May worsen sleep apnea. Monitor hematocrit prior to initiation, at 3—6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium in cancer patients at risk for hypercalcemia. Monitor for venous thromboembolism; discontinue if suspected.
Inform patients of possible increased risk of MI, stroke. May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed.
Increased fluid retention with concomitant ACTH, corticosteroids; monitor. May affect thyroid levels. Nursing mothers should not use AndroGel 4 , 8. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer 8. No formal studies were conducted involving patients with renal or hepatic insufficiencies 8.
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Warnings and Precautions 5. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Warnings and Precautions 5. These men usually have low serum testosterone levels and gonadotropins FSH, LH above the normal range.
Hypogonadotropic Hypogonadism Congenital or Acquired - idiopathic gonadotropin or luteinizing hormone-releasing hormone LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low testosterone serum levels but have gonadotropins in the normal or low range. Packets The entire contents should be squeezed into the palm of the hand and immediately applied to the application sites.
If the serum testosterone concentration is below the normal range, the daily AndroGel dose may be increased from 5 g to 7. If the serum testosterone concentration exceeds the normal range, the daily AndroGel dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 5 g, AndroGel therapy should be discontinued. Prescribers should be aware that testosterone is contraindicated in men with known or suspected prostate cancer. Therefore, evaluation for prostate cancer prior to initiation of AndroGel therapy is appropriate [see Contraindications 4 ].
Therefore, periodic assessments for signs and symptoms of BPH are recommended in patients taking AndroGel. Hematocrit, serum lipid profile, and liver function test should be monitored in patients taking AndroGel [see Warnings and Precautions 5. AndroGel is available in the following three package containers: 2 x 75 g pumps each pump dispenses 60 metered 1.
AndroGel should not be used in any of the following patients: Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions 5. Women who are or may become pregnant, or who are breastfeeding. AndroGel can cause fetal harm when administered to a pregnant woman. AndroGel may cause serious adverse reactions in nursing infants.
Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with AndroGel [see Warnings and Precautions 5. Men with known hypersensitivity to any of its ingredients, including alcohol and soy products. Patients treated with androgens may be at increased risk for prostate cancer.
Evaluation of the patient for prostate cancer prior to initiating and during treatment with androgens is appropriate. Most of these increases were seen within the first year of therapy [see Contraindications 4 , Warnings and Precautions 5.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel-treated skin: Children and women should avoid contact with unwashed or unclothed application site s of men using testosterone gel. Patients should wash their hands immediately with soap and water after applying AndroGel. Patients should cover the application site s with clothing e. Prior to any situation in which skin-to-skin contact with the application site is anticipated, patients should wash the application site s thoroughly with soap and water to remove any testosterone residue.
In the event that unwashed or unclothed skin to which AndroGel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. Studies show that residual testosterone is removed from the skin surface by washing with soap and water.
Increase in red blood cell mass may increase the risk for a thromboembolic event. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Androgens should be used with caution in cancer patients at risk of hypercalcemia and associated hypercalciuria. Regular monitoring of serum calcium concentrations is recommended in these patients. Adverse Event Dose of AndroGel 5 g 7. Secondary Exposure to Testosterone in Children Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. Hypogonadal Men Table 4 includes adverse reactions that have been identified postmarketing.
Testosterone and other androgens may adversely affect lactation. Distribution Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin SHBG and albumin.
Metabolism There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to minutes. Disposal Used AndroGel pumps or used AndroGel packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
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. This will ensure that the greatest amount of AndroGel is absorbed into their system. Patent No. What is the most important information I should know about AndroGel?
Signs and symptoms of early puberty in a child may include: enlarged penis or clitoris early development of pubic hair increased erections or sex drive aggressive behavior AndroGel can transfer from your body to others. Signs and symptoms of exposure to AndroGel in children may include: enlarged penis or clitoris early development of pubic hair increased erections or sex drive aggressive behavior Signs and symptoms of exposure to AndroGel in women may include : changes in body hair a large increase in acne To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions: Apply AndroGel only to areas that will be covered by a short sleeve T-shirt.
These areas are your shoulders and upper arms, or stomach area abdomen , or shoulders, upper arms and stomach area. Wash your hands right away with soap and water after applying AndroGel. After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
If a woman or child makes contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away. What is AndroGel? AndroGel is not meant for use in women. Who should not use AndroGel? Do not use AndroGel if you: have breast cancer have or might have prostate cancer are pregnant or may become pregnant or breast-feeding.
AndroGel may harm your unborn or breast-feeding baby. See the end of this Medication Guide for a complete list of ingredients in AndroGel. What should I tell my healthcare provider before using AndroGel? Before you use AndroGel, tell your healthcare provider if you: have breast cancer or prostate cancer have urinary problems due to an enlarged prostate have heart problems have liver or kidney problems have problems breathing while you sleep sleep apnea 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.
Using AndroGel with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin corticosteroids medicines that decrease blood clotting Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
How should I use AndroGel? It is important that you apply AndroGel exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much AndroGel to apply and when to apply it. Your healthcare provider may change your AndroGel dose.
Do not change your AndroGel dose without talking to your healthcare provider. AndroGel is for skin use only. Do not allow others to apply AndroGel to your body. Applying AndroGel: AndroGel comes in a pump or in packets.
If you are using the AndroGel pump: Before using the pump for the first time, you will need to prime the pump. To prime AndroGel, fully push down on the pump 3 times. Do not use any AndroGel that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your AndroGel pump is ready to use now. Your healthcare provider will tell you the number of times to press the pump for each dose.
If you are using AndroGel packets: Tear open the packet completely at the dotted line. Squeeze all of the AndroGel out of the packet into the palm of your hand. Squeeze from the bottom of the packet to the top. Throw away the packet in the trash out of the reach of children to avoid accidental exposure. Squeeze the medicine into the palm of your hand and apply to clean dry, intact skin at the same time each day.
Conversely, the presence of this link does not imply the linked site's endorsement of AndroGel. When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part D , Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE.
Initiating Therapy. Four steps to help initiate treatment Patients with adult male hypogonadism due to an associated medical condition may face uncertainty when beginning testosterone replacement therapy TRT. Specify the starting dose of AndroGel 1. Set expectations 1 Talk specifically with patients about what to expect during treatment, including: The amount of time it may take for testosterone levels to normalize The need for ongoing monitoring to ensure patients are on the right dose The need to properly apply AndroGel 1.
Clarify application instructions 1 Provide clear instructions on how to apply AndroGel 1. Prescribing AndroGel 1. Days: Apply 2 pump presses to one upper arm and shoulder and then apply 1 pump press to the opposite upper arm and shoulder once daily in the morning. It is best to apply testosterone gel or solution in the morning. To help you remember to apply testosterone topical, apply it at around the same time every day.
Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. But heart attacks aren't the only dramatically increased health-related AndroGel risk and other testosterone supplements. For patients taking these treatments, the risk of stroke also skyrockets.
Strokes, like a heart attack, can be fatal. While using Androgel , patients were instructed to apply the gel to the upper arms, shoulders and abdomen. While using Testim , patients were instructed to apply the gel to the upper arms and shoulders. In addition, people who abuse testosterone may experience withdrawal symptoms when they stop taking the drug. Those symptoms can include fatigue, irritability, loss of appetite, insomnia and decreased libido. Testim 1 percent testosterone gel is supplied in tubes and applied once daily.
As this study has shown in a randomized, double-blind, double-dummy, placebo-controlled manner, exogenous testosterone therapy with Androgel can clearly decrease sperm production and potentially impact fertility," said Dr.
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