Finished product reference
Dienogest
Tablet · Oral · 2 mg
- List code
- 50401
- Pharmacologic class
- Progestogen (19-nortestosterone derivative with antiandrogenic activity)
What it is and how it works
Dienogest is a progestogen with strong endometrial effects and moderate antiandrogenic activity. Continuous administration produces a hypo-oestrogenic, hypergestagenic endocrine environment that causes decidualisation and then atrophy of endometriotic lesions.
Indications
Treatment of endometriosis.
Dosage and administration (summary)
2 mg orally once daily, taken continuously without regard to vaginal bleeding.
Contraindications
Active venous thromboembolic disorder; arterial or cardiovascular disease, past or present; diabetes with vascular involvement; severe hepatic disease or liver tumours; known or suspected sex-hormone-dependent malignancy; and undiagnosed vaginal bleeding.
Warnings and precautions
Changes in bleeding pattern are common. Depressed mood may occur, and patients with a history of depression should be monitored. Long-term use may cause a modest reduction in bone mineral density, particularly in adolescents.
Pregnancy
Not indicated in pregnancy; discontinue if pregnancy occurs.
Storage and supply
Store below 30 °C in the original package.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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