Primary hypogonadism is caused by defects of the gonads, such as Klinefelter Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus or pituitary to produce sufficient gonadotropins FSH, LH.
Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin SHBG and albumin. Testosterone is metabolized to various keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone DHT. There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to minutes. Inactivation of testosterone occurs primarily in the liver.
Hypogonadal concentrations are reached within 24 hours following system removal. There is no accumulation of testosterone during continuous treatment. Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Men were between 34 and 76 years of age mean: 55 years. Table 3 summarizes testosterone C avg categories by treatment. Each system contains 9. Each system contains Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.
Patients should be informed that treatment with androgens may lead to adverse reactions that include:. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Selling or giving away this medicine may harm others and it is against the law.
Talk to your healthcare provider before taking this medicine if you have any of the above conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take:.
Know the medicines you take. Ask your healthcare provider or pharmacist for a list of all your medicines if you are not sure.
Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Call your healthcare provider right away if you have any of the serious side effects listed above.
Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. It may harm them. If you would like more information, talk to your healthcare provider. For more information, go to www. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. View Package Photos. Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Approval: Testosterone may cause fetal harm. Use with caution, particularly in patients with cardiac, renal, or hepatic disease.
Primary hypogonadism congenital or acquired : testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins FSH, LH above the normal range.
Hypogonadotropic hypogonadism congenital or acquired : gonadotropin or luteinizing hormone-releasing hormone LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Patients using 7. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It is appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices [see Contraindications 4 ].
Table 1. Table 2. Cardiovascular Disorders: Myocardial infarction, stroke [see Warnings and Precautions 5. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. Distribution Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin SHBG and albumin.
Metabolism Testosterone is metabolized to various keto steroids through two different pathways. Excretion There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to minutes. Mutagenesis Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. Impairment of Fertility The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.
Table 3. Patients should be informed that treatment with androgens may lead to adverse reactions that include: Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and having a weak urine flow Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness Too frequent or persistent erections of the penis Nausea, vomiting, changes in skin color, or ankle swelling Patients Should be Advised of these Application Instructions ANDRODERM should not be applied to the scrotum.
Application to these sites has been associated with burn-like blister reactions. The site of application should be rotated, with an interval of 7 days between applications to the same site. If a patch falls off before noon, replace it with a fresh patch and wear it until you apply a fresh patch es that evening.
If it falls off later in the day, do not replace it until you apply a fresh patch es that evening. Do not use if the individual pouch seal is broken or if the patch appears to be damaged.
Do not cut patches. Only intact patches should be applied. Strenuous exercise or excessive perspiration may loosen a patch or cause it to fall off. All rights reserved. Before you use ANDRODERM, tell your healthcare provider if you: have breast cancer have or might have prostate cancer have urinary problems due to an enlarged prostate have heart problems have kidney or liver problems have problems breathing while you sleep sleep apnea have diabetes have any other medical conditions Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially, tell your healthcare provider if you take: insulin medicines that decrease blood clotting corticosteroids Know the medicines you take.
Wait 3 hours before showering, bathing, or swimming. You should remove the old patch before applying the new one. Do not use a site that you have used before for at least 7 days.
If your skin redness does not go away, talk to your healthcare provider. Your healthcare provider may tell you to use an over-the-counter hydrocortisone cream on your red skin. Patches that have aluminum in them can cause skin burns at the patch site during a magnetic resonance imaging scan MRI. Throw it away and get a new one. Open the foil pouch. Tear along the edge and remove the patch from the pouch See Figure C. Remove the protective plastic liner and silver disc from the patch.
Hold on to the tabs on the patch and the protective plastic liner and gently pull the two apart to remove the plastic liner and silver disc from the patch See Figure D. This will expose the adhesive and central reservoir area on the patch See Figure E. The patch should pull off easily from the protective plastic liner. Check the protective plastic liner.
You should not see any glue adhesive sticking to the liner. Throw away the clear plastic liner and silver disc. We will continue to honor any Allergan-provided privacy notices for personal information previously collected, used, and maintained by Allergan.
For Healthcare Professionals. Yes No. Prescribing Information. Learn more. Before you use ANDRODERM, tell your healthcare provider if you: have breast cancer have or might have prostate cancer have urinary problems due to an enlarged prostate have heart problems have kidney or liver problems have problems breathing while you sleep sleep apnea have diabetes have any other medical conditions Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
This can include: increased urination at night trouble starting your urine stream having to pass urine many times during the day having an urge that you have to go to the bathroom right away having a urine accident being unable to pass urine or weak urine flow Possible increased risk of prostate cancer.
Blood clots in the legs or lungs. Signs and symptoms can include leg pain, swelling or redness of your legs, difficulty breathing or chest pain. Possible increased risk of heart attack or stroke. Swelling of your ankles, feet, or body, with or without heart failure.
Enlarged or painful breasts.
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