FULL PRESCRIBING INFORMATION: CONTENTS*

[See Dosage and Administration (2.3) and Warnings and Precautions (5.8)].8.7 Renal

InsufficiencyIn clinical pharmacology studies using single-dose

Proper Use

No overall differences in efficacy or safety were observed between subjects over 65 years of age compared to younger subjects, therefore no dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. [See Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentIn clinical pharmacology studies, tadalafil exposure (AUC) in subjects with mild or moderate hepatic impairment (Child-Pugh Class A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. Insufficient data are available for subjects with severe hepatic impairment (Child-Pugh Class C). tadalafil (5 to 10 mg), tadalafil

exposure (AUC) doubled in subjects with mild (creatinine clearance 51 to

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80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min) renal insufficiency.

12.3 Pharmacokinetics

When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.CYP2C9 (e.g. Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)]. Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers.

Contraindicated combinations

Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5.6), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)]. Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. [See Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)]. Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. [See Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)]. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax

Release Form and Composition

Surviving offspring had normal development and reproductive performance. (See Animal Toxicology and/or Pharmacology Section 13.2)8.3 Nursing MothersCIALIS is not indicated for use in women. It is not known whether tadalafil is excreted into human milk. While tadalafil or some metabolite of tadalafil was excreted into rat milk, drug levels in animal breast milk may not accurately predict levels of drug in human breast milk.8.4 Pediatric UseCIALIS is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years has not been established.8.5 Geriatric UseOf the total number of subjects in clinical studies of tadalafil, approximately 25 percent were 65 and over, while approximately 3 percent were 75 and over. and 2.7- to 4.1-fold increase in AUC following

Dosing & Uses

CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown. Cytochrome P450 Substrates — CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.

How should I store tadalafil?

8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyPregnancy Category B — CIALIS (tadalafil) is not indicated for use in women. There are no adequate and well controlled studies of CIALIS use in pregnant women. Animal reproduction studies in rats and mice revealed no evidence of fetal harm.Non-teratogenic effects — Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. single-dose administration of 10 or 20 mg tadalafil.

Exposure to total methylcatechol (unconjugated plus glucuronide) was 2- to 4-fold higher

What Does ‘Low-Dose’ Mean?

[See Dosage and Administration (2.4) and Warnings and Precautions (5.10)]. Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. Cytochrome P450 Inhibitors — CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure. CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone.

Related treatment guides

Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by cialis for sale cheap 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.4)]. Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.4)]. Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure. in subjects with renal impairment, compared to those with normal renal function.

• [Part of a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors.]
• [Other PDE5 inhibitors include sildenafil (Viagra) and vardenafil (Levitra).]
• [Tadalafil is distinguished by its significantly longer duration of action.]
• [Choice of medication depends on individual response, side effects, and lifestyle.]
• [Do not take tadalafil concurrently with other PDE5 inhibitors.]

Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination.

In case of emergency/overdose

[See Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].7.2 Potential for Other Drugs to Affect CIALIS[See Dosage and Administration (2.4) and Warnings and Precautions (5.10)].Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.H2Antagonists (e.g. Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.Cytochrome P450 Inhibitors — CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.4)].Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone.

Grapefruit and grapefruit juice

Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.4)].Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown.7.3 Potential for CIALIS to Affect Other DrugsCytochrome P450 Substrates — CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.CYP1A2 (e.g. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline.