Product image of Intrarosa (Prasterone) supplied by GNH India

Intrarosa

Active Ingredient:
Prasterone
Origin:
EU

Intrarosa (Prasterone)

Prasterone, the active ingredient in Intrarosa, is an androgen (steroid hormone) presented as a vaginal insert for vaginal use. It is indicated for the treatment of dyspareunia caused by vulvar and vaginal atrophy in postmenopausal women, helping to restore tissue integrity and lubrication. GNH India supplies Intrarosa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches for global distribution.

Manufacturer / TM Owner

Endoceutics S.A.

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Indications & Clinical Uses

  • Intrarosa (prasterone) is used to address vulvovaginal atrophy, a condition associated with postmenopausal estrogen deficiency.
  • Dyspareunia due to vulvar and vaginal atrophy: reduces pain during intercourse by improving vaginal lubrication and epithelial health.
  • Vaginal dryness associated with atrophy: increases moisture and comfort during daily activities.
  • Vulvar irritation linked to atrophic changes: promotes tissue thickness and reduces irritation.

How It Works

  • Prasterone is locally converted within vaginal tissues to both estrogen and androgen metabolites. These hormones bind to their respective receptors, stimulating epithelial cell proliferation, glycogen accumulation, and increased vascularization, which together enhance mucosal thickness, lubrication, and overall vaginal health.

Side Effects

Intrarosa may cause a range of adverse reactions.

Common Side Effects

  • Vaginal discharge or spotting.
  • Mild abdominal or pelvic discomfort.
  • Headache.
  • Nausea.
  • Breast tenderness.
  • Local irritation at the insertion site.

Serious or Rare Side Effects

  • Unexplained vaginal bleeding.
  • Endometrial hyperplasia.
  • Severe abdominal pain.
  • Allergic reaction such as rash, itching, or swelling.
  • Signs of hormonal imbalance (e.g., hirsutism, voice changes).

Precautions & Warnings

  • Before using Intrarosa, consider the following safety measures.
  • Pregnancy: safety not established; avoid use in pregnant women.
  • Breastfeeding: unknown effects; weigh potential risks.
  • Hormone‑sensitive conditions: use with caution in patients with estrogen‑dependent tumors.
  • Concomitant estrogen therapy: may increase systemic hormone exposure.
  • Allergy: discontinue if hypersensitivity reactions occur.
  • Store at room temperature: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Intrarosa can interact with other hormonal or metabolic agents.

Major Interactions (Avoid)

  • Systemic estrogen therapy: may raise overall hormone levels.
  • Androgenic drugs: additive hormonal effects.
  • Strong CYP3A4 inhibitors: could increase local metabolite concentrations.

Moderate Interactions (Monitor Closely)

  • Vaginal antifungal preparations: may affect drug absorption.
  • Hormonal contraceptives: monitor for altered efficacy.
  • Other vaginal inserts or medications: avoid concurrent use to prevent interference.

Frequently Asked Questions

Intrarosa is prescribed to treat dyspareunia caused by vulvar and vaginal atrophy in postmenopausal women. By improving the health of vaginal tissues, it helps reduce pain during intercourse and alleviates associated symptoms such as dryness and irritation.

Prasterone is locally converted within the vaginal mucosa into estrogen and androgen metabolites. These hormones bind to their receptors, stimulating epithelial cell growth, increasing glycogen storage, and enhancing blood flow, which together improve tissue thickness, lubrication, and overall vaginal comfort.

The dosage of Intrarosa is determined by the prescribing healthcare professional based on individual patient needs. Typically, a single vaginal insert is administered according to the clinician’s instructions, and the treatment schedule may be adjusted during follow‑up visits.

Safety of Intrarosa in pregnancy has not been established, and it is generally avoided in pregnant women. Information on use while breastfeeding is limited; therefore, the potential risks and benefits should be carefully evaluated by a healthcare provider before use.

To order Intrarosa, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

The main alternative to Intrarosa is topical estrogen therapy, which delivers estrogen systemically through the vaginal mucosa. Intrarosa provides both estrogenic and androgenic activity locally, potentially offering broader tissue benefits. Choice of therapy depends on patient preference, tolerance, and clinician assessment.

Intrarosa should be stored at room temperature, away from excessive heat and moisture. Keep the inserts in their original packaging until use, and protect them from direct sunlight. Do not refrigerate or freeze the product unless specifically instructed by the manufacturer.

Intrarosa is a vaginal insert designed for intravaginal placement. The patient inserts the device into the vagina using a clean fingertip or applicator as directed by the prescribing clinician, typically before bedtime to allow optimal absorption.

Serious risks include unexplained vaginal bleeding, endometrial hyperplasia, severe abdominal pain, and allergic reactions such as rash or swelling. Patients should seek immediate medical attention if they experience any of these symptoms while using the product.

Intrarosa is contraindicated in women who are pregnant, have known hypersensitivity to prasterone or any excipients, or have active hormone‑dependent cancers such as breast or endometrial carcinoma. It should also be used with caution in patients with uncontrolled metabolic disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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