METANDIENONE 10mg – TABLETS

Methandrostenolone 10mg

Molecular Formula:

C20H28O2

Molecular Weight:

300.442 g/mol

Structure:

DESCRIPTION

Methandrostenolone is a synthetic steroid with anabolic properties that are more pro- nounced than its androgenic effects. It has little progestational activity. It is similar to the naturally occuring steroid testosterone.

CLINICAL PHARMACOLOGY

Endogenous androgens such as testosterone or derivatives are responsible for the devel- opment and growth of the male sexual organs and post-adolescent secondary sex char- acteristics. Androgen effects include but are not limited to the maturation of the penis, scrotum, prostate, seminal tubules, laryngeal enlargement, vocal cord thickening, changes in muscle mass and fat distribution, and the development and distribution of male hair (facial, pubic, chest, back, axillary).

Androgens have been linked to increased protein anabolism and consequent decreased protein catabolism.

Androgens increase retention of sodium, potassium, and phosphorus. Androgens decrease urinary excretion of calcium.

Androgens are responsible for the growth spurt of adolescence and the aromatization of androgens to estrogens for the eventual termination of linear growth, which is brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens ac- celerate linear growth rates but may cause a disproportionate advancement in bone mat- uration. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate the pro- duction of red blood cells by enhancing the production of erythropoietin stimulating factor. Androgens may suppress gonadotrophic function of the pituitary. During exogenous ad- ministration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). With large doses, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

INDICATION AND USAGE

Males: Androgen Replacement Therapy:

Metandienone is used to promote weight gain following extensive surgery, chronic in- fection, or severe trauma, and in other cases that result in inadequate weight gain or maintenance. Metandienone is also used to decrease muscle loss caused by treatment with corticosteroids and to reduce bone pain associated with osteoporosis.

CONTRAINDICATIONS

1. Diagnosed or suspected carcinoma of the male breast or
2. Women who are pregnant or may become pregnant because of possible masculinization of the fetus. When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus. This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure.
3. Patients with a history of hypersensitivity to Metandienone or any of its
4. Patients with serious renal, cardiac, or hepatic

WARNINGS

1. In breast cancer patients, androgen therapy may cause hypercalcemia through stim- ulated osteolysis. Frequent monitoring of urine and serum calcium is indicated in such If hypercalcemia presents, the androgen should be discontinued.
2. Prolonged usage of high doses of androgens has been associated with peliosis hepatis, hepatic neoplasms, and hepatocellular carcinoma as well as azoospermia, oligospermia, and reduced ejaculatory volume.

3. If liver function tests become abnormal or the patient presents with cholestatic hep- atitis with jaundice, androgen therapy should be discontinued pending determination of the
4. Edema due to sodium and water retention may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease, migraines, epilepsy, and other condi- Edema may be increased in patients on concurrent adrenal cortical steroid or ACTH therapy.
5. Liver cell tumors have also been reported, most often benign and androgen-dependent, although fatal malignant tumors have also been reported. Termination of the drug gener- ally results in regression or the cessation of tumor progression.
6. Geriatric patients receiving androgen therapy may be at increased risk for prostate hypertrophy and prostatic carcinoma.
7. Virilization of female patients may If signs of virilization present during treatment of breast carcinoma, androgen therapy should be discontinued.

SIDE EFFECTS

Males: Frequent or persistent penile erections and increases in the appearance of acne vulgaris.

Females: Hoarseness of the voice, acne, changes in menstrual periods, or more facial hair. All patients: Nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory Tests and Patient Monitoring:

Examination of bone age by x-ray should be conducted during treatment of children to determine bone maturation rate and effect on epiphyseal centers.

Women with breast carcinoma should have frequent assays of serum and urine calcium throughout the course of treatment.

Androgens have been associated with increases in low-density lipoproteins and reduction in high-density lipoproteins in serum. Periodic serum lipid assays are recommended during treatment.

Serum assays for hematocrit and hemoglobin are recommended to screen for polycythe- mia in patients receiving large doses of androgens.

Hepatic function determinations should be made periodically including at a minimum AST and ALT, particularly with concomitant use of hepatotoxic medications or with a history of liver disease.

Androgen therapy patients, particularly those over 50 years of age, should be evaluated periodically for prostatic acid phosphatase and prostate specific antigen (PSA) total and free.

Total testosterone, free testosterone, and bioavailable testosterone in serum should as- sayed periodically and dosing titrated as necessary to achieve desired levels.

For treatment of breast carcinoma:

-Alkaline phosphatase serum values, physical examination, and x-rays of known or sus- pected metastases.

-Calcium

For gender change androgen therapy:

• LH (Luteinizing Hormone)
• ALT (Alkaline aminotransferase)

Thyroid Testing Interaction: Androgens have been shown to reduce concentration of thy- roxine-binding globulin and consequently decreasing the total serum T4 and increasing uptake of both T3 and T4. Serum concentration of free (unbound) thyroid hormones will not change.

DRUG INTERACTIONS

Anti-diabetic drugs and Insulin: In diabetic patients, the metabolic effects of androgens may reduce blood glucose, insulin, and anti-diabetic medication requirements.

Adrenal steroids or ACTH: May exacerbate edema in patients on concurrent adrenal-cor- tical steroids or ACTH therapy.

Anticoagulants: Patients on anticoagulants such as warfarin should be carefully monitored during androgen therapy as androgens may increase sensitivity to oral anticoagulants which may require a concomitant reduction in anticoagulant dosage to achieve a desir- able prothrombin time (PT). Concurrent use of anti-diabetic agents, insulin, cyclosporines, hepatotoxic medications, and/or human growth hormone (somatropin) has been reported to decrease anticoagulant requirements. Anticoagulant patients should be monitored reg- ularly during androgen therapy, particularly during initiation and termination of therapy. Oxyphenbutazone: Elevated serum levels of oxyphenbutazone may result.

DOSAGE AND ADMINISTRATION

Male Androgen Replacement Therapy: The dose of these medicines will be different for different patients. Follow your doctor’s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

PACKAGING

10 mg/tablets, 100 tablets per box

STORAGE

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.