Generic Medicine Info
Indications and Dosage
Adult: For the treatment of moderate to severe cases caused by postmenopausal vulvar and vaginal atrophy: 6.5 mg (1 pessary) once daily at bedtime. Treatment should be reassessed at least every 6 months.
Undiagnosed abnormal vaginal bleeding, untreated endometrial hyperplasia, history of known or suspected breast cancer, known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer), acute liver disease or history of liver disease wherein LFTs have failed to return to normal, previous or current venous thromboembolism (e.g. DVT, pulmonary embolism), known thrombophilic disorders (e.g. protein S, protein C, antithrombin deficiency), active or recent arterial thromboembolic disease (e.g. angina, MI), porphyria.
Special Precautions
Patient with hypertension, diabetes mellitus (with or without vascular involvement), SLE, migraine or severe headache, asthma, epilepsy, cholelithiasis, otosclerosis, leiomyoma or endometriosis; history of endometrial hyperplasia, women who have undergone hysterectomy due to endometriosis; risk factors for thromboembolic disorders (e.g. older age, major surgery, prolonged immobilisation, obesity [BMI >30 kg/m2], use of estrogens); risk factors for estrogen dependent tumours (e.g. 1st degree heredity for breast cancer); liver disorders (e.g. liver adenoma).
Adverse Reactions
Investigations: Weight fluctuations.
Reproductive system and breast disorders: Vaginal discharge, abnormal Pap smear. Rarely, benign breast mass, cervical/uterine polyps.
Monitoring Parameters
Perform physical (including breast and pelvic) examination and obtain a complete personal and family medical history before initiating therapy. Monitor for excessive bleeding or vaginal discharge.
Mechanism of Action: Prasterone is an inactive endogenous steroid that is converted into active androgens and/or estrogens. Its exact mechanism of action is not fully established, however, studies suggest that it exhibits androgenic and estrogenic activity.
Synonym: dehydroepiandrosterone (DHEA).
Metabolism: Metabolised by dehydrogenase, reductase, and aromatase into 2 active metabolites (estradiol and testosterone).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5881, Dehydroepiandrosterone. Accessed Apr. 26, 2022.

Store between 5-30°C. Do not freeze. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
A14AA07 - prasterone ; Belongs to the class of androstan derivative anabolic steroids used as systemic anabolic agents.
Anon. Prasterone. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. Accessed 20/04/2022.

Anon. Prasterone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 21/12/2021.

Buckingham R (ed). Prasterone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 21/12/2021.

Intrarosa (Millicent US, Inc.). DailyMed. Source: U.S. National Library of Medicine. Accessed 21/12/2021.

Intrarosa 6.5 mg Pessary (Basic Pharma Manufacturing B.V.). European Medicines Agency [online]. Accessed 21/12/2021.

Intrarosa Pessary 6.5 mg (Endoceutics Pharma [MSH] Inc). MIMS Hong Kong. Accessed 20/04/2022.

Joint Formulary Committee. Prasterone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 21/12/2021.

Disclaimer: This information is independently developed by MIMS based on Prasterone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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