Dinosen(Dienogest)
Therapeutic Group: Gynaecological
Presentation
Dinosen : Each tablet contains Dienogest BP 2 mg.
Description
Dienogest is a nortestosterone derivative with antiandrogenic activity. Dienogest acts on endometriosis by reducing the endogenous production of oestradiol and thereby suppressing the trophic effects of oestradiol on both the eutopic and ectopic endometrium.
Indications
Dienogest is indicated for the treatment of endometriosis.
Dosage & Administration
Tablet taking can start on any day of the menstrual cycle. The dosage of Dienogest is one tablet daily without any break, taken preferably at the same time. When a pack is finished the next one should be started without interruption.
In the event of missed tablet(s), the woman should take one tablet only, as soon as she remembers and should then continue on the next day to take the tablet at her usual time.
If a short acting, e.g. oral, hormonal treatment was prescribed before starting treatment with Dienogest, then treatment may be started on the first day of menstrual bleeding after cessation of treatment. If a long-acting, i.e. injectable, hormonal treatment was administered before starting treatment with Dienogest, then Dienogest may be started once metabolism/excretion of the previously administered drug is expected to be
completed.
Side Effects
The most frequently reported undesirable effects are headache, breast discomfort, depressed mood, acne, sleep disorder, abdominal pain, gastritis, spotting, dysfunctional uterine bleeding, urinary tract infection, vulvovaginal dryness, genital discharge, fatigue, asthenia, malaise and edema.
Precautions
During treatment, patients are advised to use non-hormonal methods of contraception to prevent unwanted pregnancies. If any of the conditions like circulatory disorders, chloasma, osteoporosis, gestational diabetes mellitus persists then an individual risk-benefit analysis should be done before Dienogest is started or continued.
Use in Pregnancy & Lactation
Pregnancy: Pregnancy Category B3. The administration of Dienogest during pregnancy is contraindicated.
Lactation: Treatment with Dienogest during lactation is not recommended. Physiochemical properties and animal data indicate excretion of Dienogest in breast
milk.
Drug Interaction
Inducers or inhibitors of CYP3A4 may affect the drug metabolism of Dienogest. Azole antifungals (e.g. Ketoconazole, Itraconazole, Fluconazole, Voriconazole), Verapamil, Macrolides (e.g. Erythromycin, Clarithromycin), Diltiazem, antidepressants (e.g. Fluvoxamine, Fluoxetine) can increase plasma concentrations of the progestogens.
Over Dose
There is no specific antidote. 20 - 30 mg Dienogest per day (10 to 15 times higher dose than in Dienogest) over 24 weeks of use was well tolerated.
Storage
Dienogest tablets should be stored between 20°C to 30°C. Keep out of the reach of children. Store in a cool and dry place protected from light.
Commercial Pack
Dinosen : Each box contains 3 Alu-PVDC blister strips of 10 tablets.