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Megace ES (Megestrol Acetate) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Megace ® ES (megestrol acetate) oral suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37° C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52.

The chemical formula is C24H32O4 and the structural formula is represented as follows:


                                                                                        

                                                                 

Megace ® ES (megestrol acetate) is a concentrated formula supplied as an oral suspension containing 125 mg of megestrol acetate per mL.

Megace ® ES (megestrol acetate) oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, hydroxypropyl methylcellulose (hypromellose), natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose.

CLINICAL PHARMACOLOGY

                                                        

ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY

DESCRIPTION OF CLINICAL STUDIES

ADVERSE REACTIONS section).

Megestrol Acetate Oral Suspension Clinical Efficacy Trials
  Trial 1 Trial 2
  Study Accrual Dates Study Accrual Dates
  11/88 to 12/90 5/89 to 4/91
Megestrol Acetate, mg/day 0 100 400 800   0 800
Entered Patients 38 82 75 75   48 52
Evaluable Patients 28 61 53 53   29 36
Mean Change in Weight (lb.)              
Baseline to 12 Weeks 0.0 2.9 9.3 10.7   -2.1 11.2
% Patients ≥ 5 Pound Gain              
At Last Evaluation in 12 weeks 21 44 57 64   28 47
Mean Changes in Body Composition:              
Fat Body Mass (lb.) 0.0 2.2 2.9 5.5   1.5 5.7
Lean Body Mass (lb.) -1.7 -0.3 1.5 2.5   -1.6 -0.6
Water (liters) -1.3 -0.3 0.0 0.0   -0.1 -0.1
% Patients With Improved Appetite:              
At Time of Maximum Weight Change 50 72 72 93   48 69
At Last Evaluation in 12 Weeks 50 72 68 89   38 67
Mean Change in Daily Caloric Intake:              
Baseline to Time of Maximum Weight Change -107 326 308 646   30 464
*Based on bioelectrical impedance analysis determinations at last evaluation in 12 weeks

Presented below are the results of mean weight changes for patients evaluable for efficacy in trials 1 and 2.


                                                        

            







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