Version May 2024
Dyspareunia: Intravaginal: 6.5 mg once daily at bedtime.
Missed dose: Canadian labeling: If the next dose is due in ≥8 hours, administer the missed dose as soon as possible. If the next dose is due in <8 hours, skip the missed dose. Do not administer 2 doses at the same time.
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.
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.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to prasterone or any component of the formulation.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
No
INST (Intrarosa Vaginal)
6.5 mg (per each): $9.37
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
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)
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)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
