malarone atovaquone and proguanil hydrochloride tablet film coated

1 INDICATIONS AND USAGE MALARONE 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 ) 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria 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.

glaxosmithkline llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] headache` `[3] nausea` `[4] fatigue` `[5] depression` `[6] off label use` `[7] dyspnoea` `[8] pain` `[9] anxiety` `[10] diarrhoea`

6 years ago

ROUND PINK GX CM3

6 years ago

GX CM3 ROUND PINK

16 HOW SUPPLIED/STORAGE AND HANDLING MALARONE tablets, containing 250 mg atovaquone and 100 mg proguanil hydrochloride. • Bottle of 100 tablets with child-resistant closure (NDC 0173-0675-01). • Unit Dose Pack of 24 tablets with child-resistant lid foil (NDC 0173-0675-02). MALARONE pediatric tablets, containing 62.5 mg atovaquone and 25 mg proguanil hydrochloride. • Bottle of 100 tablets with child-resistant closure (NDC 0173-0676-01). 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).

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malarone atovaquone and proguanil hydrochloride tablet film coated

FDA Reported Adverse Reactions [1] drug ineffective [2] headache [3] nausea [4] fatigue [5] depression [6] off label use [7] dyspnoea [8] pain [9] anxiety [10] diarrhoea

ROUND PINK GX CM3

GX CM3 ROUND PINK

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] headache` `[3] nausea` `[4] fatigue` `[5] depression` `[6] off label use` `[7] dyspnoea` `[8] pain` `[9] anxiety` `[10] diarrhoea`