dydrogesterone: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
dydrogesterone: clinical details
Prescribing considerations
- Establish the cause of abnormal or irregular vaginal bleeding before treatment.
- Investigate persistent, concerning or later-onset bleeding; endometrial assessment may be required.
- Review depression, porphyria, liver dysfunction, cholestatic jaundice or pruritus.
- For HRT, assess relevant history, breast and pelvic findings, and risks and contraindications of the accompanying oestrogen.
- Safety and efficacy have not been established in adolescents aged 12–18 years.
Contraindications and cautions
- Hypersensitivity to dydrogesterone or an excipient.
- Known or suspected progestogen-dependent tumour, including current or previous meningioma.
- Unexplained vaginal bleeding.
- Severe acute or chronic liver disease, specified bile-pigment metabolism disorders, or previous or current liver tumour.
- Thrombophlebitis or thromboembolic disease.
- When combined with oestrogen, any contraindication applying to that oestrogen.
Monitoring
- Bleeding pattern and persistent or later-onset breakthrough bleeding.
- Symptoms or signs of meningioma; discontinue if meningioma is diagnosed.
- Liver function and symptoms of cholestasis where clinically indicated.
- Mood, porphyria recurrence and clinically significant persistent hypertension.
- For HRT, periodically reassess benefits and risks and maintain appropriate screening.
Clinical pharmacology
Dydrogesterone is an orally active pregnadien progestogen. It produces secretory transformation of oestrogen-activated endometrium and is rapidly converted to active 20α-dihydrodydrogesterone; CYP3A4 contributes to further metabolism.
Formulation and product differences
- The selected product is a single-ingredient, white film-coated oral tablet rather than a combined oestrogen–dydrogesterone HRT product.
- It contains lactose monohydrate and is unsuitable for people with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Available pack sizes may differ, and not all authorised pack sizes are necessarily marketed.
dydrogesterone preparations and strengths
Tablet
Route: Oral
Strengths: 10 mg
dydrogesterone interactions
Medicines and herbal products that increase CYP enzyme activity may speed up dydrogesterone metabolism and reduce its effect.
Phenobarbital, phenytoin or carbamazepine
These enzyme-inducing antiseizure medicines may reduce dydrogesterone’s effect.
Rifampicin or rifabutin
These antibiotics may increase dydrogesterone metabolism and reduce its effect.
Nevirapine or efavirenz
These antiviral medicines may reduce dydrogesterone exposure and effectiveness.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.