Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
1.1 Limitations of Use
Other Treatable Causes
Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.
Prophylactic Use
Megestrol acetate is not intended for prophylactic use to avoid weight loss.
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-methyl pregna-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 C 24H 32O 4 and the structural formula is represented as follows:
Figure 1: Megestrol Acetate Chemical Structure
Megestrol acetate oral suspension is an oral suspension containing 125 mg of megestrol acetate per mL.
Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max. 0.07% v/v from flavor), citric acid monohydrate, hypromellose, lemon flavor, lime flavor, sodium benzoate, sodium citrate dihydrate, sodium lauryl sulfate, and sucrose.
Cold And Flu Nighttime Relief | Twi Pharmaceuticals, Inc.
The recommended adult initial dosage of megestrol acetate oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Shake the container well before using.
This strength (125 mg/mL) is not substitutable with other strengths (e.g., 40 mg/mL). Refer to the prescribing information of the 40 mg/mL product for dosage recommendations for the 40 mg/mL strength.
Cold And Flu Nighttime Relief | Chain Drug Consortium, Llc
take only as directed – see Overdose warning
use dose cup or tablespoon (TBSP)
do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 TBSP) every 6 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL= milliliter
age
dose
adults & children 12 yrs and over
30 mL every 6 hrs
children 4 to 11 yrs
do not use unless directed by a doctor
children under 4 yrs
do not use
When using other Day Time or Night Time products, carefully read each label to ensure correct dosing
do not take more than 4 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL= milliliter
age
dose
adults & children 12 yrs and over
30 mL every 6 hrs
children 4 to 11 yrs
do not use unless directed by a doctor
children under 4 yrs
do not use
When using other Day Time or Night Time products, carefully read each label to ensure correct dosing