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

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

PD-Rx Pharmaceuticals, Inc.

INN (nume internaţional):

ATOVAQUONE

Compoziție:

ATOVAQUONE 250 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. - Atovaquone and Proguanil Hydrochloride tablets are 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 tablets are contraindicated for prophylaxis of P.   falciparum malaria in patients with sever

Rezumat produs:

Atovaquone and Proguanil Hydrochloride tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride, are pink, film‑coated, round, biconvex tablets engraved with “GX CM3” on one side. Bottles of 190 (NDC 43063-522-68) Bottles of 280 (NDC 43063-522-69) Bottles of 375 (NDC 43063-522-73) Storage Conditions Store at 25°C (77°F). Temperature excursions are permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

ATOVAQUONE AND PROGUANIL HCL- ATOVAQUONE AND PROGUANIL
HYDROCHLORIDE TABLET, FILM COATED
PD-RX 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 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:
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)
Prophylaxis of _P. falciparum_ malaria in patients with severe renal
impairment (creatinine clearance <30
_ _mL/min). ( 4)
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
antimalarial therapy may be
required. ( 5.1)
In mi