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 presented as a 6.5 mg vaginal insert for vaginal use. It is indicated for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women, improving vaginal tissue health and comfort.

GNH India supplies Intrarosa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable access to this specialty therapy for qualified prescribers. The company adheres to stringent quality standards and offers comprehensive logistics support for global distribution.

Manufacturer / TM Owner

Endoceutics S.A.

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Indications & Clinical Uses

Intrarosa is used in the management of vulvar and vaginal atrophy, a condition related to estrogen deficiency in postmenopausal women.

  • Dyspareunia associated with vulvar and vaginal atrophy: reduces pain during intercourse and improves vaginal lubrication.
  • Vulvar atrophy: restores tissue elasticity and reduces dryness.
  • Vaginal atrophy: promotes epithelial maturation and increases moisture.

How It Works

  • Prasterone is locally converted within vaginal tissues to both estrogen and androgen metabolites. These hormones bind to estrogen and androgen receptors in the epithelium, stimulating cellular proliferation, glycogen accumulation, and increased vascularization, which together enhance epithelial maturation, lubrication, and reduce dyspareunia.

Side Effects

Adverse reactions reported with vaginal inserts of prasterone are generally mild and localized.

Common Side Effects

  • Vaginal discharge or spotting.
  • Local irritation or itching.
  • Mild abdominal discomfort.
  • Headache.

Serious or Rare Side Effects

  • Significant vaginal bleeding.
  • Allergic reaction such as rash or swelling.
  • Systemic hormonal effects, including unexpected breast tenderness or changes in menstrual pattern.

Precautions & Warnings

Before prescribing Intrarosa, consider the following precautions:

  • Pregnancy: safety not established; avoid use in pregnant women.
  • Breastfeeding: unknown safety; weigh potential risks and benefits.
  • Hormone‑sensitive conditions: use with caution in patients with estrogen‑dependent tumors.
  • Allergy: discontinue if hypersensitivity to prasterone or excipients occurs.
  • Local irritation: monitor for severe irritation or infection.
  • Store at room temperature: keep in original packaging, protect from moisture and heat.

Avoid Interactions

Prasterone may interact with other hormonal or vaginal products.

Major Interactions (Avoid)

  • Systemic estrogen therapy: may increase overall hormone exposure.
  • Other androgenic agents: additive hormonal effects.
  • Concurrent vaginal antifungal or antibiotic preparations: may alter local conversion.

Moderate Interactions (Monitor Closely)

  • CYP450 inhibitors or inducers: could affect metabolism of prasterone metabolites.
  • Hormonal contraceptives: monitor for potential efficacy changes.
  • Other local vaginal products: assess for irritation or reduced effectiveness.

Frequently Asked Questions

Intrarosa is indicated for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women. It helps reduce pain during intercourse by improving vaginal tissue health, lubrication, and epithelial maturation.

Prasterone is converted locally within the vaginal epithelium to estrogen and androgen metabolites. These hormones bind to their respective receptors, stimulating cell proliferation, increasing glycogen storage, and enhancing vascularization, which together improve tissue elasticity and lubrication.

The prescribed dose of Intrarosa is determined by the treating physician based on the patient’s clinical condition. The product is supplied as a 6.5 mg vaginal insert, and the healthcare professional will provide specific dosing instructions.

Safety of Intrarosa in pregnancy has not been established, and it is generally avoided in pregnant women. Information on use during breastfeeding is limited; clinicians should consider potential risks and benefits before prescribing to nursing mothers.

To order Intrarosa, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details and import documentation.

Intrarosa delivers a local androgen and estrogen effect directly to vaginal tissues, whereas systemic hormone replacement therapy provides broader hormonal exposure. Compared with non‑hormonal lubricants, Intrarosa addresses underlying tissue changes, offering longer‑term improvement in dyspareunia.

Intrarosa should be stored at room temperature, kept in its original packaging, and protected from moisture and excessive heat. Do not expose the inserts to direct sunlight or humidity to maintain product integrity.

Intrarosa is administered as a vaginal insert. The patient inserts the 6.5 mg device into the vagina, typically once daily, following the specific instructions provided by the prescribing healthcare professional.

Serious risks include significant vaginal bleeding, allergic reactions such as rash or swelling, and systemic hormonal effects that could affect hormone‑sensitive conditions. Patients should report any severe or unexpected symptoms to their healthcare provider promptly.

Intrarosa should not be used by women who are pregnant, have known hypersensitivity to prasterone or any excipients, or have active estrogen‑dependent malignancies without careful medical supervision. Contraindications are determined by the prescribing clinician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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