ENDOSIS
GENERIC NAME: Dienogest
THERAPEUTIC CATEGORY: Progestine
PHARMACOLOGIC CLASS: Female Sex Hormone
COMPOSITION: Each film-coated tablet contains Dienogest 2mg
PREGNANCY AND LACTATION: Not recommended
MECHANISM OF ACTION:
Dienogest acts as an agonist at the progesterone receptor (PR) with weak affinity that is comparable to that of progesterone 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 level of endogenous production of oestradiol and thereby suppressing the trophic effects of oestradiol on both the eutopic and ectopic endometrium. Continous administration of dienogest results in hyper progestogenic and moderately hypoestrogenic endocrine environment, which causes initial decidualization of endometrial tissue. It is an antagonist at androgen receptors, improve androgenic symptoms such as acne and hirsutism.
INDICATIONS:
Indicated for use as the treatment of endometriosis.
CONTRAINDICATIONS:
- Active venous thromboembolic disorder.
- Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- Hypersensitivity to the active substance or to any of the excipients.
DOSAGE:
The dosage is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food.
Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of this medicine. If contraception is required, non-hormonal methods of contraception should be used.
ADVERSE EFFECTS:
The common adverse effects are weight increase, depressed mood, sleep disorder, nervousness loss of libido, altered mood, headache /migraine, nausea, abdominal pain, flatulence, abdominal distension, vomiting, acne, alopecia.
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