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.
Contraindications
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.
Action
Description: 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). Pharmacokinetics: Metabolism: Metabolised by dehydrogenase, reductase, and aromatase into 2 active metabolites (estradiol and testosterone).
Chemical Structure
Prasterone Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5881, Dehydroepiandrosterone. https://pubchem.ncbi.nlm.nih.gov/compound/Dehydroepiandrosterone. Accessed Apr. 26, 2022.
Storage
Store between 5-30°C. Do not freeze. Follow applicable procedures for receiving, handling, administration, and disposal.
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