Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Megestrol Acetate Oral Suspension USP, 400 mg/10 mL is available as a white suspension with a lemon-lime aroma containing 40 mg of micronized megestrol acetate per mL. 10 mL unit dose cups: 30 cups (3 x 10) NDC 60687‐916‐08 10 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐916‐56 STORAGE Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from heat. Keep this and all drugs out of the reach of children. DO NOT USE IF SEAL IS BROKEN. SPECIAL 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 ADVERSE REACTIONS ). Women at risk of pregnancy should avoid such exposure. Distributed by: American Health Packaging Columbus, OH 43217 R06/25; Package/Label Display Panel – Tray Label 30 Count Case NDC 60687-916-08 100 Count Case NDC 60687-916-56 Cup NDC 60687-916-42 Megestrol Acetate Oral Suspension, USP 400 mg/10 mL Each mL contains 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. See package insert for indications and dosage schedule. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Shake well immediately before dosing Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from heat. For Institutional Use Only T103810C0625 R06/25 400 mg 10 mL Megestrol Acetate Oral Suspension Tray Label.jpg; Package/Label Display Panel – Cup – 400 mg/10 mL NDC 60687- 916 -42 MEGESTROL ACETATE ORAL SUSPENSION, USP 400 mg/10 mL Delivers 10 mL Shake well immediately before dosing PROTECT FROM HEAT. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F103810C0625 400 mg 10 mL Megestrol Acetate Oral Suspension Lid.jpg
- HOW SUPPLIED Megestrol Acetate Oral Suspension USP, 400 mg/10 mL is available as a white suspension with a lemon-lime aroma containing 40 mg of micronized megestrol acetate per mL. 10 mL unit dose cups: 30 cups (3 x 10) NDC 60687‐916‐08 10 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐916‐56 STORAGE Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from heat. Keep this and all drugs out of the reach of children. DO NOT USE IF SEAL IS BROKEN. SPECIAL 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 ADVERSE REACTIONS ). Women at risk of pregnancy should avoid such exposure. Distributed by: American Health Packaging Columbus, OH 43217 R06/25
- Package/Label Display Panel – Tray Label 30 Count Case NDC 60687-916-08 100 Count Case NDC 60687-916-56 Cup NDC 60687-916-42 Megestrol Acetate Oral Suspension, USP 400 mg/10 mL Each mL contains 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. See package insert for indications and dosage schedule. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Shake well immediately before dosing Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from heat. For Institutional Use Only T103810C0625 R06/25 400 mg 10 mL Megestrol Acetate Oral Suspension Tray Label.jpg
- Package/Label Display Panel – Cup – 400 mg/10 mL NDC 60687- 916 -42 MEGESTROL ACETATE ORAL SUSPENSION, USP 400 mg/10 mL Delivers 10 mL Shake well immediately before dosing PROTECT FROM HEAT. See package insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F103810C0625 400 mg 10 mL Megestrol Acetate Oral Suspension Lid.jpg
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: citric acid, lemon-lime flavor (propylene glycol, ethyl alcohol, natural flavor), propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose and xanthan gum. Image 1
Indications & Usage
INDICATIONS & USAGE 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).
Dosage & Administration
DOSAGE & ADMINISTRATION The recommended adult initial dosage of megestrol acetate oral suspension 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, and 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 ) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting 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 revealed the 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 Megestrol Acetate, mg/day No. of Patients Trial 1 (N=236) Trial 2 (N=87) Open Label Trial 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 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 and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied. Megestrol acetate may interact with warfarin and increase International Normalized Ratio (INR). Closely monitor INR in patients taking megestrol acetate and warfarin. Animal Toxicology Long-term treatment with megestrol acetate may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts was observed in a two-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats.
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