ENDOMETRIN Vaginal insert (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Ferring Pharmaceuticals Inc.

Λέξεις κλειδιά

55566-6500

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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 ...

2. Dosage and Administration

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. ...

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.

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 <em>[see Description (11)]</em> Undiagnosed ...

5. Warnings and Precautions

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 ...

6. Adverse Reactions

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, ...

6.1. 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 ...

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 ...

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 ...

8.3. Nursing Mothers

Detectable amounts of progesterone have been identified in the milk of nursing mothers. The effect of this on the nursing infant has not been determined.

8.4. Pediatric Use

This drug is not intended for pediatric use and no clinical data have been collected in children. Therefore, the safety and effectiveness of ENDOMETRIN in pediatric patients have not been established. ...

8.5. Geriatric Use

No clinical data have been collected in patients over age 65.

10. Overdosage

Treatment of overdosage consists of discontinuation of ENDOMETRIN together with institution of appropriate symptomatic and supportive care.

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 ...

12.1. Mechanism of Action

Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into ...

12.3. Pharmacokinetics

Absorption Progesterone serum concentrations increased following the administration of the ENDOMETRIN Vaginal Insert in 12 healthy pre-menopausal females. On single dosing, the mean C<sub>max</sub> was ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Nonclinical toxicity studies to determine the potential of ENDOMETRIN to cause carcinogenicity or mutagenicity have not been performed. The effect of ENDOMETRIN on fertility has not been evaluated in animals. ...

14. Clinical Studies

14.1 Luteal Supplementation During Assisted Reproductive Treatment Study A randomized, open-label, active-controlled study evaluated the efficacy of 10 weeks of treatment with two different daily dosing ...

16.1. How Supplied

Each ENDOMETRIN Vaginal Insert is a white to off-white oblong-shaped insert debossed with FPI on one side and 100 on the other side. Each ENDOMETRIN (progesterone) Vaginal Insert, 100 mg, is packed individually ...

16.2. Storage and Handling

Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F).

17. Patient Counseling Information

See FDA-Approved Patient Labeling (17.4). 17.1 Vaginal Bleeding Inform patients of the importance of reporting irregular vaginal bleeding to their doctor as soon as possible. 17.2 Common Adverse Reactions ...