Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Erectile Dysfunction 2 DOSAGE AND ADMINISTRATION 2.1 Erectile Dysfunction 2.2 Use with Food 2.3 Use in Special Populations 2.4 Concomitant Medications 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Nitrates 4.2 Hypersensitivity Reactions 5 WARNINGS AND PRECAUTIONS 5.1 Cardiovascular 5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use 5.3 Prolonged Erection 5.4 Eye 5.5 Sudden Hearing Loss 5.6 Alpha blockers and Antihypertensives 5.7 Renal Insufficiency 5.8 Hepatic Impairment 5.9 Alcohol 5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4) 5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies 5.12 Effects on Bleeding 5.13 Counseling Patients About Sexually Transmitted Diseases 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with CIALIS 7.2 Potential for Other Drugs to Affect CIALIS 7.3 Potential for CIALIS to Affect Other Drugs 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Insufficiency 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 CIALIS for Use as Needed 14.2 CIALIS for Once Daily Use 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION 17.1 Nitrates 17.2 Cardiovascular Considerations 17.3 Concomitant Use with Drugs Which Lower Blood Pressure 17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use 17.5 Priapism 17.6 Vision 17.7 Sudden Hearing Loss 17.8 Alcohol 17.9 Sexually Transmitted Disease 17.10 Recommended Administration * Sections or subsections omitted from the full prescribing information are not listed.