Dyspareunia: Intravaginal: 6.5 mg once daily at bedtime.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
No
Insert in vagina at bedtime using supplied applicator (for one time use only). Empty bladder and wash hands prior to insertion.
This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Prasterone (or its metabolites) may cause carcinogenicity, teratogenicity, reproductive toxicity, and has a structural or toxicity profile similar to existing hazardous agents. Assess risk to determine appropriate containment strategy (USP-NF 2017).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage (NIOSH 2016).
Dyspareunia: Treatment of moderate to severe dyspareunia (a symptom of vulvar and vaginal atrophy due to menopause)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Genitourinary: Vaginal discharge (6% to 14%)
1% to 10%: Genitourinary: Abnormal pap smear (2%)
Undiagnosed abnormal genital bleeding
Concerns related to adverse effects:
• Vaginal discharge: May occur with use.
Disease-related concerns:
• Breast cancer: Use caution in patients with a history of known or suspected breast cancer; estrogen is a metabolite of prasterone.
• Vaginal bleeding: Prior to treatment, evaluate and determine cause of any undiagnosed, persistent, or recurring genital bleeding.
None known.
There are no known significant interactions.
Other formulations of prasterone (dehydroepiandrosterone [DHEA]) have been evaluated to improve pregnancy outcomes in patients with diminished ovarian reserve (Gleicher 2011; Narkwichean 2013). This product is only approved for use in postmenopausal patients.
Animal reproduction studies have not been conducted with this preparation; this product is only approved for use in postmenopausal patients.
It is not known if prasterone is present in breast milk following vaginal administration.
Steroids, including prasterone, are endogenous to breast milk (Sahlberg 1986).
Evaluate any persistent or recurring genital bleeding.
An inactive steroid that is converted into active androgens and/or estrogens; the mechanism of action in postmenopausal patients with vulvar and vaginal atrophy is unknown.
Metabolism: Metabolized via dehydrogenase, reductase, and aromatase to 2 active metabolites (estradiol and testosterone)
INST (Intrarosa Vaginal)
6.5 mg (per each): $9.37
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