ects on the newborn, nursing should be discontinued if Megace ® ES (megestrol acetate) oral suspension is required.
Use in HIV Infected Women
Although megestrol acetate has been used extensively in women for the treatment of endometrial and breast cancers, its use in HIV infected women has been limited.
All 10 women in the clinical trials reported breakthrough bleeding.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
ADVERSE REACTIONS
ADVERSE REACTIONS
Clinical Adverse Events
Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing Megace ® ES (megestrol acetate) oral suspension.
ADVERSE EVENTS% of Patients Reporting
Open
Trial 1 (N=236) Trial 2 (N=87) Label Trial
Megestrol Acetate, Placebo Placebo
mg/day 0 100 400 800 0 800 1200
No. of Patients N=34 N=68 N=69 N=65 N=38 N=49 N=176
Diarrhea 15 13 8 15 8 6 10
Impotence 3 4 6 14 0 4 7
Rash 9 9 4 12 3 2 6
Flatulence 9 0 1 9 3 10 6
Hypertension 0 0 0 8 0 0 4
Asthenia 3 2 3 6 8 4 5
Insomnia 0 3 4 6 0 0 1
Nausea 9 4 0 5 3 4 5
Anemia 6 3 3 5 0 0 0
Fever 3 6 4 5 3 2 1
Libido Decreased 3 4 0 5 0 2 1
Dyspepsia 0 0 3 3 5 4 2
Hyperglycemia 3 0 6 3 0 0 3
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