Lee's Pharm
Concise Prescribing Info
Vulvar & vag atrophy in postmenopausal women having moderate to severe symptoms.
Dosage/Direction for Use
6.5 mg (1 pessary) once daily, at bedtime.
Special Precautions
Should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks & benefits should be reassessed at least every 6 mth. If any of the following conditions are present, have occurred previously, &/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised: Leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours eg, 1st degree heredity for breast cancer; HTN; liver disorders (eg, liver adenoma); DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; a history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue in case a contraindication is discovered & in the following situation: Jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; pregnancy. Women w/ vag infection should be treated w/ appropriate antimicrobial therapy before treatment initiation. Expected increase in vag secretion due to melting of the hard fat base. Avoid use w/ condoms, diaphragms or cervical caps made of latex. Not indicated in pre-menopausal women of childbearing age, including pregnancy; fertile women; during breastfeeding.
Adverse Reactions
Vag discharge/application site discharge; abnormal Pap smear; wt fluctuation.
Drug Interactions
Not recommended w/ systemic hormone replacement therapy (oestrogen-only or oestrogen-progestagen combination or androgen treatment) or vag oestrogens.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03XX01 - prasterone ; Belongs to the class of other sex hormones and modulators of the genital system. Used as vaginal preparation.
Intrarosa pessary 6.5 mg
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