Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ATOVAQUONE (UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT), PROGUANIL HYDROCHLORIDE (UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V)
Bryant Ranch Prepack
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 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. Risk Summary Available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride 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 fola
NDC: 63629-5531-1: 10 Tablets in a BOTTLE NDC: 63629-5531-2: 24 Tablets in a BOTTLE NDC: 63629-5531-3: 5 Tablets in a BOTTLE NDC: 63629-5531-4: 12 Tablets in a BOTTLE
New Drug Application Authorized Generic
ATOVAQUONE AND PROGUANIL HCL- ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- 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: • • DOSAGE AND ADMINISTRATION • Prophylaxis (2.1): • • Treatment (2.2): • Renal Impairment (2.3): • • DOSAGE FORMS AND STRENGTHS Tablets (adult strength): 250 mg atovaquone and 100 mg proguanil hydrochloride. (3) 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 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. Adults: Four adult strength tablets as a single daily dose for 3 days. 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. 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 <30mL/min). (4) 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 antima Soma hati kamili