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* Cachexia - Cystic fibrosis<ref name="pmid10997370">{{cite journal| author=Marchand V, Baker SS, Stark TJ, Baker RD| title=Randomized, double-blind, placebo-controlled pilot trial of megestrol acetate in malnourished children with cystic fibrosis. | journal=J Pediatr Gastroenterol Nutr | year= 2000 | volume= 31 | issue= 3 | pages= 264-9 | pmid=10997370 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10997370  }} </ref>
* Cachexia - Cystic fibrosis<ref name="pmid10997370">{{cite journal| author=Marchand V, Baker SS, Stark TJ, Baker RD| title=Randomized, double-blind, placebo-controlled pilot trial of megestrol acetate in malnourished children with cystic fibrosis. | journal=J Pediatr Gastroenterol Nutr | year= 2000 | volume= 31 | issue= 3 | pages= 264-9 | pmid=10997370 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10997370  }} </ref>
* Carcinoma of prostate, Advanced hormone-refractory<ref name="pmid3975650">{{cite journal| author=Bonomi P, Pessis D, Bunting N, Block M, Anderson K, Wolter J et al.| title=Megestrol acetate used as primary hormonal therapy in stage D prostatic cancer. | journal=Semin Oncol | year= 1985 | volume= 12 | issue= 1 Suppl 1 | pages= 36-9 | pmid=3975650 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=3975650  }} </ref>
* Carcinoma of prostate, Advanced hormone-refractory<ref name="pmid3975650">{{cite journal| author=Bonomi P, Pessis D, Bunting N, Block M, Anderson K, Wolter J et al.| title=Megestrol acetate used as primary hormonal therapy in stage D prostatic cancer. | journal=Semin Oncol | year= 1985 | volume= 12 | issue= 1 Suppl 1 | pages= 36-9 | pmid=3975650 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=3975650  }} </ref>
* Endometrial hyperplasia
* Endometrial hyperplasia<ref name="pmid3798126">{{cite journal| author=Gal D| title=Hormonal therapy for lesions of the endometrium. | journal=Semin Oncol | year= 1986 | volume= 13 | issue= 4 Suppl 4 | pages= 33-6 | pmid=3798126 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=3798126  }} </ref>
* Endometriosis
* Endometriosis<ref name="pmid2314784">{{cite journal| author=Schlaff WD, Dugoff L, Damewood MD, Rock JA| title=Megestrol acetate for treatment of endometriosis. | journal=Obstet Gynecol | year= 1990 | volume= 75 | issue= 4 | pages= 646-8 | pmid=2314784 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=2314784  }} </ref>
* Hot sweats, In women with a history of breast cancer
* Hot sweats, In women with a history of breast cancer<ref name="pmid18375894">{{cite journal| author=Goodwin JW, Green SJ, Moinpour CM, Bearden JD, Giguere JK, Jiang CS et al.| title=Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626. | journal=J Clin Oncol | year= 2008 | volume= 26 | issue= 10 | pages= 1650-6 | pmid=18375894 | doi=10.1200/JCO.2006.10.6179 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18375894  }} </ref>
* Malignant melanoma
* Malignant melanoma<ref name="pmid7083227">{{cite journal| author=Creagan ET, Schutt AJ, Ahmann DL, Green SJ| title=Phase II study of high-dose megestrol acetate in patients with advanced malignant melanoma. | journal=Cancer Treat Rep | year= 1982 | volume= 66 | issue= 5 | pages= 1239-40 | pmid=7083227 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=7083227  }} </ref>
* Malignant neoplasm of liver
* Malignant neoplasm of liver<ref name="pmid11286465">{{cite journal| author=Villa E, Ferretti I, Grottola A, Buttafoco P, Buono MG, Giannini F et al.| title=Hormonal therapy with megestrol in inoperable hepatocellular carcinoma characterized by variant oestrogen receptors. | journal=Br J Cancer | year= 2001 | volume= 84 | issue= 7 | pages= 881-5 | pmid=11286465 | doi=10.1054/bjoc.2000.1534 | pmc=PMC2363845 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11286465  }} </ref>
* Mullerian mixed tumor, Adenosarcoma
* Mullerian mixed tumor, Adenosarcoma<ref name="pmid11925144">{{cite journal| author=Hines BJ, Porges RF, Mittal K, Muggia FM, Curtin JP| title=Use of medroxyprogesterone acetate in the treatment of Müllerian adenosarcoma: a case report. | journal=Gynecol Oncol | year= 2002 | volume= 85 | issue= 1 | pages= 192-5 | pmid=11925144 | doi=10.1006/gyno.2002.6585 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11925144  }} </ref>
* Ovarian carcinoma
* Ovarian carcinoma<ref name="pmid11593052">{{cite journal| author=Wilailak S, Linasmita V, Srisupundit S| title=Phase II study of high-dose megestrol acetate in platinum-refractory epithelial ovarian cancer. | journal=Anticancer Drugs | year= 2001 | volume= 12 | issue= 9 | pages= 719-24 | pmid=11593052 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11593052  }} </ref>




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Revision as of 15:01, 6 February 2015

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];

Disclaimer

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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[1]
  • Cachexia - Cystic fibrosis[2]
  • Carcinoma of prostate, Advanced hormone-refractory[3]
  • Endometrial hyperplasia[4]
  • Endometriosis[5]
  • Hot sweats, In women with a history of breast cancer[6]
  • Malignant melanoma[7]
  • Malignant neoplasm of liver[8]
  • Mullerian mixed tumor, Adenosarcoma[9]
  • Ovarian carcinoma[10]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

{{#ask: Page Name::Megestrol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Megestrol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

Drug Shortage Status

Price

References

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

  1. ↑ Loprinzi CL, Ellison NM, Schaid DJ, Krook JE, Athmann LM, Dose AM; et al. (1990). "Controlled trial of megestrol acetate for the treatment of cancer anorexia and cachexia". J Natl Cancer Inst. 82 (13): 1127–32. PMID 2193166.
  2. ↑ Marchand V, Baker SS, Stark TJ, Baker RD (2000). "Randomized, double-blind, placebo-controlled pilot trial of megestrol acetate in malnourished children with cystic fibrosis". J Pediatr Gastroenterol Nutr. 31 (3): 264–9. PMID 10997370.
  3. ↑ Bonomi P, Pessis D, Bunting N, Block M, Anderson K, Wolter J; et al. (1985). "Megestrol acetate used as primary hormonal therapy in stage D prostatic cancer". Semin Oncol. 12 (1 Suppl 1): 36–9. PMID 3975650.
  4. ↑ Gal D (1986). "Hormonal therapy for lesions of the endometrium". Semin Oncol. 13 (4 Suppl 4): 33–6. PMID 3798126.
  5. ↑ Schlaff WD, Dugoff L, Damewood MD, Rock JA (1990). "Megestrol acetate for treatment of endometriosis". Obstet Gynecol. 75 (4): 646–8. PMID 2314784.
  6. ↑ Goodwin JW, Green SJ, Moinpour CM, Bearden JD, Giguere JK, Jiang CS; et al. (2008). "Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626". J Clin Oncol. 26 (10): 1650–6. doi:10.1200/JCO.2006.10.6179. PMID 18375894.
  7. ↑ Creagan ET, Schutt AJ, Ahmann DL, Green SJ (1982). "Phase II study of high-dose megestrol acetate in patients with advanced malignant melanoma". Cancer Treat Rep. 66 (5): 1239–40. PMID 7083227.
  8. ↑ Villa E, Ferretti I, Grottola A, Buttafoco P, Buono MG, Giannini F; et al. (2001). "Hormonal therapy with megestrol in inoperable hepatocellular carcinoma characterized by variant oestrogen receptors". Br J Cancer. 84 (7): 881–5. doi:10.1054/bjoc.2000.1534. PMC 2363845. PMID 11286465.
  9. ↑ Hines BJ, Porges RF, Mittal K, Muggia FM, Curtin JP (2002). "Use of medroxyprogesterone acetate in the treatment of Müllerian adenosarcoma: a case report". Gynecol Oncol. 85 (1): 192–5. doi:10.1006/gyno.2002.6585. PMID 11925144.
  10. ↑ Wilailak S, Linasmita V, Srisupundit S (2001). "Phase II study of high-dose megestrol acetate in platinum-refractory epithelial ovarian cancer". Anticancer Drugs. 12 (9): 719–24. PMID 11593052.
  11. ↑ Empty citation (help)
  12. ↑ "http://www.ismp.org". External link in |title= (help)

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