Table 11. Treatment-Emergent Laboratory Test Abnormalities in the Pentamidine Comparative PCP Treatment Study  Laboratory Test Percentage of Patients Developing a Laboratory Test Abnormality
Abnormality MEPRON Pentamidine
Anemia (Hgb<8.0 g/dL) 4% 9%
Neutropenia (ANC<750 cells/mm3) 5% 9%
Hyponatremia (<0.96 x LLN) 10% 10%
Hyperkalemia (>1.18 x ULN) 0% 5%
Alkaline phosphatase (>2.5 x ULN) 5% 2%
Hyperglycemia (>1.8 x ULN) 9% 13%
Elevated AST (>5 x ULN) 0% 5%
Elevated amylase (>1.5 x ULN) 8% 4%
Elevated creatinine (>1.5 x ULN) 0% 7%

ULN = upper limit of normal range.

LLN = lower limit of normal range.

Postmarketing Experience
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of MEPRON. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to MEPRON.

Blood and Lymphatic System Disorders
Methemoglobinemia, thrombocytopenia.

Immune System Disorders
Hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria.

Eye Disorders
Vortex keratopathy.

Gastrointestinal Disorders
Pancreatitis.

Hepatobiliary Disorders
Rare cases of hepatitis, and one case of fatal liver failure have been reported with atovaquone usage.

Skin and Subcutaneous Tissue Disorders
Erythema multiforme, Stevens-Johnson syndrome, and skin desquamation have been reported in patients receiving multiple drug therapy including atovaquone.

Renal and Urinary Disorders
Acute renal impairment.

OVERDOSAGE
There is no known antidote for atovaquone, and it is currently unknown if atovaquone is dialyzable. The median lethal dose is higher than the maximum oral dose tested in mice and rats (1,825 mg/kg/day). Overdoses up to 31,500 mg of atovaquone have been reported. In 1 such patient who also took an unspecified dose of dapsone, methemoglobinemia occurred. Rash has also been reported after overdose.

DOSAGE AND ADMINISTRATION

Dosage

Prevention of PCP: Adults and Adolescents (13 to 16 Years)
The recommended oral dose is 1,500 mg (10 mL) once daily administered with a meal.

Treatment of Mild-to-Moderate PCP: Adults and Adolescents (13 to 16 Years)
The recommended oral dose is 750 mg (5 mL) administered with meals twice daily for 21 days (total daily dose 1,500 mg).

Note: Failure to administer MEPRON Suspension with meals may result in lower plasma atovaquone concentrations and may limit response to therapy (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Administration
Foil Pouch
Open pouch by removing tab at perforation and tear at notch. Take entire contents by mouth. Can be discharged into a dosing spoon or cup or directly into the mouth.

Bottle
SHAKE BOTTLE GENTLY BEFORE USING.

HOW SUPPLIED
MEPRON Suspension (bright yellow, citrus flavored) containing 750 mg atovaquone in each teaspoonful (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 1