Andriol (Testosterone Undecanoate)

ANDRIOL

Organon

Testosterone Undecanoate

Androgen

Action And Clinical Pharmacology: Testosterone undecanoate, an orally active testosterone preparation, is a fatty acid ester of the natural androgen testosterone. Unlike other oral testosterone preparations, testosterone undecanoate is able to by-pass the liver via the lymphatic system and is therefore orally bioavailable.

Therapy with Andriol increases plasma levels of testosterone and its active metabolites, leading to a regular therapeutic effect. In eugonadal men, peak testosterone levels are reached in approximately 4 to 5 hours after ingestion returning to basal levels after about 10 hours. In volunteers and hypogonadal men, 77 to 93% of an orally administered dose of testosterone undecanoate was excreted in the urine and feces within 3 to 4 days.

Indications And Clinical Uses: For replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone: for the management of congenital or acquired primary hypogonadism and hypogonadotropic hypogonadism; to develop and maintain secondary sexual characteristics in males with testosterone deficiency. Testosterone undecanoate is also indicated to stimulate puberty in carefully selected males with clearly delayed puberty not secondary to pathological disorder.

It is also used as replacement therapy in impotence or for male climacteric symptoms when the conditions are due to a measured or documented androgen deficiency.

Contra-Indications: Known hypersensitivity to any of the components of the product; males with carcinoma of the breast; males with known or suspected carcinoma of the prostate gland; patients with serious cardiac, hepatic or renal disease; hypercalcemia; impaired liver function; prepubertal males; patients easily stimulated sexually. Androgens are also contraindicated in patients with nephrosis or the nephrotic phase of nephritis.

Manufacturers’ Warnings In Clinical States: Hypercalcemia may occur in immobilized patients and in patients with breast cancer. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-alpha-alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma and peliosis hepatis – all potentially life-threatening complications.

Cholestatic hepatitis and jaundice may occur with 17-alpha-alkyl-androgens. Should this occur, the drug should be discontinued. This is reversible with discontinuation of the drug. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. Androgen therapy should be used cautiously in males with delayed puberty. Androgens can accelerate bone maturation without producing compensatory gain in linear growth. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. These adverse effects may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

Precautions: Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

Drug Interactions: Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started and stopped.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

May potentiate cyclosporine and increase risk of nephrotoxicity.

Concurrent use of somatrem or somatropin with androgens in prepubertal males may accelerate epiphyseal maturation.

Increased serum oxyphenbutazone concentrations have been reported with concurrent administration of androgen and oxyphenbutazone.

May interact with adrenocorticoids, glucocorticoids, especially with significant mineralocorticoid activity, mineralocorticoids, or corticotropins, especially prolonged use, or sodium-containing medications or foods.

Laboratory Test Interference: Alterations may occur in the following clinical laboratory tests: metyrapone test, fasting blood sugar (FBS) and glucose tolerance test, thyroid function tests (decrease in thyroxine-binding capacity and radioactive iodine uptake, and an increase in T3 uptake by the red blood cells or resin; free thyroxine levels remain unchanged); electrolytes (retention of sodium chloride, water, potassium, calcium, and inorganic phosphates), blood coagulation tests (suppression of clotting factors II, V, VII, and X), alteration to liver function tests, increased serum cholesterol and miscellaneous laboratory tests (decreased creatinine and creatine excretion lasting up to 2 weeks after discontinuing therapy). Androgens enhance blood fibrinolytic activity and increase hematocrit and serum hemoglobin levels; effects on plasma lipids are variable. Administration of testosterone, but not the 17-alpha-alkyl substituted derivatives, elevates the level of urinary 17-ketosteroids.

Laboratory Tests: Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of prepubertial males to determine the rate of bone maturation and the effect of androgen therapy on the epiphyseal centers.

Adverse Reactions: The following adverse reactions have occurred with androgen therapy: inhibition of testicular function, testicular atrophy and oligospermia, impotence, gynecomastia, epididymitis and bladder irritability, excessive frequency and duration of penile erections, nausea, cholestatic jaundice, peliosis hepatis, polyerythemia, headache, anxiety, depression, generalized paresthesia and rarely anaphylactoid reaction. In addition, the following reactions are known to occur with anabolic steroids: increased or decreased libido, flushing of the skin, acne, habituation, excitation and sleeplessness, chills, leukopenia, and bleeding in patients on concomitant anticoagulant therapy. There have been rare reports of hepatocellular carcinoma, particularly in association with long-term therapy, in patients receiving methyltestosterone or other androgenic and anabolic steroids.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No experience with overdosage has been reported. No specific antidote is available.

Dosage And Administration: The dosage should be adjusted according to the response of the individual patient.

Usually, an initial dosage of 120 to 160 mg daily in 2 divided doses for 2 to 3 weeks is adequate, followed by a maintenance dosage of 40 to 120 mg daily.

The capsules should be taken after meals and swallowed without chewing.

Storage: Pharmacist: Refrigerate at 2 to 8°C. Protect from light and moisture. Do not freeze. Patient: Store between 15 and 25°C. Protect from light and moisture. Use within 90 days.

Availability And Storage: Each oval, reddish-brown, soft gelatin capsule, marked D3V, contains: testosterone undecanoate 40 mg in oleic acid. Nonmedicinal ingredients: gelatin, glycerol, iron oxide red (E172), karion 83, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and titanium dioxide. Bottles of 60. (Shown in Product Recognition Section)

ANDRIOL Organon Testosterone Undecanoate Androgen

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