Generic
Dienogest + Estradiol Valerate
1 brands available in the market
At a glance
Dienogest + Estradiol Valerate is a Hormone Replacement Therapy (HRT) used for the relief of post-menopausal symptoms including hot flushes and vaginal dryness.
Description
Estradiol valerate is an estrogen that controls elevated gonadotropin levels in postmenopausal women and relieves hot flushes and vaginal dryness. Dienogest is a progestin that binds to the progesterone receptor, transforms the secretory function of the endometrium and protects against endometrial proliferation.
Indications
- Post-menopausal symptoms (hot flushes, vaginal dryness)
- Complete stoppage of menstrual bleeding due to impending menopause
- Menopausal symptoms obstructing normal daily activities
Therapeutic class
Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones
Pharmacological class
HRT (Estrogen + Progestin)
Pharmacology
Estradiol valerate is an estrogen that controls elevated gonadotropin levels in postmenopausal women. Dienogest is a progestin that binds to the progesterone receptor, transforms the secretory function of the endometrium and protects against endometrial proliferation.
Mechanism of action
Estradiol relieves hot flushes and vaginal dryness; Dienogest prevents endometrial proliferation and ensures regular bleeding.
Dosage
Adult (Postmenopausal): 1 tablet daily at the same time, without interruption (28-day pack).
Administration
Take at the same time each day with some liquid. Swallow the tablet whole. Start the next pack immediately without a break.
Missed dose
If you miss a dose, take it as soon as possible. If more than 24 hours have elapsed, do not take an extra tablet.
Side effects
Common (1-10%): Unexpected menstruation-like bleeding, breast tenderness/pain, headache, migraine, dizziness, tiredness, anxiety, depressive mood, hypertension, nausea, abdominal pain, diarrhea, increased gamma GT, endometrial thickening, hot flushes, weight changes.
Uncommon (0.1-1%): Insomnia, nervousness, vein inflammation, venous blood clot, constipation, bloating, increased sweating, hair loss, eczema, acne-like dermatitis.
Precautions & warnings
HRT use increases risk of breast cancer, endometrial cancer, ovarian cancer, venous thromboembolism, heart disease and stroke. Caution in uterine fibroids, endometriosis, hypertension, diabetes, migraine, epilepsy, asthma, gallstones.
Contraindications
Known or suspected breast cancer; estrogen-dependent malignant tumors; undiagnosed genital bleeding; untreated endometrial hyperplasia; venous thromboembolism; arterial thromboembolic disease; thrombophilic disorders; acute liver disease or history of liver disease until LFTs normalize; porphyria; hypersensitivity; pregnancy and lactation.
Drug interactions
Epilepsy drugs (phenobarbital, phenytoin, carbamazepine): May reduce effect.
TB drugs (rifampicin, rifabutin): May reduce effect.
HIV drugs (nevirapine, efavirenz, ritonavir, nelfinavir): May reduce effect.
St. John's wort: May reduce effect.
Food interactions
It is not known whether it is safe to consume alcohol with Dienogest + Estradiol Valerate.
Use in pregnancy
Pregnancy Category X. Do not use during pregnancy.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Do not use during lactation.
Pediatric use
Not indicated for the pediatric population.
Geriatric use
For postmenopausal women only; risk of memory loss if started over age 65.
Renal / hepatic impairment
Caution in liver disease; contraindicated in severe liver disease.
Overdose effects
Overdose may cause nausea, vomiting, and withdrawal bleeding; no specific antidote.
Storage conditions
Keep below 30°C temperature, away from light & moisture.
Chemical structure
Dienogest + Estradiol Valerate