United States - English - NLM (National Library of Medicine)

glaxosmithkline llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - malarone is indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. malarone is indicated for the treatment of acute, uncomplicated p. falciparum malaria. malarone has 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 malarone 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 malarone acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue folate supplementation to prevent neural tube defects [see clinical pharmacology (12.4)] . pregnant women with malaria are at increased risk for adverse pregnancy outcomes (see clin

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: poloxamer; povidone; hyprolose; purified water; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; macrogol 8000; hypromellose; iron oxide red; macrogol 400 - atovaquopro gh is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; poloxamer; purified water; hyprolose; colloidal anhydrous silica; sodium starch glycollate type a; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; iron oxide red; macrogol 400 - atovaquopro gh is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; poloxamer; hyprolose; magnesium stearate; povidone; purified water; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; iron oxide red; macrogol 400 - atovaquopro lapl is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - 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 severe renal impairment (creatinine clearance < 30 ml/min) because

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - 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 severe renal impairment (creatinine clearance < 30 ml/min) because

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - atovaquone, proguanil hydrochloride - film-coated tablet - atovaquone 62.5 mg proguanil hydrochloride 25 mg - antiprotozoals

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet, film coated - excipient ingredients: poloxamer; hyprolose; hypromellose; macrogol 400; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; macrogol 8000; iron oxide red; povidone - malarone is indicated for the treatment of plasmodium falciparum malaria in adults and children aged 3 years or older. indications as at 1 november 2001: "prophylaxis of plasmodium falciparum malaria in individuals weighing >40kg". this approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application. indications as at 13 january 2003: prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

dowelhurst ltd - proguanil hydrochloride - oral tablet - 100mg

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - atovaquone, proguanil hydrochloride - film-coated tablet - atovaquone 250 mg proguanil hydrochloride 100 mg - antiprotozoals