Androgel 1% Gel (25mg) 30x2.5gm Pkt

Manufacturer ABBVIE Active Ingredient Testosterone Gel(tes TOS ter one) Pronunciation AN-droh-jel
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 1% is a topical gel containing testosterone, a male hormone. It is 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, reduced libido, 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 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 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 follow the instructions for correct application. Refer to the package insert for more detailed information.

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 scheduled dose, skip the missed dose and resume your regular dosing 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 5 hours after application.
  • Avoid skin-to-skin contact with women or children at the application site to prevent secondary exposure.
  • If contact occurs, the exposed individual should wash the affected area with soap and water immediately.
  • Regular follow-up appointments and blood tests are crucial to monitor testosterone levels and potential side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg (5 grams of 1% gel) applied once daily to the shoulders, upper arms, or abdomen.
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

hypogonadism: Initial dose 50 mg (5 grams of 1% gel) applied once daily. Dose may be adjusted based on serum testosterone levels, up to a maximum of 100 mg (10 grams of 1% gel) daily. Serum testosterone should be measured approximately 14 days after starting treatment or dose adjustment.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in males under 18 years of age. Use in children is contraindicated due to potential for adverse effects on bone maturation and sexual development.)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for fluid retention.
Moderate: No specific dose adjustment recommended, but monitor for fluid retention.
Severe: Use with caution; monitor for fluid retention and adverse effects.
Dialysis: Not available; use with caution and monitor closely.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated due to potential for exacerbation of hepatic dysfunction and cholestatic hepatitis.

Pharmacology

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Mechanism of Action

Exogenous testosterone diffuses across the skin and is absorbed into the systemic circulation. Testosterone and its active metabolite, dihydrotestosterone (DHT), bind to androgen receptors in target tissues, stimulating gene transcription and protein synthesis. This leads to the development and maintenance of male primary and secondary sexual characteristics, including spermatogenesis, prostate growth, and muscle development.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 9-14% (transdermal absorption is variable)
Tmax: Approximately 4 hours (for serum testosterone after application)
FoodEffect: Not applicable (topical application)

Distribution:

Vd: Not readily quantifiable for transdermal, but testosterone distributes widely in tissues.
ProteinBinding: Approximately 98% (to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (testosterone can cross the blood-brain barrier, but the extent of CNS penetration from transdermal application is not fully quantified)

Elimination:

HalfLife: Approximately 10-100 minutes (endogenous testosterone); effective half-life after transdermal application is longer due to continuous absorption.
Clearance: Not readily quantifiable for transdermal application.
ExcretionRoute: Approximately 90% in urine (as conjugates of testosterone and its metabolites), 6% in feces (unconjugated testosterone)
Unchanged: Less than 6% (in urine)
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Pharmacodynamics

OnsetOfAction: Clinical effects may be observed within weeks to months (e.g., libido, energy, mood). Serum testosterone levels reach steady state within 2-4 days of daily application.
PeakEffect: Peak serum testosterone levels typically occur 2-4 hours post-application.
DurationOfAction: Daily application maintains therapeutic testosterone levels over 24 hours.

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 with testosterone topical products. Patients should be advised to strictly adhere to recommended application instructions to minimize the potential for secondary exposure. Androgel 1% is contraindicated in women who are pregnant or may become pregnant, or who are breastfeeding. Testosterone can cause fetal harm when administered to a pregnant woman. Testosterone is excreted in human milk and may cause serious adverse reactions in nursing infants.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ 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 (priapism)
Urinary problems, such as:
+ Trouble passing urine
+ Pain while urinating
+ Weak or dripping 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
Upset stomach or vomiting
Trouble breathing during sleep
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. While many people may not experience any side effects or only minor 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 guidance:

Headache
Acne
Diarrhea
Emotional changes
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., increased body hair, acne, voice changes, enlarged clitoris in females; enlarged penis/clitoris, pubic hair, aggressive behavior in children).
  • Signs of fluid retention (e.g., swelling in ankles or feet, sudden weight gain).
  • Difficulty urinating, increased frequency of urination, or weak urine stream (may indicate prostate issues).
  • Chest pain, shortness of breath, leg pain or swelling (signs of blood clots or cardiovascular issues).
  • Yellowing of skin or eyes (jaundice), dark urine, severe stomach pain (signs of liver problems).
  • Unexplained mood changes, irritability, or aggression.
  • Worsening of sleep apnea (loud snoring, gasping for air during sleep).
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Before Using This Medicine

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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are a male with a history of breast or prostate cancer.
If you have any pre-existing medical conditions, including heart disease, kidney disease, or liver disease.
If you are female, as this medication is not approved for use in women. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential risks with your doctor, as this medication may harm an unborn baby.
* If the patient is a child, as this medication is not intended for pediatric use.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust 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 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.

If you have sleep apnea, consult with your 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. 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, so discuss this with your doctor.

Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.

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, and misuse or abuse of anabolic steroids can lead to dependence and severe health problems, including cardiovascular issues, stroke, liver damage, and mental or mood disorders. Discuss the risks with your doctor.

In some individuals with cancer, medications like this one have caused high calcium levels. 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, symptoms may include a deepened voice, changes in body hair, or acne. If this occurs, contact the doctor promptly. If a pregnant woman is exposed to the gel or solution, seek medical attention immediately.

Older adults (65 years and older) 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 risks and benefits with your doctor.

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

Overdose Symptoms:

  • High testosterone levels (above normal range)
  • Polycythemia (high red blood cell count, leading to symptoms like headache, dizziness, fatigue)
  • Fluid retention (edema)
  • Mood changes, 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).

Drug Interactions

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Major Interactions

  • 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 fluid retention and edema, especially in patients with cardiac, hepatic, or renal disease.
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Moderate Interactions

  • Insulin and oral hypoglycemics: Testosterone may decrease blood glucose levels, potentially requiring a reduction in insulin or oral hypoglycemic dosage.
  • Thyroid hormones: May decrease levels of thyroid-binding globulin, leading to increased free thyroid hormone levels. No clinical significance usually, but monitor thyroid function if symptoms arise.
  • Immunosuppressants (e.g., Cyclosporine): Potential for increased cyclosporine levels, though data is limited. Monitor cyclosporine levels.

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, two separate measurements recommended).

Hematocrit/Hemoglobin

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 benign prostatic hyperplasia (BPH) in men over 40-50 years, as testosterone can stimulate prostate growth.

Timing: Prior to initiation of therapy (in men over 40-50 years).

Digital Rectal Exam (DRE)

Rationale: To screen for prostate abnormalities.

Timing: Prior to initiation of therapy (in men over 40-50 years).

Lipid Panel

Rationale: Testosterone therapy can affect lipid profiles.

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 every 3-6 months once stable.

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

Action Threshold: If consistently above 1000 ng/dL, reduce dose or discontinue. If consistently below 300 ng/dL, consider dose increase.

Hematocrit/Hemoglobin

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

Target: <54%

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

Prostate-Specific Antigen (PSA) and DRE

Frequency: At 3-6 months after initiation, then annually (in men over 40-50 years).

Target: Stable or within normal limits for age.

Action Threshold: Significant increase in PSA or abnormal DRE 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 baseline and follow-up if patient has osteoporosis or risk factors for it.

Target: Improvement or stabilization.

Action Threshold: Not applicable for direct dose adjustment, but for overall management.

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Symptom Monitoring

  • Signs of secondary exposure (e.g., virilization in women/children: clitoromegaly, hirsutism, voice deepening, premature puberty)
  • Signs of fluid retention (e.g., edema, weight gain)
  • Symptoms of BPH (e.g., urinary frequency, urgency, nocturia, decreased stream)
  • Mood changes, irritability, aggression
  • Sleep apnea (worsening or new onset)
  • Breast tenderness or enlargement (gynecomastia)
  • Skin irritation at application site
  • Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg swelling, weakness on one side of body)

Special Patient Groups

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Pregnancy

Contraindicated. Testosterone can cause virilization of a female fetus (e.g., clitoromegaly, abnormal vaginal development).

Trimester-Specific Risks:

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

Contraindicated. Testosterone is excreted in human milk and may cause serious adverse reactions in nursing infants, including virilization.

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

Contraindicated in males under 18 years of age due to potential for adverse effects on bone maturation (premature epiphyseal closure) and sexual development (precocious puberty). Safety and efficacy not established.

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Geriatric Use

Use with caution. Older men may have an increased risk of prostate enlargement (BPH) and prostate cancer. Increased monitoring of PSA and DRE is recommended. Also, older men may be at higher risk for cardiovascular events.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to application instructions to prevent secondary exposure to women and children. This is a critical safety point.
  • Always measure serum testosterone levels in the morning before the next dose, approximately 14 days after starting or adjusting therapy, to ensure steady-state levels are achieved.
  • Be vigilant for signs of polycythemia (elevated hematocrit) and fluid retention, especially in patients with pre-existing cardiac, renal, or hepatic conditions.
  • Counsel patients on the importance of regular prostate monitoring (PSA and DRE) in men over 40-50 years, as testosterone can stimulate prostate growth.
  • Testosterone therapy is not indicated for age-related decline in testosterone unless there is a clear diagnosis of hypogonadism.
  • 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

  • Other testosterone formulations (e.g., testosterone cypionate/enanthate injections, testosterone transdermal patches, testosterone buccal systems, testosterone nasal gel, testosterone oral capsules)
  • Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for central hypogonadism, though less common for primary hypogonadism)
  • Clomiphene citrate (off-label use for secondary hypogonadism to stimulate endogenous testosterone production)
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Cost & Coverage

Average Cost: $400 - $700 per 30x2.5gm Pkt (Androgel 1%)
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 safe use, 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 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, 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 reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.