Understanding Compounded Medications
Compounded tadalafil is prescribed under federal law but is not FDA-approved, meaning it does not undergo the same regulatory evaluation for safety, effectiveness, or manufacturing standards. Your healthcare provider at Good Medics may recommend a specific compounded tadalafil formulation based on your health assessment and treatment needs.
Warning: Risks Associated with Tadalafil
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used for treating erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). While effective, tadalafil carries potential risks, particularly for individuals with underlying cardiovascular conditions. It is essential to discuss all benefits and risks with your provider before starting treatment.
Tadalafil may cause a sudden drop in blood pressure, especially when taken with certain other medications. Do not take tadalafil if you:
- Use nitrates for chest pain (such as nitroglycerin or isosorbide dinitrate)
- Take guanylate cyclase stimulators like riociguat (used for pulmonary hypertension)
- Have severe heart disease or a history of recent heart attack or stroke
What is Tadalafil Used For?
Tadalafil is used for:
- Erectile Dysfunction (ED): Helps achieve and maintain an erection by improving blood flow to the penis.
- Benign Prostatic Hyperplasia (BPH): Relieves symptoms such as difficulty urinating, weak urine stream, and the urgent need to urinate frequently.
- Pulmonary Arterial Hypertension (PAH): In some cases, tadalafil is prescribed to improve exercise ability in individuals with PAH.
Limitations of Use
- Tadalafil does not protect against sexually transmitted infections (STIs).
- It should not be taken more than once per day.
- The effectiveness of tadalafil can be reduced by excessive alcohol consumption.
Who Should Not Use Tadalafil?
Do not take tadalafil if you:
- Use nitrate medications for chest pain, as this can cause a dangerous drop in blood pressure.
- Have a severe heart condition or experienced a heart attack or stroke within the past six months.
- Have low blood pressure (hypotension) or uncontrolled high blood pressure.
- Have severe liver or kidney disease requiring dialysis.
- Have vision problems such as non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition that can lead to sudden vision loss.
- Are allergic to tadalafil or any of its components.
How to Take Tadalafil
Tadalafil is taken orally, with or without food. It can be used in two ways:
- As needed: Take at least 30 minutes before sexual activity. Effects may last up to 36 hours.
- Daily use: Take once daily at the same time each day to allow for spontaneous sexual activity.
Do not take more than the prescribed dose. Consult your provider before changing your dosage.
What to Discuss with Your Provider Before Taking Tadalafil
Before starting tadalafil, inform your healthcare provider of all prescription and over-the-counter medications, supplements, and herbal products you take.
Medication Interactions:
- Nitrates and guanylate cyclase stimulators (e.g., nitroglycerin, isosorbide dinitrate, riociguat) can cause severe low blood pressure.
- Alpha-blockers (used for high blood pressure or prostate issues) may lead to excessive blood pressure reduction.
- Certain antifungal and antibiotic medications (such as ketoconazole, itraconazole, erythromycin, and clarithromycin) may affect tadalafil metabolism.
- HIV medications (such as ritonavir) can increase tadalafil levels in the body.
- Other PDE5 inhibitors (e.g., sildenafil, vardenafil) should not be taken alongside tadalafil.
Medical Conditions to Disclose
Before using tadalafil, inform your provider if you have or have had:
- Heart disease, irregular heartbeat, or heart failure
- Recent heart attack or stroke (within six months)
- High or low blood pressure
- Liver or kidney disease
- Blood cell disorders (sickle cell anemia, multiple myeloma, or leukemia)
- Stomach ulcers or bleeding disorders
- Retinitis pigmentosa (a genetic eye disease)
- A history of vision loss related to blood flow issues (NAION)
- Penile conditions (e.g., Peyronie’s disease, priapism)
Serious Side Effects
If you experience a medical emergency, call 911 immediately.
Serious side effects of tadalafil include:
- Heart attack or stroke symptoms (chest pain, shortness of breath, sudden weakness, slurred speech, vision changes)
- Sudden vision loss in one or both eyes (linked to NAION)
- Sudden hearing loss or ringing in the ears
- Prolonged or painful erections (priapism) lasting more than 4 hours
- Severe dizziness or fainting
- Severe allergic reactions (swelling of the face, lips, or throat, difficulty breathing, rash)
Seek immediate medical attention if you experience these symptoms.
Common Side Effects
Common but less serious side effects include:
- Headache
- Flushing (redness or warmth in the face, neck, or chest)
- Indigestion or heartburn
- Nasal congestion
- Muscle or back pain
- Dizziness or lightheadedness
- Blurred vision or color vision changes
Use in Special Populations
- Older Adults: May be more sensitive to tadalafil’s effects, particularly its blood pressure-lowering properties.
- Pregnancy & Breastfeeding: Tadalafil is not for use in women.
Alcohol and Tadalafil
Drinking excessive alcohol while taking tadalafil may increase the risk of:
- Dizziness
- Low blood pressure
- Fainting
Monitoring and Follow-Ups
Regular check-ups are recommended to monitor:
- Heart and cardiovascular health
- Kidney and liver function
- Potential drug interactions
- Overall treatment effectiveness
Reporting Side Effects
If you experience side effects, report them to your healthcare provider or the FDA MedWatch program at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This document is not exhaustive. For complete safety information, refer to the official prescribing information or consult your healthcare provider.
