July 30, 2015
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Mepron

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Mepron




Indications
Dosage
How Supplied

INDICATIONS

Prevention Of Pneumocystis Jiroveci Pneumonia

MEPRON® suspension is indicated for the prevention of Pneumocystis jiroveci pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprimsulfamethoxazole (TMP-SMX).

Treatment Of Mild-To-Moderate Pneumocystis Jiroveci Pneumonia

MEPRON suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.

Limitations Of Use

Clinical experience with MEPRON for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO2] ≤ 45 mm Hg). Treatment of more severe episodes of PCP with MEPRON has not been studied. The efficacy of MEPRON in subjects who are failing therapy with TMP-SMX has also not been studied.

DOSAGE AND ADMINISTRATION

Dosage For The Prevention Of P. Jiroveci Pneumonia

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

Dosage For The Treatment Of Mild-to-Moderate P. Jiroveci Pneumonia

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

Important Administration Instructions

Administer MEPRON oral suspension with food to avoid lower plasma atovaquone concentrations that may limit response to therapy [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

MEPRON Foil Pouch
  • Open each 5-mL pouch by removing tab at perforation and tear at notch.
  • 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 two pouches.
MEPRON Bottle

Shake bottle gently before administering the recommended dosage.

HOW SUPPLIED

Dosage Forms And Strengths

MEPRON is a bright yellow, citrus-flavored, oral suspension containing 750 mg of atovaquone in 5 mL. MEPRON is supplied in 210-mL bottles or 5-mL foil pouches.

Storage And Handling

MEPRON suspension (bright yellow, citrus-flavored) containing 750 mg atovaquone in 5 mL.

Bottle of 210 mL with child-resistant cap (NDC 0173-0665-18). Store at 15° to 25°C (59° 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 (NDC 0173-0547-00). Store at 15° to 25°C (59° to 77°F). Do not freeze.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2015.

Last reviewed on RxList: 6/26/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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