← Search & browse all drugs
GENITO URINARY SYSTEM AND SEX HORMONES › SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › Selective estrogen receptor modulators
ospemifene
G03XC05
Forms & Strengths
- Tablets: 60mg
- Oral formulation
Adult Dosing
- 1 tablet orally once daily
- No dose adjustment for mild or moderate renal impairment
- Monitor patients with severe renal impairment
Pediatric Dosing
- Not indicated for use in pediatric patients
- Safety and efficacy not established in patients under 18 years
Indications
- Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause
- Treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause
Mechanism of Action
- Selective estrogen receptor modulator (SERM)
- Estrogen agonist/antagonist activity
- Stimulates estrogen receptors in the vagina, while acting as an antagonist on other tissues
Contraindications
- Known or suspected estrogen-dependent neoplasia
- Active or history of deep vein thrombosis or pulmonary embolism
- Known or suspected pregnancy
- Severe hepatic impairment
- Undiagnosed abnormal vaginal bleeding
Adverse Reactions
- Hot flashes
- Vaginal discharge
- Genital discharge
- Throat infection
- Vulvovaginal mycotic infection
- Headache
- Pelvic pain
Drug Interactions
- Estrogenic agents, including oral contraceptives
- Inducers or inhibitors of CYP2C9 or CYP3A4
- Warfarin and other anticoagulants
- Other SERMs
Curated Content: Needs Vetting Before Put to Clinical Use