Drug Catalog - Product Detail
MEGESTROL ACETATE ORAL SUSPENSION SUSP 625MG/5ML 150ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0230-69 | ENDO USA | 150 | 625MG/5ML | SUSPENSION |
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Description
11 DESCRIPTION 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 24 H 32 O 4 and the structural formula is represented as follows: Figure 1: Megestrol Acetate Chemical Structure Megestrol acetate oral suspension contains 125 mg of megestrol acetate per mL. 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. Molecular Formula.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Click here to enter How Supplied 16.1 How Supplied Megestrol Acetate Oral Suspension is a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Available in bottles of 150 mL (5 fl oz) NDC 49884-230-69. 16.2 Storage Store megestrol acetate oral suspension between 15° to 25° C (59° to 77° F) and dispense in a tight container. Protect from heat. 16.3 Safe Handling Health Hazard Data There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or overdose at levels approaching recommended dosing levels could result in side effects described above [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )]. Women at risk of pregnancy should avoid such exposure.
Indications & Usage
1 INDICATIONS AND USAGE Megestrol Acetate Oral Suspension (125 mg/mL) is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Limitations of Use 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. Megestrol acetate is not intended for prophylactic use to avoid weight loss. Megestrol Acetate Oral Suspension is a progestin indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment ( 2.1 ). The recommended adult initial dosage of Megestrol Acetate Oral Suspension (125 mg/mL) is 625 mg/day (5 mL/day or one teaspoon daily) ( 2.2 ). Shake container well before using ( 2.2 ). 2.1 Testing Prior to Megestrol Acetate Administration Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment with megestrol acetate [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )]. 2.2 Dosage and Administration The recommended adult initial dosage of megestrol acetate oral suspension (125 mg/mL) 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.