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ANDROGEL is a brand name for Testosterone, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ANDROGEL (testosterone) is indicated for: • testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). ANDROGEL should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 08/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 6 5 OVERDOSAGE............................................................................................................
7
). With large doses of exogenous androgens, including ANDROGEL, spermatogenesis may be reversibly suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count (see 10 CLINICAL PHARMACOLOGY).
Testicular atrophy, subfertility, and infertility have been reported in men who abuse anabolic androgenic steroids. The administration of exogenous testosterone has been reported to suppress spermatogenesis in rats, dogs, and non-human primates, which was reversible on cessation of the treatment.
• Function Gynecomastia may frequently develop (reported in 1-3% of patients in clinical trials) and occasionally persist in patients being treated for hypogonadism. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage through feedback inhibition of pituitary follicle-stimulating hormone (FSH).
2 Pharmacodynamics - General Androgen Effects) • Teratogenic Risk Pregnant and nursing women should avoid skin contact with ANDROGEL application sites on men. Testosterone is teratogenic and may cause fetal harm. 1 Pregnant Women). Respiratory The treatment of hypogonadal men with testosterone may potentiate sleep apnea, particularly for those with risk factors such as obesity or chronic lung diseases.
Skin Changes in body hair distribution, significant increase in acne, or other signs of virilization of the female partner or in any person (including children) exposed to skin-to skin contact, should be brought to the attention of a physician.
Application site reactions associated with the use of transdermal testosterone may manifest as skin irritation (including erythema, induration or burning). If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.
4 Geriatrics 08/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 6 5 OVERDOSAGE............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 Availability of Dosage Forms .............................................................................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................
• ANDROGEL is not indicated for use in women. • Pregnant and nursing women should avoid skin contact with ANDROGEL application sites on men. Testosterone may cause fetal harm. 1 Special Populations). In the event that unwashed or unclothed skin to which ANDROGEL has been applied or clothing exposed to ANDROGEL comes in direct contact with the skin of a pregnant or nursing woman, the general area of contact on the woman should be immediately washed with soap and water.
• ANDROGEL is contraindicated in patients with known hypersensitivity to this drug or to any ingredient in the formulation, including testosterone USP that is chemically synthesized from soy. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Androgens are contraindicated in men with known or suspected carcinoma of the prostate or breast. ANDROGEL® testosterone Page 5 of 43
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Pregnant Women Pregnant Women and Nursing Women: ANDROGEL is not indicated for use in women, due to lack of evaluation and possible virilising effects (see 2 CONTRAINDICATIONS). Although it is not known how much testosterone transfers into human milk, ANDROGEL is contraindicated in nursing women because of the potential for serious adverse reactions in nursing ANDROGEL® testosterone Page 14 of 43 infants.
(see 2 CONTRAINDICATIONS) Pregnant and nursing women should avoid skin contact with ANDROGEL application sites on men. Testosterone is teratogenic and may cause fetal harm. Testosterone exposure during pregnancy has been reported to be associated with fetal abnormalities.
In the event that unwashed or unclothed skin to which ANDROGEL has been applied or clothing exposed to ANDROGEL comes in direct contact with the skin of a pregnant or nursing woman, the general area of contact on the woman should be immediately washed with soap and water (see 2 CONTRAINDICATIONS).
3 Pediatrics ANDROGEL is not indicated for use in children < 18 years of age since safety and efficacy have not been established in this patient population. Androgen therapy should be used cautiously in males with hypogonadism causing delayed puberty.
Androgens can accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child is the greater risk of compromising final mature height.
The effect of androgens on bone maturation should be monitored closely by assessing bone age of the wrist and hand on a regular basis. 4 Geriatrics There are very limited controlled clinical study data supporting the use of testosterone in the geriatric population and virtually no controlled clinical studies on subjects 75 years and over.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma and for worsening of lower urinary tract signs and symptoms. Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of testosterone replacement therapy.
9%) was the most frequently observed adverse drug reactions at the recommended dosage. Frequently observed adverse drug reactions also included changes in laboratory parameters, including elevated PSA, AST, ALT, testosterone, hemoglobin or hematocrit, cholesterol, cholesterol/LDL ratio, triglycerides, HDL, or serum creatinine.
Routine monitoring during treatment is therefore recommended (see 7 WARNINGS AND PRECAUTIONS). Anxiety has also frequently been reported. Reactions at the application site (erythema, acne, dry skin) were observed as adverse drug reactions.
If the patient develops a severe application site reaction, the treatment should be reviewed and discontinued if necessary (see 7 WARNINGS AND PRECAUTIONS). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In a controlled clinical study, 154 patients were treated with ANDROGEL (testosterone) for up to 6 months (see 14 CLINICAL TRIALS). Adverse Events possibly, probably or definitely related to the use of ANDROGEL and reported by ≥1% of the patients are listed in Table 1.
The four most reported adverse events are: acne (1-8%), lab test abnormal*(3-6%), application site reaction […]
1 Special Populations .............................................................................................. 1 Pregnant Women ............................................................................................. 3 Pediatrics..........................................................................................................
4 Geriatrics .......................................................................................................... 14 8 ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data............................................................................................................. 5 Post-Market Adverse Reactions...........................................................................
19 9 DRUG INTERACTIONS .............................................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 23 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 26 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 26 PART II: SCIENTIFIC INFORMATION .....................................................................................
27 13 PHARMACEUTICAL INFORMATION .......................................................................... 27 14 CLINICAL TRIALS ......................................................................................................
1 Trial Design and Study Demographics ................................................................. 2 Study Results ........................................................................................................ 28 15 MICROBIOLOGY ......................................................................................................
30 16 NON-CLINICAL TOXICOLOGY .................................................................................... 31 PATIENT MEDICATION INFORMATION ................................................................................ 34 ANDROGEL® testosterone Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ANDROGEL (testosterone) is indicated for: • testosterone […]