PROGESTERONE VAGINAL INSERTS 100 mg/1

progesterone · INSERT · Glenmark Pharmaceuticals Inc., USA

No Recall HistoryCurrently in Shortage

Plain English

PROGESTERONE VAGINAL INSERTS is a insert containing progesterone at 100 mg/1, taken vaginal. Manufactured by Glenmark Pharmaceuticals Inc., USA.

Key Facts

Brand Name: PROGESTERONE VAGINAL INSERTS
Generic Name: progesterone
NDC Code (Product): 68462-175
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Strength: 100 mg/1
Dosage Form: INSERT
Route: VAGINAL
Marketing Status
Application #: ANDA216363
Drug Class: Progesterone [EPC]
Marketing Start: 04/08/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache1,660 reports

off label use1,542 reports

drug ineffective1,488 reports

fatigue1,437 reports

pain1,184 reports

nausea1,174 reports

exposure during pregnancy831 reports

foetal exposure during pregnancy813 reports

rash808 reports

dizziness743 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 ).

Dosage & Administration

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.

Contraindications

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 )

Drug Interactions

7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted for progesterone vaginal insert. 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 progesterone vaginal insert has not been assessed. Progesterone vaginal insert 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 )] .

Adverse Reactions

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 w…

Frequently Asked Questions

What is PROGESTERONE VAGINAL INSERTS used for?

PROGESTERONE VAGINAL INSERTS contains progesterone. It is a insert taken vaginal. Consult your doctor for specific uses.

Is PROGESTERONE VAGINAL INSERTS a controlled substance?

PROGESTERONE VAGINAL INSERTS is not classified as a controlled substance by the DEA.

What is the generic name for PROGESTERONE VAGINAL INSERTS?

The generic name for PROGESTERONE VAGINAL INSERTS is progesterone. There are 12 other brand versions of progesterone.

What is the NDC code for PROGESTERONE VAGINAL INSERTS 100 mg/1?

The NDC (National Drug Code) for PROGESTERONE VAGINAL INSERTS 100 mg/1 is 68462-175, listed by Glenmark Pharmaceuticals Inc., USA.

Product NDC

68462-175

Package NDC

68462-175-33

Other Progesterone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)