3 DOSAGE FORMS AND STRENGTHS

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.

3. What if I am taking other medicines?

Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil tablets. These events may be accompanied by tinnitus and dizziness. PATIENT INFORMATION Tadalafil (ta da′ la fil) tablets, USPRx OnlyRead this patient information before you start taking tadalafil tablets and each time you get a refill. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.What is the most important information I should know about tadalafil tablets?Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines:Your blood pressure could drop quickly to an unsafe levelYou could get dizzy, faint and even have a heart attack or stroke.

Check with your doctor if you have or have had:

Pulmonary arterial hypertension

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. Carcinogenesis — 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. 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) greater than or equal to 25 mm Hg, pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mm Hg, and pulmonary vascular resistance (PVR) greater than or equal to 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 to 90 years) with the majority of subjects being Caucasian (81%) and female (78%).

Dosage (mg)	Tablet Description	Recommended Use	Onset Time	Duration of Effect
2.5	Small white pill	Daily use for erectile dysfunction	30-60 min	Up to 24 hours
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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 buy cheap cialis professional online baseline at week 16 in 6-MWD (see Figure 4).

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In the tadalafil tablets 40 mg treatment group, the placebo-adjusted mean change increase in 6-MWD was 33 meters (95% C.I. The improvement in 6-MWD was apparent at 8 weeks of treatment and then maintained at week 12 and week 16.Figure 4: 6-Minute Walk Distance (meters) Mean Change from Baseline, with 95% Confidence IntervalsPlacebo-adjusted changes in 6-MWD at 16 weeks were evaluated in subgroups (see Figure 5). In patients taking only tadalafil tablets 40 mg (i.e., without concomitant bosentan), the placebo-adjusted mean change in 6-MWD was 44 meters. In patients taking tadalafil tablets 40 mg and concomitant bosentan therapy, the placebo adjusted mean change in 6-MWD was 23 meters.Figure 5: Placebo-adjusted Mean Change in 6-Minute Walk Distance (meters) of tadalafil tablets 40 mg, with 95% Confidence IntervalsThere was less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy [prostacyclin or analog, endothelin receptor antagonist, PDE5 inhibitor], or worsening WHO functional class) in the tadalafil tablets 40 mg group compared to the placebo group and the groups that used lower doses of tadalafil tablets.The Kaplan-Meier plot of times to clinical worsening is shown below in Figure 6.Figure 6: Kaplan-Meier Plot of Time to Clinical Worsening14.2 Long-Term Treatment of Pulmonary Arterial HypertensionPatients (N=357) from the placebo-controlled study entered a long-term extension study.

4. Generic tadalafil is no different from brand-name Cialis

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. Carcinogenesis — 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.

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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) greater than or equal to 25 mm Hg, pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mm Hg, and pulmonary vascular resistance (PVR) greater than or equal to 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).

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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 to 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 these, 311 patients have been treated with tadalafil for at least 6 months and 182 for 1 year (median exposure 356 days; range 2 days to 415 days). The survival rate in the extension study was 96.5 per 100 patient years. Without a control group, these data must be interpreted cautiously. A 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) greater than or equal to 25 mm Hg, pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mm Hg, and pulmonary vascular resistance (PVR) greater than or equal to 3 Wood units via right heart catheterization.

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Of the 405 subjects, 341 completed the study.The primary efficacy endpoint was the change from buy cheap cialis professional online baseline at week 16 in 6-MWD (see Figure 4). In the tadalafil tablets 40 mg treatment group, the placebo-adjusted mean change increase in 6-MWD was 33 meters (95% C.I. The improvement in 6-MWD was apparent at 8 weeks of treatment and then maintained at week 12 and week 16.Figure 4: 6-Minute Walk Distance (meters) Mean Change from Baseline, with 95% Confidence IntervalsPlacebo-adjusted changes in 6-MWD at 16 weeks were evaluated in subgroups (see Figure 5). In patients taking only tadalafil tablets 40 mg (i.e., without concomitant bosentan), the placebo-adjusted mean change in 6-MWD was 44 meters. In patients taking tadalafil tablets 40 mg and concomitant bosentan therapy, the placebo adjusted mean change in 6-MWD was 23 meters.Figure 5: Placebo-adjusted Mean Change in 6-Minute Walk Distance (meters) of tadalafil tablets 40 mg, with 95% Confidence IntervalsThere was less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy [prostacyclin or analog, endothelin receptor antagonist, PDE5 inhibitor], or worsening WHO functional class) in the tadalafil tablets 40 mg group compared to the placebo group and the groups that used lower doses of tadalafil tablets.The Kaplan-Meier plot of times to clinical worsening is shown below in Figure 6.Figure 6: Kaplan-Meier Plot of Time to Clinical Worsening14.2 Long-Term Treatment of Pulmonary Arterial HypertensionPatients (N=357) from the placebo-controlled study entered a long-term extension study.

Generic version

Of these, 311 patients have been treated with tadalafil for at least 6 months and 182 for 1 year (median exposure 356 days; range 2 days to 415 days). The survival rate in the extension study was 96.5 per 100 patient years. Without a control group, these data must be interpreted cautiously. A 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) greater than or equal to 25 mm Hg, pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mm Hg, and pulmonary vascular resistance (PVR) greater than or equal to 3 Wood units via right heart catheterization. The use of prostacyclin or analogue, L–arginine, phosphodiesterase inhibitor, or other chronic PAH medications were not permitted.

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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. 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 to 90 years) with the majority of subjects being Caucasian (81%) and female (78%). Of the 405 subjects, 341 completed the study. The primary efficacy endpoint was the change from baseline at week 16 in canadian pharmace cialis 6-MWD (see Figure 4). 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.

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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 to 90 years) with the majority of subjects being Caucasian (81%) and female (78%). Of the 405 subjects, 341 completed the study. The primary efficacy endpoint was the change from baseline at week 16 in canadian pharmace cialis 6-MWD (see Figure 4). The improvement in 6-MWD was apparent at 8 weeks of treatment and then maintained at week 12 and week 16. Figure 4: 6-Minute Walk Distance (meters) Mean Change from Baseline, with 95% Confidence Intervals Placebo-adjusted changes in 6-MWD at 16 weeks were evaluated in subgroups (see Figure 5). In patients taking tadalafil tablets 40 mg and concomitant bosentan therapy, the placebo adjusted mean change in 6-MWD was 23 meters.

Mechanism of action

The improvement in 6-MWD was apparent at 8 weeks of treatment and then maintained at week 12 and week 16. Figure 4: 6-Minute Walk Distance (meters) Mean Change from Baseline, with 95% Confidence Intervals Placebo-adjusted changes in 6-MWD at 16 weeks were evaluated in subgroups (see Figure 5). In patients taking tadalafil tablets 40 mg and concomitant bosentan therapy, the placebo adjusted mean change in 6-MWD was 23 meters. Figure 5: Placebo-adjusted Mean Change in 6-Minute Walk Distance (meters) of tadalafil tablets 40 mg, with 95% Confidence Intervals There was less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy [prostacyclin or analog, endothelin receptor antagonist, PDE5 inhibitor], or worsening WHO functional class) in the tadalafil tablets 40 mg group compared to the placebo group and the groups that used lower doses of tadalafil tablets. The Kaplan-Meier plot of times to clinical worsening is shown below in Figure 6.

Reporting side effects

Figure 6: Kaplan-Meier Plot of Time to Clinical Worsening Patients (N=357) from the placebo-controlled study entered a long-term extension study. 17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information)Inform patients of contraindication of tadalafil tablets with any use of organic nitrates or GC stimulators.Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking tadalafil tablets not to take CIALIS or other PDE5 inhibitors.Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil tablets. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil tablets.

What if I miss a dose?

These events may be accompanied by tinnitus and dizziness.Product of IndiaManufactured by:Ajanta Pharma Limited, India.Manufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman Islands# All trademarks are the properties of their respective owners. See FDA-Approved Patient Labeling (Patient Information) Inform patients of contraindication of tadalafil tablets with any use of organic nitrates or GC stimulators. Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking tadalafil tablets not pharmacy cialis uk to take CIALIS or other PDE5 inhibitors. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil tablets. Figure 5: Placebo-adjusted Mean Change in 6-Minute Walk Distance (meters) of tadalafil tablets 40 mg, with 95% Confidence Intervals There was less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy [prostacyclin or analog, endothelin receptor antagonist, PDE5 inhibitor], or worsening WHO functional class) in the tadalafil tablets 40 mg group compared to the placebo group and the groups that used lower doses of tadalafil tablets. The Kaplan-Meier plot of times to clinical worsening is shown below in Figure 6. Figure 6: Kaplan-Meier Plot of Time to Clinical Worsening Patients (N=357) from the placebo-controlled study entered a long-term extension study.

Condition	Risk Level	Explanation	Recommendation
Heart disease	High	May cause dangerous blood pressure drops	Consult cardiologist first
Nitrate medication	Severe	Life-threatening drop in blood pressure	Do not combine
Liver impairment	Moderate	Slower metabolism of the drug	May require dose adjustment
Kidney disease	Moderate	Delayed elimination of drug	Monitor function regularly
Allergy to tadalafil	Severe	Risk of anaphylaxis	Do not use

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information)Inform patients of contraindication of tadalafil tablets with any use of organic nitrates or GC stimulators.Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking tadalafil tablets not to take CIALIS or other PDE5 inhibitors.Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil tablets. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil tablets. These events may be accompanied by tinnitus and dizziness.Product of IndiaManufactured by:Ajanta Pharma Limited, India.Manufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman Islands# All trademarks are the properties of their respective owners. See FDA-Approved Patient Labeling (Patient Information) Inform patients of contraindication of tadalafil tablets with any use of organic nitrates or GC stimulators. Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking tadalafil tablets not pharmacy cialis uk to take CIALIS or other PDE5 inhibitors. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil tablets. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.

• Men with liver or kidney issues should consult a doctor before using white Cialis.
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Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil tablets. These events may be accompanied by tinnitus and dizziness. PATIENT INFORMATION Tadalafil (ta da′ la fil) tablets, USPRx OnlyRead this patient information before you start taking tadalafil tablets and each time you get a refill. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.What is the most important information I should know about tadalafil tablets?Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines:Your blood pressure could drop quickly to an unsafe levelYou could get dizzy, faint and even have a heart attack or stroke.