Testosterone HRT Cream | Compounded Topical
Important Safety Information: Testosterone HRT Cream | Compounded Topical
What is this?
This Important Safety Information summarizes key warnings and precautions for Testosterone (1%) 10 mg/g Hormone Replacement Therapy (HRT) Cream, a compounded topical formulation used to treat clinically diagnosed low testosterone levels in adult males. Testosterone is an androgen hormone responsible for maintaining muscle mass, bone density, mood stability, libido, and overall hormonal balance. This compounded topical formulation has not been reviewed or approved by the U.S. Food and Drug Administration for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.
Most Serious Warnings
Product can cause:
Severe allergic reactions, including rash, itching, swelling of the face or throat, or difficulty breathing
Blood clots or thromboembolic events, including chest pain, shortness of breath, swelling, warmth, or pain in an arm or leg
Increased risk of heart attack, stroke, or cardiovascular complications, especially in individuals with heart disease
Worsening of prostate enlargement or potential stimulation of prostate cancer
Liver problems, including yellowing of the skin or eyes, dark urine, or abdominal pain
Mood or behavioral changes, including depression, irritability, or aggression
Secondary exposure risk. Women and children exposed to treated skin may develop unintended androgen effects
Compounded topical testosterone may carry formulation or absorption variability risks due to limited FDA oversight.
Who Should NOT Use Testosterone Cream
Do not use this medication if you:
Have known or suspected prostate or male breast cancer
Have a known allergy to testosterone or any ingredient in the formulation
Are female, pregnant, or breastfeeding
Are a child or adolescent
Have been advised to avoid androgen therapy
Before Using Testosterone Cream, Tell Your Healthcare Provider if You:
Have a history of blood clots or cardiovascular disease
Have high blood pressure or high cholesterol
Have liver or kidney disease
Have sleep apnea
Have diabetes
Have an enlarged prostate or difficulty urinating
Take any prescription, over the counter, or herbal medications
Are planning fertility, as testosterone therapy may suppress sperm production
Possible Side Effects
Common (mild to moderate):
Skin irritation at the application site
Acne or oily skin
Headache
Emotional changes
Increased red blood cell count
Serious (seek medical care immediately):
Signs of a blood clot such as chest pain, sudden shortness of breath, or leg swelling
Signs of stroke such as weakness on one side, slurred speech, or vision changes
Severe allergic reaction
Persistent or painful erections
Severe mood changes or suicidal thoughts
Signs of liver problems
While Using Testosterone Cream
Tell your healthcare provider immediately if you:
Notice worsening urinary symptoms
Experience leg swelling, chest pain, or shortness of breath
Develop severe headaches or neurological symptoms
Observe signs of unintended exposure in women or children such as voice changes, acne, or abnormal hair growth
Apply only to clean, dry, intact skin as directed. Wash hands thoroughly after application. Allow the area to dry completely and cover with clothing to prevent transfer. Wash the application site before skin to skin contact with others.
Pregnancy and Secondary Exposure Warning
Testosterone can cause harm to an unborn baby. Women who are pregnant or may become pregnant should avoid contact with treated skin. If accidental exposure occurs, wash the area immediately with soap and water and contact a healthcare provider.
Overdose
Symptoms of overdose may include severe mood changes, excessive swelling, difficulty breathing, or prolonged erection. Seek emergency medical care or contact Poison Control immediately if overdose is suspected.
Missed Dosage
If you miss a dose:
Apply as soon as remembered unless it is close to the next scheduled dose
Do not apply extra medication to make up for a missed dose
Storage
Store at room temperature
Keep tightly closed and protect from excessive heat
Keep out of reach of children and pets
Medication Disposal
Dispose of unused or expired medication according to local hazardous medication guidelines. Do not flush medication down the toilet or drain. Contact your pharmacy for proper disposal instructions.
Provider Oversight and Order Review
This compounded medication requires ongoing monitoring by a licensed Superior Health and Wellness provider. Blood work, prostate monitoring, and clinical follow up are required to ensure safe and appropriate therapy. Dosing adjustments may be made based on lab results and clinical response.
Telemedicine Disclosure
This prescription may have been issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about testosterone therapy and should not replace medical advice. Always consult your healthcare provider or pharmacist for complete safety information, potential drug interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the U.S. Food and Drug Administration for safety or efficacy.
Superior Health & Wellness
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
