Androgel 1% Gel (25mg) 30x2.5gm Pkt
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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
Baseline Monitoring
Rationale: To confirm diagnosis of hypogonadism and establish baseline for dose titration.
Timing: Prior to initiation of therapy (morning sample, two separate measurements recommended).
Rationale: To assess for polycythemia, a common adverse effect of testosterone therapy.
Timing: Prior to initiation of therapy.
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).
Rationale: To screen for prostate abnormalities.
Timing: Prior to initiation of therapy (in men over 40-50 years).
Rationale: Testosterone therapy can affect lipid profiles.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
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.
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.
Frequency: Annually.
Target: Within normal limits.
Action Threshold: Significant adverse changes may require intervention or re-evaluation of therapy.
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.
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
Pregnancy
Contraindicated. Testosterone can cause virilization of a female fetus (e.g., clitoromegaly, abnormal vaginal development).
Trimester-Specific Risks:
Lactation
Contraindicated. Testosterone is excreted in human milk and may cause serious adverse reactions in nursing infants, including virilization.
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.
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
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.
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)