Progesterone Capsules IR

(Commercial Product)

Available Dosage Strengths

100 mg | 200 mg

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Disclaimer: Images are for reference only; actual products may vary.

Product Overview

Description

Progesterone Capsules IR Description^1-3

Micronized progesterone is a bioidentical form of the naturally occurring hormone progesterone, formulated into micron-sized particles to enhance oral absorption. It is used in various clinical settings within women’s health, including hormone replacement therapy (HRT), management of luteal phase defects, menstrual disorders, infertility treatments, and prevention of endometrial hyperplasia in postmenopausal women receiving estrogen therapy. Progesterone can be prepared in capsule form to be taken by mouth.

Mechanism of Action

Mechanism of Action^1-3

Progesterone is a steroid hormone primarily secreted by the corpus luteum and, during pregnancy, the placenta, it binds PR-A & PR-B receptors and the primary actions in women include:

Endometrial transformation: Converts the endometrium from a proliferative to a secretory state, supporting implantation and pregnancy.
Regulation of gonadotropin secretion: Via negative feedback on the hypothalamic-pituitary axis.
Stabilization of the endometrium helps to prevent irregular bleeding in women receiving estrogen therapy.
CNS effects: Modulates mood, sleep, and neuroprotective pathways through GABA-A receptor modulation.

Adverse Reactions

Common^1-3

Drowsiness or sedation
Breast tenderness
Headache
Bloating
Mood changes
Irregular bleeding or spotting
Dizziness

Contraindications & Precautions

Contraindications^1-3

Micronized progesterone should not be used in individuals with:

Known or suspected pregnancy (when used outside pregnancy-supporting protocols)
Undiagnosed abnormal menstrual bleeding
Known, suspected, or history of breast cancer
Active or history of thromboembolic disorders (stroke, DVT, heart attack etc…)
Liver dysfunction or disease
Hypersensitivity to progesterone or any formulation components

Precautions^1-3

Use in patients with a history of depression should be monitored closely.
Caution in cardiovascular disease, migraine, or seizure disorders.
In women with a uterus, progesterone is required alongside estrogen to prevent endometrial hyperplasia.

Storage

Store at controlled room temperature (20°C to 25°C / 68°F to 77°F)
Protect from moisture and light
Keep in a tightly closed container

References

FDA Label for Prometrium® (micronized progesterone); accessed July 2025 through: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf
Cynthia A. Stuenkel, Susan R. Davis, Anne Gompel, Mary Ann Lumsden, M. Hassan Murad, JoAnn V. Pinkerton, Richard J. Santen, Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline, The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 11, 1 November 2015, Pages 3975–4011, accessed July 2025 through: https://doi.org/10.1210/jc.2015-2236
Clinical Pharmacology Progesterone clinical monograph accessed July 2025 through: https://www.clinicalkey.com/pharmacology/monograph/515?n=Progesterone

Disclaimer

Wells Pharmacy Network is a 503B-registered outsourcing facility that compounds sterile medications in accordance with current good manufacturing practices (cGMP). Certain FDA-approved products referenced on this site are distributed separately from compounded preparations and are not manufactured by Wells Pharmacy Network. Actual products in stock at time of dispensing may vary due to supply chain variability.

This information may not cover all possible drug information about this product. Call your doctor for medical advice and/or about side effects. You may report side effects to the FDA at 1-800-FDA-1088. A Wells Pharmacy Network pharmacist will be happy to answer any questions. For consultation, please call 1-800-622-4510.