Endogest 2 mg (Tablet)

Indications

• Treatment of endometriosis
• Reduces pelvic pain in endometriosis
• Reduces effects of estrogen on endometrium and breast
• Belongs to progestins medication class

Pharmacology

• Acts as agonist at progesterone receptor
• Causes endometrial atrophy
• Promotes antiproliferative, immunologic and antiangiogenic effects on endometrial tissue
• Reduces endogenous production of estradiol
• Suppresses trophic effects of estradiol on endometrium
• Results in hyperprogestogenic and moderately hypoestrogenic endocrine environment
• Improves androgenic symptoms such as acne and hirsutism
• Antagonist at androgen receptors

Dosage & Administration

• Dosage of 2 mg daily without any break
• Can be started on any day of menstrual cycle
• Taken preferably at the same time each day
• Tablet must be taken continuously without regard to vaginal bleeding
• In the event of missed tablet(s), should be taken as soon as remembered
• Tablet not absorbed due to vomiting or diarrhea should be replaced by 2 mg

Interaction

• Metabolized mainly by cytochrome P450 3A4 system
• Inhibitors of CYP3A4 may affect progestogen drug metabolism
• Known CYP3A4 inhibitors may increase plasma levels of progestogens and result in adverse reactions

Contraindications

• Hypersensitivity to dienogest
• Active venous thromboembolic disorder
• Arterial and cardiovascular disease
• Diabetes mellitus with vascular involvement
• Severe hepatic disease
• Liver tumors
• Sex hormone-dependent malignancies
• Undiagnosed vaginal bleeding

Side Effects

• More common during the 1st months after start of intake
• Subside with duration of treatment
• Reported undesirable effects: headache, breast discomfort, depressed mood, acne, migraine, circulatory system disorder, palpitations, hypotension, nausea, abdominal pain, flatulence, weight increase, irritability, nervousness, altered mood

Pregnancy & Lactation

• Limited data from use in pregnant women
• Animal studies reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans
• Not recommended in pregnancy
• Not recommended during lactation

Precautions & Warnings

• Pregnancy must be excluded before starting treatment
• Use nonhormonal methods of contraception during treatment
• Affects menstrual bleeding pattern
• Contraindicated in patients with severe hepatic disease
• Inhibition of ovulation
• Not a contraceptive

Use in Special Populations

• Not indicated in children prior to menarche
• Safety and efficacy in adolescents not yet established
• No relevant indication for use in the geriatric population

Overdose Effects

• Acute toxicity studies did not indicate a risk of acute adverse effects
• No specific antidote
• Very well tolerated at 10-15 times higher dose with no adverse effects over 24 weeks

Therapeutic Class

• Female sex hormones

Storage Conditions

• Keep in a cool and dry place
• Protect from light
• Keep out of the reach of children

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