Product image of Novostella (Prasterone) supplied by GNH India

Novostella

Active Ingredient:
Prasterone
Origin:
EU

Novostella (Prasterone)

Prasterone, the active ingredient in Novostella, is an androgen presented as an oral formulation for oral use. It is employed in hormone replacement therapy to alleviate menopausal symptoms, improve sexual function, and support patients with adrenal insufficiency.

GNH India supplies Novostella as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring consistent quality, regulatory compliance, and reliable logistics across multiple regions. The company leverages a robust distribution network and adheres to stringent quality standards to meet the needs of healthcare providers in Europe, Asia, Africa and the Americas.

Manufacturer / TM Owner

Aflofarm Farmacja Polska Sp. Z O.O.

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Indications & Clinical Uses

Novostella (prasterone) acts on androgen pathways to address several endocrine‑related conditions.

  • Menopausal symptoms: alleviates hot flashes, night sweats and improves mood and vaginal health.
  • Sexual dysfunction: enhances libido and sexual response in both men and women with hormonal deficits.
  • Adrenal insufficiency: supports endogenous steroid production, helping to maintain energy and metabolic balance.

How It Works

  • Prasterone is a dehydroepiandrosterone (DHEA) pro‑hormone that is converted intracellularly by steroidogenic enzymes into androgens such as testosterone and dihydrotestosterone, and into estrogens via aromatase. By increasing the pool of endogenous sex steroids, it restores hormonal balance in tissues that express the relevant receptors, thereby mitigating symptoms of deficiency.

Side Effects

Prasterone may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Acne: mild to moderate skin eruptions.
  • Hair loss: increased shedding or thinning.
  • Mood changes: irritability or anxiety.
  • Fluid retention: mild edema in extremities.

Serious or Rare Side Effects

  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Hormone‑dependent tumor growth: stimulation of existing prostate or breast neoplasms.
  • Severe allergic reaction: rash, angioedema or anaphylaxis.

Precautions & Warnings

When prescribing Novostella, clinicians should consider several precautionary measures to ensure patient safety.

  • Assess baseline hormone levels: evaluate androgen and estrogen status before initiation.
  • Monitor liver function: periodic testing recommended during therapy.
  • Screen for hormone‑sensitive cancers: avoid use in patients with active prostate or breast malignancies.
  • Evaluate cardiovascular risk: consider history of thrombosis or hypertension.
  • Use caution in elderly: dose adjustments may be required due to altered metabolism.
  • Store at ambient temperature: keep below 25 °C in original packaging, protected from moisture.

Avoid Interactions

Prasterone can influence the activity of other medications through enzymatic pathways and hormone‑mediated mechanisms.

Major Interactions (Avoid)

  • CYP3A4 inhibitors: strong inhibitors (e.g., ketoconazole) may increase prasterone levels, risking toxicity.
  • Hormonal contraceptives: may reduce efficacy of estrogen‑containing birth control.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: androgenic effects can alter coagulation parameters, requiring INR monitoring.
  • Antidiabetic agents: changes in insulin sensitivity may necessitate glucose monitoring.
  • Thyroid hormones: potential alteration of thyroid function tests.

Frequently Asked Questions

Novostella contains prasterone, an androgen pro‑hormone used in hormone replacement therapy to relieve menopausal symptoms such as hot flashes, to improve sexual desire and response, and to support patients with adrenal insufficiency by enhancing endogenous steroid production.

Prasterone is a precursor of both androgens and estrogens. After oral administration it is taken up by cells and converted by steroid‑converting enzymes into testosterone, dihydrotestosterone, and estradiol, thereby increasing the body’s natural sex‑steroid pool and correcting hormonal deficits.

The dosage of Novostella is individualized. A qualified prescriber determines the appropriate strength, frequency and duration based on the patient’s clinical condition, laboratory results and response to therapy. No fixed regimen is provided in public information.

Safety data for prasterone during pregnancy or lactation are limited. Because it can affect hormone levels, the product is generally not recommended for pregnant or nursing women unless the potential benefit justifies the potential risk and a specialist’s guidance is obtained.

To request Novostella, 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 (including any cold‑chain requirements) and the necessary import documentation.

Novostella delivers prasterone, a natural DHEA precursor, whereas many androgen products provide direct testosterone. Prasterone allows the body to balance both androgenic and estrogenic pathways, which can be advantageous for patients needing broader hormonal support, but individual response varies and should be evaluated by a clinician.

Novostella tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in bathrooms or other humid environments.

Novostella is taken orally, usually with water. The exact timing (e.g., with food or on an empty stomach) depends on the prescriber’s instructions. Patients should follow the dosing schedule provided by their healthcare professional and not alter the regimen without medical advice.

Serious adverse events associated with prasterone include hepatotoxicity (elevated liver enzymes or hepatitis), stimulation of hormone‑sensitive tumors such as prostate or breast cancer, and severe allergic reactions like anaphylaxis. Patients should report any signs of liver dysfunction, unusual swelling, or allergic symptoms promptly.

Novostella is contraindicated in individuals with known hypersensitivity to prasterone, active hormone‑dependent cancers (e.g., prostate or breast carcinoma), severe liver disease, or uncontrolled cardiovascular conditions. Caution is also advised for the elderly, pregnant or nursing women, and patients taking strong CYP3A4 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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