Formulary
Dienogest: Indications, Dosing, Side Effects and Interactions
Dienogest is a nortestosterone derivative that has a progestogenic effect in the uterus, reducing the production of estradiol and thereby suppressing...
MedNext Academy | 3 min read
Dienogest: Indications, Dosing, Side Effects and Interactions
Dienogest is a nortestosterone derivative that has a progestogenic effect in the uterus, reducing the production of estradiol and thereby suppressing...
Drug action
Dienogest is a nortestosterone derivative that has a progestogenic effect in the uterus, reducing the production of estradiol and thereby suppressing endometriotic lesions.
Indications and dose
**Endometriosis for dienogest**
- **Females of childbearing potential** (By mouth): 2 mg once daily, can be started on any day of cycle, dose should be taken continuously at the same time each day.
Cautions
Diabetes (progestogens can decrease glucose tolerance-monitor patient closely); history of depression; history of ectopic pregnancy; history of gestational diabetes; patients at risk of osteoporosis; patients at risk of venous thromboembolism Cautions, further information Immobilisation Manufacturer advises to discontinue treatment during prolonged immobilisation. For elective surgery, treatment should be discontinued at least 4 weeks before surgery; treatment may be restarted 2 weeks after complete remobilisation.
Contraindications
Arterial disease (past or present); cardiovascular disease (past or present); diabetes with vascular involvement; liver tumours (past or present); sex hormone-dependent malignancies (confirmed or suspected); undiagnosed vaginal bleeding; venous thromboembolism (active)
Side effects
Common or very common Alopecia; anxiety; asthenic conditions; breast abnormalities; depression; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; headaches; hot flush; libido loss; mood altered; nausea; ovarian cyst; pain; skin reactions; sleep disorder; vomiting; vulvovaginal disorders; weight changes Uncommon Anaemia; appetite increased; autonomic dysfunction; broken nails; circulatory system disorder; concentration impaired; constipation; dandruff; diarrhoea; dry eye; dyspnoea; genital discharge; hair changes; hyperhidrosis; hypotension; increased risk of infection; limb discomfort; muscle spasms; oedema; palpitations; pelvic pain; photosensitivity reaction; tinnitus Frequency not known Glucose tolerance impaired; insulin resistance; menstrual cycle irregularities
Interactions
**Severe interactions:**
- Co-administration of rifampicin with estradiol valerate/dienogest tablets led to significant decreases in steady state concentrations and systemic exposures of dienogest and estradiol.
**Other interactions (9):**
- Note: The prescribing information of concomitant medication should be consulted to identify potential interactions.
- An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of Dienogest 2 mg tablets and may result in undesirable effects e.g.
- A reduced clearance of sex hormones due to enzyme inhibition may increase the exposure to dienogest and may result in undesirable effects.
- The effect of the CYP 3A4 inducer rifampicin was studied in healthy postmenopausal women.
- The systemic exposure of dienogest and estradiol at steady state, measured by AUC (0-24h) , were decreased by 83% and 44%, respectively.
- The net effect of these changes may be clinically relevant in some cases.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises avoid in severe impairment (no information available).
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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