Testogel^® Prescribing Information

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• Essential Information
  TESTOGEL^® 50 mg, gel in sachet
• Composition
  Active ingredient: one sachet of 5 g contains 50 mg of testosterone.
• Indications
  Testosterone treatment for confirmed male hypogonadism.
  Pharmacologically inactive ingredients
  Carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, -purified water.
• Contraindications
  Cases of known or suspected cancer of the prostate or breast known hypersensitivity to testosterone or to any other constituent of the gel, skin conditions prohibiting the topical application of medication. Side effects: Possible local side effects: erythema, acne, dry skin. Possible systemic side effects: prostatic disorders, gynecomastia, mastalgia, dizziness, hyper- and paresthesia, amnesia, mood disorders, hypertension, diarrhea, alopecia, polycythemia, increased serum lipids. Other known adverse drug reactions of treatments containing testosterone are: prostatic changes and progression of sub-clinical prostatic cancer, urinary obstruction, pruritus, arterial vasodilatation, nausea, cholestatic jaundice, changes in liver function tests, increased libido, nervousness, myalgia and, during high dose prolonged treatment, electrolyte changes, oligospermia and priapism.
• Special warnings and precautions for use
  Exclusion of risk of pre-existing prostatic cancer, monitoring of the prostate gland and breast. Regular monitoring of serum calcium concentrations is recommended in cancer patients at risk of hypercalcemia (and associated hypercalciuria), due to bone metastases. Testogel^® may cause edema with or without congestive cardiac failure in patients suffering from severe cardiac, hepatic or renal insufficiency. In this case, treatment must be stopped immediately. Testogel^® should be used with caution in patients with ischemic heart disease. Testosterone may cause a rise in blood pressure and should be used with caution in patients with hypertension. Beside laboratory tests of the testosterone concentrations in patients on long-term androgen treatment the following laboratory parameters should be checked periodically: hemoglobin, hematocrit (to detect polycythemia), liver function tests. Testogel^® should be used with caution in patients with epilepsy and migraine as these conditions may be aggravated.
  
  Warnings: Testogel^® is not indicated for use in children and has not been evaluated clinically in males under 18 years of age. Pregnant women must avoid any contact with Testogel^® application sites. This product may have adverse virilizing effects on the fetus. Testogel^® is no treatment for male impotence or sterility. For further details refer to the package insert or contact your local Bayer HealthCare Pharmaceuticals organisation.
• Certain clinical signs
  Irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. In case of severe application site reactions, treatment should be reviewed and discontinued if necessary. This proprietary medicinal product contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests. Testogel^® should not be used by women. If no precaution is taken, testosterone can be transferred to other persons by close skin to skin contact, -resulting in increased testosterone serum levels- and possibly adverse effects in case of repeat contact (inadvertent androgenization). Testogel^® should not be prescribed in patients with a major risk of non-compliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).
• Posology and method of administration
  Cutaneous use. The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily. The daily dose should not exceed 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen. Allow drying for at least 3–5 minutes before dressing.
• Contact
  Bayer Pharma AG, 13353 Berlin, Germany.
  Adverse reactions can be reported to GPV.CaseProcessing@bayerhealthcare.com.
  Date of preparation of PI: 4 July 2006
  Date of preparation of ad: 14 October 2009