Androgel (testosterone 1% gel)
ANDROGEL (testosterone gel) – a topical testosterone replacement product commonly for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. AndroGel exerts its effect by delivering physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal concentrations seen in healthy men.
FDA approved uses: Androgel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired). Hypogonadotropic hypogonadism (congenital or acquired). Important limitations of use – Safety and efficacy of AndroGel 1% in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure.
Available dosage forms: Metered-dose pump that delivers 12.5 mg of testosterone per actuation. Packets containing 25 mg of testosterone. Packets containing 50 mg of testosterone.
Usual dosage: The recommended starting dose Starting dose of AndroGel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied once daily in the morning. Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply AndroGel 1% to any other parts of the body including the genitals, chest or back. Dose adjustment: AndroGel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration.
Contraindications: Androgel (testosterone gel hydrochloride) is contraindicated in patients with known hypersensitivity to testosterone gel hydrochloride or to any excipients used in the formulation.
Special warnings: WARNING: SECONDARY EXPOSURE TO TESTOSTERONE – Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Adverse reactions (side effects) of these medications: The most common side effects of Androgel include acne, application site reaction, abnormal lab tests, and prostatic disorders. Other adverse events reported include alopecia, application site reactions, asthenia, depression, emotional lability, gynecomastia, headache, hypertension, lab test abnormalities, decreased libido, prostate disorders, testicular disorders, nervousness, and breast pain .
Common drug interactions: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants. The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
Special instructions for patients: Use this medication exactly as directed by physician. Patients should wash hands immediately with soap and water after applying AndroGel 1% and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. Before starting AndroGel tell healthcare provider if you: have had breast cancer; have or might have prostate cancer; have urinary problems due to enlarged prostate; have heart, kidney or liver problems; have sleep apnea; any other serious medical problems.
Full prescribing information may be found at the manufacturer‘s official website Androgel.com or at the U.S. Food and Drug Administration’s website at Androgel Info at Drugs@FDA
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