Dienogest

Dienogest acts as an agonist at the progesterone receptor with weak affinity but has a very potent progestagenic effect in the endometrium, causing endometrial atrophy after prolonged use. It promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue. Dienogest reduces the endogenous production of estradiol, suppressing the trophic effects of estradiol on both the eutopic and ectopic endometrium.

• Endometriosis (pelvic pain)

Dienogest acts as an agonist at the progesterone receptor with weak affinity but has a very potent progestagenic effect in the endometrium. It promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue. Dienogest reduces endogenous estradiol production, suppressing trophic effects on endometrium.

Dienogest reduces endogenous estradiol production, suppressing endometrial tissue growth and reducing pelvic pain associated with endometriosis.

Adult: 2 mg once daily without interruption, taken preferably at the same time each day.

Take at the same time each day with some liquid. Continue without interruption.

If you miss a dose, take 2 mg as soon as you remember and continue the next day at your usual time.

Common (1-10%): Headache (9%), breast discomfort (5.4%), depressed mood (5.1%), acne (5.1%), nausea, abdominal pain, flatulence, weight increase (3.6%), irritability, nervousness.
Uncommon: Migraine, palpitations, hypotension.

Does not usually affect driving ability. Avoid pregnancy; use non-hormonal contraception. Changes in bleeding pattern may occur. Caution in liver disease.

Hypersensitivity; active venous thromboembolic disorder; arterial and cardiovascular disease (MI, CVA, ischemic heart disease); diabetes with vascular involvement; severe liver disease; liver tumors; sex hormone-dependent malignancies; undiagnosed vaginal bleeding; pregnancy; children prior to menarche.

CYP3A4 inducers (phenytoin, barbiturates, carbamazepine, rifampicin, oxcarbazepine, topiramate, griseofulvin, St. John's wort): Increased clearance.
CYP3A4 inhibitors (ketoconazole, itraconazole, fluconazole, cimetidine, verapamil, erythromycin, clarithromycin, diltiazem, ritonavir, fluvoxamine): Increased plasma levels.

It is not known whether it is safe to consume alcohol with Dienogest. Please consult your doctor.

Pregnancy Category X. Dienogest is highly unsafe during pregnancy. Studies have shown significant harmful effects to the developing baby.

Use during lactation is not recommended. Dienogest may be excreted in breast milk.

Not indicated in children prior to menarche.

There is no relevant indication for use in the geriatric population.

Limited information available on use in kidney disease. Caution in liver disease.

Acute toxicity is not expected in case of overdose. No specific antidote.

Keep below 30°C temperature, away from light & moisture. Keep out of reach of children.

Dienogest