquone and Proguanil Hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride 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. Risk Summary Available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. The proguanil component of Atovaquone and Proguanil Hydrochloride tablets acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue fola

Resumen del producto:

NDC: 63629-5531-1: 10 Tablets in a BOTTLE NDC: 63629-5531-2: 24 Tablets in a BOTTLE NDC: 63629-5531-3: 5 Tablets in a BOTTLE NDC: 63629-5531-4: 12 Tablets in a BOTTLE

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

ATOVAQUONE AND PROGUANIL HCL- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOVAQUONE AND
PROGUANIL HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE.
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Atovaquone and Proguanil Hydrochloride tablets are an antimalarial
indicated for:
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DOSAGE AND ADMINISTRATION
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Prophylaxis (2.1):
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•
Treatment (2.2):
•
Renal Impairment (2.3):
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DOSAGE FORMS AND STRENGTHS
Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil
hydrochloride. (3)
CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
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prophylaxis of _Plasmodium falciparum_ malaria, including in areas
where chloroquine resistance has
been reported. (1.1)
treatment of acute, uncomplicated _P. falciparum_ malaria. (1.2)
Atovaquone and Proguanil Hydrochloride tablets should be taken with
food or a milky drink.
Start prophylaxis 1 or 2 days before entering a malaria‑endemic area
and continue daily during the
stay and for 7 days after return.
Adults: One adult strength tablet per day.
Adults: Four adult strength tablets as a single daily dose for 3 days.
Do not use for prophylaxis of malaria in patients with severe renal
impairment.
Use with caution for treatment of malaria in patients with severe
renal impairment.
Known serious hypersensitivity reactions to atovaquone or proguanil
hydrochloride or any component
of the formulation. (4)
Prophylaxis of _P. falciparum_ malaria in patients with severe renal
impairment (creatinine clearance
<30mL/min). (4)
Atovaquone absorption may be reduced in patients with diarrhea or
vomiting. If used in patients who
are vomiting, parasitemia should be closely monitored and the use of
an antiemetic considered. In
patients with severe or persistent diarrhea or vomiting, alternative
antima