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In dogs, an increased incidence of disseminated arteritis was observed in 1– and 6-month studies at

4.1 Concomitant Organic Nitrates

Systemic drug exposures, as measured by AUC of unbound tadalafil, were approximately 5–fold for mice, and 7– and 14–fold for male and female rats, respectively, the exposures at the maximum recommended human dose (MRHD) of 40 mg.Mutagenesis— Tadalafil was not mutagenic in the in vitrobacterial Ames assays or the forward mutation test in mouse lymphoma cells. Tadalafil was not clastogenic in the in vitro chromosomal aberration test in human lymphocytes or the in vivo rat micronucleus assays.Impairment of Fertility— There were no effects on fertility, reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg/kg/day, a dose producing AUCs for unbound tadalafil of 6–fold for males or 17–fold for females the exposures at the MRHD of 40 mg. In beagle dogs given tadalafil daily for 3 to 12 months, there was treatment–related non–reversible degeneration and atrophy of the seminiferous tubular epithelium in the testes in 20 to 100% of the dogs that resulted in a decrease in spermatogenesis in 40 to 75% of the dogs at doses of ≥10 mg/kg/day. Systemic exposure (based on AUC) at no–observed–adverse-effect–level (NOAEL) (10 mg/kg/day) for unbound tadalafil was similar to that expected in humans at the MRHD of 40 mg.There were no treatment–related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.13.2 Animal Toxicology and/or PharmacologyAnimal studies showed vascular inflammation in tadalafil–treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 1– to 17–fold the human exposure (AUCs) at the MRHD of 40 mg. unbound tadalafil exposure of 0.5– to 38–fold the human exposure (AUC) at the MRHD of 40 mg.

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In a 12–month dog study, no disseminated arteritis was observed, but

2.2 Dose Adjustment in Renal Impairment

Tadalafil is a substrate of and predominantly metabolized by CYP3A. Ketoconazole increased tadalafil exposure relative to the values for tadalafil alone (Figure 2). Although specific interactions have not been studied, other CYP3A inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure. Ritonavir increased tadalafil 20–mg single-dose exposure relative to the values for tadalafil alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure.

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Rifampin (600 mg daily), a CYP3A inducer, reduced tadalafil 10 mg single–dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone [see Drug Interactions (7.5)] . Bosentan, a substrate of CYP2C9 and CYP3A and a moderate inducer of CYP3A, CYP2C9 and possibly CYP2C19, reduced tadalafil systemic exposure following multiple-dose co-administration (Figure 2). Although specific interactions have not been studied, other CYP3A inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. Exposure changes of tadalafil following co-administration with other drugs are shown in Figure 2. b[see Dosage and Administration (2.4)]. 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate

Active Ingredient and Indications

The effects of tadalafil on blood pressure alone and administered with antihypertensives, alcohol, and alpha-blockers is shown in Figure 1. aIn some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed, and dizziness occurred at a similar frequency to alcohol alone. bIn studies of tadalafil co-administration with doxazosin, the number of subjects with potentially clinically significant standing blood pressure decreases was greater for the combination. Some patients had symptoms associated with the decrease in blood pressure including syncope.

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Figure 1: Effects of Tadalafil on Blood Pressure The effect of a single 100 mg dose of tadalafil (2.5 times the recommended dose) on the QT interval was evaluated at the time of peak tadalafil concentration in a randomized, double–blinded, placebo, and active–controlled (intravenous ibutilide) crossover study in 90 healthy males aged 18 to 53 years. In this study, the mean increase in heart rate associated with a 100 mg dose of tadalafil compared to placebo was 3.1 beats per minute. Of note, in this study, in some subjects who received tadalafil followed by sublingual nitroglycerin in the post– exercise period, clinically significant reductions in blood pressure were observed, consistent with the augmentation by tadalafil of the blood–pressure–lowering effects of nitrates. Single oral doses of PDE inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green), using the Farnsworth–Munsell 100–hue test, with peak effects near the time of peak plasma levels. Across all clinical studies with tadalafil, reports of changes in color vision were rare (<0.1% of patients). decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately

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4– to 10–fold the human exposure at the MRHD of 40 mg.

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The abnormal blood–cell findings were reversible within 2 weeks upon removal of the drug.

Ingredient	Amount per Dose	Purpose	Notes
Tadalafil	20 mg	Active ingredient, vasodilator	Main component for ED
Microcrystalline Cellulose	-	Filler	Binds ingredients
Magnesium Stearate	-	Excipient	Improves pill stability
Titanium Dioxide	-	Coloring agent	Provides yellow color

Carcinogenesis— Tadalafil was not carcinogenic to rats or mice when

5.6 Prolonged Erection

Figure 2: Impact of Other Drugs on the Pharmacokinetics of Tadalafil Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Exposure changes of drugs following co-administration with tadalafil are shown in Figure 3. aA small augmentation (increase of 3 beats per minute) in heart rate was observed with theophylline. bTadalafil (40 mg qd) had no clinically significant effect on exposure (AUC and C max) of bosentan metabolites. Figure 3: Impact of Tadalafil on the Pharmacokinetics of Other Drugs 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesis— Tadalafil was not carcinogenic to rats or mice when administered daily for 2 years at doses up to 400 mg/kg/day. administered daily for 2 years at doses up to 400 mg/kg/day.

Discreet Packaging

Three studies were conducted in men to assess the potential effect on sperm characteristics of tadalafil 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily. In addition there was no adverse effect on mean concentrations of reproductive hormones, testosterone, luteinizing hormone or follicle stimulating hormone with either 10 or 20 mg of tadalafil compared to placebo. Dose-response relationships, between 20 mg and 40 mg, were not observed for 6-minute walk distance or pulmonary vascular resistance (PVR) in subjects with PAH in the placebo-controlled study. Mean change from baseline PVR was -254 dynes*sec*cm -5and -209 dynes*sec*cm -5at 16 weeks in patients receiving 20 mg and 40 mg daily, respectively. Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.

Less common

In PAH patients administeredbetween 20 and 40 mg of tadalafil, an approximately 1.5-fold greater AUC was observed indicating a less than proportional increase in exposure over the entire dose range of 2.5 to 40 mg. During tadalafil 20 and 40 mg once daily dosing, steady-state plasma concentrations were attained within 5 days, and exposure was approximately 1.3-fold higher than after a single dose. Absorption— After single oral-dose administration, the maximum observed plasma concentration (Cmax) of tadalafil is achieved between 2 and 8 hours (median time of 4 hours). Distribution— The mean apparent volume of distribution following oral administration is approximately 77 L, indicating that tadalafil is distributed into tissues. Metabolism— Tadalafil is predominantly metabolized by CYP3A to a catechol metabolite. Systemic drug exposures, as measured by AUC of unbound

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Elimination— Following 40 mg, the mean oral clearance for tadalafil is 3.4 L/hr and the mean terminal half-life is 15 hours in healthy subjects. Population pharmacokinetics— In patients with pulmonary hypertension not receiving concomitant bosentan, the average tadalafil exposure at steady-state following 40 mg was 26% higher when compared to those of healthy volunteers. The results suggest a lower clearance of tadalafil in patients with pulmonary hypertension compared to healthy volunteers. In healthy male elderly subjects (65 years or over) after a 10 mg dose, a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) with no effect on C maxwas observed relative to that in healthy subjects 19 to 45 years of age. In clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil exposure (AUC) doubled in subjects with mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min) renal impairment.

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Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination [see Dosage and Administration ( 2.2)] . Insufficient data 10mg cialis price are available for subjects with severe hepatic impairment (Child-Pugh Class C) [see Dosage and Administration ( 2.3)] . In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure (AUC) was reduced approximately 19% and Cmaxwas 5% lower than that observed in healthy subjects. Pharmacokinetic studies have included subjects from different ethnic groups, and no differences in the typical exposure to tadalafil have been identified. In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure (AUC and C max) were observed. tadalafil, were approximately 5–fold for mice, and 7– and

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14–fold for male and female rats, respectively, the exposures at the maximum recommended human dose (MRHD) of 40 mg.

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