Medication Description:

• Testosterone transdermal cream 100 mg/mL – White cream.

What this medication is and how it works

Testosterone hormone replacement therapy (TRT) helps treat low testosterone levels, which is associated with low energy and low sexual drive. Testosterone cream helps provide a consistent testosterone dose to the body, which helps alleviate side effects associated with rapid testosterone absorption.

• Testosterone: A crucial steroid hormone, the main male sex hormone, produced in testes (men) and ovaries/adrenals (women), vital for male development (voice, hair, muscle) but also aHecting libido, bone density, fat, mood, and red blood cell production in both sexes, acting as a chemical messenger throughout the body. It drives puberty, supports sexual function, maintains muscle/bone, and influences mental well-being, with levels naturally declining with age.

How to apply the topical solution

1. Read Instructions: Always follow the specific instructions on your prescription label and the manufacturer's patient information, as application sites and wait times can vary by product type and concentration.

2. Prepare the Site: Apply the cream to clean, dry, and unbroken skin, preferably in the morning at the same time each day. Avoid applying it to the armpits, chest, stomach, penis, or scrotum unless explicitly directed by your physician for a specific compounded cream.

3. Dispense the Dose: Pumps: If using a new pump for the first time, you must first "prime" it by pressing the pump a few times (check instructions for the exact number) and discarding that initial amount safely. Then, pump your prescribed dose into the palm of your hand or directly onto the application site.

4. Apply the Cream: Use your palm or fingers to gently rub a thin layer of the cream into the skin until it is fully absorbed. If applying more than one dose, use both the left and right sides of your body as directed (e.g., one pump per shoulder).

5. Wash Hands: Immediately and thoroughly wash your hands with soap and water to prevent accidental transfer to other people or objects.

6. Cover the Area: Allow the application site to dry completely for several minutes (typically 3-10 minutes) before putting on clothing that covers the area, such as a t-shirt.

7. Wait Before Washing/Swimming: Avoid showering, swimming, or bathing for at least 2 to 6 hours after application to ensure maximum absorption of the medication.

What to do if you miss a dose

If you miss a dose, apply it when you remember unless it's close to the time for your next scheduled dose. In that case, skip missed dose and continue your regular dosing schedule. Do not apply a double dose to compensate.

Storage

Store at room temperature (68°F to 77°F) away from moisture and heat. Store it out of reach of children and pet.

Important safety information

• Testosterone cream is contraindicated in individuals with known hypersensitivity to testosterone or any excipients in the base vehicle, including penetration enhancers or preservatives that may precipitate allergic or irritant contact dermatitis.
• Men with carcinoma of the breast or known or suspected prostate cancer must not receive exogenous androgens, as stimulation of androgen-responsive neoplastic tissue could accelerate tumor progression; therefore, screening digital rectal examination and age-appropriate PSA testing remain obligatory prior to initiation and during therapy.
• Serious caution applies to patients with uncontrolled heart failure, untreated severe obstructive sleep apnea,polycythemia, or poorly controlled hypertension, since testosterone-mediated erythropoiesis, fluid retention, and alterations in vascular tone could exacerbate these conditions, necessitating either stabilization of comorbidities or selection of alternative modalities before considering topical therapy.
• Do NOT flush down the toilet or pour it down the sink. Contact pharmacy for proper disposal instructions.

Possible side effects

Common side effects often include skin irritation at the application site, acne, and headache.

More serious potential side effects include:

• Blood clots (pain, swelling, or redness in the leg; sudden shortness of breath; chest pain).
• Increased risk of heart attack or stroke.
• Worsening of prostate symptoms (diHiculty urinating, weak urine flow).
• Enlarged or painful breasts.
• Swelling of the hands, feet, or ankles due to fluid retention.
• Worsening of sleep apnea.
• Decreased sperm count.
• Mood changes, including depression or aggression.

Interactions

• Testosterone is primarily metabolized by hepatic CYP3A4; potent inhibitors (e.g., azole antifungals, ritonavir) may raise serum testosterone and DHT concentrations, whereas inducers (e.g., carbamazepine, rifampin) can reduce efficacy.
• Clinically significant potentiation of the anticoagulant eHect of warfarin has been documented, attributed to multidimensional changes in clotting factor synthesis and metabolism. INR should be monitored closely following androgen initiation or dose adjustments, and warfarin requirements may decline.
• Corticosteroids, growth hormone, and insulin sensitizers may interact with testosterone’s anabolic eHects on protein metabolism, potentially necessitating dosage adjustments of these agents to avoid additive edema or alterations in glucose homeostasis; prescribers should evaluate cumulative endocrine load in polypharmacy scenarios.

If you have any questions concerning this or any of your medications, a pharmacist is available during normal business hours to answer your questions. You can report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.