eiving 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 15° to 25°C (59° to 77°F). DO NOT FREEZE.
1 (A-a)DO2 = [(713 x FiO2 ) − (PaCO2/0.8)]− PaO2 (mm Hg)
GlaxoSmithKline
Research Triangle Park, NC 27709
©2008, GlaxoSmithKline. All rights reserved.
May 2008 MPR:1PI
Principal Display Panel
NDC 0173-0665-18
MEPRON®
(atovaquone)
SUSPENSION
750 mg/5mL
210 mL
Rx only
Each 5mL (1 teaspoonful) contains 750 mg atovaquone.
See package insert for Dosage and Administration.
Store at 15o to 25oC (59o to 77oF).
DO NOT FREEZE.
SHAKE GENTLY BEFORE USING.
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Canada
A022402 Rev. 12/05
MEPRON Suspension Label Image - 750mg/5mL (210mL)
PrincipalDisplay Panel
NDC 0173-0547-00
MEPRON®
(atovaquone)
SUSPENSION
750 mg/ 5mL
5 mL
Rx only
Each 5 mL sachet (1 teaspoonful) contains 750 mg atovaquone.
Store at 15o to 25oC (59o to 77oF).
DO NOT FREEZE.
See accompanying prescribing information for Dosage and Administration.
Contains 42 sachets of 5 mL each
GlaxoSmithKline
A076214 Rev. 12/09
MEPRON Suspension Label Image - 750mg/5mL (5mL sachet)
MEPRON
atovaquone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0173-0665
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOVAQUONE (ATOVAQUONE) |
