Complete Tabs — Important Safety Information
Compounded sildenafil / papaverine / oxytocin sublingual tablet. Contraindicated with nitrates. Watch for prolonged erection, vision/hearing changes, and blood-pressure drops.
Complete Tabs are compounded by a licensed 503A pharmacy in accordance with Section 503A of the Federal Food, Drug & Cosmetic Act, and may only be dispensed pursuant to a valid, patient-specific prescription issued by a licensed healthcare practitioner following an individualized medical evaluation. The FDA does not review or approve compounded medications for safety, effectiveness, or quality, and this combination formulation has not been FDA-approved. Individual results will vary.
What is in Complete Tabs?
Complete Tabs are a compounded sublingual formulation containing sildenafil, a phosphodiesterase-5 (PDE5) inhibitor; papaverine, a smooth-muscle relaxant and vasodilator; and oxytocin, a naturally occurring peptide. Sildenafil is FDA-approved on its own for erectile dysfunction (ED). This combination product is compounded and is not FDA-approved.
Who should not use Complete Tabs?
- You take nitric oxide donors (organic nitrates or nitrites). Sildenafil and papaverine can increase the blood-pressure-lowering effect of nitrates.
- You take guanylate cyclase stimulators, such as riociguat.
- You have a known allergy to sildenafil, papaverine, or oxytocin.
- You have a condition that predisposes you to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) or an anatomical deformation of the penis.
How should I take Complete Tabs?
Place one tablet under the tongue and allow it to dissolve fully; do not chew or swallow it whole. Take about 15 to 30 minutes before anticipated sexual activity, or exactly as directed by your provider. Do not take more than once in a 24-hour period, and do not combine with other ED medications or PDE-5 inhibitors.
What should I tell my EOS Health-affiliated provider?
Tell your provider all medications you take. Watch for interactions with nitrates, alpha-blockers, other antihypertensives, other vasodilators, and CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, erythromycin).
Share your full medical history, especially: cardiovascular risk, chest pain requiring nitroglycerin, predisposition to priapism, ventricular outflow obstruction, impaired autonomic control of blood pressure, history of heart attack/stroke/arrhythmia, low or high blood pressure, unstable angina, NAION, bleeding disorders, kidney or liver disease, and retinitis pigmentosa.
Most serious side effects
If experiencing a medical emergency, call 911.
- Cardiac risk of sexual activity.
- Prolonged erection (priapism): Seek emergency treatment for an erection lasting more than 4 hours. This risk may be higher with combination vasodilator therapy.
- Vision changes: Sudden loss of vision could be a sign of NAION.
- Sudden hearing loss.
- Severe blood-pressure drop with alpha-blockers, other blood-pressure-lowering drugs, or ritonavir.
- Combination with other PDE-5 inhibitors — do not exceed once per 24 hours or combine with other ED medications.
- Effects on bleeding in patients with bleeding disorders or ulcers.
- STIs: Complete Tabs do not protect against sexually transmitted infections.
Most common side effects
- Headache, flushing, indigestion, nasal congestion, dizziness, vision changes, nausea, back or muscle pain, and a feeling of warmth. Papaverine and oxytocin may add to flushing, dizziness, or changes in blood pressure.
You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for sildenafil for complete safety information on the primary active ingredient.