ATOVAQUONE AND PROGUANIL HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

ATOVAQUONE

Sammansättning:

ATOVAQUONE 62.5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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. Available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride tablets 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 fo

Produktsammanfattning:

Atovaquone and Proguanil Hydrochloride Tablets are available containing 250 mg of atovaquone, USP and 100 mg of proguanil hydrochloride, USP. The 250 mg/100 mg tablets are buff, film-coated, round, unscored tablets debossed with A-P over 2 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4162-01 bottles of 100 tablets Atovaquone and Proguanil Hydrochloride Pediatric Tablets are available containing 62.5 mg of atovaquone, USP and 25 mg of proguanil hydrochloride, USP. The 62.5 mg/25 mg tablets are buff, film-coated, round, unscored tablets debossed with A-P over 1 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4160-01 bottles of 100 tablets Storage Conditions: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ATOVAQUONE AND
PROGUANIL HYDROCHLORIDE TABLETS.
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, FOR ORAL USE
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS, FOR ORAL USE
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
•
Prophylaxis (2.1):
•
•
•
Treatment (2.2):
•
•
Renal Impairment (2.3):
•
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
•
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.
Pediatric Patients: Dosage based on body weight (see Table 1).
Adults: Four adult strength tablets as a single daily dose for 3 days.
Pediatric Patients: Dosage based on body weight (see Table 2).
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.
Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil
hydrochloride. (3)
Pediatric tablets: 62.5 mg atovaquone and 25 mg proguanil
hydrochloride. (3)
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
impa