← Search & browse all drugs
GENITO URINARY SYSTEM AND SEX HORMONES › SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › PROGESTOGENS AND ESTROGENS IN COMBINATION › Progestogens and estrogens, sequential preparations
dydrogesterone and estrogen
G03FB08
Forms & Strengths
- Oral tablets: Estradiol 1 mg / dydrogesterone 5 mg
- Oral tablets: Estradiol 2 mg / dydrogesterone 10 mg
- Continuous combined sequential formulations vary by regional availability
Adult Dosing
- Menopausal hormone therapy: 1 tablet daily continuously without interruption
- Administer orally at the same time each day with or without food
- Use the lowest effective dose for the shortest duration consistent with treatment goals
Pediatric Dosing
- Not indicated for use in pediatric populations
- Safety and efficacy have not been established in children or adolescents
Indications
- Hormone therapy for estrogen deficiency symptoms in postmenopausal women with an intact uterus
- Prevention of postmenopausal osteoporosis in women at high risk of future fracture who are intolerant of other approved agents
Mechanism of Action
- Estradiol: Replaces endogenous estrogen, binding to estrogen receptors to maintain bone density and alleviate vasomotor symptoms
- Dydrogesterone: A retro-progesterone that provides potent progestational activity on the endometrium, preventing estrogen-induced endometrial hyperplasia
Contraindications
- Known, suspected, or history of breast cancer
- Known or suspected estrogen- or progestin-dependent malignant tumors
- Undiagnosed abnormal genital bleeding
- Active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
- Active or history of arterial thromboembolic disease (stroke, myocardial infarction)
- Known hepatic impairment or active liver disease
- Known hypersensitivity to estradiol, dydrogesterone, or any excipient
- Known or suspected pregnancy
Adverse Reactions
- Breast tenderness, enlargement, or pain
- Breakthrough bleeding, spotting, or dysmenorrhea
- Headache or migraine exacerbation
- Nausea, abdominal cramps, and bloating
- Mood changes, depression, or anxiety
- Peripheral edema and weight fluctuations
- Increased risk of venous thromboembolism, stroke, and gallbladder disease
Drug Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's wort) decrease estradiol plasma concentrations and therapeutic efficacy
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase plasma concentrations of estrogen and progestin
- Antidiabetic agents: Estrogens may decrease glucose tolerance, potentially requiring adjustment of antidiabetic therapy
- Anticoagulants: Hormone therapy may alter efficacy of anticoagulant medications
Curated Content: Needs Vetting Before Put to Clinical Use