Androgel 1% Gel (50mg) 5gm Pkts

Manufacturer ABBVIE Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation An-dro-jel (for brand); Tes-TOS-ter-own (for active ingredient)
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
Feb 2000
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DEA Schedule
Schedule III

Overview

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What is this medicine?

Androgel is a gel containing testosterone, a male hormone. It's used to treat men who have low testosterone levels (hypogonadism) due to certain medical conditions. It helps restore testosterone levels, which can improve symptoms like low energy, decreased 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.
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's 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 once or use extra doses to make up for the missed one.
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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 to prevent transfer to others.
  • Avoid swimming, showering, or washing the application site for at least 5 hours after application.
  • Minimize skin-to-skin contact with others, especially women and children, after application and until the gel has dried and the site is covered.
  • If skin-to-skin contact is unavoidable, ensure the application site is thoroughly washed before contact.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 50 mg (one 50 mg packet or 4 pump actuations) applied once daily to clean, dry, intact skin of the shoulders, upper arms, or abdomen. Dose may be adjusted based on serum testosterone levels.
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

hypogonadism: Initial dose 50 mg once daily. Adjust dose based on morning serum testosterone levels obtained approximately 14 days after initiation of therapy or dose adjustment. The dose can be increased to 75 mg or 100 mg once daily. The maximum recommended dose is 100 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
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. 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. Monitor for fluid retention and liver function.
Severe: Not recommended. Use with extreme caution and close monitoring due to potential for fluid retention and hepatic effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Exogenous testosterone diffuses across the skin and enters the systemic circulation. Testosterone and its active metabolite, dihydrotestosterone (DHT), bind to androgen receptors in target tissues (e.g., prostate, seminal vesicles, epididymis, skin, hair follicles, muscle, bone), stimulating gene expression and mediating androgenic effects. These effects include the development and maintenance of primary and secondary male sexual characteristics, promotion of protein anabolism, and reduction of protein catabolism.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% (transdermal)
Tmax: 2-4 hours (after initial application)
FoodEffect: Not applicable (transdermal)

Distribution:

Vd: Not available (large, lipophilic)
ProteinBinding: Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (exogenous testosterone, but metabolites can cross)

Elimination:

HalfLife: Variable (transdermal, effective half-life for steady state is longer than for IV)
Clearance: Not available
ExcretionRoute: Renal (approximately 90% as conjugates of testosterone and its metabolites), Fecal (approximately 10%)
Unchanged: Less than 6% (in urine)
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Pharmacodynamics

OnsetOfAction: Days to weeks for clinical effects (e.g., mood, energy); weeks to months for full effects (e.g., muscle mass, bone density)
PeakEffect: Steady-state serum concentrations typically achieved within 2-3 days of daily application.
DurationOfAction: 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 with testosterone topical gel products. Patients should be advised to strictly adhere to the instructions for use to minimize the potential for secondary exposure.
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Side Effects

Urgent Side Effects: Seek Medical Attention 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 help 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
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 may not experience any side effects or may only have 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 help:

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 (e.g., new or increased body hair, acne, voice changes, enlarged clitoris in women; enlarged penis/clitoris, pubic hair, aggressive behavior in children). Seek immediate medical attention.
  • Swelling of ankles, feet, or hands (fluid retention).
  • Difficulty urinating, increased frequency of urination, or weak urine stream (may indicate prostate issues).
  • Breast tenderness or enlargement.
  • Shortness of breath, chest pain, or leg pain/swelling (signs of blood clot).
  • Yellowing of skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Mood changes, depression, or increased aggression.
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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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
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 administer 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 determine whether it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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. 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 can cause high blood pressure, which may increase the risk of heart attack, stroke, or death from heart disease. Have your blood pressure checked regularly as advised by your doctor, and discuss any concerns if you have pre-existing high blood pressure or heart disease.

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 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, 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 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, contact the doctor right away. If a pregnant individual is exposed to the gel or solution, seek medical attention promptly.

Older adults (65 years and above) should use this medication with caution, as they may be more susceptible to side effects.

This medication is not approved for treating low testosterone levels caused by aging. Discuss the implications with your doctor.

High doses of this medication can affect sperm production in males, potentially impacting fertility. This effect may not be reversible after stopping the medication. If you have concerns, consult your doctor.
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Overdose Information

Overdose Symptoms:

  • High testosterone levels (above normal range)
  • Polycythemia (abnormally high red blood cell count, leading to symptoms like headache, dizziness, fatigue)
  • Fluid retention (edema)
  • Mood disturbances (irritability, aggression)
  • Priapism (prolonged, painful erection)

What to Do:

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

Drug Interactions

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Major Interactions

  • Oral anticoagulants (e.g., warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Mechanism: Possible changes in clotting factors or displacement from protein binding sites.
  • Corticosteroids (e.g., prednisone): Concomitant use may increase the risk of edema, especially in patients with pre-existing cardiac, renal, or hepatic disease. Mechanism: Additive fluid retention.
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Moderate Interactions

  • Insulin and other antidiabetic agents: Testosterone may decrease blood glucose levels, potentially reducing insulin requirements. Mechanism: Improved glucose utilization and reduced insulin resistance.
  • Thyroid hormones: May decrease serum concentrations of thyroxine-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Mechanism: Altered protein binding.

Monitoring

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Baseline Monitoring

Serum Testosterone (total and free)

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

Timing: Before initiation of therapy (morning sample)

Hematocrit (Hct) and Hemoglobin (Hgb)

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

Timing: Before initiation of therapy

Prostate-Specific Antigen (PSA)

Rationale: To screen for prostate cancer and establish baseline, especially in men over 40 or with risk factors.

Timing: Before initiation of therapy

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

Rationale: Testosterone therapy can affect lipid profiles.

Timing: Before initiation of therapy

Liver Function Tests (LFTs)

Rationale: To assess baseline liver function, though transdermal testosterone has less hepatic impact than oral.

Timing: Before initiation of therapy

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Routine Monitoring

Serum Testosterone (total)

Frequency: Approximately 14 days after initiation or dose adjustment, then every 3-6 months once stable.

Target: 300-1000 ng/dL (or within normal physiological range for healthy young men)

Action Threshold: If consistently above target range, reduce dose or discontinue. If consistently below target range, consider dose increase.

Hematocrit (Hct)

Frequency: At 3 months, then annually.

Target: <54%

Action Threshold: If Hct >50%, reduce dose or temporarily discontinue. If Hct >54%, discontinue therapy until Hct decreases, then restart at a lower dose.

Prostate-Specific Antigen (PSA)

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

Target: Age-dependent, typically <4 ng/mL for most men.

Action Threshold: Significant increase from baseline, or values above age-specific norms, warrant further urological evaluation.

Digital Rectal Exam (DRE)

Frequency: Annually (or more frequently based on age and risk factors).

Target: Normal prostate size and consistency.

Action Threshold: Abnormal findings (e.g., nodule, induration) warrant further urological evaluation.

Lipid Panel

Frequency: Annually.

Target: Within normal limits.

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)
  • Breast tenderness or enlargement (gynecomastia)
  • Mood changes, irritability, aggression
  • Sleep apnea (new onset or worsening)
  • Skin reactions at application site (e.g., irritation, rash)
  • Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE) (e.g., leg pain/swelling, chest pain, shortness of breath)

Special Patient Groups

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Pregnancy

Contraindicated. Testosterone can 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. Testosterone is excreted in breast milk and can cause serious adverse reactions in a nursing infant, including virilization.

Infant Risk: High risk of virilization (e.g., clitoral enlargement, pubic hair, acne, voice changes) in female infants.
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Pediatric Use

Contraindicated in children due to the risk of virilization (e.g., premature pubic hair, phallic enlargement, acne, aggressive behavior) and premature epiphyseal closure, which can result in compromised adult height. Safety and efficacy have not been established.

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Geriatric Use

Use with caution. Older men treated with androgens may be at increased risk for the development of prostatic hypertrophy and prostate carcinoma. Increased risk of cardiovascular events (e.g., myocardial infarction, stroke) has been reported in some studies, though data are conflicting. Close monitoring of PSA, DRE, Hct, and cardiovascular risk factors is essential.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of proper application technique and strict adherence to instructions to prevent secondary exposure to women and children.
  • Morning application is preferred to mimic the natural diurnal rhythm of testosterone.
  • Patients should be advised that the full benefits of testosterone therapy may take several weeks to months to manifest.
  • Regular monitoring of serum testosterone, Hct, and PSA is crucial for safety and efficacy.
  • Counsel patients on the signs and symptoms of polycythemia, fluid retention, and prostate issues.
  • Consider alternative formulations (e.g., injections, patches) if patient compliance with daily gel application or concerns about transfer are significant.
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Alternative Therapies

  • Testosterone cypionate (injection)
  • Testosterone enanthate (injection)
  • Testosterone undecanoate (oral, injection)
  • Testosterone transdermal patch (e.g., Androderm)
  • Testosterone buccal system (e.g., Striant)
  • Testosterone nasal gel (e.g., Natesto)
  • Testosterone implantable pellets (e.g., Testopel)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600 per 30 packets (50mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand), generic often Tier 1 or 2.
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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, a patient fact sheet that provides crucial information. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.