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 (dehydroepiandrosterone, DHEA) presented as a vaginal insert for vaginal use. It is indicated for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women, helping to restore vaginal tissue health and lubrication.

GNH India supplies Intrarosa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing for this prescription‑only product while adhering to stringent quality standards and offering regulatory support for global distribution.

Manufacturer / TM Owner

Endoceutics S.A.

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Indications & Clinical Uses

  • Intrarosa, a vaginal DHEA therapy, is used to address conditions related to postmenopausal vulvovaginal atrophy.
  • Vulvar atrophy: improves tissue health and reduces thinning of the vulvar epithelium.
  • Vaginal dryness: enhances natural lubrication and moisture levels.
  • Dyspareunia: lessens pain during sexual intercourse associated with atrophic changes.

How It Works

  • After intravaginal administration, prasterone (DHEA) is locally converted by vaginal epithelial cells into active androgens and estrogens. These hormones bind to androgen and estrogen receptors in the vaginal mucosa, stimulating cellular proliferation, increasing glycogen content, and promoting the production of natural lubricants, thereby restoring the integrity of the vaginal epithelium and reducing atrophy‑related symptoms.

Side Effects

Intrarosa may cause local and systemic adverse reactions.

Common Side Effects

  • Vaginal irritation or burning sensation.
  • Increased vaginal discharge or spotting.
  • Itching or mild rash in the genital area.
  • Unpleasant odor from the insert.
  • Mild abdominal discomfort.
  • Headache.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis) with swelling or difficulty breathing.
  • Significant vulvar edema or swelling.
  • Persistent vaginal bleeding.
  • Hormone‑related systemic effects such as hirsutism.
  • Unexplained weight gain or mood changes.
  • Signs of infection at the insertion site.

Precautions & Warnings

  • Before prescribing Intrarosa, clinicians should consider several safety aspects.
  • Assess contraindications: verify absence of known hypersensitivity to prasterone or excipients.
  • Monitor for irritation: advise patients to report persistent burning or severe discomfort.
  • Evaluate hormonal status: consider potential interactions with systemic hormone therapies.
  • Avoid use in active genital infections: ensure infections are treated prior to initiation.
  • Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Intrarosa can interact with other medications that affect hormonal pathways or vaginal environment.

Major Interactions (Avoid)

  • Systemic estrogen or androgen therapy: additive hormonal effects may increase risk of side effects.
  • Strong CYP3A4 inducers (e.g., rifampin): may reduce local conversion of DHEA to active hormones.

Moderate Interactions (Monitor Closely)

  • Antifungal vaginal agents (e.g., clotrimazole): may alter local absorption.
  • Antimicrobial vaginal gels or spermicides: monitor for increased irritation.
  • Oral contraceptives containing estrogen: observe for potential hormonal imbalance.

Frequently Asked Questions

Intrarosa is prescribed to treat dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women. By delivering prasterone directly to the vaginal tissue, it helps restore the epithelium, improve lubrication, and reduce pain during sexual activity.

Prasterone (DHEA) in Intrarosa is converted locally within the vaginal mucosa into active androgens and estrogens. These hormones bind to their respective receptors, stimulating cellular growth, increasing glycogen production, and enhancing natural lubrication, which together reverse atrophic changes.

The dosage of Intrarosa is determined by the prescribing healthcare professional based on the patient’s condition and clinical guidelines. The product is supplied as a vaginal insert, and the prescriber specifies the frequency and duration of use.

Intrarosa is intended for postmenopausal women and is not recommended for use during pregnancy or lactation. Safety data for these populations are lacking, and the product should be avoided unless a specialist determines a clear benefit outweighs potential risks.

To place an order, submit an enquiry on the Intrarosa product page at gnhindia.com, indicating 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.

Intrarosa delivers a locally acting androgen (DHEA) that is converted to both androgens and estrogens within the vagina, offering a dual‑hormone effect. Conventional treatments often use systemic estrogen alone, which may have broader systemic exposure. Intrarosa’s local conversion can provide targeted symptom relief with potentially fewer systemic effects.

Intrarosa should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and direct sunlight. Keep the product out of reach of children and do not use if the packaging is damaged.

Intrarosa is supplied as a vaginal insert. The patient inserts the device into the vagina according to the prescriber’s instructions, typically at bedtime, allowing the insert to dissolve and release prasterone locally over a defined period.

Serious risks include severe allergic reactions such as anaphylaxis, significant vulvar edema, persistent vaginal bleeding, and systemic hormonal effects like hirsutism or mood changes. Patients should seek immediate medical attention if they experience any of these symptoms.

Intrarosa should not be used by individuals with known hypersensitivity to prasterone or any excipients, those with active genital infections, or women who are pregnant or breastfeeding. It is also contraindicated in patients receiving systemic hormone therapy unless specifically advised by a qualified healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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