Megestrol


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Palliative treatment of breast carcinoma
Adult: As tab: 160 mg once daily as a single dose or in divided doses for at least 2 months.
Elderly: Initiate at the lower end of the dosing range.

Oral
Palliative treatment of endometrial carcinoma
Adult: As tab: 40-320 mg daily in divided doses for at least 2 months.
Elderly: Initiate at the lower end of the dosing range.

Oral
Anorexia and cachexia in patients with cancer or AIDS
Adult: As tab or susp containing 40 mg/mL: 400-800 mg daily. As susp containing 125 mg/mL: 625 mg once daily. Megestrol suspensions are not equivalent on a mg-per-mg basis and are not interchangeable.
Elderly: Initiate at the lower end of the dosing range.

Oral
AIDS-related weight loss
Adult: As tab or susp containing 40 mg/mL: 400-800 mg daily. As susp containing 125 mg/mL: 625 mg once daily. Megestrol suspensions are not equivalent on a mg-per-mg basis and are not interchangeable.
Elderly: Initiate at the lower end of the dosing range.
Administration
Megace ES: May be taken with or without food.
Standard formulation: Should be taken with food.
Contraindications
Pregnancy and lactation.
Special Precautions
Patient with history of thromboembolic disease, diabetes mellitus. Not indicated for prevention of weight loss. Renal and hepatic impairment. Elderly. Monitoring Parameters Assess pregnancy status before therapy. Monitor blood pressure, weight, blood glucose level, signs of thromboembolic events.
Adverse Reactions
Significant: Weight gain, thrombophlebitis, hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushingoid syndrome, new-onset or exacerbation of diabetes mellitus (long-term use); vaginal bleeding or discharge. Cardiac disorders: Cardiac failure, dyspnoea. Endocrine disorders: Hypercalcaemia. Gastrointestinal disorders: Constipation, diarrhoea, flatulence, nausea, vomiting. General disorders and administration site conditions: Asthenia, pain, oedema, malaise. Metabolism and nutrition disorders: Hyperglycaemia, increased appetite. Neoplasms benign, malignant and unspecified: Tumour flare. Nervous system disorders: Carpal tunnel syndrome. Psychiatric disorders: Altered mood, lethargy. Renal and urinary disorders: Pollakiuria. Reproductive system and breast disorders: Menorrhagia, erectile dysfunction. Skin and subcutaneous tissue disorders: Alopecia, rash. Vascular disorders: Hypertension, hot flush.
Potentially Fatal: Pulmonary embolism.
ROUTE(S) : PO: D For tablet.
ROUTE(S) : PO: X For oral suspension.
Overdosage
Symptoms: Diarrhoea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, chest pain. Management: Supportive treatment.
Drug Interactions
May decrease exposure of indinavir. May reduce the therapeutic effect of anticoagulants, antidiabetic agents.
Action
Megestrol is a synthetic progestin with anti-estrogenic properties. It disrupts the normal estrogen cycle resulting in a decreased luteinising hormone (LH) titer which may also have direct effect on the endometrium. The mechanism of its antineoplastic effect is unknown but may be due to the pituitary-mediated anti-luteinising effect. Additionally, it antagonises the metabolic effects of catabolic cytokines which may result in appetite stimulation.
Onset: Approx 2 months of continuous treatment (breast or endometrial cancer); 2-4 weeks (weight gain).
Absorption: Well absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1-3 hours (tab); 5 hours (susp).
Distribution: Enters breast milk.
Metabolism: Metabolised in the liver into free steroids and glucuronide conjugates.
Excretion: Via urine (57-78%; 5-8% as metabolites); faeces (8-30%). Elimination half-life: 15-20 hours (tab); 20-50 hours (susp).
Storage
Oral: Store below 25°C. Protect from heat, light and moisture. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
CIMS Class
Appetite Enhancers / Hormonal Chemotherapy
ATC Classification
G03DB02 - megestrol ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
G03AC05 - megestrol ; Belongs to the class of progestogens. Used as systemic contraceptives.
L02AB01 - megestrol ; Belongs to the class of progestogens.
Disclaimer: This information is independently developed by CIMS based on megestrol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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