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.

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

• Do 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.
• Seek emergency treatment if an erection lasts >4 hours. Use tadalafil with caution if predisposed to priapism.
• Stop using 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).
• Stop taking 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
• A dosage adjustment may be needed with creatinine clearance 30 to 50 mL/min.
• For use as needed: Dose should not exceed 5 mg every 72 hours if you have creatinine clearance less than 30 mL/min or are on hemodialysis. Once daily use is also not recommended.

Questions and Comments

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