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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Testosterone Gel, 1%
Generic Name
Testosterone Gel, 1%
Active Ingredient
TestosteroneCategory
Androgen [EPC]
Salt Form
Cypionate
Variants
2
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 10 mg/g | GEL | TRANSDERMAL | 21922-019 |
| 10 mg/g | GEL | TRANSDERMAL | 72162-1274 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Testosterone Gel, 1%, you must consult a qualified healthcare professional.
Detailed information about Testosterone Gel, 1%
Testosterone is a primary androgenic hormone used in replacement therapy for males with conditions associated with a deficiency or absence of endogenous testosterone. It belongs to the Androgen [EPC] drug class and is essential for the development of male sex characteristics.
The dosage of Testosterone Cypionate is highly individualized based on the patient's age, diagnosis, and clinical response. For the treatment of male hypogonadism, the standard adult dosage typically ranges from 50 mg to 400 mg administered every 2 to 4 weeks. Healthcare providers often start with a lower dose and adjust based on serum testosterone levels measured just before the next injection (trough levels). For example, a common starting regimen might be 200 mg every 2 weeks. The goal of therapy is to maintain testosterone levels within the mid-normal range (typically 300 to 1,000 ng/dL).
Testosterone should be used with extreme caution in pediatric patients. For the stimulation of puberty in carefully selected males with delayed puberty, doses of 40 to 50 mg/m² per month are sometimes used for a limited period (usually 4 to 6 months). Because testosterone can cause premature closure of the epiphyseal plates (growth plates), healthcare providers must perform X-rays of the hand and wrist every 6 months to monitor bone age. Testosterone is generally not recommended for children under the age of 12 unless specifically directed by a pediatric endocrinologist.
Specific dosage adjustment guidelines for patients with renal impairment are not provided in the standard labeling. However, because testosterone can cause fluid retention (edema), patients with pre-existing renal disease must be monitored closely. If significant edema occurs, the medication may need to be discontinued or the dose reduced.
Testosterone is metabolized by the liver. While specific dose adjustments for mild hepatic impairment are not always required, the drug should be used with caution in patients with significant liver dysfunction. Prolonged use of high doses of androgens has been associated with hepatic adenomas and peliosis hepatis.
Clinical studies of testosterone replacement therapy in men over the age of 65 are limited. There is some evidence that older men may be at a higher risk for cardiovascular events and prostate enlargement while on testosterone. Healthcare providers typically use the lowest effective dose and monitor prostate-specific antigen (PSA) levels and hematocrit more frequently in this population.
Testosterone Cypionate is intended for intramuscular (IM) injection only. It should never be administered intravenously. The injection is typically given in the gluteal muscle (buttocks).
If you miss a scheduled injection, contact your healthcare provider to reschedule. Do not double the dose to catch up. Maintaining a consistent schedule is important for keeping your hormone levels stable and avoiding the "rollercoaster" effect of fluctuating testosterone levels.
Acute overdose of testosterone is unlikely to result in life-threatening toxicity. However, chronic overuse or very high doses can lead to symptoms such as extreme mood swings, aggressive behavior, high blood pressure, and fluid retention. In the event of a suspected overdose or if someone has accidentally swallowed the injection solution, contact a poison control center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or frequency of administration without medical guidance, as this can lead to hormonal imbalances and adverse effects.
Many patients starting testosterone therapy experience mild to moderate side effects as their bodies adjust to the exogenous hormone. Common side effects include:
Testosterone is a Schedule III controlled substance under the Controlled Substances Act. This classification is due to the potential for misuse and abuse, particularly by individuals seeking to enhance athletic performance or physical appearance. Abuse of testosterone can lead to severe adverse outcomes, including heart attack, heart failure, stroke, liver disease, and psychiatric disturbances such as "roid rage" (extreme aggression). It is vital to use this medication only as prescribed by a licensed healthcare provider.
No specific FDA black box warning exists for Testosterone Cypionate regarding secondary exposure (unlike gels); however, healthcare providers are cautioned about the risk of serious pulmonary oil microembolism (POME) reactions and anaphylaxis. These reactions can be life-threatening and require immediate medical intervention. Always ensure your injections are administered by a trained professional or that you have been thoroughly trained in the correct technique.
There are few drugs that are strictly contraindicated with testosterone, but it should never be used alongside other anabolic steroids or non-prescribed androgens. Using multiple androgenic agents significantly increases the risk of liver damage, cardiovascular strain, and severe hormonal imbalances. Additionally, testosterone should not be used by women who are pregnant or may become pregnant due to the risk of virilization of the fetus.
Testosterone must NEVER be used in the following circumstances:
Testosterone is strictly contraindicated in women who are pregnant. According to the FDA, androgens like testosterone can cause fetal harm when administered to a pregnant woman. Specifically, exposure to androgens during pregnancy can lead to the virilization of a female fetus, resulting in the development of male physical traits (clitoral hypertrophy, labial fusion). If pregnancy occurs while taking this medication, it must be discontinued immediately, and the patient should be apprised of the potential hazard to the fetus.
It is not known whether exogenous testosterone is excreted in human milk. However, because of the potential for serious adverse reactions in nursing infants (including premature puberty and bone age advancement), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. In general, testosterone therapy is not indicated for women who are breastfeeding.
In children, testosterone must be used with extreme caution. The primary concern is the acceleration of bone maturation without a compensatory gain in linear growth. This can result in the premature closure of the epiphyses and a reduced final adult height. Pediatric endocrinologists typically monitor bone age every 6 months via X-ray. Testosterone can also cause precocious (early) puberty in young males. It is not approved for use in children under 12 years of age for hypogonadism.
Testosterone Cypionate is an esterified form of the endogenous androgen testosterone. The mechanism of action involves the binding of testosterone to specific nuclear androgen receptors (AR) in target tissues. Once bound, the testosterone-AR complex acts as a transcription factor, migrating to the cell nucleus and binding to androgen response elements (AREs) on the DNA. This process stimulates the expression of genes involved in the development of male primary and secondary sex characteristics, such as muscle growth, bone density, and the stimulation of erythropoiesis (red blood cell production). In some tissues, testosterone is converted to dihydrotestosterone (DHT) by 5-alpha-reductase, which has an even higher affinity for the AR.
Testosterone exhibits a dose-response relationship regarding its effects on muscle mass, strength, and sexual function. The onset of effect varies; improvements in libido may be noticed within 3 to 6 weeks, while changes in muscle mass and bone density may take 6 months or longer. Chronic administration of exogenous testosterone suppresses the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland through a negative feedback loop, which leads to a decrease in endogenous testosterone and sperm production.
Common questions about Testosterone Gel, 1%
Testosterone is primarily used as a hormone replacement therapy (HRT) for men who have low levels of natural testosterone, a condition known as hypogonadism. It is prescribed to treat both primary hypogonadism (testicular failure) and hypogonadotropic hypogonadism (pituitary or hypothalamic failure). By restoring testosterone levels to a normal range, it helps improve symptoms like low sex drive, fatigue, loss of muscle mass, and depressed mood. In some specific cases, it may also be used to treat delayed puberty in adolescent boys. It is not intended for use in men with age-related low testosterone unless a specific medical condition is present.
The most common side effects of testosterone injections include reactions at the injection site, such as pain, redness, or swelling. Patients also frequently report an increase in acne, oily skin, and mild fluid retention which may cause swelling in the ankles or feet. Some men may experience breast tenderness or enlargement (gynecomastia) due to the conversion of testosterone into estrogen. Mood changes, including increased irritability or nervousness, are also common, particularly shortly after an injection. Most of these side effects are manageable, but you should discuss any persistent symptoms with your healthcare provider.
There is no direct chemical interaction that makes drinking alcohol strictly prohibited while on testosterone therapy. However, moderate to heavy alcohol consumption can interfere with the effectiveness of the treatment by further suppressing natural hormone production and increasing the risk of liver strain. Alcohol can also worsen certain side effects of testosterone, such as fluid retention and sleep disturbances. For the best results from your therapy, healthcare providers generally recommend limiting alcohol intake. Always consult your doctor about your lifestyle habits to ensure they don't interfere with your medical treatment.
No, testosterone is absolutely not safe during pregnancy and is classified by the FDA in Pregnancy Category X. If a pregnant woman is exposed to testosterone, it can cause significant and permanent birth defects in a female fetus, specifically virilization (the development of male physical characteristics). Women who are pregnant or planning to become pregnant should avoid all contact with testosterone products. If you are a woman using testosterone for a specific medical reason and become pregnant, you must stop the medication immediately and contact your doctor. Men using testosterone should also be careful to prevent secondary exposure to their pregnant partners.
The timeline for seeing results from testosterone therapy varies depending on the symptom being treated. Improvements in sexual desire and libido typically begin within 3 to 6 weeks of starting treatment. Changes in mood and quality of life may also be noticed within the first month. However, physical changes such as increased muscle mass, decreased body fat, and improved bone density take much longer, often requiring 3 to 6 months of consistent therapy to become evident. Your doctor will monitor your blood levels and clinical progress to ensure the medication is working effectively for you.
Stopping testosterone therapy suddenly is generally not recommended because it can cause your hormone levels to crash, leading to unpleasant withdrawal-like symptoms. These symptoms can include extreme fatigue, depression, irritability, loss of appetite, and a significant drop in libido. Because exogenous testosterone suppresses your body's own natural production, it takes time for your system to start making its own hormones again after you stop the medication. If you need to discontinue therapy, your healthcare provider will likely suggest a gradual tapering process or may prescribe other medications to help stimulate your natural hormone production.
If you miss a scheduled dose of Testosterone Cypionate, you should contact your healthcare provider as soon as possible to reschedule your injection. Do not attempt to administer a double dose to make up for the missed one, as this can cause your testosterone levels to spike too high, increasing the risk of side effects. Maintaining a regular injection schedule is crucial for keeping your hormone levels stable. If you find it difficult to remember your appointments, consider setting a reminder on your phone or using a calendar to track your treatment schedule.
Testosterone can cause changes in body weight, but the type of weight gained is usually different from typical fat gain. Many men experience an increase in lean muscle mass and a decrease in body fat while on therapy, which may lead to a slight increase in overall body weight. However, testosterone can also cause the body to retain sodium and water, leading to edema (swelling) and water weight gain. If you notice sudden, rapid weight gain or significant swelling in your legs and feet, you should notify your doctor, as this could be a sign of fluid retention that needs to be managed.
Testosterone can interact with several other medications, so it is vital to provide your doctor with a full list of everything you are taking. Significant interactions occur with blood thinners like warfarin, as testosterone can increase the risk of bleeding. It may also affect blood sugar levels, requiring adjustments to insulin or oral diabetes medications. Additionally, taking testosterone with corticosteroids can increase the risk of fluid retention and swelling. Your healthcare provider will review your current medications to ensure that testosterone is safe for you and will monitor you closely for any signs of drug interactions.
Yes, Testosterone Cypionate is widely available as a generic medication. Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name version (such as Depo-Testosterone). Generic testosterone is typically much more affordable than brand-name products and is covered by most insurance plans. When you receive your prescription, the vial may look different depending on the manufacturer, but the clinical effect should be identical. Talk to your pharmacist if you have questions about the specific generic version you are receiving.
Other drugs with the same active ingredient (Testosterone)
> Warning: Stop taking Testosterone and call your doctor immediately if you experience any of these serious symptoms:
Prolonged use of testosterone may lead to several chronic health considerations. One of the most significant is the potential for prostate enlargement (benign prostatic hyperplasia) or the stimulation of subclinical prostate cancer. While testosterone does not necessarily cause prostate cancer, it can cause existing tumors to grow more rapidly. Long-term use also results in the suppression of the hypothalamic-pituitary-gonadal axis, which means the body may stop producing its own testosterone entirely, leading to a dependence on replacement therapy. Additionally, chronic elevation of red blood cell counts requires regular monitoring to avoid vascular complications.
While Testosterone Cypionate does not carry the same "Secondary Exposure" black box warning as testosterone gels (which can rub off on others), it is subject to the class-wide FDA warnings regarding the risk of Pulmonary Oil Microembolism (POME) and Anaphylaxis. Although more commonly associated with the undecanoate ester, any oil-based injection carries a risk where tiny droplets of oil enter the bloodstream and travel to the lungs. Symptoms include an immediate urge to cough, shortness of breath, dizziness, and chest pain occurring during or immediately after the injection. Patients must be monitored by a healthcare professional for a period after the injection to ensure safety.
Report any unusual symptoms or side effects to your healthcare provider promptly to ensure your treatment remains safe and effective.
To ensure the safety of testosterone therapy, your healthcare provider will require regular laboratory monitoring:
Testosterone generally does not interfere with the ability to drive or operate heavy machinery. However, if you experience dizziness or sudden changes in vision as a side effect, avoid these activities until you know how the medication affects you.
There is no direct contraindication between alcohol and testosterone; however, excessive alcohol consumption can lower natural testosterone levels and worsen certain side effects like fluid retention and liver strain. It is best to consume alcohol only in moderation while on hormone replacement therapy.
Do not stop taking testosterone abruptly without consulting your doctor. Sudden discontinuation can lead to symptoms of hormone withdrawal, including extreme fatigue, depression, loss of libido, and irritability. If you need to stop therapy, your doctor may suggest a tapering schedule or provide other medications to help restart your body's natural hormone production.
> Important: Discuss all your medical conditions, especially heart, liver, or kidney disease, with your healthcare provider before starting Testosterone.
Testosterone therapy can interfere with several laboratory tests:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete list helps prevent dangerous interactions and ensures your therapy is as effective as possible.
Conditions requiring a careful risk-benefit analysis by a healthcare professional include:
Patients who are allergic to other androgenic steroids may also be allergic to testosterone. Furthermore, because Testosterone Cypionate is formulated in cottonseed oil, individuals with a severe nut or seed allergy should exercise caution and inform their doctor. If an allergic reaction occurs (hives, swelling, difficulty breathing), seek emergency care immediately.
> Important: Your healthcare provider will evaluate your complete medical history and perform necessary screenings (like a PSA test) before prescribing Testosterone to ensure it is safe for you.
There is insufficient data from controlled clinical trials to determine if men over 65 respond differently than younger men. However, geriatric patients may be at an increased risk for developing prostatic hypertrophy (enlarged prostate) and prostatic carcinoma. There is also a heightened concern regarding the cardiovascular safety of testosterone in older men. Healthcare providers often monitor PSA levels and hematocrit more frequently in this age group and start with the lowest possible dose.
Testosterone should be used with caution in patients with renal impairment due to the risk of sodium and water retention. Patients with pre-existing kidney disease should be monitored for signs of edema (swelling) and increases in blood pressure. No specific GFR-based (Glomerular Filtration Rate) dose adjustments are standardized, but therapy should be individualized.
Because testosterone is primarily metabolized by the liver, patients with hepatic impairment may experience higher systemic levels of the drug. Prolonged use of high-dose androgens has been linked to rare but serious liver conditions like peliosis hepatis (blood-filled cysts in the liver). Regular liver function tests are recommended for any patient with a history of liver disease who is starting testosterone therapy.
> Important: Special populations require individualized medical assessment. Always disclose your full medical history and any plans for pregnancy to your healthcare provider.
| Parameter | Value |
|---|---|
| Bioavailability | 100% (Intramuscular) |
| Protein Binding | 98% (SHBG and Albumin) |
| Half-life | ~8 days (Cypionate ester) |
| Tmax | 24 - 72 hours (Peak levels) |
| Metabolism | Hepatic (CYP3A4 involvement) |
| Excretion | Renal 90%, Fecal 6% |
Testosterone belongs to the therapeutic class of Androgens. It is chemically categorized as an anabolic-androgenic steroid (AAS). Related medications in this class include Testosterone Enanthate, Testosterone Undecanoate, and Methyltestosterone. While all share a similar core structure, their pharmacokinetic profiles differ significantly based on the ester attached to the testosterone molecule.