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.
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* Sections or subsections omitted from the full prescribing information are not listed.
Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.14).įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 1.1 Erectile Dysfunction 1.2 Benign Prostatic Hyperplasiaġ.3 Erectile Dysfunction and Benign Prostatic HyperplasiaĢ DOSAGE AND ADMINISTRATION 2.1 CIALIS for Use as Needed for Erectile Dysfunction 2.2 CIALIS for Once Daily Use for Erectile Dysfunction 2.3 CIALIS for Once Daily Use for Benign Prostatic HyperplasiaĢ.4 CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic HyperplasiaĢ.5 Use with Food 2.6 Use in Specific Populations 2.7 Concomitant Medications 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4.1 Nitrates 4.2 Hypersensitivity Reactions 4.3 Concomitant Guanylate Cyclase (GC) Stimulators 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 Effects on the Eye 5.5 Sudden Hearing Loss 5.6 Alpha-blockers and Antihypertensives 5.7 Renal Impairment 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 5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPHĦ ADVERSE REACTIONS 6.1 Clinical Trials 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 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Impairment 8.7 Renal Impairment 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 for ED 14.2 CIALIS for Once Daily Use for ED 14.3 CIALIS 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)ġ4.4 CIALIS 5 mg for Once Daily Use for ED and BPHġ6 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION 17.1 Nitrates 17.2 Guanylate Cyclase (GC) Stimulators 17.3 Cardiovascular Considerations 17.4 Concomitant Use with Drugs Which Lower Blood Pressure 17.5 Potential for Drug Interactions When Taking CIALIS for Once Daily Use 17.6 Priapism 17.7 Sudden Loss of Vision 17.8 Sudden Hearing Loss 17.9 Alcohol 17.10 Sexually Transmitted Disease 17.11 Recommended Administration. Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.5). Patients with a "crowded" optic disc may also be at an increased risk of NAION ( 5.4, 6.2). 
CIALIS should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).Use CIALIS with caution in patients predisposed to priapism ( 5.3). Patients should seek emergency treatment if an erection lasts >4 hours.
Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers.
CIALIS 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. Use of CIALIS with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6, 5.9). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status ( 5.1).
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