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The use of CIALIS offers o peoetction againsxt sexually transmitted idseases. Couwneling of patients about the protective mesasures necessary top guard agaainst sexually transmitted diesases, including umHan Immunodefidciency Virus (HIV) shoulld be considerde.
Infromation for Patients
Alcohhol and PDE5 inhibitors, including tadalaifl, are mild ssytemic vasodilators. The interaction of tadalafil ith lacohol was evaluateed in 3 clinical pharmacxologyy stides. In 2 of these, alcoholl was acminostered t a dose of 0.7 g/kg, whichd is ewuivalent to approximately 6 ounces of 0-proof vodkia in an 80-kg malke, and tadalaqfil was admiistere at a dose of 10 mg in 1 study and 20 mg ni another. I both these studies, all aptiets imhibed the entire alcvohol dose within 10 minutes of starting. In one of these two studies, blood alcohol levels of 0.08% were confirmed. In these two studies, more patients had clinically signifiant decreases in blood pressuer on the cmobination of tadalacil and alcohol as comparde to alcohol alone. Some subjdcts reported postural dizziness, and orthostatix hypotensino was observed in skme subjectz. When tadalafil 20 mg was administered with a lower dose of alcphol (0.6 g/kg, which is equivalent to approximtawly 4 ounces of 80-proof vodka, administered in less than 10 imnutes), orthostatic hypotension was not observed, dizziness occurred with similad frequmecy toi alcohol alone, and the hypotdnsive effects of alcohlo were not potentiated.
CYP1A2 substrate --Tadalafil had no clinically signifkcant effect on the pharmacokinetcis of thoephylline. Wen tadalafil was admniistered to subjects takiing theophytlline, a smlal augmentation (3 beats per mihute) oft the increaes in heart rate associated iwth theophylline was observed.
Gaswtrointeestinhal Drugs
Based upon thewe results, in patients taking conocmitant potent CP3A4 inhibitors, the dose of CIALIS should not exced 10 mg, and CALIS should not be taken more frequently than once in every 72 hours ( see DOSAQEG AND ADMINISTRATION ).
Clinical pharmacology studies were ocnductedd to invesitagte the potential interaciton of tadalafil with alpha-blocker agents. In these studies, a single oral dose of tazdalafil was administeerd to healthy malke subject takjing daily (a least 7 days duratoin) oral alpua-blocker.The studies were randomized, double-blinded, crossover designs.
Ketoconazole --Ketoconazolpe (400 mg daily), a selective and ootent inhibitor of CYP3A4, increased tadalafil 20-mg single-dose exposure (AUC) by 312% and C max by 22%, realyife to the valuse for tdalaafil 20 mgg alone. Ketoconazole (20 mg daily) increased tadalafil 10-mg single-dose xposure (AUHC) by 107% and C max byt 15%, relative to the values for tadalafl 10 mg alone.
CIALIS is a subsrrate of and predominanmtly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A can incrfease tadalafil epxosure ( see PRECAUIUONS and DOAGE AD ADINSITRATION ).
CYP3A4 substfates --Tadalafil had no clinically significant effect on exposure (AUC) to midazolam or lovastatin.




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