Retained Kenya · PPB

PROVIRON

Mesterolone

H2010/1949/R1 Tablet genito urinary system and sex hormones INN generic

What it does

Mesterolone is a man-made form of a natural male hormone (testosterone). It is used to treat conditions related to low testosterone levels.

Commonly used for: low testosterone levels (hypogonadism), male hormone replacement therapy

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2010/1949/R1
Registration date
2026 September 02
Expiry date
2031 September 02
Status
Retained
Active ingredient
Mesterolone
Dosage form
Tablet
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
G03BB - 5-androstanon (3) derivatives
RxNorm RxCUI
6781
Manufacturer / MAH
Bayer Pharma AG
Applicant / LTR
BAYER EAST AFRICA LTD
Country of origin
Germany
Manufacturer location
Müllerstraße 178, 13353 Berlin, Germany

Source: Pharmacy and Poisons Board · fetched 2026-09-25 02:01:46 · updated 2026-09-25 02:01:59

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Mesterolone is a man-made form of a natural male hormone (testosterone). It is used to treat conditions related to low testosterone levels.

What it treats

  • low testosterone levels (hypogonadism)
  • male hormone replacement therapy

How it works

Mesterolone helps increase the levels of testosterone in the body, which is important for male sexual development and overall health.

Who it's for

This medication is for adult men who have low testosterone levels.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: mesterolone

BNF-referenced

Mesterolone is an androgen and anabolic steroid primarily used in the management of male hypogonadism and infertility. It is a synthetic derivative of dihydrotestosterone (DHT) and functions by mimicking the effects of testosterone in the body. Mesterolone's anabolic properties make it useful in treating conditions associated with androgen deficiency, while its ability to enhance libido and improve sperm production is beneficial in certain fertility issues.

Indications

  • Male hypogonadism
  • Infertility in males
  • Androgen deficiency syndromes

Dosage

Children: Paediatric dosing information is not specified. Refer to the BNF for Children for appropriate dosing guidance.

Adults: The usual adult dose of mesterolone is 50 mg to 100 mg daily, divided into two or three doses.

Mechanism of action

Mesterolone acts as an androgen receptor agonist, binding to androgen receptors in various tissues, which leads to an increase in the synthesis of proteins involved in muscle growth and development. Additionally, it influences the hypothalamic-pituitary-gonadal axis, promoting the production of endogenous testosterone and enhancing spermatogenesis.

Pharmacodynamics

Mesterolone exhibits both anabolic and androgenic effects. Anabolically, it contributes to muscle hypertrophy and strength gains, while androgenically, it enhances male secondary sexual characteristics such as body hair growth and increased libido. Its effects on metabolism also include the modulation of fat distribution and the promotion of erythropoiesis.

Pharmacokinetics

Mesterolone is well absorbed after oral administration, with a bioavailability that can be affected by food intake. It is metabolized in the liver, with a half-life that allows for regular dosing. The drug is excreted primarily in the urine, with metabolites being eliminated within a few days post-administration. Its pharmacokinetic profile supports its use in sustained therapeutic regimens.

Contra-indications

  • Prostate carcinoma
  • Pregnancy
  • Severe liver dysfunction
  • Nephrosis
  • Hypercalcemia

Adverse effects

  • Acne
  • Oily skin
  • Mood changes
  • Nausea
  • Headache
  • Gynecomastia
  • Decreased libido
  • Erectile dysfunction
  • Water retention

Interactions

  • Anticoagulants
  • Insulin
  • Oral hypoglycaemics
  • Corticosteroids
  • Cyclosporine

Precautions

  • Cardiovascular disease
  • Liver impairment
  • Cholesterol abnormalities
  • Prostate disorders
  • Diabetes

Pregnancy

Mesterolone is contraindicated in pregnancy due to potential harm to the developing fetus.

Breast-feeding

It is not known whether mesterolone is excreted in human milk; caution should be exercised.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: mesterolone

PubChem CID 15020

Molecular formula: C20H32O2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

Malawi 1 product
Tanzania 1 product
Zimbabwe 1 product