Visanne

Visanne

dienogest

Manufacturer:

Bayer

Distributor:

Bayer
Concise Prescribing Info
Contents
Dienogest
Indications/Uses
Dosage/Direction for Use
1 tab daily w/o interruption, taken preferably at the same time each day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder. Presence or history of arterial & CV disease (eg, MI, CVA, ischemic heart disease); severe hepatic disease as long as liver function values have not returned to normal; benign or malignant liver tumors. DM w/ vascular involvement; known or suspected sex hormone-dependent malignancies; undiagnosed vag bleeding. Pregnancy. Childn prior to menarche.
Special Precautions
Obtain a complete medical history & perform physical & gynecological exam prior to initiation or reinstitution of therapy. Patients w/ history of extrauterine pregnancy or impairment of tube function, depression, chloasma gravidarum, gestational DM. Increased risk of MI or cerebral thromboembolism, DVT, pulmonary embolism; breast cancer, hepatic tumor. Adenomyosis uteri or uterine leiomyomata; recurrence of cholestatic jaundice &/or pruritus; persistent ovarian follicles. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Lactation. Changes in bone mineral density (BMD) in adolescents (menarche to 18 yr).
Adverse Reactions
Increased wt; depressed mood, sleep disorder, nervousness, loss of libido, altered mood; headache, migraine; nausea, abdominal pain or distension, flatulence, vomiting; acne; alopecia; back pain; breast discomfort, ovarian cyst, hot flush, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance w/ enzyme inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin; oxcarbazepine, topiramate, felbamate, griseofulvin, nevirapine, St. John's wort-containing products. Increased plasma levels w/ enzyme inhibitors eg, ketoconazole, itraconazole, fluconazole; voriconazole; verapamil; erythromycin, clarithromycin, diltiazem; grapefruit juice.
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
28's
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