MEPRON Oral suspension Ref.[10869] Active ingredients: Atovaquone

2.1 Dosage for the Prevention of P. jirovecii Pneumonia

The recommended oral dosage is 1,500 mg (10 mL) once daily administered with food.

2.2 Dosage for the Treatment of Mild-to-Moderate P. jirovecii Pneumonia

The recommended oral dosage is 750 mg (5 mL) twice daily (total daily dose = 1,500 mg) administered with food for 21 days.

2.3 Important Administration Instructions

Administer MEPRON oral suspension with food to avoid low plasma atovaquone concentrations that may limit response to therapy [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3)].

MEPRON Foil Pouch:

• Open each 5-mL pouch by folding along the dotted line and tearing open at horizontal slit as directed by arrow on pouch.
• For a 5-mL dose, take entire contents either by placing directly into the mouth or by dispensing into a dosing spoon (5 mL) or cup prior to administration by mouth.
• For a 10-mL dose, take the entire contents of 2 pouches.

MEPRON Bottle:

Shake bottle gently before administering the recommended dosage.

Overdoses up to 31,500 mg of atovaquone have been reported. In one such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose. There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable.

Bottle of 210 mL with child-resistant cap: Store at 15°C to 25°C (59°F to 77°F). Do not freeze. Dispense in tight container as defined in USP.

5-mL child-resistant foil pouch – unit dose pack of 42: Store at 15°C to 25°C (59°F to 77°F). Do not freeze.