Proviron (Tablets) Instructions for Use
Marketing Authorization Holder
Schering, AG (Germany)
ATC Code
G03BB01 (Mesterolone)
Active Substance
Mesterolone (Rec.INN registered by WHO)
Dosage Form
| Proviron | Tablets 25 mg: 20 or 50 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Mesterolone | 25 mg |
20 pcs. – bottles (1) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.
Clinical-Pharmacological Group
Androgenic drug
Pharmacotherapeutic Group
Androgen
Pharmacological Action
Androgenic agent. It stimulates the development of male genital organs and secondary sexual characteristics, activates libido and potency, and has an anabolic effect.
Indications
Psychovegetative disorders, decreased performance, potency disorders, hypofunction of the gonads, male infertility, aplastic anemia.
ICD codes
| ICD-10 code | Indication |
| D61.9 | Aplastic anemia, unspecified |
| E29.1 | Testicular hypofunction |
| F45.3 | Somatoform dysfunction of the autonomic nervous system |
| F52.2 | Insufficiency of genital response (psychogenic impotence) |
| N46 | Male infertility |
| N48.4 | Impotence of organic origin |
| Z73.0 | Burn-out |
| ICD-11 code | Indication |
| 2A60.40 | Transient abnormal myelopoiesis |
| 3A70.1Z | Acquired aplastic anemias, unspecified |
| 5A81.1 | Testicular hypofunction |
| 6C20.Z | Bodily distress disorder, unspecified |
| CB40.1 | Young's syndrome |
| GB04.Z | Male infertility, unspecified |
| HA01.00 | Female sexual arousal dysfunction, lifelong, generalized |
| HA01.01 | Female sexual arousal dysfunction, lifelong, situational |
| HA01.02 | Female sexual arousal dysfunction, acquired, generalized |
| HA01.03 | Female sexual arousal dysfunction, acquired, situational |
| HA01.0Z | Female sexual arousal dysfunction, unspecified |
| HA01.10 | Male erectile dysfunction, lifelong, generalized |
| HA01.11 | Male erectile dysfunction, lifelong, situational |
| HA01.12 | Male erectile dysfunction, acquired, generalized |
| HA01.13 | Male erectile dysfunction, acquired, situational |
| HA01.1Z | Male erectile dysfunction, unspecified |
| HA01.Z | Sexual arousal dysfunctions, unspecified |
| QD85 | Burn-out |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take the tablet orally with a sufficient amount of liquid.
For the treatment of male hypogonadism, infertility, and psychovegetative or potency disorders, administer 25 mg one to three times daily.
Continue this therapy for several months as directed by a physician; treatment duration depends on clinical response and laboratory parameters.
For the management of aplastic anemia, administer a higher dose of 50 mg three times daily.
Do not exceed the prescribed daily dosage.
Adjust the dosing schedule based on individual therapeutic needs and tolerability.
Regularly monitor clinical status and relevant biochemical markers during long-term treatment.
Adverse Reactions
Possible undesirable frequent or prolonged erection.
Rarely benign or malignant changes in the liver.
Contraindications
Prostate cancer, liver tumors (including history).
Use in Pregnancy and Lactation
Mesterolone is used only in men.
Use in Hepatic Impairment
Contraindicated in liver tumors (including history).
Pediatric Use
Contraindicated for use in children and adolescents under 18 years of age.
Special Precautions
Mesterolone is used only in men.
Androgens are not intended to stimulate muscle tissue growth in healthy individuals or to enhance their performance.
During use, regular rectal examination of the prostate is recommended.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical Disclaimer