Dienosis

Endometriosis.

Adult 1 tab daily w/o any break.

May be taken with or without food: Take at the same time each day w/ some liqd as needed.

Hypersensitivity. Current VTE or history of DVT or pulmonary embolism; known hereditary or acquired predisposition for VTE (eg, APC-resistance including factor V Leiden, antithrombin-III-deficiency, protein C & protein S deficiency), major surgery w/ prolonged immobilisation, high risk of VTE due to the presence of multiple risk factors. Current arterial thromboembolism (ATE), history of ATE (eg, MI) or prodromal condition (eg, angina pectoris), cerebrovascular disease [eg, current stroke, history of stroke or prodromal condition (eg, transient ischaemic attack)], hereditary or acquired predisposition for ATE (eg, hyperhomocysteinaemia & antiphospholipid-Abs), history of migraine w/ focal neurological symptoms, high ATE risk due to multiple risk factors or to the presence of 1 serious risk factor (eg, DM w/ vascular symptoms, severe HTN & severe dyslipoproteinaemia). Arterial & CV disease (eg, MI, CVA, ischemic heart disease). DM w/ vascular involvement. Presence or history of liver tumors (benign or malignant). Known or suspected sex hormone-dependent malignancies. Undiagnosed vag bleeding. Severe hepatic disease.

Not a contraceptive. Increased risk of VTE during use of any combined hormonal contraceptive. Slightly increased relative risk of breast cancer diagnosis in women using OCs. May affect menstrual bleeding pattern; discontinue use if bleeding is heavy & continuous over time, leading to anemia (severe in some cases). Consider adequate intake of Ca & vit D. Carefully observe patients who have history of depression & discontinue use if depression recurs to serious degree. W/draw Dienosis & treat HTN if sustained clinically significant HTN develops. Carefully observe diabetic women especially those w/ history of gestational DM. Women w/ tendency to chloasma should avoid exposure to sun or UV radiation while taking Dienogest. Possible persistent ovarian follicles may occur. Perform complete medical history, physical & gynecological exam (eg, BP, breasts, abdomen & pelvic organs including cervical cytology) prior to treatment initiation or reinstitution & repeat regularly. Exclude pregnancy before starting treatment; advise patients to use non-hormonal contraception methods (eg, barrier method) if contraception is required. History of extrauterine pregnancy or tube function impairment. Discontinue use if recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids. Not to be administered to pregnant women. Not recommended during lactation. Possible decrease of bone mineral density in lumbar spine in adolescents (12-18 yr) over a treatment period of 12 mth. Not indicated in childn prior to menarche.

Increased wt; depressed mood, sleep disorder, nervousness, libido loss, altered mood; headache, migraine; nausea, flatulence, vomiting, abdominal pain & distension; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flush, uterine/vag bleeding including spotting; asthenic conditions, irritability.

Increased clearance of sex hormones w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Possible variable effects on the clearance of sex hormones w/ HIV/HCV PI & NNRTIs. Decreased clearance of sex hormones & increased plasma conc w/ strong & moderate CYP3A4 inhibitors [eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice]. May influence certain lab test results including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of carrier proteins (eg, lipid/lipoprotein fractions, carbohydrate metabolism, coagulation & fibrinolysis parameters).

Oestrogens, Progesterones & Related Synthetic Drugs

G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

POM