Testosterone 10mg/act Gel(120pumps)

Manufacturer ACTAVIS PHARMA Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation tes-TOS-ter-one
WARNING: Wash the site where the drug was used before it touches anyone else's skin.Do not let this drug or the treated area touch anyone else's skin. They could have side effects from touching this drug. Cover the treated area with clothes.If a female or a child touches the gel, they will need to wash their skin with soap and water. @ COMMON USES: It is used to treat low testosterone levels.
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Drug Class
Androgen
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Pharmacologic Class
Androgen receptor agonist
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Pregnancy Category
Category X
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FDA Approved
Aug 2010
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DEA Schedule
Schedule III

Overview

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What is this medicine?

Testosterone gel is a medication applied to the skin to replace the hormone testosterone in men who have low levels (hypogonadism). It helps improve symptoms like low energy, low sex drive, and muscle weakness.
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How to Use This Medicine

Proper Use of This Medication

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: 40 mg (4 actuations) applied once daily to the front and inner thighs
Dose Range: 20 - 70 mg

Condition-Specific Dosing:

hypogonadism: Initial dose of 40 mg (4 actuations) once daily. Dose may be adjusted based on serum testosterone levels and clinical response, up to a maximum of 70 mg (7 actuations) daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Contraindicated due to risk of virilization and premature epiphyseal closure)
Adolescent: Not established (Contraindicated due to risk of virilization and premature epiphyseal closure)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for fluid retention.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution. Monitor for fluid retention and liver function.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for fluid retention and liver function.
Confidence: Medium

Pharmacology

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Mechanism of Action

Testosterone is an endogenous androgen. Androgens bind to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, testes, skeletal muscle, skin, kidney, liver, bone marrow, central nervous system) and regulate gene expression, promoting the development and maintenance of male primary and secondary sexual characteristics. Testosterone and its active metabolite, dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and for the maintenance of secondary sex characteristics.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% (transdermal absorption varies by site and formulation)
Tmax: Approximately 2-4 hours after application
FoodEffect: Not applicable for transdermal gel

Distribution:

Vd: Approximately 1 L/kg
ProteinBinding: Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Endogenous testosterone: 10-100 minutes; Effective half-life from gel: longer due to reservoir effect in skin (approximately 10-100 hours for serum levels to return to baseline after discontinuation)
Clearance: Approximately 1000 mL/min
ExcretionRoute: Urine (approximately 90%), Feces (approximately 10%)
Unchanged: <6% (in urine)
Confidence: Medium
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Pharmacodynamics

OnsetOfAction: Clinical effects (e.g., libido, energy) may be observed within weeks; full effects on muscle mass, bone density, and mood may take months.
PeakEffect: Serum testosterone levels peak approximately 2-4 hours after application.
DurationOfAction: Daily application maintains therapeutic serum levels.
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported. Patients should be advised to strictly adhere to recommended application instructions to minimize the potential for secondary exposure. WARNING: VENOUS THROMBOEMBOLISM (VTE). Cases of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with symptoms of VTE and, if a VTE is suspected, discontinue testosterone treatment and initiate appropriate workup and management.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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.
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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).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

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.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

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.
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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

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Major Interactions

  • Warfarin (and other oral anticoagulants)
  • Corticosteroids
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Moderate Interactions

  • Insulin and oral hypoglycemic agents
  • Thyroid hormones
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Confidence Interactions

Monitoring

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Baseline Monitoring

Serum Testosterone (total and free)

Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.

Timing: Before initiation of therapy (at least two morning measurements)

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer, as testosterone therapy can stimulate prostate growth.

Timing: Before initiation of therapy

Hematocrit (Hct)

Rationale: To assess for polycythemia, a common side effect of testosterone therapy.

Timing: Before initiation of therapy

Lipid Panel

Rationale: To assess cardiovascular risk factors, as testosterone therapy can affect lipid profiles.

Timing: Before initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.

Timing: Before initiation of therapy (if clinically indicated)

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Routine Monitoring

Serum Testosterone (total)

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.

Hematocrit (Hct)

Frequency: Baseline, at 3-6 months, then annually

Target: <54%

Action Threshold: If Hct >54%, reduce dose, temporarily discontinue therapy, or consider phlebotomy.

Prostate-Specific Antigen (PSA)

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.

Lipid Panel

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.

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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

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Pregnancy

Contraindicated. Testosterone can cause virilization of a female fetus.

Trimester-Specific Risks:

First Trimester: High risk of virilization of female fetus.
Second Trimester: High risk of virilization of female fetus.
Third Trimester: High risk of virilization of female fetus.
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Lactation

Contraindicated. Testosterone is excreted in breast milk and can cause serious adverse reactions in a breastfed infant.

Infant Risk: High risk of virilization and other adverse effects in the infant.
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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.

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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

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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.
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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
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 120-pump container
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

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.