Androgel 1.62% (20.25mg/1.25gm)pkts
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.
Drug Class
Androgen
Pharmacologic Class
Androgen receptor agonist
Pregnancy Category
Category X
FDA Approved
Aug 2009
DEA Schedule
Schedule III
Overview
What is this medicine?
Androgel 1.62% is a clear, colorless gel containing testosterone. It is applied to the skin to help men whose bodies do not make enough natural testosterone (a condition called hypogonadism). It helps restore testosterone levels, which can improve symptoms like low energy, low sex drive, and mood changes.
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 and 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 details. 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 Site
Apply the medication to clean, dry, healthy skin. Certain products are designed for use on specific areas of the body. Be sure to read the package insert to determine the correct application site.
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.
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 and 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 details. 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 Site
Apply the medication to clean, dry, healthy skin. Certain products are designed for use on specific areas of the body. Be sure to read the package insert to determine the correct application site.
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.
Lifestyle & Tips
- Apply the gel once daily at approximately the same time each morning, to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Do not apply to the genitals or breasts.
- 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.
- Avoid skin-to-skin contact with other people (especially women and children) at the application site until the gel has dried and the site is covered with clothing or washed.
- If skin-to-skin contact is anticipated, wash the application site thoroughly with soap and water beforehand.
- Do not swim or shower for at least 5 hours after applying the gel to ensure proper absorption.
- Store at room temperature, away from heat and open flame.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 20.25 mg testosterone (one 1.25 g packet) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen.
Dose Range:
20.25 - 81 mg
Condition-Specific Dosing:
dose_titration:
Dose may be adjusted based on serum testosterone levels and clinical response. Serum testosterone should be measured approximately 14 days after initiation of therapy or dose adjustment. The dose can be increased to 40.5 mg, 60.75 mg, or 81 mg daily. The maximum recommended dose is 81 mg daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Contraindicated for most uses due to risk of premature epiphyseal closure and virilization)
Adolescent:
Not established (Use in adolescents with delayed puberty is typically with other formulations and under strict medical supervision; gel not generally recommended due to transfer risk)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution.
Dialysis:
Considerations: Not specifically studied; use with caution and monitor for fluid retention.
Hepatic Impairment:
Mild:
No specific dose adjustment provided; use with caution.
Moderate:
No specific dose adjustment provided; use with caution.
Severe:
No specific dose adjustment provided; use with caution; contraindicated in severe hepatic impairment due to risk of cholestatic hepatitis and jaundice.
Pharmacology
Mechanism of Action
Testosterone is an endogenous androgen. Androgens 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, where it binds to DNA and stimulates gene transcription and protein synthesis. In some tissues, testosterone is converted to dihydrotestosterone (DHT) by 5-alpha reductase, which is a more potent androgen.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9-14% of applied testosterone is absorbed systemically.
Tmax:
Serum testosterone concentrations reach steady-state within 2-4 days of daily application. Tmax is typically 2-4 hours post-application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Approximately 1 L/kg (for endogenous testosterone)
ProteinBinding:
Approximately 98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration:
Yes, but limited; testosterone can cross the blood-brain barrier.
Elimination:
HalfLife:
Endogenous testosterone has a short half-life (10-100 minutes). However, with topical application, a sustained release and absorption lead to relatively stable serum concentrations over 24 hours.
Clearance:
Not readily quantifiable for topical application due to continuous absorption.
ExcretionRoute:
Approximately 90% of a testosterone dose is excreted in the urine as conjugates of testosterone and its metabolites; about 10% is excreted in the feces, mostly as unconjugated metabolites.
Unchanged:
Very little unchanged testosterone is excreted.
Pharmacodynamics
OnsetOfAction:
Clinical effects (e.g., improvement in libido, mood, energy) are gradual, typically observed over weeks to months.
PeakEffect:
Peak therapeutic effects are generally observed after several weeks to months of consistent daily application, once steady-state testosterone levels are achieved and maintained.
DurationOfAction:
Sustained with daily application; serum levels remain elevated for approximately 24 hours after a single dose.
Safety & Warnings
BLACK BOX WARNING
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported with testosterone topical gel products. Patients should be advised to strictly adhere to the instructions for use to minimize the potential for secondary exposure.
Cases of secondary exposure to testosterone resulting in virilization of children and women have been reported with testosterone topical gel products. Patients should be advised to strictly adhere to the instructions for use to minimize the potential for secondary exposure.
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
Urinary 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
Changes in skin color
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
Signs of liver problems, including:
+ 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.
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
Urinary 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
Changes in skin color
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
Signs of liver problems, including:
+ 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.
Seek Immediate Medical Attention If You Experience:
- Signs of testosterone transfer to others: In women, new or increased body hair, significant acne, voice changes (deepening), or changes in menstrual periods. In children, enlarged genitals, premature pubic hair, increased erections, or aggressive behavior.
- Signs of blood clots: Pain, swelling, warmth, or redness in the leg (DVT); sudden shortness of breath or chest pain (PE).
- Signs of prostate problems: Difficulty urinating, frequent urination (especially at night), weak urine stream, or urgent need to urinate.
- Signs of fluid retention: Swelling in the ankles, feet, or hands; sudden weight gain.
- Signs of liver problems: Yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, nausea, vomiting, or stomach pain.
- Signs of sleep apnea: Worsening snoring or difficulty breathing during sleep.
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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and severity.
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, planning to become pregnant, or breastfeeding, discuss this with your doctor.
* This medication is not suitable for children. Do not administer this medication to a child.
To ensure safe treatment, it is crucial to disclose all 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 consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and severity.
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, planning to become pregnant, or breastfeeding, discuss this with your doctor.
* This medication is not suitable for children. Do not administer this medication to a child.
To ensure safe treatment, it is crucial to disclose all 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 consulting your doctor first.
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 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 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.
Blood clots have been reported in individuals taking this medication. If you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse 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. Seek immediate medical attention 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 immediately.
If a pregnant individual comes into contact with the gel or solution, seek medical attention right away.
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 stopping the medication. If you have concerns, discuss them with your doctor.
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 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 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.
Blood clots have been reported in individuals taking this medication. If you have a history of blood clots, inform your doctor.
This medication is an anabolic steroid, which has been associated with abuse and misuse. Anabolic steroid abuse 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. Seek immediate medical attention 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 immediately.
If a pregnant individual comes into contact with the gel or solution, seek medical attention right away.
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 stopping the medication. If you have concerns, discuss them with your doctor.
Overdose Information
Overdose Symptoms:
- Symptoms of excessive androgen exposure may include irritability, acne, oily skin, hair loss, or increased body hair.
- No specific antidote for testosterone overdose.
What to Do:
If you suspect an overdose, seek immediate medical attention or call a Poison Control Center at 1-800-222-1222. Treatment is supportive and symptomatic; discontinue the medication and monitor testosterone levels.
Drug Interactions
Contraindicated Interactions
- Not typically contraindicated with other drugs, but caution with severe hepatic impairment.
Major Interactions
- Oral Anticoagulants (e.g., Warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Monitor INR/PT closely.
- Corticosteroids (e.g., Prednisone): Concomitant use may increase the risk of edema, especially in patients with cardiac, renal, or hepatic disease.
Moderate Interactions
- Insulin and Oral Hypoglycemics: Androgens may decrease blood glucose levels, potentially reducing insulin or oral hypoglycemic requirements. Monitor blood glucose.
- Thyroid Hormones: Androgens may decrease levels of thyroid-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Clinical significance is usually minimal, but monitor thyroid function if clinically indicated.
Minor Interactions
- Not typically listed as minor interactions with significant clinical impact.
Monitoring
Baseline Monitoring
Serum Testosterone (total and free)
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Prior to initiation of therapy (usually two morning measurements).
Hematocrit (Hct) and Hemoglobin (Hgb)
Rationale: To assess for polycythemia, a common side effect of testosterone therapy.
Timing: Prior to initiation of therapy.
Prostate-Specific Antigen (PSA)
Rationale: To screen for prostate cancer in men aged 40 and older, as testosterone can stimulate prostate growth.
Timing: Prior to initiation of therapy (in men âĨ40 years old).
Lipid Panel
Rationale: To assess cardiovascular risk factors, as testosterone therapy may affect lipid profiles.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess baseline liver function, especially given potential for hepatic effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Testosterone (total)
Frequency: Approximately 14 days after initiation or dose adjustment, then every 3-6 months for the first year, then annually.
Target: Generally 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: At 3 and 6 months after initiation, then annually.
Target: <54%
Action Threshold: If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose or consider phlebotomy.
Prostate-Specific Antigen (PSA)
Frequency: At 3-6 months after initiation, then annually (in men âĨ40 years old).
Target: Stable or within normal limits for age.
Action Threshold: Significant increase from baseline or age-specific normal range, or abnormal prostate exam, warrants further urological evaluation.
Lipid Panel
Frequency: Annually.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
Bone Mineral Density (BMD)
Frequency: Consider for men with osteoporosis or high fracture risk, especially if hypogonadism is long-standing.
Target: Improvement or stabilization.
Action Threshold: Not applicable for dose adjustment, but for overall management.
Symptom Monitoring
- Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly, premature puberty) in household contacts.
- Signs of prostate enlargement (e.g., urinary hesitancy, frequency, nocturia, decreased stream).
- Signs of fluid retention (e.g., ankle swelling, weight gain).
- Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE) (e.g., leg pain/swelling, shortness of breath, chest pain).
- Mood changes, irritability, aggression.
- Sleep apnea (worsening or new onset).
- Breast tenderness or enlargement (gynecomastia).
Special Patient Groups
Pregnancy
Contraindicated. Testosterone is classified as Pregnancy Category X. It can cause fetal harm when administered to a pregnant woman. Exposure to androgens during pregnancy may lead to virilization of the external genitalia 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.
Lactation
Contraindicated. It is not known whether testosterone is excreted in human milk. However, due to the potential for serious adverse reactions in the breastfed infant, including virilization, testosterone is contraindicated during breastfeeding. Women should not breastfeed while using Androgel 1.62%.
Infant Risk:
High risk of virilization and other adverse effects.
Pediatric Use
Not indicated for use in pediatric patients. Use in children can cause virilization (e.g., phallic enlargement, premature development of pubic hair, increased libido) and premature epiphyseal closure, resulting in compromised adult height. Safety and efficacy have not been established.
Geriatric Use
Geriatric patients treated with androgen therapy may be at an increased risk for the development of prostate hypertrophy and prostate carcinoma. Increased risk of cardiovascular events (e.g., MI, stroke) has been reported in some studies, particularly in older men. Close monitoring for prostate health and cardiovascular risk factors is essential.
Clinical Information
Clinical Pearls
- Emphasize the critical importance of proper application technique and adherence to instructions to prevent secondary testosterone transfer to women and children, which can cause serious adverse effects.
- Patients should be advised to wash hands thoroughly after application and cover the application site with clothing once dry.
- Regular monitoring of serum testosterone, hematocrit, and PSA is crucial for safe and effective therapy.
- Be aware of the potential for fluid retention, especially in patients with pre-existing cardiac, renal, or hepatic disease.
- Counsel patients on the signs and symptoms of polycythemia, prostate enlargement, and potential cardiovascular events.
- Androgel 1.62% is designed to deliver a consistent daily dose; do not apply more than the prescribed amount or to areas other than recommended.
Alternative Therapies
- Other topical testosterone formulations (e.g., patches, other gels like Testim, Fortesta, Vogelxo)
- Testosterone injections (e.g., testosterone cypionate, enanthate)
- Testosterone buccal system (Striant)
- Testosterone pellets (Testopel)
- Testosterone nasal gel (Natesto)
Cost & Coverage
Average Cost:
$400 - $700 per 30 packets (20.25mg/packet)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand); Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 you receive a refill of this medication. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.