Progesterone
Generic Name: progesterone
Brand Names:
Endometrin
11 DESCRIPTION ENDOMETRIN (progesterone) Vaginal Insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present in 100 mg amount along with other excipients. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C 21 H 30 O 2 and a molecular weight of 314.5. Progesterone exists in two polymorphic forms.
Overview
11 DESCRIPTION ENDOMETRIN (progesterone) Vaginal Insert contains micronized progesterone. ENDOMETRIN is supplied with polyethylene vaginal applicators. The active ingredient, progesterone, is present in 100 mg amount along with other excipients. The chemical name for progesterone is pregn-4-ene-3,20-dione. It has an empirical formula of C 21 H 30 O 2 and a molecular weight of 314.5. Progesterone exists in two polymorphic forms.
Uses
1 INDICATIONS AND USAGE ENDOMETRIN ® (progesterone) 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. ENDOMETRIN ® is a progesterone 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. (1)
Dosage
2 DOSAGE AND ADMINISTRATION 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. ( 2.1 ) 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.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions reported (greater than 2%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome. (6) This leaflet summarizes the most important information about ENDOMETRIN. To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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.
Interactions
7 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 [ see Warnings and Precautions (5.3) ].
Warnings
5 WARNINGS AND PRECAUTIONS Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with ENDOMETRIN. Discontinue ENDOMETRIN if any of these are suspected. ( 5.1 ) Observe patients with a history of depression closely. Consider discontinuation if symptoms worsen. ( 5.2 ) 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. ( 5.3 ) 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. 4 CONTRAINDICATIONS ENDOMETRIN is contraindicated in individuals with any of the following conditions: Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN [ see Description (11) ] Undiagnosed vaginal bleeding Known missed abortion or ectopic pregnancy Liver disease Known or suspected malignancy of the breast or genital organs Active arterial or venous thromboembolis...
Pregnancy
8.1 Pregnancy ENDOMETRIN has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The live birth outcomes of these pregnancies were as follows: Among the 404 subjects treated with ENDOMETRIN twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths).
Storage
Store at 20 - 25°C (68 - 77°F); excursions permitted between 15 - 30°C (59 - 86°F).
Frequently Asked Questions
What is Progesterone used for?▼
1 INDICATIONS AND USAGE ENDOMETRIN ® (progesterone) 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. ENDOMETRIN ® is a progesterone 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. (1)
What are the side effects of Progesterone?▼
6 ADVERSE REACTIONS The most common adverse reactions reported (greater than 2%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome. (6) This leaflet summarizes the most important information about ENDOMETRIN. To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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.
Can I take Progesterone during pregnancy?▼
8.1 Pregnancy ENDOMETRIN has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The live birth outcomes of these pregnancies were as follows: Among the 404 subjects treated with ENDOMETRIN twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths).
What are the important warnings for Progesterone?▼
5 WARNINGS AND PRECAUTIONS Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with ENDOMETRIN. Discontinue ENDOMETRIN if any of these are suspected. ( 5.1 ) Observe patients with a history of depression closely. Consider discontinuation if symptoms worsen. ( 5.2 ) 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. ( 5.3 ) 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. 4 CONTRAINDICATIONS ENDOMETRIN is contraindicated in individuals with any of the following conditions: Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN [ see Description (11) ] Undiagnosed vaginal bleeding Known missed abortion or ectopic pregnancy Liver disease Known or suspected malignancy of the breast or genital organs Active arterial or venous thromboembolis...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.