**Important Disclaimer:** This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product's internal leaflet or consult a healthcare professional before use.
**Drug Name:** Acdisteron 25 mg 20 f.c. tabs
**Manufacturer:**
Acdisteron is manufactured by Acdima International Trading (AIT).
**Introduction:**
Acdisteron 25 mg 20 f.c. tabs contains Mesterolone, a synthetic androgen primarily used to treat conditions related to low testosterone levels in men. It is an orally active steroid that helps to supplement the body's natural male hormones, addressing issues such as hypogonadism and certain forms of male infertility.
**Indications and Usage:**
Mesterolone is indicated for the treatment of various conditions in men related to androgen deficiency. These include:
* **Male Hypogonadism:** A condition where the testes produce insufficient testosterone.
* **Male Infertility:** Specifically, oligozoospermia (low sperm count) due to low hormone levels.
* **Androgen Deficiency:** Addressing symptoms like fatigue, lack of concentration, decreased libido, and potency disturbances.
* **Delayed Puberty in Boys:** In some cases, to support the development of male secondary sexual characteristics.
* **Andropause:** To manage symptoms in older men.
**Characteristics:**
Mesterolone is a synthetic dihydrotestosterone (DHT) derivative, classified as an androgen and anabolic steroid (AAS). It is orally active and has strong androgenic effects with relatively weak anabolic effects. A key characteristic of Mesterolone is that it is not a substrate for aromatase, meaning it is not converted into estrogen in the body. This prevents estrogenic side effects such as gynecomastia (breast enlargement) and fluid retention, which can occur with other testosterone derivatives. Unlike some other oral anabolic steroids, Mesterolone is generally considered to have little or no potential for hepatotoxicity (liver damage) because it is not 17α-alkylated. It works by stimulating androgen receptors in tissues and organs, promoting the growth and development of male sex organs and maintaining secondary sex characteristics.
**Dosage and Administration:**
Acdisteron is administered orally as tablets.
* **Form:** Film-coated tablets, 25 mg.
* **Recommended Use:**
* **Initial Dose:** Typically 75-100 mg daily, divided into 3-4 doses, for several months.
* **Maintenance Dose:** Usually 50-75 mg daily.
* **For Male Infertility:** 2-3 tablets per day for approximately 90 days, corresponding to the spermatogenesis cycle.
* **Administration Method:** Swallow the tablet whole with a glass of water. It can be taken with or without food, though some sources suggest taking it after meals to enhance absorption.
* **Frequency:** Doses should be taken at the same times each day to aid remembrance.
* **Important Note:** Do not exceed the prescribed dose. The dosage and duration of treatment are determined by the physician based on the patient's medical condition.
**Contraindications:**
Mesterolone should not be used in individuals with the following conditions:
* Prostate cancer.
* Male breast cancer.
* Current or history of liver tumors (benign or malignant).
* Severe liver disease or hepatic impairment.
* Nephrotic syndrome.
* Hypercalcemia (high blood calcium levels).
* Hypersensitivity or allergy to Mesterolone or any of the product's constituents.
* Not indicated for use in women, especially during pregnancy or lactation, due to potential harm to the fetus and lack of indication.
**Warnings and Precautions:**
* **Prostate Health:** Regular examinations of the prostate gland (including PSA levels) are essential before and during treatment, as androgens can stimulate the growth of existing prostate cancer.
* **Cardiovascular Risk:** Use with caution in patients with cardiovascular disease, high blood pressure, or a history of myocardial infarction (MI) or coronary artery disease (CAD). Mesterolone can affect cholesterol levels (decreasing HDL and increasing LDL).
* **Liver Function:** Although generally considered less hepatotoxic, rare cases of liver tumors have been reported with long-term androgen therapy. Liver function should be monitored.
* **Fluid Retention:** Caution is advised in patients with conditions influenced by edema, such as cardiovascular disease, epilepsy, or migraines.
* **Diabetes:** Mesterolone may affect blood sugar levels; caution is advised in diabetic patients.
* **Blood Disorders:** Caution in patients with polycythemia (increased red blood cell count).
* **Abuse Potential:** Mesterolone, like other anabolic-androgenic steroids, has been abused, which carries serious health risks including cardiovascular, hepatic, and psychiatric events, and dependency. It is not indicated for enhancing muscular development or physical ability in healthy individuals.
* **Lactose Content:** Contains lactose, so patients with rare genetic conditions like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not use this medication.
* **Erections:** If frequent or very prolonged erections are observed, the dose should be reduced or treatment suspended to avoid damage to the penis.
**Nutrient Absorption and Metabolism (Pharmacokinetics):**
* **Absorption:** Following oral ingestion, Mesterolone is rapidly and almost completely absorbed. Its absolute bioavailability is approximately 3%. Maximum serum drug levels (Cmax) of about 3.1 ± 1.1 ng/mL are reached approximately 1.6 to 2 hours after a 25 mg dose.
* **Distribution:** Mesterolone is highly bound to serum proteins (98%), with 58% binding to Sex Hormone Binding Globulin (SHBG) and 40% to albumin.
* **Metabolism:** It is rapidly metabolized in the liver. The main metabolite identified is 1α-methyl-androsterone. Mesterolone is not converted into estrogens.
* **Elimination:** The serum levels decrease with a terminal half-life of 12-13 hours. Mesterolone is excreted primarily in the form of metabolites, with approximately 80% recovered in urine and up to 13% in faeces within seven days.
**Side Effects:**
Common side effects associated with Mesterolone include:
* Oily skin and acne.
* Increased body or facial hair growth (hirsutism).
* Scalp hair loss (male pattern baldness).
* Increased libido.
* Mood changes, including irritability, aggression, anxiety, or depression.
* Headache.
* Fluid retention and edema.
* Frequent or persistent erections.
* Stomach discomfort, abdominal pain, indigestion, nausea, and vomiting.
* Itching, fever, rash, hives.
* Changes in liver enzymes and lipid profile.
Serious or rare side effects can include:
* Benign or malignant liver tumors, and intra-abdominal hemorrhage.
* Hepatotoxicity (liver toxicity), especially with prolonged use.
* Cardiovascular events, including changes in cholesterol levels, increased blood pressure, and increased risk of heart attacks.
* Suppression of natural testosterone production, potentially leading to testicular atrophy and decreased sperm production, which can paradoxically cause infertility with prolonged use.
* Venous thromboembolism (VTE).
**Drug Interactions:**
Mesterolone may interact with several other medications:
* **Anticoagulants (e.g., Warfarin, Acenocoumarol):** Mesterolone can increase their anticoagulant activity, leading to a higher risk of bleeding.
* **Antidiabetic Drugs (e.g., Insulin, Metformin, Sulfonylureas, GLP-1 agonists, SGLT2 inhibitors):** Mesterolone may increase their hypoglycemic (blood sugar lowering) activities, requiring dose adjustments.
* **Corticosteroids (e.g., Prednisone, Dexamethasone):** Concomitant use can increase the risk or severity of edema (fluid retention).
* **Immunosuppressants (e.g., Cyclosporine):** Mesterolone may increase the risk of liver damage when combined with drugs like cyclosporine.
* **Anticonvulsants (e.g., Phenobarbital, Phenytoin):** These drugs may reduce the levels of Mesterolone in the body.
* **Thyroid Hormones (e.g., Thyroxine):** Mesterolone may interfere with thyroid function tests.
* **Neuromuscular Blockers:** May cause resistance to treatment.
**Patient Counseling:**
* Always take Mesterolone exactly as prescribed by your doctor and do not exceed the recommended dose.
* Regular medical check-ups, including blood tests (to monitor red blood cells, liver function, testosterone, and lipid profile) and prostate examinations, are crucial during treatment.
* Report any unusual or persistent side effects to your doctor immediately, especially frequent or prolonged erections, irritability, nervousness, significant weight gain, or signs of liver problems (e.g., yellowing of skin/eyes, severe abdominal pain).
* Mesterolone is intended for male patients only and should not be used by women, children, or adolescents. It is not for enhancing muscle development or physical ability in healthy individuals.
* Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
* Use with caution if you have pre-existing conditions such as heart disease, high blood pressure, diabetes, kidney problems, epilepsy, or migraines.
* Maintain a balanced diet, engage in regular exercise, ensure adequate sleep, and practice stress management techniques to support overall health.
* Avoid excessive alcohol consumption while on this medication, as it may exacerbate side effects and impact liver function.
* Do not stop taking the medication abruptly without consulting your doctor, as gradual tapering may be required.
* Store the medication below 30°C.
**Sources:**
* Truemeds: https://www.truemeds.in/medicine/mesterolone-1
* NPS MedicineWise: https://www.nps.org.au/medicine-finder/proviron-tablets
* DrugBank Online: https://go.drugbank.com/drugs/DB13587
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