Testosterone 10mg/act Gel(120pumps)
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication only as directed.
Apply this medication to your skin only, as instructed by your doctor. Do not take it by mouth.
Wash your hands before and after applying the medication to prevent spreading it to other parts of your body or to other people.
Use this medication at the same time every day to maintain a consistent routine.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid applying this medication to sensitive areas, such as the genitals, and keep it out of your eyes.
If you're using a pump, prime it according to the package insert instructions before the first use. Some products come in pumps, while others come in packets.
After Applying the Medication
Wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific instructions.
Allow the medication to dry completely before covering the treated area with clothing.
Avoid exposure to fire, flames, or smoking until the medication is dry.
Apply the medication to clean, dry, healthy skin.
Specific Application Instructions
Certain products are designed for use on specific areas of the body. Be sure to read the package insert to understand where to apply this medication.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
Protect the medication from heat or open flames.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply the gel to clean, dry, intact skin of the front and inner thighs only. Do not apply to other body parts like the abdomen, chest, or genitals.
- Wash hands thoroughly with soap and water immediately after applying the gel.
- Allow the application site to dry completely before dressing. This usually takes several minutes.
- Cover the application site with clothing after the gel has dried to prevent transfer to others.
- Avoid skin-to-skin contact with other people (especially women and children) at the application site for at least 2 hours after application, or until the site is washed.
- Shower or wash the application site thoroughly before any anticipated skin-to-skin contact with others.
- Do not swim, shower, or wash the application site for at least 2-5 hours after application to ensure proper absorption.
- Store at room temperature, away from moisture and heat. Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
- Testosterone Cyp 200mg/ml Sdv 1ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Cyp 200mg/ml Mdv 10ml
- Testosterone Enan 200mg/ml Mdv 5ml
- Testosterone Cyp 100mg/ml Mdv 10ml
- Testosterone 1%(50mg)gel 5gm Pkt
- Testosterone 1% (12.5mg/1.25gm)pump
- Testosterone 1%(50mg) Gel 5gm Udt
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 1% Gel(25mg)30x2.5gm
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 30mg/act Solution
- Testosterone 30mg/act Topsolution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 10mg/act Gel(120pumps)
- Testosterone 30mg/act Solution
- Testosterone 1.62% Gel (60 Pumps)
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone 1%(50mg) Gel 5gm Pk
- Testosterone 1.62%(40.5mg/2.5gm)pkt
- Testosterone 1.62%(20.25mg/1.25gm)
- Testosterone Cyp 100mg/ml Mdv 10ml
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Prolonged or frequent erections (priapism)
Urinary problems, such as:
+ Difficulty starting or stopping urination
+ Painful urination
+ Weak or interrupted urine flow
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Suicidal thoughts
Breast changes, such as:
+ Enlargement
+ Pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Gastrointestinal issues, such as:
+ Upset stomach
+ Vomiting
Sleep-related breathing difficulties
Excessive daytime sleepiness
Weakness or numbness on one side of the body
Speech or cognitive difficulties
Balance problems
Drooping or facial weakness
Blurred vision
Skin color changes
Testicular changes (size or shape)
Blood Clots and Liver Problems
Seek immediate medical attention if you experience any signs of a blood clot, such as:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty speaking or swallowing
Liver problems can be life-threatening. Contact your doctor right away if you notice any signs of liver issues, including:
Dark urine
Fatigue
Decreased appetite
Stomach pain or upset
Light-colored stools
Vomiting
Yellow skin or eyes
Other Side Effects
While many people may not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help:
Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the application site
Reporting Side Effects
This list is not exhaustive. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of virilization in women or children (e.g., increased body hair, acne, voice changes, enlarged clitoris in females; enlarged penis/clitoris, early puberty signs in children). Seek immediate medical attention.
- Signs of blood clots (e.g., pain, swelling, warmth, or redness in a leg; sudden chest pain; shortness of breath). Seek immediate medical attention.
- Signs of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream).
- Signs of fluid retention (e.g., swelling in ankles, feet, or hands; sudden weight gain).
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, unusual tiredness).
- Severe skin irritation or rash at the application site.
- Changes in mood, aggression, or irritability.
- Worsening or new onset of sleep apnea (interrupted breathing during sleep).
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, including heart disease, kidney disease, or liver disease.
Additionally, please note the following:
This medication is not approved for use in females. If you are female, you should not take this medication, as it may harm an unborn baby if taken during pregnancy. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss this with your doctor.
* This medication is not intended for children. Do not give this medication to a child.
To ensure safe treatment, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to assess potential interactions and determine the safety of taking this medication with your other treatments. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
If you have diabetes, you will need to closely monitor your blood sugar levels.
There may be an increased risk of developing prostate cancer. Discuss this with your doctor.
If you have an enlarged prostate, your symptoms may worsen while using this medication. Contact your doctor if you experience any changes.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
High blood pressure has been reported in individuals taking this medication. Follow your doctor's instructions for regular blood pressure checks.
High blood pressure can increase the risk of heart attack, stroke, or death from heart disease. If you have a history of high blood pressure or heart disease, discuss this with your doctor.
Treatment with this medication may lead to elevated cholesterol and triglyceride levels. The impact of these changes on heart health is unknown, so it is crucial to discuss this with your doctor.
Regularly undergo blood work and other laboratory tests as advised by your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, notify your doctor and discuss this further.
This medication is an anabolic steroid, and anabolic steroid abuse can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.
In some individuals with cancer, high calcium levels have been reported with medications similar to this one. Immediately contact your doctor if you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain.
If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these effects may include aggressive behavior, enlarged sex organs, or premature pubic hair growth. In females, these effects may include a deepened voice, changes in body hair, or acne. If this occurs, contact your doctor promptly.
If a pregnant individual comes into contact with the gel or solution, contact your doctor immediately.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.
High doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after discontinuing the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Symptoms of excessive androgen exposure (e.g., severe acne, increased body hair, irritability, aggression, fluid retention, polycythemia).
- No specific symptoms of acute overdose are reported for transdermal testosterone, but chronic excessive exposure can lead to adverse effects.
What to Do:
Discontinue the medication and seek medical attention. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Major Interactions
- Warfarin (and other oral anticoagulants)
- Corticosteroids
Moderate Interactions
- Insulin and oral hypoglycemic agents
- Thyroid hormones
Confidence Interactions
Monitoring
Baseline Monitoring
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Before initiation of therapy (at least two morning measurements)
Rationale: To screen for prostate cancer, as testosterone therapy can stimulate prostate growth.
Timing: Before initiation of therapy
Rationale: To assess for polycythemia, a common side effect of testosterone therapy.
Timing: Before initiation of therapy
Rationale: To assess cardiovascular risk factors, as testosterone therapy can affect lipid profiles.
Timing: Before initiation of therapy
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.
Timing: Before initiation of therapy (if clinically indicated)
Routine Monitoring
Frequency: 2-4 weeks after initiation or dose adjustment, then every 6-12 months
Target: 300-1000 ng/dL (or within the mid-normal range for healthy young men)
Action Threshold: If levels are consistently above 1000 ng/dL, reduce dose or discontinue. If levels are consistently below 300 ng/dL, consider dose increase.
Frequency: Baseline, at 3-6 months, then annually
Target: <54%
Action Threshold: If Hct >54%, reduce dose, temporarily discontinue therapy, or consider phlebotomy.
Frequency: Baseline, at 3-6 months, then annually (more frequently in men at higher risk for prostate cancer)
Target: Age-dependent, stable
Action Threshold: Significant increase in PSA or abnormal prostate exam warrants further urological evaluation.
Frequency: Annually
Target: Normal ranges for LDL, HDL, triglycerides
Action Threshold: Significant adverse changes may require dose adjustment or discontinuation, and/or lipid-lowering therapy.
Symptom Monitoring
- Signs of virilization (e.g., hirsutism, voice deepening, clitoromegaly in females; premature epiphyseal closure, phallic enlargement in children)
- Fluid retention/edema (e.g., swelling of ankles, feet, hands)
- Prostate symptoms (e.g., urinary frequency, urgency, difficulty urinating)
- Gynecomastia
- Mood changes (e.g., irritability, aggression)
- Sleep apnea (worsening or new onset)
- Skin reactions at application site (e.g., irritation, rash)
- Signs of venous thromboembolism (e.g., leg pain, swelling, redness; chest pain, shortness of breath)
Special Patient Groups
Pregnancy
Contraindicated. Testosterone can cause virilization of a female fetus.
Trimester-Specific Risks:
Lactation
Contraindicated. Testosterone is excreted in breast milk and can cause serious adverse reactions in a breastfed infant.
Pediatric Use
Contraindicated in children due to the risk of virilization (e.g., phallic enlargement, premature development of secondary sexual characteristics) and premature epiphyseal closure, which can result in compromised adult height. Safety and efficacy have not been established.
Geriatric Use
Older men treated with testosterone may be at increased risk for prostate enlargement (benign prostatic hyperplasia) and prostate cancer. Increased monitoring of PSA and prostate exams is recommended. Also, potentially increased risk of cardiovascular events.
Clinical Information
Clinical Pearls
- Proper application technique is critical to ensure adequate absorption and minimize the risk of secondary exposure to women and children. Emphasize hand washing and covering the application site.
- Testosterone gel should be applied to clean, dry, intact skin. Avoid applying to broken or irritated skin.
- Patients should be advised to wait at least 2-5 hours after application before showering or swimming to allow for optimal absorption.
- Regular monitoring of serum testosterone, hematocrit, and PSA is essential to ensure therapeutic levels, detect polycythemia, and screen for prostate issues.
- Counsel patients on the signs and symptoms of potential adverse effects, including virilization in others, fluid retention, and symptoms of venous thromboembolism.
- Consider alternative formulations (e.g., injections, patches) if patient adherence to daily gel application or concerns about secondary transfer are significant.
Alternative Therapies
- Other testosterone formulations (e.g., injectable testosterone esters like testosterone cypionate or enanthate, testosterone transdermal patches, testosterone buccal systems, testosterone subcutaneous pellets, testosterone nasal gel)
- For secondary hypogonadism: Gonadotropin therapy (e.g., hCG) to stimulate endogenous testosterone production
- Lifestyle modifications (e.g., weight loss, exercise) for some cases of functional hypogonadism
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.