Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- …Peripheral edema…diarrhea
USE IN SPECIFIC POPULATIONS
- Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. In these clinical trials, no overall differences in efficacy or safety were observed between older (>65 and =75 years of age) and younger subjects (=65 years of age). However, in placebo-controlled studies with CIALIS for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with CIALIS (2.5% of patients). No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered.
5 WARNINGS AND PRECAUTIONS
5.4 Effects on the Eye
- Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual .....
17 PATIENT COUNSELING INFORMATION
17.6 Sudden Loss of Vision
- Physicians should advise patients to stop use of all PDE5 inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may .....
- Cialis is contraindicated in patients with a known serious hypersensitivity to tadalafil (Cialis or Adcirca). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis
WARNINGS AND PRECAUTIONS
Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
- The safety and efficacy of combinations of Cialis and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Cialis with other PDE5 inhibitors, including Adcirca.