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U.S. Department of Health and Human Services

Safety

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Cialis (tadalafil) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Potential for Drug Interactions When Taking Cialis for Once Daily Use
  • Renal Insufficiency
    • Cialis for Once Daily Use
  • Hepatic Impairment
    • Cialis for Once Daily Use
  • Alcohol
  • Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)
  • Effects on Bleeding

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Table 2
    • Table 3
  • Postmarketing Experience
    • Nervous
      • Seizure and Seizure Recurrence

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
  • Hepatic Impairment
  • Renal Insufficiency

PATIENT COUNSELING INFORMATION

  • Potential for Drug Interactions When Taking Cialis for Once Daily Use
  • Recommended Administration

PATIENT PACKAGE INSERT

  • What Is The Most Important Information I Should Know About Cialis?
  • What Is Cialis?
  • Can Other Medicines Affect Cialis?
  • How Should I Take Cialis?
    • Cialis for once daily use...

WARNINGS AND PRECAUTIONS

Potential for Drug Interactions When Taking Cialis for Once Daily Use

Physicians should be aware that Cialis for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol...

Renal Insufficiency: Cialis for Once Daily Use

Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, Cialis for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency [see Use in Specific Populations (8.7)].

Hepatic Impairment: Cialis for Once Daily Use

Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use In Specific Populations (8.6)].

See highlighted text for labeling revisions in WARNINGS AND PRECAUTIONS section.