Potential for secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Children and women must avoid contact with unwashed or unclothed application sites. Evaluate for prostate cancer prior to and during therapy. Monitor hematocrit prior to initiation, at 3—6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level.
Pre-existing cardiac, renal, or hepatic disease discontinue if edema occurs. Possible sleep apnea in patients with obesity or chronic lung diseases. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Avoid showering or swimming for at least 2hrs after application.
May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. May affect thyroid levels. Androgens, including TESTIM, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4.
Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a controlled clinical study, patients were treated with TESTIM 50 mg or mg or placebo gel for up to 90 days. Subjects could be counted in both TESTIM treatment groups if they received both 50 mg and mg at different points in the study and experienced an adverse reaction at both dose levels. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse reaction.
In the pivotal US and European Phase 3 trials combined, at the mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the mg dose group, 2. The results from these studies are consistent with those reported for the US controlled clinical trial. The following adverse reactions have been identified during post-approval use of testosterone gel products. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Secondary Exposure to Testosterone in Children. Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris with surgical intervention or of the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.
In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported.
Venous thromboembolism [see Warnings and Precautions 5. Myocardial infarction, stroke [see Warnings and Precautions 5. Polycythemia [see Warnings and Precautions 5. Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication. 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 warfarin, especially at the initiation and termination of androgen therapy.
The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease. Testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action [see Contraindications 4 and Clinical Pharmacology Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal development studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. In developmental studies conducted in rats, rabbits, pigs, sheep, and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment.
Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring.
Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. During treatment with large doses of exogenous androgens, including TESTIM, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions 5.
Reduced fertility is observed in some men taking testosterone replacement therapy. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence 9.
With either type of use, the impact on fertility may be irreversible. Improper use may result in acceleration of bone age and premature closure of epiphyses. There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer [see Warnings and Precautions 5. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects.
Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids AAS , and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
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. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Behaviors Associated with Addiction. Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:. Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. There is a single report in the literature of acute overdosage after injection of testosterone enanthate. Treatment of overdosage would consist of discontinuation of TESTIM, washing the application site with soap and water, and appropriate symptomatic and supportive care.
TESTIM testosterone gel is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. The structural formula is shown in the following figure:. Endogenous androgens, including testosterone and dihydrotestosterone DHT , are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.
These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement; vocal cord thickening; and alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has 2 main etiologies.
Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's syndrome or Leydig cell aplasia, while secondary hypogonadism hypogonadotropic hypogonadism is the failure of the hypothalamus or pituitary to produce sufficient gonadotropins FSH, LH. TESTIM testosterone gel delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal concentrations e.
The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. In single-dose studies, when either TESTIM 50 mg or mg was administered, absorption of testosterone into the blood continued for the entire 24 hour dosing period. Also, mean peak and average serum concentrations within the normal range were achieved within 24 hours. With single daily applications of TESTIM 50 mg and mg, follow-up measurements at 30 and 90 days after starting treatment have confirmed that serum testosterone and DHT concentrations are generally maintained within the normal range.
Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin SHBG and albumin. Testosterone is metabolized to various keto steroids through 2 different pathways. The major active metabolites of testosterone are estradiol and DHT. There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to minutes.
Inactivation of testosterone occurs primarily in the liver. In the first trial, 30 couples were evenly randomized to 5 groups. In the first 4 groups, mg of TESTIM was applied to the male abdomen and the couples were then asked to rub abdomen-to-abdomen for 15 minutes at 1 hour, 4 hours, 8 hours or 12 hours after dose application, respectively.
In these couples, serum testosterone concentrations in female partners increased from baseline by at least 6 times and potential for transfer was seen at all time points. When 6 males used a shirt to cover the abdomen at 15 minutes post-application and partners again rubbed abdomens for 15 minutes at the 1-hour time point, serum testosterone concentrations in female partners increased from baseline by approximately 3 times. In the second trial, 24 couples were evenly randomized to 4 groups.
In one group, 15 minutes of direct skin-to-skin rubbing began at 4 hours after application. In these 6 women, all of whom showered immediately after the rubbing activity, mean maximum serum testosterone concentrations increased from baseline by approximately 4 times. When males wore a long-sleeved T-shirt and rubbing was started at 1 and at 4 hours after application, the transfer of testosterone from male to female partners was prevented.
The effect of showering with mild soap at 1, 2 and 6 hours post application of TESTIM mg was evaluated in a clinical trial in 12 men. The study demonstrated that the overall effect of washing was to decrease testosterone concentrations; however, when washing occurred 2 or more hours post drug application, serum testosterone concentrations remained within the normal range. 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. The study was double-blind for the doses of TESTIM and placebo, but open-label for the non-scrotal testosterone transdermal system. At Day 60, patients receiving TESTIM were maintained at the same dose, or were titrated up or down within their treatment group, based on hour averaged serum testosterone concentration obtained on Day Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows:.
Contents are flammable [see Warnings and Precautions 5. Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children. Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:.
Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from TESTIM in men [see Medication Guide ]:. Patients should be informed that treatment with androgens may lead to adverse reactions which include:. San Antonio, TX US Patent Nos. Testim can transfer from your body to others including, children and women.
Children and women should avoid contact with the unwashed or not covered unclothed areas where Testim has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used Testim. Signs and symptoms of early puberty in a child when they come in direct contact with Testim may include:.
Signs and symptoms in women when they come in direct contact with Testim may include:. Stop using Testim and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have placed Testim. To lower the risk of transfer of Testim from your body to others, follow these important instructions:. Testim is a prescription medicine that contains testosterone.
Testim is used to treat adult males who have low or no testosterone due to certain medical conditions. Testim is a controlled substance CIII because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Testim in a safe place to protect it. Never give your Testim to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.
Before using Testim, tell your healthcare provider about all of your medical conditions including if you:. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Testim with certain other medicines can affect each other.
Especially, tell your healthcare provider if you take:. 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. These are not all the possible side effects of Testim. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Testim for a condition for which it was not prescribed. Do not give Testim to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Testim that is written for health professionals. Read this Instructions for Use for Testim before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
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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: 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.
Testosterone may cause fetal harm. Secondary exposure to testosterone can produce signs of virilization.
However, when testosterone is used within the context of an approved therapeutic dose, as in testosterone replacement therapy, it carries a much lower risk of side effects. These drugs were initially developed to help men recover from hypogonadism, delayed puberty, cancer, or surgery, and they are now instrumental in helping millions of men maintain health and quality of life.
Empirical evidence consistently shows that TRT can successfully alleviate these and other symptoms. But more importantly, this therapy helps men regain their confidence and their sense of overall wellness. To learn more about testosterone therapy and how it can help you feel like yourself again, we recommend partnering with a highly qualified doctor in your area who specializes in hormone health.
This practitioner will thoroughly discuss your symptoms and perform a variety of tests to assess your hormone levels before prescribing a testosterone medication that works for you. Topical testosterone, while often prescribed, has to get absorbed through the skin, so often does not give the same results as pellets or injections which get right into the bloodstream. The difference between testosterone therapy and steroids is a matter of intention and outcome.
Reach out to the BodyLogicMD network to get started with testosterone replacement therapy. BodyLogicMD-affiliated practitioners are certified to practice holistic hormone health and integrative medicine and are dedicated to helping men reach their optimal level of health. These highly regarded professionals specialize in creating comprehensive, individualized treatment plans that include hormone medications, nutrition counseling, and lifestyle recommendations for a well-rounded plan of action.
Contact a local practitioner in your area to get started. Or, consider taking the BodyLogicMD Hormone Balance Quiz to learn more about how low testosterone may be impacting you and your daily life. Disclaimer: These statements have not been evaluated by the Food and Drug Administration.
All content on this website is for informational purposes only. The content is not intended diagnose, treat, cure or prevent diseases. Charlotte is a patient care coordinator specializing in bioidentical hormone replacement therapy. She is committed to helping patients who struggle with the symptoms of hormonal change and imbalance explore their treatment options and develop effective strategies to optimize wellness. View all posts.
I prefer natural whenever possible. I would suggest reading this, deciding if you want to try a natural way first, or, if you feel strongly that testosterone gel side-effect potential is something you can overlook. Testim is a topical gel designed to increase testosterone levels in men who suffer from Low T low testosterone. Some people believe that testosterone gel is the solution, and others do not.
We tend to lean more towards actual testosterone booster supplements as opposed to the gel, however there are still some potential benefits to using topical gel. A good testosterone supplement can potentially stimulate the natural production of testosterone in your body via the ingestion of clinically studied ingredients like Fenugreek , D Aspartic Acid , Zinc , etc. Check out our testosterone booster reviews to learn more.
Testim on the other hand is actual testosterone instead of natural ingredients that lead to testosterone production. For that reason, a lot of people believe it works better. According to user reviews, Testim additionally tends to cause more side effects than natural testosterone supplements. We believe your best bet is going to be a natural testosterone booster instead of going with the actual testosterone gel because the natural supplements could potentially get your body to produce its own testosterone in a completely safe and natural way, which is in our opinion much more preferable over Testim.
As I mentioned before, Testim is really comprised of only one ingredient, which is actual testosterone.