Visanne

Visanne

dienogest

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Dienogest
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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder. DM w/ vascular involvement. Known or suspected sex hormone-dependent malignancies. Undiagnosed vag bleeding. Presence or history of arterial & CV disease eg, MI, CVA, ischaemic heart disease; liver tumors (benign or malignant); severe hepatic disease as long as liver function values have not returned to normal.
Special Precautions
Take tab continuously w/o regard to vag bleeding. Stop any hormonal contraception prior to treatment initiation. May aggravate uterine bleeding. Consider discontinuation in the event of anemia. Changes in menstrual bleeding pattern. Slightly enhanced risk of stroke in women w/ HTN. Discontinue treatment in case of long-term immobilization (at least 4 wk in advance in case of elective surgery) & do not resume treatment until 2 wk after complete remobilization. Consider increased risk of thromboembolism in the puerperium. Discontinue treatment in case of symptoms of arterial or venous thrombotic event or suspicion thereof. Reports, in rare cases, of benign liver tumours, & even more rarely, malignant liver tumours. Changes in bone mineral density. W/draw treatment if a sustained clinically significant HTN develops during use. Discontinue use upon recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids. May have slight effect on peripheral insulin resistance & glucose tolerance. Chloasma may occasionally occur, especially in women w/ history of chloasma gravidarum. Persistent ovarian follicles may occur during use. May influence the results of certain lab tests, including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins (eg, corticosteroid binding globulin & lipid/lipoprotein fractions), parameters of carbohydrate metabolism, & parameters of coagulation & fibrinolysis. Patients w/ increased risk of osteoporosis; history of depression; history of extrauterine pregnancy or impairment of tube function; rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Do not administer to pregnant women. Not recommended during lactation. Inhibited ovulation during treatment. Menstrual cycle returns to normal w/in 2 mth after treatment cessation. Not indicated in childn prior to menarche. No relevant indication in the elderly.
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 flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance (diminished efficacy) w/ CYP3A4 inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort. Increased or decreased progestin plasma conc w/ combinations of HIV PIs & NNRTIs, including combinations w/ HCV inhibitors. Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Visanne tab 2 mg
Packing/Price
(2 x 14) 1 × 28's
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