Testosterone 30mg/act Solution

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), 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 stimulates gene transcription and protein synthesis.

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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Prolonged or frequent erections (priapism)
Urination problems: difficulty starting to urinate, painful urination, weak urine flow, or frequent urination
Loss of bladder control
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Enlarged breasts or breast pain
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Nausea or vomiting
Sleep apnea (trouble breathing while sleeping)
Excessive daytime sleepiness
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Skin color changes
Changes in testicle size or shape
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing
Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes (jaundice)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild 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 advice:

Headache
Acne
Diarrhea
Mood swings
Fatigue or weakness
Sleep disturbances
* Irritation at the site of application

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.

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. Be sure to describe the allergic reaction 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.

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 suitable for children. Do not give this medication to a child.

To ensure safe use, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Never start, stop, or change the dosage of any medication without consulting your doctor first.

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 deteriorate in some people taking testosterone.

High blood pressure is a potential side effect of this medication. Follow your doctor's instructions for regular blood pressure checks. Elevated blood pressure can increase the risk of heart attack, stroke, or death from heart disease. 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 it is crucial to discuss this with your doctor.

Adhere to your doctor's recommendations for regular blood work and other laboratory tests.

This medication may interfere with certain lab tests. 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, notify 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 damage, 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 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 your doctor promptly.

If a pregnant woman is exposed to the gel or solution, seek medical attention immediately.

For individuals 65 years 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 associated with 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.

• Oral Anticoagulants (e.g., Warfarin): May increase anticoagulant activity, leading to increased risk of bleeding. Monitor INR/PT closely.
• Corticosteroids: Concomitant use may increase the risk of edema, especially in patients with cardiac, renal, or hepatic disease.
• Insulin and Oral Hypoglycemics: Testosterone may decrease blood glucose levels, requiring a reduction in insulin or oral hypoglycemic dosage.

• Cyclosporine: Testosterone may increase cyclosporine levels, potentially leading to increased toxicity. Monitor cyclosporine levels.
• Thyroid Hormones: Testosterone may decrease levels of thyroid-binding globulin, leading to decreased total T4 levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and clinical hypothyroidism is rare.

• Signs of virilization in women or children (e.g., voice deepening, hirsutism, clitoromegaly)
• Signs of fluid retention (e.g., edema, weight gain)
• Symptoms of benign prostatic hyperplasia (BPH) or prostate cancer (e.g., urinary frequency, urgency, nocturia, difficulty voiding)
• Mood changes, irritability, aggression
• Sleep apnea exacerbation
• Skin reactions at application site (e.g., irritation, rash)

Testosterone is contraindicated in pregnant women. It can cause virilization of the female fetus, including clitoral enlargement, abnormal vaginal development, and fusion of genital folds.

Testosterone is 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 (e.g., virilization), 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.

Testosterone therapy is not indicated for male hypogonadism in children. Use in pediatric patients can cause accelerated bone maturation and premature epiphyseal closure, resulting in compromised adult stature. Safety and efficacy have not been established in pediatric patients.

Geriatric patients treated with androgen therapy may be at an increased risk for the development of prostate hyperplasia and prostate carcinoma. Increased risk of cardiovascular events (e.g., MI, stroke) has been reported in some studies, though data are conflicting. Close monitoring for prostate and cardiovascular adverse events is recommended.

• Ensure patients understand the importance of proper application technique and hand washing to prevent secondary transfer to women and children.
• Emphasize covering the application site with clothing after drying to minimize transfer risk.
• Monitor hematocrit closely, especially in the first year of therapy, as polycythemia is a common dose-limiting side effect.
• Regular prostate monitoring (PSA and DRE) is crucial, particularly in older men.
• Advise patients to report any signs of fluid retention, such as swelling in the ankles or feet.
• Testosterone levels should be measured at steady state (e.g., 2-4 hours after application for topical solutions) to ensure accurate assessment and dose titration.

• Testosterone Gels (e.g., AndroGel, Testim, Fortesta, Vogelxo)
• Testosterone Patches (e.g., Androderm)
• Testosterone Injections (e.g., Testosterone Cypionate, Testosterone Enanthate)
• Testosterone Pellets (e.g., Testopel)
• Testosterone Buccal Tablets (e.g., Striant)
• Testosterone Nasal Gel (e.g., Natesto)
• Gonadotropin-releasing hormone (GnRH) agonists/antagonists (for central hypogonadism, off-label)
• Clomiphene citrate (off-label for secondary hypogonadism to stimulate endogenous production)

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 provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the 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.