Androgel 1.62% (20.25mg/1.25gm)pump

Manufacturer ABBVIE Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation AN-droh-jel (tes-TOS-ter-own)
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; Sex hormone
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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 clear, colorless gel containing testosterone, a male hormone. It is used to treat adult men who have low or no testosterone due to certain medical conditions. You apply it to your skin, usually on your shoulders, upper arms, or abdomen, once a day. It helps restore testosterone 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. It is 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 are using a pump, prime it according to the package insert instructions before the first use.
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.
To minimize fire risk, avoid exposure to flames, sparks, or smoking until the medication is dry.
Apply this medication to clean, dry, healthy skin only.
Certain products are designed for specific areas of the body, so ensure you understand where to apply this medication. Consult the package insert for more information.

Storage and Disposal

To maintain the medication's effectiveness and safety:

Store it at room temperature, avoiding freezing temperatures.
Keep it in a dry place, away from bathrooms and areas prone to moisture.
Protect the medication from heat sources, open flames, or sparks.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for the missed one.
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Lifestyle & Tips

  • Apply the gel to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Do not apply to the genitals, chest, or other areas.
  • Wash your 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.
  • Avoid skin-to-skin contact with other people (especially women and children) at the application site. If contact is anticipated, wash the application site thoroughly with soap and water prior to contact.
  • Do not swim or shower for at least 5 hours after applying the gel 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: Initial dose: 40.5 mg (2 pump actuations) applied once daily to shoulders, upper arms, or abdomen.
Dose Range: 20.25 - 81 mg

Condition-Specific Dosing:

hypogonadism: Initial dose: 40.5 mg (2 pump actuations) applied once daily. Dose may be adjusted based on serum testosterone levels, not to exceed 81 mg (4 pump actuations) daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Contraindicated for use in children due to risk of adverse effects on bone maturation and virilization)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for fluid retention.
Dialysis: Use with caution. Monitor for fluid retention and adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution. Monitor for fluid retention and adverse effects.
Severe: No specific dose adjustment recommended, use with caution. Monitor for fluid retention and adverse effects.

Pharmacology

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Mechanism of Action

Testosterone is an endogenous androgen, responsible for the normal growth and development of male sex organs and for maintenance of secondary sex characteristics. It acts by binding to androgen receptors in target tissues, forming a hormone-receptor complex that translocates to the nucleus and regulates gene expression, leading to protein synthesis and cellular differentiation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% (topical absorption varies significantly)
Tmax: Approximately 4-7 hours after application
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Approximately 1 L/kg (for endogenous testosterone)
ProteinBinding: Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (some penetration, but clinical significance for topical application is not primary)

Elimination:

HalfLife: Approximately 10-100 minutes (for endogenous testosterone in circulation); effective half-life from topical application is longer due to reservoir effect in skin, leading to sustained release.
Clearance: Approximately 1.2 L/min (for endogenous testosterone)
ExcretionRoute: Approximately 90% in urine (as conjugates of testosterone and its metabolites), 6% in feces (unconjugated metabolites)
Unchanged: Less than 6% (in urine)
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Pharmacodynamics

OnsetOfAction: Within days to weeks for clinical effects (e.g., libido, energy); serum levels increase within hours.
PeakEffect: Weeks to months for full therapeutic effects (e.g., muscle mass, bone density).
DurationOfAction: Daily application maintains therapeutic levels.

Safety & Warnings

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BLACK BOX WARNING

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Cases of secondary exposure 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 recommended application instructions to minimize the potential for secondary exposure.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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
+ Trouble 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
+ Passing out
+ Changes in eyesight
Prolonged or frequent erections
Urination problems, such as:
+ Trouble passing urine
+ Pain while passing urine
+ Weak or dripping urine stream
+ Frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Enlarged breasts or breast pain
Shortness of breath, significant weight gain, or swelling in the arms or legs
Upset stomach or vomiting
Trouble breathing while sleeping
Excessive daytime sleepiness
Weakness on one side of the body, trouble speaking or thinking, balance changes, 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
+ Trouble speaking or swallowing
Liver problems, which can be life-threatening. Seek medical help if you experience:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Headache
Acne
Diarrhea
Emotional changes
Fatigue or weakness
Trouble sleeping
* Irritation at the site of application

This is not an exhaustive list of possible side effects. 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 who may have come into contact with the gel (e.g., new or increased body hair, acne, voice deepening, enlarged clitoris in females; enlarged penis/clitoris, premature pubic hair, increased erections/libido, aggressive behavior in children). Seek immediate medical attention.
  • Signs of prostate problems (e.g., difficulty urinating, frequent urination, weak urine stream, blood in urine).
  • Signs of blood clots (e.g., pain, swelling, warmth, redness in leg; sudden shortness of breath, chest pain).
  • Signs of fluid retention (e.g., swelling in ankles or feet, sudden weight gain).
  • Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, nausea, vomiting).
  • Sleep disturbances, including worsening of sleep apnea.
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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. Be sure to describe the allergic reaction you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, such as 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 administer 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 have. Your doctor and pharmacist need this information to verify that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dosage 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.

This medication may cause high blood pressure. 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 pre-existing high blood pressure or heart disease, discuss this with your doctor.

Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor.

Regularly undergo blood work and other laboratory tests as advised by your doctor. This medication may affect the results of certain lab tests, so 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, inform your doctor.

This medication is an anabolic steroid, which has been subject to abuse and misuse in the past. Anabolic steroid abuse can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss this with your doctor.

In some individuals with cancer, medications like this one have caused high calcium levels. 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 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 the medication is discontinued. If you have concerns, discuss this with your doctor.
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Overdose Information

Overdose Symptoms:

  • Headache
  • Nausea
  • Vomiting
  • Diarrhea
  • Fluid retention (edema)
  • Weight gain
  • Increased hematocrit
  • Irritability
  • Acne
  • Hirsutism (excessive hair growth)

What to Do:

There is no specific antidote for testosterone overdose. Treatment is symptomatic and supportive. Discontinue the medication and monitor for adverse effects. In case of suspected overdose, contact a poison control center or emergency medical services. Call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding.
  • Corticosteroids: Concomitant use may increase the risk of fluid retention and edema.
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Moderate Interactions

  • Insulin and oral hypoglycemics: Testosterone may decrease blood glucose, requiring adjustment of antidiabetic medication dosage.
  • Thyroid hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels (though clinical significance is often limited).

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 (morning sample)

Hematocrit and Hemoglobin

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

Timing: Prior to initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer and benign prostatic hyperplasia (BPH) in men over 40.

Timing: Prior to initiation of therapy

Lipid Profile

Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid levels.

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 or dose adjustment, then periodically (e.g., every 3-6 months) once stable.

Target: 300-1000 ng/dL (mid-normal range)

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 and Hemoglobin

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

Target: Hematocrit < 54%

Action Threshold: If hematocrit > 54%, discontinue therapy until hematocrit decreases, then restart at a lower dose or discontinue permanently.

Prostate-Specific Antigen (PSA)

Frequency: At 3, 6, and 12 months after initiation, then annually (for men over 40).

Target: Age-dependent, stable

Action Threshold: Significant increase in PSA or abnormal prostate exam warrants further urological evaluation.

Lipid Profile

Frequency: Annually or as clinically indicated.

Target: Normal ranges

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

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Symptom Monitoring

  • Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, premature puberty)
  • Signs of fluid retention (e.g., edema, weight gain)
  • Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary frequency, urgency, nocturia, decreased stream)
  • Symptoms of cardiovascular events (e.g., chest pain, shortness of breath, leg pain/swelling)
  • Mood changes, aggression, irritability
  • Sleep apnea exacerbation

Special Patient Groups

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Pregnancy

Contraindicated in pregnant women. Testosterone is known to cause virilization of the female fetus.

Trimester-Specific Risks:

First Trimester: High risk of virilization of female fetus (e.g., clitoral enlargement, abnormal external genitalia).
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. Testosterone is excreted in breast milk and may cause serious adverse reactions in the nursing infant.

Infant Risk: High risk of virilization in the nursing infant.
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Pediatric Use

Contraindicated in children. Safety and efficacy have not been established. Use in children may cause accelerated bone maturation and premature epiphyseal closure, resulting in compromised adult height, and may cause virilization.

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Geriatric Use

Use with caution in elderly men. Increased risk of prostate enlargement (BPH) and prostate cancer. Increased risk of cardiovascular events. More frequent monitoring of PSA, hematocrit, and prostate health is recommended.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to application instructions to prevent secondary exposure to women and children.
  • Patients should be advised that the full therapeutic effects may take several weeks to months to become apparent.
  • Regular monitoring of testosterone levels, hematocrit, and PSA is crucial for safe and effective therapy.
  • Educate patients on signs of virilization in household contacts and the importance of immediate medical attention if observed.
  • Consider alternative formulations (e.g., injections, patches) if topical application is problematic due to adherence, skin irritation, or transfer risk.
  • Androgel 1.62% is more concentrated than Androgel 1%, requiring fewer pump actuations for the same dose of testosterone.
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Alternative Therapies

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

Average Cost: Varies widely, typically $400-$800 per 75gm pump (approx. 30 days supply)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), 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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.