"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
DOSAGE AND ADMINISTRATION
The recommended adult initial dosage of Megace® ES (megestrol acetate) oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Please refer to the table below for correct dosing and administration. Shake container well before using.
|Megace® and other
megestrol acetate oral suspensions
|mg/mL||125 mg/mL||40 mg/mL|
|625 mg||800 mg|
|Daily VolumeIntake||5 mL||20 mL|
|Formulation||Concentrated formula||Regular formula|
In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day of megestrol acetate oral suspension (800 mg/20 mL equivalent to 625 mg/5 mL of Megace® ES formula) were found to be clinically effective.
Megace® ES (megestrol acetate) oral suspension is a concentrated formula available as a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL.
|NDC 49884-949-69||Bottles of 150 mL (5 fl. oz.)|
|NDC 49884-949-52||Unit Dose Bottles of 5 mL (0.17 fl. Oz.)-Institutional Use Only|
Store Megace® ES (megestrol acetate) oral suspension between 15°-25° C (59°-77° F) and dispense in a tight container. Protect from heat.
Health Hazard Data
There is no threshold limit value established by OSHA, NIOSH, or ACGIH.
Exposure or overdose at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS sections). Women at risk of pregnancy should avoid such exposure.
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, New York 10977
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
FDA rev date: 8/12/2008.
Last reviewed on RxList: 8/28/2008
Additional Megace ES Information
Megace ES - User Reviews
Megace ES User Reviews
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Report Problems to the Food and Drug Administration
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