Megestrol

Megestrol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Megestrol is a progestin that is FDA approved for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).. Common adverse reactions include Hypertension, Rash, Hot sweats, Weight gain, Diarrhea, Mood swings, Erectile dysfunction.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• MEGACE 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

• The recommended adult initial dosage of MEGACE 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.

A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Megestrol in adult patients.

Non–Guideline-Supported Use

• Cachexia - Cancer
• Cachexia - Cystic fibrosis
• Carcinoma of prostate, Advanced hormone-refractory
• Endometrial hyperplasia
• Endometriosis
• Hot sweats, In women with a history of breast cancer
• Malignant melanoma
• Malignant neoplasm of liver
• Mullerian mixed tumor, Adenosarcoma
• Ovarian carcinoma

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Megestrol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Megestrol in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Megestrol in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Megestrol in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Megestrol in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Megestrol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Megestrol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Megestrol with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Megestrol with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Megestrol with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Megestrol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Megestrol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Megestrol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Megestrol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Megestrol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Megestrol in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Megestrol in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Megestrol in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Megestrol in the drug label.

Pharmacology

There is limited information regarding Megestrol Pharmacology in the drug label.

Mechanism of Action

Structure

File:Megestrol01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Megestrol in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Megestrol in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Megestrol in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Megestrol in the drug label.

How Supplied

Storage

There is limited information regarding Megestrol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Megestrol in the drug label.

Precautions with Alcohol

• Alcohol-Megestrol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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