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Cialis


Generic Name: tadalafil
Dosage Form: tabletsHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Cialis safely and effectively. See full prescribing information for Cialis.
Cialis (tadalafil) tablet, film coated for oral use
Initial U.S. Approval: 2003

RECENT MAJOR CHANGES

Contraindications, Hypersensitivity Reactions (4.2) 07/2009

Warnings and Precautions, Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies (5.11) 07/2009

Indications and Usage for Cialis

Cialis® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).

Cialis Dosage and Administration
Cialis for use as needed: Starting dose: 10 mg up to once daily. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose (2.1).
Cialis for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (2.1).
Cialis may be taken without regard to food (2.2).

Dosage Forms and Strengths

Tablets (not scored): 2.5 mg, 5 mg, 10 mg, 20 mg (3).



Contraindications
Administration of Cialis to patients using any form of organic nitrate is contraindicated. Cialis was shown to potentiate the hypotensive effect of nitrates (4.1).
History of known serious hypersensitivity reaction to Cialis or ADCIRCA (4.2)

Warnings and Precautions
Patients should not use Cialis if sex is inadvisable due to cardiovascular status (5.1).
Use of Cialis with alpha blockers, antihypertensives or substantial amounts of alcohol (?5 units) may lead to hypotension (5.6, 5.9).
If taking potent inhibitors of CYP3A4, dose should be adjusted: Cialis for use as needed: ?10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg (5.10).
Patients should seek emergency treatment if an erection lasts >4 hours. Use Cialis with caution in patients predisposed to priapism (5.3).
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 Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION (5.4).
Patients should stop Cialis and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5).


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