Progesterone (oral): Difference between revisions

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|genericName=Progesterone
|genericName=Progesterone
|aOrAn=a
|aOrAn=a
|drugClass=hormone
|indicationType=treatment
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=<span style="color:#FF0000;">WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY</span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Cardiovascular Disorders and Probable Dementia: </span></i>


* Content
*Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Probable dementia.)
 
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)
 
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use.)
 
<i><span style="color:#FF0000;">Breast Cancer: </span></i>
 
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer.)
 
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
 
Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->
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<!--Drug box 2-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|drugBox=[[File:Progesterone image.png|600px|thumbnail|left]]
{{clear}}
|mechAction=*  
|mechAction=*  


<!--Structure-->
<!--Structure-->
|structure=*
|structure=PROMETRIUM (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:
 
[[File:Progesterone structure.png|600px|thumbnail|left]]
{{clear}}
 
Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone.


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.


<!--Pharmacodynamics-->
The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization.
 
Pharmacokinetics
 
A. Absorption
 
After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours. The absolute bioavailability of micronized progesterone is not known. Table 1 summarizes the mean pharmacokinetic parameters in postmenopausal women after five oral daily doses of PROMETRIUM Capsules 100 mg as a micronized soft-gelatin capsule formulation.
 
[[File:Progesterone table 1.png|600px|thumbnail|left]]
{{clear}}
 
 


<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


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<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|packLabel=[[File:Progesterone pdp.jpg|600px|thumbnail|left]]
{{clear}}


<!--Precautions with Alcohol-->
[[File:Progesterone label.png|600px|thumbnail|left]]
{{clear}}
|fdaPatientInfo=[[File:Progesterone table 1.png|600px|thumbnail|left]]
{{clear}}
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


Revision as of 14:22, 2 December 2014

Progesterone (oral)
Black Box Warning
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]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

Disclaimer

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Black Box Warning

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
See full prescribing information for complete Boxed Warning.
Cardiovascular Disorders and Probable Dementia:
  • Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Probable dementia.)

The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use.)

Breast Cancer:

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Overview

Progesterone (oral) is a hormone that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Progesterone intrauterine insert (Progestasert(R)) was discontinued on 06/01/2001.View additional information.

a) Important Notes 1) Before insertion of the intrauterine device containing progesterone, the patient must read and initial each section of the Patient Information Leaflet supplied with the system [5]. The intrauterine system should be inserted only by physicians familiar with the instructions. Prior to insertion, a cervical Pap smear, tests for Neisseria gonorrhoeae and Chlamydia, and a pelvic exam should be conducted. b) One system containing 38 mg of progesterone should be inserted into the uterus using the inserter provided [5]. The system should be removed and replaced every 12 months for continued effectiveness. c) Patients should be advised that this product will not protect them from HIV infection or other sexually transmitted diseases. d) The patient should return for a check up 3 months after insertion and at 12 months for removal and replacement of the system. e) Should not be inserted until involution of the uterus is complete following abortion or child birth. 

       Abnormal uterine bleeding unrelated to menstrual cycleView additional information.

a) Progesterone 5 to 10 mg is injected IM daily for 6 doses. The bleeding should be expected to stop within 6 days. If the menstrual flow begins during the course of progesterone injections, therapy should be stopped. If estrogen therapy is to be used, progesterone should be initiated after 2 weeks of estrogen therapy [9]. 

       Assisted reproductive technology; Adjunct - Female infertilityView additional information.

a) Vaginal Gel 1) Progesterone gel (Crinone(R) 8%) 90 mg once daily is administered vaginally in women who require progesterone supplementation. In women with partial or complete ovarian failure who require progesterone replacement, a dose of 90 mg twice daily is administered [8]. 2) A desired dosage increase from the 4% gel can only be achieved by using the 8% gel rather than increasing the volume of the 4% gel [8]. b) Vaginal Insert 1) Administer 100 mg vaginal insert vaginally 2 to 3 times a day starting the day after oocyte retrieval and continuing for up to 10 weeks total duration for women undergoing Assisted Reproductive Technology treatment for infertility [19]. 

       ContraceptionView additional information.
       Endometrial hyperplasia; ProphylaxisView additional information.

a) Oral micronized progesterone should be given as a single daily dose in the evening, 200 mg for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogen tablets [10]. 

       Secondary physiologic amenorrheaView additional information.

a) In the treatment of amenorrhea, progesterone 5 to 10 mg in oil should be administered IM daily for 6 to 8 days (Prod Info Progesterone USP, 2000). If a proliferative endometrium is produced, withdrawal bleeding should occur within 48 to 72 hours after discontinuing the progesterone. This may be followed by spontaneous normal cycles.

a) Oral progesterone may be given as a single daily dose of 400 mg in the evening for 10 days [10].

a) For secondary amenorrhea, vaginal progesterone gel 4% is administered every other day up to a total of 6 doses. For those who fail to respond, a trial of 8% (90 mg) every other day up to a total of 6 doses may be used (Prod Info Crinone(R), 2000).


Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

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 Progesterone (oral) in adult patients.

Non–Guideline-Supported Use

Premature birth of newborn, Short cervix; Prophylaxis
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Progesterone (oral) 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 Progesterone (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (oral) in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
See full prescribing information for complete Boxed Warning.
Cardiovascular Disorders and Probable Dementia:
  • Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Probable dementia.)

The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use.)

Breast Cancer:

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Progesterone (oral) 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 Progesterone (oral) 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 Progesterone (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Progesterone (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Progesterone (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Progesterone (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Progesterone (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Progesterone (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Progesterone (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Progesterone (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Progesterone (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Progesterone (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Progesterone (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Progesterone (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Progesterone (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Progesterone (oral) in the drug label.

Pharmacology

Mechanism of Action

Structure

PROMETRIUM (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is:

File:Progesterone structure.png

Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone.

The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.

The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Progesterone (oral) in the drug label.

Pharmacokinetics

PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization.

Pharmacokinetics

A. Absorption

After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours. The absolute bioavailability of micronized progesterone is not known. Table 1 summarizes the mean pharmacokinetic parameters in postmenopausal women after five oral daily doses of PROMETRIUM Capsules 100 mg as a micronized soft-gelatin capsule formulation.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Progesterone (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Progesterone (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Progesterone (oral) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Progesterone (oral) |?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::Progesterone (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

Precautions with Alcohol

  • Alcohol-Progesterone (oral) 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. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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Retrieved from "https://www.wikidoc.org/index.php?title=Progesterone_(oral)&oldid=1044099"