Androgel 1.62% (40.5mg/2.5gm)pkts

Manufacturer ABBVIE Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation AN-dro-jel (for Androgel); tes-TOS-ter-own (for Testosterone)
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 2009
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DEA Schedule
Schedule III

Overview

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What is this medicine?

Androgel 1.62% is a gel containing testosterone, a male hormone. It is used to treat men who have low testosterone levels due to certain medical conditions. You apply it to your skin, and the testosterone is absorbed into your body to help restore normal levels, which can 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. Use this medication only on your skin, as directed. It is essential to wash your hands before and after applying the medication.

Application Instructions

Apply the medication at the same time every day.
Be aware that different products may have varying strengths, so carefully read and follow the label instructions.
Avoid getting the medication on other parts of your body or on other people.
Do not apply the medication to the genital area.
* Keep the medication out of your eyes.

Special Instructions for Pump or Packet Products

If you are using a pump product, you will need to prime it before the first use. Follow the priming instructions provided in the package insert. If you are using a packet product, follow the instructions for application.

Post-Application Instructions

After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Refer to the package insert for specific guidance. 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.

Skin Preparation and Application

Apply the medication to clean, dry, healthy skin. Certain products are designed for specific areas of the body, so be sure to read the package insert to understand where to apply the medication.

Storage and Disposal

Store the 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, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Apply the gel to clean, dry, intact skin of the shoulders, upper arms, or abdomen once daily, preferably in the morning.
  • Do not apply to the genitals, breasts, or broken skin.
  • Wash hands thoroughly with soap and water immediately after applying the gel.
  • Allow the application site to dry completely before dressing. Cover the application site with clothing after the gel has dried to prevent transfer to others.
  • Avoid swimming, showering, or washing the application site for at least 2 hours after application.
  • If skin-to-skin contact with another person is anticipated, wash the application site thoroughly with soap and water beforehand.
  • 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: Initial dose of 40.5 mg (one packet) of testosterone applied once daily to the shoulders, upper arms, or abdomen.
Dose Range: 20.25 - 81 mg

Condition-Specific Dosing:

maleHypogonadism: Initial dose of 40.5 mg (one packet) of testosterone applied once daily. The dose may be adjusted based on serum testosterone levels and clinical response, up to a maximum of 81 mg (two packets) daily. Serum testosterone levels should be measured approximately 14 days after initiation of therapy or dose adjustment.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Contraindicated for use in females and not indicated for use in pediatric males under 18 years of age)
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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. Use with caution and monitor for fluid retention.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: Not recommended due to potential for fluid retention and exacerbation of liver disease. Use with extreme caution if necessary, and monitor liver function closely.
Confidence: Medium

Pharmacology

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Mechanism of Action

Endogenous androgens, including testosterone, are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Testosterone acts by binding to androgen receptors in target tissues, forming a hormone-receptor complex that translocates to the nucleus and interacts with DNA to regulate gene expression. Testosterone can also be converted to dihydrotestosterone (DHT) by 5-alpha reductase, which is a more potent androgen, or to estradiol by aromatase.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% of applied testosterone is absorbed systemically.
Tmax: Approximately 4 hours after application.
FoodEffect: Not applicable for transdermal gel.

Distribution:

Vd: Approximately 1 L/kg (for testosterone)
ProteinBinding: Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (Testosterone can cross the blood-brain barrier, but the extent of penetration for transdermal application is not fully quantified.)

Elimination:

HalfLife: Approximately 10-100 minutes (for endogenous testosterone, but the effective half-life from transdermal application is longer due to continuous absorption from the skin reservoir, leading to sustained levels over 24 hours).
Clearance: Approximately 10 mL/min/kg (for endogenous testosterone)
ExcretionRoute: Approximately 90% in urine as conjugates of testosterone and its metabolites; approximately 6% in feces, mostly unconjugated metabolites.
Unchanged: Less than 6% of a testosterone dose is excreted unchanged in the urine.
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Pharmacodynamics

OnsetOfAction: Serum testosterone levels begin to rise within hours of application, reaching steady-state levels within 14 days.
PeakEffect: Steady-state serum testosterone levels are typically achieved by day 14 of daily application.
DurationOfAction: Sustained therapeutic levels for approximately 24 hours with daily application.
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. Androgel 1.62% can transfer from the patient to others in close contact. Patients should be advised to strictly adhere to the instructions for use, including proper application, hand washing, and covering the application site.
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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 immediately or seek emergency 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 speaking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Prolonged or frequent erections
Urination problems, such as:
+ Difficulty starting to urinate
+ Pain while urinating
+ Weak or dribbling urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Suicidal thoughts
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Nausea or vomiting
Sleep apnea (trouble breathing while sleeping)
Excessive daytime sleepiness
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
Signs of a blood clot, including:
+ 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, which can be life-threatening. Seek medical help if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 secondary exposure in women or children (e.g., unexpected hair growth, voice changes, acne, enlarged genitals, aggressive behavior). Seek immediate medical attention.
  • Signs of blood clots (e.g., pain, swelling, warmth, redness in leg; sudden shortness of breath; chest pain). Seek immediate medical attention.
  • Signs of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream, blood in urine). Report to your doctor.
  • Signs of fluid retention (e.g., swelling in ankles or feet, sudden weight gain). Report to your doctor.
  • Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, nausea, vomiting). Report to your doctor.
  • Signs of heart attack or stroke (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech). Seek immediate medical attention.
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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. Describe the allergic reaction you experienced, including any symptoms.
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 use, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without 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 associated with this medication. Be sure to discuss this with your doctor.

Men with an enlarged prostate should be aware that their symptoms may worsen while using this drug. If this occurs, contact your doctor promptly.

Individuals with sleep apnea should consult their doctor, as this condition may worsen with testosterone treatment.

This medication may cause high blood pressure, which can increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly, as advised by your doctor. If you have pre-existing high blood pressure or heart disease, discuss this with your doctor.

Treatment with this medication may lead to elevated cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is crucial to discuss this with your doctor.

Regularly undergo blood work and other laboratory tests as directed by your doctor. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.

There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss this further.

As an anabolic steroid, this medication has the potential for abuse and misuse, which can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver problems, 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. If you experience symptoms such as weakness, confusion, fatigue, headache, nausea, vomiting, constipation, or bone pain, contact your doctor immediately.

If a child or female accidentally comes into contact with the gel or solution, they may experience adverse effects. In children, these can include aggressive behavior, enlarged sex organs, and premature pubic hair growth. In females, possible effects include a deepened voice, changes in body hair, or acne. If this occurs, inform the doctor promptly.

If a pregnant woman is exposed to the gel or solution, contact the doctor immediately.

For individuals 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

It is essential to note that this medication is not approved for treating low testosterone levels caused by aging. Discuss this with your doctor.

Large doses of this medication may affect sperm production in males, potentially impacting fertility. This effect may be irreversible even after stopping the medication. If you have concerns, discuss them with your doctor.
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Overdose Information

Overdose Symptoms:

  • High testosterone levels (e.g., irritability, aggression, acne, polycythemia, fluid retention)
  • Priapism (prolonged, painful erection)

What to Do:

Discontinue the medication and seek medical attention. Symptomatic and supportive care. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Major Interactions

  • Oral anticoagulants (e.g., Warfarin)
  • Corticosteroids (e.g., Prednisone)
  • Insulin and oral hypoglycemic agents
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Moderate Interactions

  • Thyroid hormones (e.g., Levothyroxine)
  • Diuretics (e.g., Furosemide)

Monitoring

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Baseline Monitoring

Serum Total Testosterone

Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.

Timing: Prior to initiation of therapy.

Hematocrit (Hct) and Hemoglobin (Hb)

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

Timing: Prior to initiation of therapy.

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer and establish baseline for monitoring, especially in men over 40.

Timing: Prior to initiation of therapy.

Lipid Panel (Total Cholesterol, HDL, LDL, Triglycerides)

Rationale: Testosterone therapy can affect lipid profiles.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Total Testosterone

Frequency: Approximately 14 days after initiation of therapy or dose adjustment, then periodically (e.g., every 3-6 months) once stable.

Target: 400-700 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 target, consider dose increase.

Hematocrit (Hct) and Hemoglobin (Hb)

Frequency: At 3 and 6 months after initiation, then annually.

Target: Hct < 54%

Action Threshold: If Hct > 54%, reduce dose, temporarily discontinue, or phlebotomize.

Prostate-Specific Antigen (PSA)

Frequency: At 3, 6, and 12 months after initiation, then annually (or more frequently based on age and risk factors).

Target: Age-dependent, stable or decreasing.

Action Threshold: Significant increase from baseline or age-specific norms, or abnormal digital rectal exam (DRE), warrants urological evaluation.

Lipid Panel

Frequency: Annually or as clinically indicated.

Target: Within normal limits.

Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.

Liver Function Tests (LFTs)

Frequency: Periodically, especially if signs of hepatic dysfunction develop.

Target: Within normal limits.

Action Threshold: Significant elevations warrant investigation and potential discontinuation.

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Symptom Monitoring

  • Signs of secondary exposure (e.g., virilization in women or children: clitoromegaly, hirsutism, voice deepening, premature pubic hair, enlarged penis/clitoris, aggressive behavior)
  • Signs of fluid retention (e.g., edema, weight gain)
  • Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary hesitancy, nocturia, decreased stream)
  • Mood changes, irritability, aggression
  • Sleep apnea (new onset or worsening)
  • Cardiovascular symptoms (e.g., chest pain, shortness of breath, leg swelling)
  • Application site reactions (e.g., irritation, rash)

Special Patient Groups

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Pregnancy

Contraindicated in pregnant women. 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 in breastfeeding women. It is not known if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, use is contraindicated.

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

Not indicated for use in pediatric males under 18 years of age. Contraindicated for use in females. Potential for accelerated bone maturation and premature epiphyseal closure in pediatric males, and virilization in pediatric females.

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Geriatric Use

Use with caution in elderly men due to increased risk of benign prostatic hyperplasia (BPH) and prostate cancer. Monitor PSA and DRE closely. Increased risk of cardiovascular events and fluid retention in this population.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to application instructions and precautions to prevent secondary exposure, especially to women and children. This is a Black Box Warning.
  • Regular monitoring of serum testosterone, hematocrit, and PSA is crucial for safe and effective therapy.
  • Patients should be educated on the signs and symptoms of polycythemia, prostate issues, and cardiovascular events.
  • Testosterone therapy is not indicated for age-related decline in testosterone levels in men with normal testosterone levels.
  • Consider alternative formulations (e.g., injections, patches, buccal) if patient compliance with gel application or risk of secondary exposure is a concern.
  • Counsel patients that the full benefits of testosterone therapy may take several weeks to months to become apparent.
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Alternative Therapies

  • Other testosterone gel formulations (e.g., Testim, Fortesta, Vogelxo)
  • Testosterone transdermal patches (e.g., Androderm)
  • Testosterone injections (e.g., Testosterone Cypionate, Testosterone Enanthate)
  • Testosterone buccal system (e.g., Striant)
  • Testosterone nasal gel (e.g., Natesto)
  • Testosterone pellets (e.g., Testopel)
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Cost & Coverage

Average Cost: $400 - $600 per 30 packets (approximate)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand name), Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult 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 details about the medication taken, the amount, and the time it occurred.