Country: United States
Language: English
Source: NLM (National Library of Medicine)
ATOVAQUONE (UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT), PROGUANIL HYDROCHLORIDE (UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V)
St. Mary's Medical Park Pharmacy
ATOVAQUONE
ATOVAQUONE 250 mg
ORAL
PRESCRIPTION DRUG
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
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: 60760-0498-11 bottles of 11 60760-0498-13 bottles of 13 60760-0498-04 bottles of 4 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature) .
Abbreviated New Drug Application
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ST. MARY'S MEDICAL PARK PHARMACY ---------- 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: 2000INDICATIONS 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. PEDIATRIC PATIENTS: DOSAGE BASED ON BODY WEIGHT (SEE TABLE 1). TREATMENT ( 2.2): ADULTS: FOUR ADULT STRENGTH TABLETS AS A SINGLE DAILY DOSE FOR 3 DAYS. PEDIATRIC PATIENTS: DOSAGE BASED ON BODY WEIGHT (SEE TABLE 2). 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) PEDIATRIC TABLETS: 62.5 MG ATOVAQUONE AND 25 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 Read the complete document