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:

Blenheim Pharmacal, Inc.

INN (International namn):

ATOVAQUONE

Sammansättning:

ATOVAQUONE 250 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. 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 sever

Produktsammanfattning:

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 68462-404-60 bottles of 60 NDC 68462-404-90 bottles of 90 NDC 68462-404-01 bottles of 100 NDC 68462-404-10 bottles of 1000 NDC 68462-404-67 Carton containing two blister cards (NDC 68462-404-44) each containing 12 tablets. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature) .

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
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
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets is an antimalarial
indicated for:
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)
DOSAGE AND ADMINISTRATION
Atovaquone and proguanil hydrochloride tablets should be taken with
food or a milky drink.
Prophylaxis ( 2.1):
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.
Treatment ( 2.2) :
Adults: Four adult strength tablets as a single daily dose for 3 days.
Renal Impairment ( 2.3):
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.
DOSAGE FORMS AND STRENGTHS
Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil
hydrochloride. ( 3)
CONTRAINDICATIONS
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 severe renal
impairment (creatinine clearance <30 mL/min). ( 4.2)
WARNINGS AND PRECAUTIONS
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 an