ATOVAQUONE AND PROGUANIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ATOVAQUONE

Composition:

ATOVAQUONE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atovaquone and proguanil hydrochloride tabletsare indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. Atovaquone and proguanil hydrochloride tabletsare 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 reactions (e.g., anaphylaxis, erythema multiforme or Stevens-Johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation. Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) because of pancytopenia i

Product summary:

Atovaquone and proguanil hydrochloride tablets, containing 250 mg atovaquone USP and 100 mg proguanil hydrochloride USP, 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 63187-879-24 bottle of 24 tablets NDC 63187-879-30 bottle of 30 tablets NDC 63187-879-60 bottle of 60 tablets NDC 63187-879-90 bottle of 90 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature) .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
PROFICIENT RX LP
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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
ADMINISTRATION
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLETS, FOR ORAL
ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets is 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
•
•
CONTRAINDICATIONS
•
•
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 tabletsshould 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. (4.1)
Prophylaxis of _P. falciparum _malaria in patients with sev