Atovaquone 62.5 MG proguanil hydrochloride 25 MG Oral Tablet

1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are 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 Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria 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.

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] overdose` `[4] death` `[5] toxicity to various agents` `[6] emotional distress` `[7] drug hypersensitivity` `[8] dyspnoea` `[9] drug withdrawal syndrome` `[10] drug ineffective`

4 years ago

ROUND PINK A P 1 M

16 HOW SUPPLIED/STORAGE AND HANDLING

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Tablets are available containing 250 mg of atovaquone, USP and 100 mg of proguanil hydrochloride, USP. The 250 mg/100 mg tablets are buff, film-coated, round, unscored tablets debossed with A-P over 2 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4162-01 bottles of 100 tablets

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Pediatric Tablets are available containing 62.5 mg of atovaquone, USP and 25 mg of proguanil hydrochloride, USP. The 62.5 mg/25 mg tablets are buff, film-coated, round, unscored tablets debossed with A-P over 1 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4160-01 bottles of 100 tablets Storage Conditions: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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Mylan Pharmaceuticals Inc.

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