Par Pharmaceutical Companies, Inc.™ announces the FDA approval of Megace ES (megestrol acetate), a concentrated oral suspension. New Megace ES is an advanced formulation of megestrol acetate oral suspension, the appetite stimulant most commonly prescribed by physicians.2
Megace ES is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).1
Megace ES utilizes the NanoCrystal® Technology delivery system which improves the rate of dissolution and bioavailability.3 This results in one-fourth the total volume per dose and lower viscosity than the original formulation of megestrol acetate oral suspension.1 Additionally, Megace ES can be taken without regard to meals.1,4
Since patients with anorexia, cachexia or unintended weight loss are often not able or motivated to eat, taking Megace ES in unfed conditions and still achieving therapeutic blood levels is an important consideration.
Important safety information
Megace ES and megestrol acetate oral suspension are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation and in known or suspected pregnancy.
The most common adverse events (>1% and > placebo) associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia and hyperglycemia.
Evidence of adrenal suppression has been observed in patients receiving megestrol acetate oral suspension. The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate.
Women who participated in studies (n=10) reported breakthrough bleeding; however, it is unknown if these events are drug- or disease-related.
Read more in our announcement press release.
View our full Prescribing Information.
Don't forget to visit our full product website, www.MegaceES.com!
NanoCrystal® Technology is a trademark of Elan Pharma International, Limited.
Par licensed the Megace name from Bristol-Myers Squibb Company.
- Megace ES Prescribing Information. Par Pharmaceutical Companies, Inc.™ 2005.
- IMS Prescription Data 2004 and NDTI 2004.
- NanoCrystal® Technology Group. Technology Focus: Meeting the Challenges of Drug Delivery Brochure. Elan Drug Delivery, Inc. King of Prussia, PA 2005.
- Data on file. Par Pharmaceutical Companies, Inc.™ 2005.
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