Important Safety Information: DHEA / Anastrozole in MCT Oil (Dehydroepiandrosterone/ Anastrozole) | Compounded Injectable (Copy)

What is this?

This Important Safety Information summarizes key warnings and precautions for DHEA (dehydroepiandrosterone) combined with anastrozole in a compounded injectable formulation.

DHEA is a hormone precursor produced by the adrenal glands and serves as a building block for testosterone and estrogen. Anastrozole is an aromatase inhibitor that reduces the body’s conversion of testosterone into estrogen.

This combination may be prescribed to support hormone balance in select patients under provider supervision.

This compounded injectable formulation is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and must 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 anaphylaxis

• Liver dysfunction or liver enzyme elevations

• High blood pressure or cardiovascular complications

• Mood changes including depression, anxiety, or irritability

• Bone density loss due to estrogen suppression

• Fertility impairment

• Hormonal imbalances resulting in acne, hair loss, or voice changes

Compounded injectable formulations may carry sterility, potency, or formulation risks due to limited FDA oversight.

Who Should NOT Take This Medication

Do not use this medication if you:

• Are allergic to DHEA, anastrozole, MCT oil, or any component of the formulation

• Are pregnant or may become pregnant

• Are breastfeeding

• Have not gone through menopause and are prescribed anastrozole without provider clearance

• Have hormone-sensitive cancers unless specifically directed by an oncologist

• Are taking estrogen products or tamoxifen

• Have severe liver disease

Before Taking This Medication, Tell Your Healthcare Provider if You:

• Have heart disease, high cholesterol, or a history of ischemic heart disease

• Have high blood pressure

• Have liver problems

• Have osteoporosis or low bone density

• Have a history of blood clots

• Have depression, anxiety, or other mood disorders

• Are trying to conceive

• Take any prescription, over the counter, herbal, or supplement products

• Smoke, drink alcohol regularly, or use recreational drugs

Blood work, hormone panels, cholesterol levels, and bone density monitoring may be required during therapy.

Possible Side Effects

Common (mild to moderate):

• Hot flashes

• Headache

• Dizziness or fatigue

• Injection site irritation

• Acne or oily skin

• Mild hair thinning

• Joint or muscle discomfort

• Mood swings

• Nausea or stomach discomfort

Serious (seek medical care immediately):

• Rash, hives, swelling of the face, lips, or throat

• Yellowing of the skin or eyes

• Dark urine or light-colored stools

• Severe abdominal pain

• Chest pain or shortness of breath

• Sudden swelling in arms or legs

• Severe depression or suicidal thoughts

• New or worsening chest pain in patients with prior heart disease

While Taking This Medication

Tell your healthcare provider immediately if you:

• Experience chest pain or shortness of breath

• Notice unusual vaginal bleeding

• Develop new bone pain

• Experience significant mood changes

• Have signs of liver problems

• Notice changes in vision

• Develop swelling in your legs

Pregnancy and Fertility

This medication may cause harm to an unborn baby. A pregnancy test may be required before starting therapy. Effective birth control should be used during treatment and for the duration recommended by your provider.

Anastrozole may impair fertility. Discuss reproductive goals with your healthcare provider prior to starting therapy.

Do not breastfeed while using this medication and for at least two weeks after your last dose.

Overdose

Symptoms of overdose may include:

• Severe headache

• Dizziness or fainting

• Nausea or vomiting

• Hormonal disturbances

• Liver-related symptoms

Severe allergic reaction

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a dose:

• Take the missed dose as soon as you remember unless it is close to your next scheduled dose

• Do not double doses

• Contact your provider if you are unsure how to resume your schedule

Storage

• Store at room temperature in a dry place

• Do not store in a bathroom

• Protect from excessive heat and light

• Keep out of reach of children and pets

• Use only within the beyond-use date listed on your pharmacy label

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or pour it down household drains unless instructed. Ask your pharmacist about medication take-back programs.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing schedules and therapy adjustments must be guided by lab results, clinical response, and safety monitoring. Orders may be modified based on hormone levels, cardiovascular risk factors, or bone health considerations.

Telemedicine Disclosure

This prescription may be 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 possible information and should not replace medical guidance. 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 FDA for safety or efficacy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.