Vogelxo 1%(12.5mg/1.25gm) Pump
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. It's essential to use this medication as directed and follow all instructions carefully.
Apply this medication only to your skin, as directed. 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 read and follow the label carefully to ensure you're using the correct dosage.
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. Some products come in pumps, while others come in packets.
After applying the medication, wait for the recommended amount of time before bathing, showering, or swimming. Check the package insert for specific instructions.
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. Certain products are designed for specific areas of the body, so be sure to follow the package insert instructions for proper application.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom or areas prone to moisture.
* Protect the medication from heat, 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 the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply the gel to clean, dry, intact skin of the shoulders, upper arms, or abdomen once daily, preferably in the morning.
- Wash hands thoroughly with soap and water immediately after applying the gel.
- Allow the application site to dry completely before dressing. Do not apply to the genitals or breasts.
- 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 2 hours after application.
- To prevent accidental transfer to women or children, avoid skin-to-skin contact with others at the application site. If contact occurs, the exposed area on the other person should be washed immediately with soap and water.
- Store the medication safely out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
Generic 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
Virilization has been reported in children and women who were secondarily exposed to testosterone gel. Cases of secondary exposure were reported with both approved and unapproved testosterone products. Signs of virilization included, but were not limited to, pubic hair development, enlarged clitoris, and increased libido in females, and penile and clitoral enlargement in children. In most cases, these signs and symptoms regressed with removal of the testosterone product and avoidance of further exposure. In some cases, however, the signs and symptoms did not fully regress. To minimize the potential for secondary exposure, patients should be advised to use the product as directed and to follow precautions.
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 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 urinating
+ 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
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 list is not exhaustive, and you may experience other 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 too much testosterone: acne, hair loss, increased body hair, aggression, irritability, breast enlargement (gynecomastia), swelling in ankles or feet.
- Signs of prostate problems: difficulty urinating, frequent urination, weak urine stream, blood in urine.
- Signs of blood clots: pain, swelling, warmth, or redness in a leg, sudden shortness of breath, chest pain.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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. 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, such as 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, plan 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 consulting your doctor first.
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. Discuss this with your doctor.
If you have an enlarged prostate, your symptoms may worsen while using this medication. Contact your doctor if you experience any changes.
If you have sleep apnea, consult with your doctor, as this medication may exacerbate the condition.
This medication may cause high blood pressure, which can 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 unknown, so it is crucial to 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 certain lab tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor and discuss the potential risks.
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 effects may include aggressive behavior, enlarged sex organs, or premature pubic hair growth. In females, they may include a deepened voice, changes in body hair, or acne. If this occurs, contact the doctor promptly.
If a pregnant individual comes into contact with the gel or solution, contact the doctor immediately.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for treating low testosterone levels caused by aging. Discuss the potential benefits and risks 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:
- Severe acne
- Increased body hair
- Aggression
- Irritability
- Fluid retention (edema)
- Polycythemia (excess red blood cells, leading to symptoms like headache, dizziness, fatigue)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may involve discontinuing the medication and monitoring for adverse effects.
Drug Interactions
Major Interactions
Moderate Interactions
- Adrenocorticotropic hormone (ACTH)
- Bupropion
- Cyclosporine
- Thyroid hormones
Monitoring
Baseline Monitoring
Rationale: To confirm diagnosis of hypogonadism and establish baseline levels.
Timing: Prior to initiation of therapy (morning sample, 8-10 AM)
Rationale: To assess for polycythemia, a common side effect of testosterone therapy.
Timing: Prior to initiation of therapy
Rationale: To screen for prostate cancer, as testosterone can stimulate prostate growth. Required for men >40 years with risk factors or >50 years.
Timing: Prior to initiation of therapy
Rationale: To assess cardiovascular risk factors, as testosterone may affect lipid profiles.
Timing: Prior to initiation of therapy
Rationale: To assess baseline liver function, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Approximately 14 days after initiation or dose adjustment, then every 3-6 months, then annually.
Target: 300-1000 ng/dL (morning sample)
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 Hct >54%, reduce dose, temporarily discontinue, or phlebotomize.
Frequency: At 3-6 months after initiation, then annually (for men >40 with risk factors or >50).
Target: Stable or within age-appropriate limits
Action Threshold: If PSA increases significantly or is outside normal limits, evaluate for prostate cancer.
Frequency: Annually (for men >40 with risk factors or >50).
Target: Normal
Action Threshold: If abnormal, evaluate for prostate cancer.
Frequency: Annually.
Target: Within normal limits
Action Threshold: If abnormal, consider lifestyle modifications or lipid-lowering therapy.
Symptom Monitoring
- Signs of polycythemia (e.g., headache, dizziness, fatigue, shortness of breath)
- Signs of prostate enlargement (e.g., urinary frequency, urgency, nocturia, weak stream)
- Signs of fluid retention (e.g., edema, weight gain)
- Signs of cardiovascular events (e.g., chest pain, shortness of breath, leg pain)
- Mood changes, irritability, aggression
- Skin reactions at application site (e.g., redness, irritation, blistering)
- Signs of gynecomastia (breast enlargement or tenderness)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Testosterone can cause virilization of the female fetus.
Trimester-Specific Risks:
Lactation
Contraindicated in breastfeeding women. It is unknown if testosterone is excreted in human milk, but due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Not indicated for use in pediatric patients. Use in children can cause premature epiphyseal closure, leading to stunted growth, and virilization in females. Safety and efficacy have not been established.
Geriatric Use
Older men treated with androgens may be at an increased risk for the development of prostate hypertrophy and prostate cancer. Increased monitoring for prostate-related adverse events (PSA, DRE) is recommended. Cardiovascular risk should also be carefully considered.
Clinical Information
Clinical Pearls
- Emphasize proper application technique and strict adherence to precautions 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 therapeutic effects may not be seen for several weeks to months.
- Regular monitoring of serum testosterone, hematocrit, and prostate health (PSA, DRE) is crucial.
- Counsel patients on potential side effects, including skin irritation, polycythemia, and prostate changes.
- Testosterone therapy is not indicated for age-related decline in testosterone without a confirmed diagnosis of hypogonadism.
Alternative Therapies
- Testosterone injections (e.g., testosterone cypionate, enanthate)
- Testosterone patches (e.g., Androderm)
- Testosterone buccal system (e.g., Striant)
- Testosterone nasal gel (e.g., Natesto)
- Testosterone oral capsules (e.g., Jatenzo, Tlando)
- Testosterone pellets (e.g., Testopel)