Important Safety Information

Boost (8mg tadalafil chewable)

Compounded tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used in the treatment of erectile dysfunction (ED). Although tadalafil is FDA-approved for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (BPH), compounded medications are NOT FDA-approved and do not undergo review for safety or efficacy.

DHEA (also known as dehydroepiandrosterone or androstenolone) is a supplement that has been added to this medication for support. DO NOT take this medication if you have an allergy to DHEA. It is NOT recommended that you take additional DHEA supplements without consulting with your healthcare provider. DHEA is a hormone. Use of this supplement might increase levels of androgen and have a steroid effect. DHEA also might increase the risk of hormone-sensitive cancers, including prostate, breast and ovarian cancers. If you have any of these cancers or are at risk for these cancers, don't use DHEA. Don't use DHEA if you're pregnant or breastfeeding. Consider avoiding use of DHEA if you have high cholesterol or a condition that affects the supply of blood to the heart (ischemic heart disease). DHEA might reduce high-density lipoprotein (HDL), or "good", cholesterol levels. Use of DHEA also might worsen psychiatric disorders and increase the risk of mania in people who have mood disorders.

IMPORTANT: This is a summary and does not have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Tadalafil Contraindications

• Administration of tadalafil while using any form of organic nitrate is contraindicated. Tadalafil was shown to potentiate the hypotensive effect of nitrates.
• History of known serious hypersensitivity reaction (allergy) to tadalafil.

TADALAFIL WARNINGS AND PRECAUTIONS

• Patients should not use tadalafil if sex is inadvisable due to cardiovascular status.
• Use of tadalafil with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension.
• Tadalafil is not recommended in combination with alpha blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil is used as a treatment for ED in men taking alpha blockers.
• If taking potent inhibitors of CYP3A4, dose should be adjusted: tadalafil for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg.
• Patients should seek emergency treatment if an erection lasts > 4 hours. Use tadalafil with caution in patients predisposed to priapism.
• Patients should stop tadalafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION.
• Patients should stop tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.
• Prior to initiating treatment with tadalafil for BPH, consideration should be given to other urological conditions that may cause similar symptoms.

TADALAFIL SIDE EFFECTS: Most common adverse reactions (≥2%) include: headache, dyspepsia, back pain, myalgia, nasal congestion, flushing and pain in limb.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

TADALAFIL DRUG INTERACTIONS:

• Tadalafil can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol.
• CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure. For concomitant use with potent CYP3A4 inhibitors, dose adjustment may be needed.
• CYP3A4 inducers (e.g. rifampin) decrease tadalafil exposure.

TADALAFIL USE IN SPECIFIC POPULATIONS:

• Hepatic Impairment
• Mild or Moderate: Dosage adjustment may be needed.
• Severe: Use is not recommended.
• Renal Impairment
• Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed.
• Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended.