País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ATOVAQUONE (UNII: Y883P1Z2LT) (ATOVAQUONE - UNII:Y883P1Z2LT), PROGUANIL HYDROCHLORIDE (UNII: R71Y86M0WT) (PROGUANIL - UNII:S61K3P7B2V)
Aidarex Pharmaceuticals LLC
ATOVAQUONE
ATOVAQUONE 250 mg
ORAL
PRESCRIPTION DRUG
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES ). 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 to atovaquone or proguanil hydrochloride or any component of the formulation. Rare cases of anaphylaxis following treatment with atovaquone/proguanil have been reported. Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) (see CLINICAL PHARM
Atovaquone and proguanil hydrochloride tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride, 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 33261-900-01 unit dose pack of 24
Abbreviated New Drug Application
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE- ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS RX ONLY DESCRIPTION Atovaquone and proguanil hydrochloride is a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is _trans_-2-[4-(4- chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C H ClO . The compound has the following structural formula: The chemical name of proguanil hydrochloride USP is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride USP is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C H ClN •HCl. The compound has the following structural formula: Atovaquone and proguanil hydrochloride tablets are for oral administration. Each atovaquone and proguanil hydrochloride tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride USP. The inactive ingredients in the tablet are colloidal silicon dioxide, ferric oxide red, hypromellose 2910, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, polyethylene glycol 400, polyethylene glycol 8000, sodium starch glycolate, titanium dioxide. 22 19 3 11 16 5 glycolate, titanium dioxide. CLINICAL PHARMACOLOGY MICROBIOLOGY: Mechanism of Action: The constituents of atovaquone and proguanil hydrochloride interfere with 2 different pathways involved in the biosynthesis of pyrimidines required for nucleic acid replication. Atovaquone is a selective inhibitor of parasite mitochondrial electron transport. Proguanil hydrochloride primarily exerts its effect by means of the metabolite cycloguanil, a dihydrofolate reductase inhibitor. Inhibition of dihydrofolate reductase in the malaria par Leia o documento completo