Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Megestrol Acetate Oral Suspension, USP 40 mg/mL is available as a creamy-white, lemon-lime flavored oral suspension, for oral administration, containing 40 mg of micronized megestrol acetate per mL. NDC 0116-4011-08 Bottles of 8 fl oz (237 mL) NDC 0116-4011-16 Bottles of 16 fl oz (473 mL) NDC 0116-4011-10 10 mL unit dose cups in trays of 10; 8 fl oz (237 mL) Bottle Label NDC 0116-4011-08 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL Each mL contains : 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. Alcohol: max. 0.34% v/v. Shake well immediately before dosing. Rx Only NET: 8 fl oz (237 mL) Usual Dosage: See package insert for indications and dosage schedule. Store at 20°C - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 401108BTLLBLA REV. 06-25 8 oz bottle; 1 Pint (473 mL) Bottle Label NDC 0116-4011-16 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL Each mL contains: 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. Alcohol: max. 0.34% v/v. Shake well immediately before dosing. Rx Only NET: 1 Pint (473 mL) Usual Dosage: See package insert for indications and dosage schedule. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 401116BTLLBLA REV. 06-25 16 oz bottle; 10 mL Unit Dose Cup Label UNIT DOSE Delivers 10 mL NDC 0116-4011-10 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Shake well immediately before dosing Institutional Use Only Xttrium Laboratories, Inc. Mount Prospect, IL Rx Only 4011MEGLIDA UD Cup Lid
- HOW SUPPLIED Megestrol Acetate Oral Suspension, USP 40 mg/mL is available as a creamy-white, lemon-lime flavored oral suspension, for oral administration, containing 40 mg of micronized megestrol acetate per mL. NDC 0116-4011-08 Bottles of 8 fl oz (237 mL) NDC 0116-4011-16 Bottles of 16 fl oz (473 mL) NDC 0116-4011-10 10 mL unit dose cups in trays of 10
- 8 fl oz (237 mL) Bottle Label NDC 0116-4011-08 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL Each mL contains : 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. Alcohol: max. 0.34% v/v. Shake well immediately before dosing. Rx Only NET: 8 fl oz (237 mL) Usual Dosage: See package insert for indications and dosage schedule. Store at 20°C - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 401108BTLLBLA REV. 06-25 8 oz bottle
- 1 Pint (473 mL) Bottle Label NDC 0116-4011-16 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL Each mL contains: 40 mg of micronized megestrol acetate in a lemon-lime flavored oral suspension. Alcohol: max. 0.34% v/v. Shake well immediately before dosing. Rx Only NET: 1 Pint (473 mL) Usual Dosage: See package insert for indications and dosage schedule. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 401116BTLLBLA REV. 06-25 16 oz bottle
- 10 mL Unit Dose Cup Label UNIT DOSE Delivers 10 mL NDC 0116-4011-10 Megestrol Acetate Oral Suspension, USP 400 mg per 10 mL Shake well immediately before dosing Institutional Use Only Xttrium Laboratories, Inc. Mount Prospect, IL Rx Only 4011MEGLIDA UD Cup Lid
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 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.52. The empirical formula is C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol Acetate Oral Suspension, USP is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol Acetate Oral Suspension, USP contains the following inactive ingredients: alcohol (max. 0.34% v/v from flavor), citric acid anhydrous, lemon-lime flavor, poloxamer 124, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 4.7. Megestrol-01
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, Impairment of Fertility .) The glucocorticoid activity of Megestrol Acetate Oral Suspension, USP 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 Oral Suspension, USP. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate Oral Suspension, USP 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 Oral Suspension, USP therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megestrol Acetate Oral Suspension, USP therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (eg., 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 Oral Suspension, USP 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 (eg., 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, USP. 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, USP include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS). To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088. Table Table
Storage & Handling
STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure. Protect from heat.
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