Megestrol Acetate 20 mg/1
Megestrol Acetate · TABLET · Strides Pharma Science Limited
Megestrol Acetate is a tablet containing megestrol acetate at 20 mg/1, taken oral. Manufactured by Strides Pharma Science Limited.
Key Facts
- Brand Name
- Megestrol Acetate
- Generic Name
- Megestrol Acetate
- NDC Code (Product)
64380-158- Manufacturer
- Strides Pharma Science Limited
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA072422
- Marketing Start
- 04/11/2022
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Mckesson Packaging Services
Subpotent Drug: Out of specification for assay (stability testing)
Breckenridge Pharmaceutical, Inc.
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Mckesson Corporation
Supterpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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
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.…
Contraindications
CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
Adverse Reactions
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 we…
Frequently Asked Questions
What is Megestrol Acetate used for?
Megestrol Acetate contains Megestrol Acetate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Megestrol Acetate a controlled substance?
Megestrol Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Megestrol Acetate?
The generic name for Megestrol Acetate is Megestrol Acetate. There are no other listed brand versions of Megestrol Acetate.
What is the NDC code for Megestrol Acetate 20 mg/1?
The NDC (National Drug Code) for Megestrol Acetate 20 mg/1 is 64380-158, listed by Strides Pharma Science Limited.
Other Megestrol Acetate Dosages
- Megestrol Acetate400 mg/10mL0904-7577
- Megestrol Acetate40 mg/mL51407-910
- Megestrol Acetate40 mg/164380-159
- Megestrol Acetate400 mg/10mL0121-1038
- Megestrol Acetate40 mg/mL68094-063
- Megestrol Acetate400 mg/10mL0121-0945
- Megestrol Acetate40 mg/mL60687-916
- Megestrol Acetate40 mg/171335-2544
- Megestrol Acetate125 mg/mL24979-041
- Megestrol Acetate40 mg/mL64380-160
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)