Label: CIALIS- tadalafil tablet, film coated

In PAH patients administered between 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.

Aspect	Description	Typical Dimensions	Shape
Pill Shape	Usually oval or round	8-12 mm diameter	Oval / Round
Size	Small, easily swallowable	8-10 mm	N/A
Appearance Shape	Slightly beveled edges	N/A	Oval / Round

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). The rate and extent of absorption of tadalafil are not influenced by food; thus tadalafil tablets may be taken with or without food.

Color	Description	Brand Name Variations	Visual Notes
White	Most common, standard look	Cialis Classic	Smooth, glossy surface
Blue	Less common, for specific brands	Generic versions	Matte or shiny finish
Yellow	Rare, specialty formulations	N/A	Bright, vibrant appearance

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.

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• They often bear imprint marks for identification.
• The gloss finish gives them a polished look.
• The shape facilitates swallowing and comfort.
• Size is uniform, with slight variations for different doses.
• Some have a scored line for splitting.
• The appearance is consistent across primary producers.

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 Cmax was 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.

• In the event of a recall, appearance is a key identifier for lot numbers.
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• If appearance is wrong, it signals a major manufacturing deviation.
• Patients should be concerned if a pill looks different than usual.
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• Pharmacists are obligated to inform patients of appearance changes.
• For brand-name Cialis, the appearance has been constant for years.
• This consistency builds long-term patient trust.
• The pill's look is iconic in the pharmaceutical industry.
• It represents a blockbuster drug in the urology field.
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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 are available for subjects with severe hepatic impairment (Child-Pugh Class C) [see Dosage and Administration (2.3).

• Typical Cialis tablets are orange and oval-shaped.
• They feature specific imprints for dosage identification.
• The surface is smooth, with a glossy coating.
• Size is roughly 8-14 mm overall.
• They are designed to be discreet and easy to take.
• Some generic versions are similar but differ slightly.
• They are mostly solid, not capsule form.

In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure (AUC) was reduced approximately 19% and Cmax was 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 Cmax) were observed.

8.7 Renal Impairment

Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure. 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 cialis 10 or 20 changes of tadalafil following co-administration with other drugs are shown in Figure 2.

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b[see Dosage and Administration (2.4)]. 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 Cmax) of bosentan metabolites. Tadalafil is a substrate of and predominantly metabolized by CYP3A.

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Cialis Generic	60mg	30 + 2 Pills	85.33€ 81.27€	Buy
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Cialis Black	80mg	90 + 6 Pills	207.88€ 197.98€	Buy
Cialis Original	20mg	48 + 4 Pills	224.69€ 213.99€	Buy
Cialis Super Active	20mg	120 + 16 Pills	382.15€ 363.95€	Buy
Cialis Black	80mg	60 + 4 Pills	150.98€ 143.79€	Buy
Cialis Generic	20mg	60 + 6 Pills	117.76€ 112.15€	Buy
Cialis Original	20mg	14 + 2 Pills	95.75€ 91.19€	Buy
Cialis Original	20mg	92 + 4 Pills	377.99€ 359.99€	Buy
Cialis Soft Tabs	20mg	20 + 2 Pills	66.98€ 63.79€	Buy

Ketoconazole increased tadalafil exposure relative to the values for tadalafil alone (Figure 2).

• The future may bring digital tracking (like a QR code) on the pill.
• Currently, no such markings exist on brand Cialis tablets.
• Any change to its appearance would require regulatory approval.
• Patients and doctors would be notified well in advance.
• For now, the classic yellow, oval, imprinted tablet remains standard.
• Its appearance is a fixed point in a changing pharmaceutical landscape.
• As patents expire, the brand appearance retains its recognition.
• Generics will continue to use different looks to avoid trademark issues.
• The brand pill's appearance is its lasting visual legacy.
• It is a simple object that has impacted millions of lives.
• Understanding its appearance is part of responsible medication use.

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.

8.5 Geriatric Use

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. Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination [see Dosage and Administration (2.2). Insufficient data 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 Cmax was 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.

Pulmonary arterial hypertension

In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure (AUC and Cmax) were observed. 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. 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 cialis 10 or 20 changes of tadalafil following co-administration with other drugs are shown in Figure 2. b[see Dosage and Administration (2.4)]. 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 Cmax) 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. 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 vitro bacterial 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 20–100% of the dogs that resulted in a decrease in spermatogenesis in 40–75% of the dogs at doses of ≥10 mg/kg/day.

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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. 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. Animal studies showed vascular inflammation in tadalafil–treated mice, rats, and dogs. 14 CLINICAL STUDIES 14.1 Tadalafil Tablets for Pulmonary Arterial HypertensionA randomized, double-blind, 16 week placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension, defined as a resting mean pulmonary artery pressure (mPAP) ≥25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg, and pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization.

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Allowed background therapy included bosentan (maintenance dosing up to 125 mg twice daily) and chronic anticoagulation. The use of prostacyclin or analogue, L–arginine, phosphodiesterase inhibitor, or other chronic PAH medications were not permitted.Subjects were randomly assigned to 1 of 5 treatment groups (tadalafil 2.5, 10, 20, 40 mg, or placebo) in a 1:1:1:1:1 ratio. Subjects had to be at least 12 years of age and had a diagnosis of PAH that was idiopathic, heritable, related to connective tissue disease, anorexigen use, human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of a congenital systemic-to-pulmonary shunt of least 1 year in duration (for example, ventricular septal defect, patent ductus arteriosus). Patients with a history of left-sided heart disease, severe renal insufficiency, or pulmonary hypertension related to conditions other than specified in the inclusion criteria were not eligible for enrollment.The mean age of all subjects was 54 years (range 14 - 90 years) with the majority of subjects being Caucasian (81%) and female (78%). PAH etiologies were predominantly idiopathic or heritable PAH (61%) and related to connective tissue disease (23%). 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. In dogs, an increased incidence of disseminated arteritis was observed in 1– and 6-month studies at unbound tadalafil exposure of 0.5– to 38–fold the human exposure (AUC) at the MRHD of 40 mg.

2.4 Dose Adjustments for Use with Ritonavir

In PAH patients administered between 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). The rate and extent of absorption of tadalafil are not influenced by food; thus tadalafil tablets may be taken with or without food. Distribution — The mean apparent volume of distribution following oral administration is approximately 77 L, indicating that tadalafil is distributed into tissues.

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Metabolism — Tadalafil is predominantly metabolized by CYP3A to a catechol metabolite. 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 Cmax was observed relative to that in healthy subjects 19 to 45 years of age. In a 12–month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 4– to 10–fold the human exposure at the MRHD of 40 mg. The abnormal blood–cell findings were reversible within 2 weeks upon removal of the drug. 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. 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. 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.

2.3 CIALIS for Once Daily Use for Benign Prostatic Hyperplasia

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. 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 vitro bacterial 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 20–100% of the dogs that resulted in a decrease in spermatogenesis in 40–75% 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.

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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. In dogs, an increased incidence of disseminated arteritis was observed in 1– and 6-month studies at unbound tadalafil exposure of 0.5– to 38–fold the human exposure (AUC) at the MRHD of 40 mg. In a 12–month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 4– to 10–fold the human exposure at the MRHD of 40 mg. The abnormal blood–cell findings were reversible within 2 weeks upon removal of the drug. 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. There were no treatment–related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years. Animal studies showed vascular inflammation in tadalafil–treated mice, rats, and dogs. 14 CLINICAL STUDIES 14.1 Tadalafil Tablets for Pulmonary Arterial HypertensionA randomized, double-blind, 16 week placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension, defined as a resting mean pulmonary artery pressure (mPAP) ≥25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg, and pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization. Allowed background therapy included bosentan (maintenance dosing up to 125 mg twice daily) and chronic anticoagulation. The use of prostacyclin or analogue, L–arginine, phosphodiesterase inhibitor, or other chronic PAH medications were not permitted.Subjects were randomly assigned to 1 of 5 treatment groups (tadalafil 2.5, 10, 20, 40 mg, or placebo) in a 1:1:1:1:1 ratio. Subjects had to be at least 12 years of age and had a diagnosis of PAH that was idiopathic, heritable, related to connective tissue disease, anorexigen use, human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of a congenital systemic-to-pulmonary shunt of least 1 year in duration (for example, ventricular septal defect, patent ductus arteriosus). Patients with a history of left-sided heart disease, severe renal insufficiency, or pulmonary hypertension related to conditions other than specified in the inclusion criteria were not eligible for enrollment.The mean age of all subjects was 54 years (range 14 - 90 years) with the majority of subjects being Caucasian (81%) and female (78%). PAH etiologies were predominantly idiopathic or heritable PAH (61%) and related to connective tissue disease (23%). More than half (53%) of the subjects in the study were receiving concomitant bosentan therapy. The majority of subjects had a World Health Organization (WHO) Functional Class III (65%) or II (32%). The mean baseline 6-minute walk distance (6-MWD) was 343 meters. Of the 405 subjects, 341 completed the study.The primary efficacy endpoint was the change from baseline at week 16 in 6-MWD (see Figure 4).

5.3 Prolonged Erection

More than half (53%) of the subjects in the study were receiving concomitant bosentan therapy. The majority of subjects had a World Health Organization (WHO) Functional Class III (65%) or II (32%). The mean baseline 6-minute walk distance (6-MWD) was 343 meters. Of the 405 subjects, 341 completed the study.The primary efficacy endpoint was the change from baseline at week 16 in 6-MWD (see Figure 4).

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