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OSPHENA (OSPEMIFENE)
- Atrophic vaginitis associated with menopause
- Dyspareunia due to menopausal vulvovaginal atrophy
60 mg tablet
- 1 tablet (60 mg) by oral route once daily with food
Atrophic vaginitis associated with menopause
- 1 tablet (60 mg) by oral route once daily with food
Dyspareunia due to menopausal vulvovaginal atrophy
- 1 tablet (60 mg) by oral route once daily with food
- None
Contraindicated
- Diflucan
- fluconazole
- fluconazole in dextrose(iso-o)
- fluconazole in NaCl (iso-osm)
- Vfend
- Vfend Iv
- voriconazole
Severe
Moderate
- carbamazepine
- Carbatrol
- enzalutamide
- Epitol
- Equetro
- isoniazid-rifamp-pyrazinamide
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Tegretol
- Tegretol Xr
- Xtandi
- Acute myocardial infarction
- Acute pulmonary thromboembolism
- Carcinoma of breast
- Cerebrovascular accident
- Deep venous thrombosis
- Estrogen-dependent neoplasm
- Hemorrhagic stroke
- Pregnancy
Contraindicated
- None
Severe
Moderate
- None
OSPHENA (OSPEMIFENE)
- Atrophic vaginitis associated with menopause
- Dyspareunia due to menopausal vulvovaginal atrophy
- None
- Abnormal vaginal bleeding
- Flushing
- Hyperhidrosis
- Muscle spasm
- Night sweats
- Vaginal discharge
More Frequent
Severe
Less Severe
- None
- None
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Angioedema
- Cerebrovascular accident
- Deep venous thrombosis
- Endometrial carcinoma
- Endometrial hyperplasia
- Hypersensitivity drug reaction
- Pulmonary thromboembolism
Less Severe
- Erythema
- Headache disorder
- Pruritus of skin
- Skin rash
- Urticaria
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Ospemifene
No indication for use in pediatrics. Not studied.
- 1 Day – 18 Years
- No indication for use in pediatrics. Not studied.
Ospemifene
- Severity Level:
1
- Additional Notes: Based on animal data, embryo/fetal toxicity possible
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Ospemifene
Insufficient data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- Ospemifene may increase your risk of uterine cancer. Tell your doctor right away if you develop changes in menstrual period, unusual vaginal bleeding/discharge, or pain/pressure below your "belly button" (navel). Ospemifene may rarely cause serious blood clots to form in the legs or lungs.<br /><br />Tell your doctor if you have a history of blood clots (such as deep vein thrombosis, pulmonary embolism). Also talk to your doctor about risk factors for developing strokes (sometimes fatal) while taking this medication. Some risk factors include tobacco use, alcohol use, having high cholesterol/diabetes, or a history of heart disease. Talk to your doctor about these risks and the benefits of using ospemifene.
| Atrophic vaginitis associated with menopause | |
| N95.2 | Postmenopausal atrophic vaginitis |
| Dyspareunia due to menopausal vulvovaginal atrophy | |
| N95.2 | Postmenopausal atrophic vaginitis |
| 0-9 | A-Z |
|---|---|
| N95.2 | Postmenopausal atrophic vaginitis |
| N95.2 | Postmenopausal atrophic vaginitis |
Formulary Reference Tool