eadache 6 10 1 3 3 0 3
Pain 6 0 0 2 5 6 4
Vomiting 9 3 0 2 3 6 4
Pneumonia 6 2 0 2 3 0 1
Urinary Frequency 0 0 1 2 5 2 1
Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.
Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma
Cardiovascular System - cardiomyopathy and palpitation
Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis
Hemic and Lymphatic System - leukopenia
Metabolic and Nutritional - LDH increased, edema and peripheral edema
Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking
Respiratory System - dyspnea, cough, pharyngitis and lung disorder
Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder
Special Senses - amblyopia
Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia
Postmarketing
Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance (see WARNINGS and PRECAUTIONS sections).
OVERDOSAGE
OVERDOSAGE
No serious unexpected side effects have resulted from studies involving megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility it is postulated that dialysis would not be an effective means of treating overdose.
DOSAGE & ADMINISTRATION
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.
PRODUCT DIFFERENCES
Megace® ES Oral Suspension Megace® and other megestrol acetate oral suspensions
mg/mL 125 mg/mL 40 mg/mL
Recommended Daily Dose 625 mg 800 mg
Daily Volume Intake 5 mL (teaspoon) 20 mL (dosing cup)
Formulation Concentrated formula Regular formula
In clinical trials eva luating 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.
HOW SUPPLIED
HOW SUPPLIED
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.)
STORAGE
Store Megace ® ES (meges |
