Four Star
Concise Prescribing Info
Dosage/Direction for Use
1 tab daily w/o interruption, taken preferably at the same time each day, starting on any day of the menstrual cycle.
May be taken with or without food.
Hypersensitivity. Active venous thromboembolic disorder. Present or history of arterial & CV disease eg, MI, CVA, ischaemic heart disease; severe hepatic disease; liver tumors (benign or malignant). DM w/ vascular involvement; known or suspected sex hormone-dependent malignancies; undiagnosed vag bleeding. Pregnancy & lactation. Childn.
Special Precautions
History of extrauterine pregnancy or impairment of tube function. Increased risk of MI or cerebral thromboembolism; venous thromboembolism. Affects menstrual bleeding pattern. Discontinue in the event of anaemia. Chloasma, especially in women w/ history of chloasma gravidarum. Osteoporosis & loss of bone mineral density. History of depression. Discontinue use upon recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids. Persistent ovarian follicles. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Women w/ diabetes, especially those w/ history of gestational DM. Not indicated in childn prior to menarche.
Adverse Reactions
Increased wt; depressed mood, sleep disorder; nervousness, loss of libido, altered mood; headache, migraine; nausea, abdominal pain, flatulence, abdominal distension, vomiting; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flush, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance (diminished efficacy) w/ enzyme inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's Wort. Increased or decreased plasma conc w/ many HIV/HCV PIs (eg, ritonavir, saquinavir, indinavir, nelfinavir) & NNRTIs. Decreased clearance w/ enzyme inhibitors eg, ketoconazole, itraconazole, fluconazole, voriconazole, cimetidine, verapamil, erythromycin, clarithromycin, diltiazem, fluvoxamine, fluoxetine, grapefruit juice.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Visanne tab 2 mg
(2 x 14) 1 × 28's
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