Progesterone (vaginal)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Dosage
2.1 General Dosing Information The dose of Endometrin is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined.
3 DOSAGE FORMS AND STRENGTHS 100 mg vaginal insert is a white to off-white oblong-shaped tablet debossed with "FPI" on one side and "100" on the other side.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (vaginal) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (vaginal) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Progesterone (vaginal) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (vaginal) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (vaginal) in pediatric patients.
Contraindications
Endometrin should not be used in individuals with any of the following conditions:
Previous allergic reactions to progesterone or any of the ingredients of Endometrin [see DESCRIPTION (11)] Known missed abortion or ectopic pregnancy Liver disease Known or suspected breast cancer Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events
Warnings
5.1 Cardiovascular or Cerebrovascular Disorders The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. Endometrin should be discontinued if any of these are suspected.
5.2 Depression Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
5.3 Use of Other Vaginal Products Endometrin should not be recommended for use with other vaginal products (such as antifungal products as this may alter progesterone release and absorption from the vaginal insert.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are summarized in Table 1.
Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.
6.2 Expected Adverse Reaction Profile Seen with Progesterone Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
Postmarketing Experience
There is limited information regarding Progesterone (vaginal) Postmarketing Experience in the drug label.
Drug Interactions
No formal drug-drug interaction studies have been conducted for Endometrin. Drugs known to induce the hepatic cytochrome-P450-3A4 system (such as rifampin, carbamazepine) may increase the elimination of progesterone. The effect of concomitant vaginal products on the exposure of progesterone from Endometrin has not been assessed. Endometrin is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Progesterone (vaginal) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Progesterone (vaginal) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Progesterone (vaginal) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Progesterone (vaginal) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Progesterone (vaginal) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Progesterone (vaginal) in geriatric settings.
Gender
There is no FDA guidance on the use of Progesterone (vaginal) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Progesterone (vaginal) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Progesterone (vaginal) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Progesterone (vaginal) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Progesterone (vaginal) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Progesterone (vaginal) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Progesterone (vaginal) Administration in the drug label.
Monitoring
There is limited information regarding Progesterone (vaginal) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Progesterone (vaginal) and IV administrations.
Overdosage
There is limited information regarding Progesterone (vaginal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Progesterone (vaginal) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Progesterone (vaginal) Mechanism of Action in the drug label.
Structure
There is limited information regarding Progesterone (vaginal) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Progesterone (vaginal) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Progesterone (vaginal) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Progesterone (vaginal) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Progesterone (vaginal) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Progesterone (vaginal) How Supplied in the drug label.
Storage
There is limited information regarding Progesterone (vaginal) 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 Progesterone (vaginal) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Progesterone (vaginal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Progesterone (vaginal) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Progesterone (vaginal) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.