PROGESTERONE VAGINAL INSERTS

PROGESTERONE VAGINAL INSERTS is an FDA-registered drug product whose active ingredient is PROGESTERONE. It is labelled by Glenmark Pharmaceuticals Inc., USA taken by vaginal and marketed as a human prescription drug product. Identifiers on file: NDC 68462-175, application ANDA216363, label effective 20260417. It is one of 29 FDA drug label records sharing the active ingredient PROGESTERONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PROGESTERONE are most often described in connection with: progesterone vaginal, indicated support, embryo implantation, early pregnancy, supplementation corpus, luteal function, part assisted, reproductive technology. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Progesterone vaginal insert 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. Progesterone vaginal insert 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 ).

2 DOSAGE AND ADMINISTRATION The dose of progesterone vaginal insert 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 progesterone vaginal insert in this age group has not been determined ( 2.1 ). 2.1 General Dosing Information The dose of progesterone vaginal insert 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 progesterone vaginal insert in this age group has not been determined.

4 CONTRAINDICATIONS Progesterone vaginal insert should not be used in individuals with any of the following conditions: • Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert [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 • Previous allergic reactions to progesterone or any of the ingredients of progesterone vaginal insert ( 4 ) • Known missed abortion or ectopic pregnancy ( 4 ) • Liver disease ( 4 ) • Known or suspected breast cancer ( 4 ) • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events ( 4 )

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 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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. The safety data reflect exposure to progesterone vaginal insert 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. Progesterone vaginal insert 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 progesterone vaginal insert group are summarized in Table 1. Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Progesterone Vaginal Insert in an Assisted Reproductive Technology Study Body System Progesterone Vaginal Insert 100 mg twice daily (N=404) Progesterone Vaginal Insert 100 mg three times daily (N=404) Preferred Term Gastrointestinal Disorders Abdominal pain 50 (12%) 50 (12%) Nausea 32 (8%) 29 (7%) Abdominal distension 18 (4%) 17 (4%) Constipation 9 (2%) 14 (3%) Vomiting 13 (3%) 9 (2%) General Disorders & Administration Site Conditions Fatigue 7 (2%) 12 (3%) Infections and Infestations Urinary tract infection 9 (2%) 4 (1%) Injury, Poisoning and Procedural Complications Post-oocyte retrieval pain 115 (28%) 102 (25%) Nervous System Disorders Headache 15 (4%) 13 (3%) Reproductive System and Breast Disorders Ovarian hyperstimulation syndrome 30 (7%) 27 (7%) Uterine spasm 15 (4%) 11 (3%) Vaginal bleeding 13 (3%) 14 (3%) 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 Progesterone vaginal insert is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.

FDA lists 29 drug label records with PROGESTERONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is PROGESTERONE VAGINAL INSERTS used for?
1 INDICATIONS AND USAGE Progesterone vaginal insert 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. Progesterone vaginal insert is a progesterone indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal …

Who makes PROGESTERONE VAGINAL INSERTS?
Glenmark Pharmaceuticals Inc., USA is the labeler of record for PROGESTERONE VAGINAL INSERTS. 29 FDA label records share the active ingredient PROGESTERONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does PROGESTERONE VAGINAL INSERTS come in?
administered by vaginal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is PROGESTERONE VAGINAL INSERTS prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PROGESTERONE?
Yes. 29 FDA drug label records list PROGESTERONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has PROGESTERONE VAGINAL INSERTS been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.