Visanne

Visanne

dienogest

Manufacturer:

Bayer HealthCare Pharma

Distributor:

DKSH
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; past or present arterial & CV disease (eg, MI, CVA, ischemic heart disease); DM w/ vascular involvement; presence or history of severe hepatic disease & liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies; undiagnosed vag bleeding. Pregnancy & lactation. Childn.
Special Precautions
History of extrauterine pregnancy or impairment of tube function; VTE (DVT, pulmonary embolism); breast cancer; depression, HTN, chloasma (especially chloasma gravidarum), persistent ovarian follicles, history of gestational DM. Discontinue use in women w/ adenomyosis uterior uterine leiomyomata & recurrence of cholestatic jaundice &/or pruritus which occured 1st during pregnancy or previous use of sex steroids. Adolescent (menarche to 18 yr).
Adverse Reactions
Increased wt; depressed mood, sleep disorder, nervousness, loss of libido, altered mood; headache, migraine; nausea, abdominal pain & distention, flatulence, vomiting; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting; asthenic conditions, irritability.
Drug Interactions
Increased clearance of sex hormones w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, nevirapine & St. John's wort containing-products. Increase plasma levels w/ azole antifungals, cimetidine, verapamil, macrolides, diltiazem, PIs, antidepressants.
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 × 14's
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