Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Megestrol acetate oral suspension, USP is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. It is supplied as the following: NDC 81033-150-10: 10 mL unit-dose cup NDC 81033-150-44: Carton containing 40 unit-dose cups of 10 mL each NDC 81033-150-52: Case containing 100 unit-dose cups of 10 mL each NDC 81033-150-20: 20 mL unit-dose cup NDC 81033-150-43: Carton containing 30 unit-dose cups of 20 mL each; NDC: 81033-150-44 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Rx Only FOR INSTITUTIONAL USE ONLY 40 x 10 mL Unit Dose Cups Megestrol Acetate 10 mL 40 ct Carton; NDC: 81033-150-52 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Case = 100 UD Cups RxOnly Megestrol Acetate 10 mL 100 ct Case; NDC: 81033-150-43 Megestrol Acetate Oral Suspension, USP 800 mg per 20 mL Rx Only FOR INSTITUTIONAL USE ONLY 30 x 20 mL Unit Dose Cups Megestrol Acetate 20 mL 30 ct Carton
- HOW SUPPLIED Megestrol acetate oral suspension, USP is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. It is supplied as the following: NDC 81033-150-10: 10 mL unit-dose cup NDC 81033-150-44: Carton containing 40 unit-dose cups of 10 mL each NDC 81033-150-52: Case containing 100 unit-dose cups of 10 mL each NDC 81033-150-20: 20 mL unit-dose cup NDC 81033-150-43: Carton containing 30 unit-dose cups of 20 mL each
- NDC: 81033-150-44 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Rx Only FOR INSTITUTIONAL USE ONLY 40 x 10 mL Unit Dose Cups Megestrol Acetate 10 mL 40 ct Carton
- NDC: 81033-150-52 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Case = 100 UD Cups RxOnly Megestrol Acetate 10 mL 100 ct Case
- NDC: 81033-150-43 Megestrol Acetate Oral Suspension, USP 800 mg per 20 mL Rx Only FOR INSTITUTIONAL USE ONLY 30 x 20 mL Unit Dose Cups Megestrol Acetate 20 mL 30 ct Carton
Overview
Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the 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 C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized 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, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2. Chemical formula
Indications & Usage
Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Dosage & Administration
The recommended adult initial dosage of megestrol acetate oral suspension, USP is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.
Warnings & Precautions
WARNINGS Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility ). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealedthe frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).
Contraindications
History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
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 megestrol acetate oral suspension. ADVERSE EVENTS% of Patients Reporting Trial 1 (N = 236) Trail 2 (N=87) Open Label Trial Megestrol Acetate mg/day No. of Patients Placebo 0 N=34 100 N=68 400 N=69 800 N=65 Placebo 0 N=38 800 N=49 1200 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 Headache 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 0 2 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 and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
STORAGE: Store the oral suspension between 20°C to 25°C (68°F to 77°F). [See USP]. Dispense in a tight container. Protect from heat. Keep this and all medications out of the reach of children.
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