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Cialis

Side Effects & Drug Interactions

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SIDE EFFECTS

Tadalafil was administered to over 5700 men (mean age 59, range 19 to 87 years) during clinical trials worldwide. Over 1000 patients were treated for 1 year or longer and over 1300 patients were treated for 6 months or more.

In placebo-controlled Phase 3 clinical trials, the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo-treated patients.

When tadalafil was taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 11):

Table 11: Treatment-Emergent Adverse Events Reported by = 2% of Patients Treated withTadalafil (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight PrimaryPlacebo-Controlled Phase 3 Studies (Including a Study in Patients with Diabetes)

	Placebo	Tadalafil 5 mg	Tadalafil 10 mg	Tadalafil 20 mg
Adverse Event	(N=476)	(N=151)	(N=394)	(N=635)
Headache	5%	11%	11%	15%
Dyspepsia	1%	4%	8%	10%
Back pain	3%	3%	5%	6%
Myalgia	1%	1%	4%	3%
Nasal congestion	1%	2%	3%	3%
Flushing*	1%	2%	3%	3%
Pain in limb	1%	1%	3%	3%
* The term flushing includes: facial flushing and flushing

Back pain or myalgia was reported at incidence rates described in Table 11. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbancy. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported infrequently (< 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all tadalafil-treated subjects discontinued treatment as a consequence of back pain/myalgia. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology.

Across all studies with any tadalafil dose, reports of changes in color vision were rare (< 0.1% of patients).

The following section identifies additional, less frequent events (< 2%) reported in controlled clinical trials; a causal relationship of these events to CIALIS is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a whole: asthenia, face edema, fatigue, pain

Cardiovascular: angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive: abnormal liver function tests, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting

Musculoskeletal: arthralgia, neck pain

Nervous: dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo

Respiratory: dyspnea, epistaxis, pharyngitis

Skin and Appendages: pruritus, rash, sweating

Ophthalmologic: blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids

Urogenital: erection increased, spontaneous penile erection

Postmarketing surveillance

Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of CIALIS without sexual activity. Others were reported to have occurred hours to days after the use of CIALIS and sexual activity. It is not possible to determine whether these events are related directly to CIALIS, to sexual activity, to the patient?s underlying cardiovascular disease, to a combination of these factors, or to other factors (see WARNINGS for additional information).

Other adverse events: The following list includes other adverse events that have been identified during postmarketing use of CIALIS. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a whole: hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis

Nervous: migraine

Ophthalmologic: visual field defect, retinal vein occlusion, retinal artery occlusion

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (?crowded disc?), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient?s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see Information for Patients under PRECAUTIONS).

Urogenital: priapism (see WARNINGS)

DRUG INTERACTIONS

Effects of Other Drugs on CIALIS

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 (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Ketoconazole ? Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20-mg single-dose exposure (AUC) by 312% and Cmaxby 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone.

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. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure (see DOSAGE AND ADMINISTRATION).

Based upon these results, in patients taking concomitant potent CYP3A4 inhibitors, the dose of CIALIS should not exceed 10 mg, and CIALIS should not be taken more frequently than once in every 72 hours (see DOSAGE AND ADMINISTRATION).

Other cytochrome P450 inhibitors ? Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.

Cytochrome P450 Inducers

Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.

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. No dose adjustment is warranted.

Gastrointestinal Drugs

H2 antagonists ? An increase in gastric pH resulting from administration of nizatidine had no significant effect on tadalafil pharmacokinetics.

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.

Effects of CIALIS on Other Drugs

Drugs Metabolized by Cytochrome P450

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 substrate ? Tadalafil had no clinically significant effect on the pharmacokinetics of theophylline. 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.

CYP3A4 substrates ? Tadalafil had no clinically significant effect on exposure (AUC) to midazolam or lovastatin.

CYP2C9 substrate ? Tadalafil had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.

Alcohol

Alcohol and PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. The interaction of tadalafil with alcohol was evaluated in 3 clinical pharmacology studies. In 2 of these, alcohol was administered at a dose of 0.7 g/kg, which is equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male, and tadalafil was administered at a dose of 10 mg in 1 study and 20 mg in another. In both these studies, all patients imbibed the entire alcohol 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 significant decreases in blood pressure on the combination of tadalafil and alcohol as compared to alcohol alone. Some subjects reported postural dizziness, and orthostatic hypotension was observed in some subjects. When tadalafil 20 mg was administered with a lower dose of alcohol (0.6 g/kg, which is equivalent to approximately 4 ounces of 80-proof vodka, administered in less than 10 minutes), orthostatic hypotension was not observed, dizziness occurred with similar frequency to alcohol alone, and the hypotensive effects of alcohol were not potentiated.

Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations.

Both alcohol and CIALIS, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Anti-Hypertensives

PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected anti-hypertensive medications.

Alpha Blockers

Clinical pharmacology studies were conducted to investigate the potential interaction of tadalafil with alpha-blocker agents. In these studies, a single oral dose of tadalafil was administered to healthy male subjects taking daily (at least 7 days duration) oral alpha-blocker. The studies were randomized, double-blinded, crossover designs.

Tamsulosin ? A single oral dose of tadalafil 10, 20 mg, or placebo was administered in a 3-period, crossover design to healthy subjects taking 0.4 mg once-daily tamsulosin, a selective alpha[1A]-adrenergic blocker (N=18 subjects). Tadalafil or placebo was administered 2 hours after tamsulosin following a minimum of seven days of tamsulosin dosing.

Table 7: Tamsulosin Study: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure

Placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg)	Tadalafil 10 mg	Tadalafil 20 mg
Supine	3.2 (-2.3, 8.6)	3.2 (-2.3, 8.7)
Standing	1.7 (-4.7, 8.1)	2.3 (-4.1, 8.7)

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo dosing. There were 2, 2, and 1 outliers (subjects with a decrease from baseline in standing systolic blood pressure of > 30 mm Hg at one or more time points) following administration of tadalafil 10 mg, 20 mg, and placebo, respectively. There were no subjects with a standing systolic blood pressure < 85 mm Hg. No severe adverse events potentially related to blood-pressure effects were reported. No syncope was reported.

Doxazosin ? Two clinical pharmacology studies were conducted with tadalafil and doxazosin, an alpha[1]-adrenergic blocker.

In the first doxazosin study, a single oral dose of tadalafil 20 mg or placebo was administered in a 2-period, crossover design to healthy subjects taking oral doxazosin 8 mg daily (N=18 subjects). Doxazosin was administered at the same time as tadalafil or placebo after a minimum of seven days of doxazosin dosing.

Table 8: Doxazosin Study 1: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure

Placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg)	Tadalafil 20 mg
Supine	3.6 (-1.5, 8.8)
Standing	9.8 (4.1, 15.5)

Figure 3: Doxazosin Study 1: Mean Change from Baseline in Systolic Blood Pressure

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo administration. Outliers were defined as subjects with a standing systolic blood pressure of < 85 mm Hg or a decrease from baseline in standing systolic blood pressure of > 30 mm Hg at one or more time points. There were 9 and 3 outliers following administration of tadalafil 20 mg and placebo, respectively. Five and two subjects were outliers due to a decrease from baseline in standing systolic BP of > 30 mm Hg, while five and one subject were outliers due to standing systolic BP < 85 mm Hg following tadalafil and placebo, respectively. Severe adverse events potentially related to blood-pressure effects were assessed. No such events were reported following placebo. Two such events were reported following administration of tadalafil. Vertigo was reported in one subject that began 7 hours after dosing and lasted about 5 days. This subject previously experienced a mild episode of vertigo on doxazosin and placebo. Dizziness was reported in another subject that began 25 minutes after dosing and lasted 1 day. No syncope was reported.

In the second doxazosin study, a single oral dose of tadalafil 20 mg was administered to healthy subjects taking oral doxazosin, either 4 or 8 mg daily. The study (N=72 subjects) was conducted in three parts, each a 3-period crossover.

In part A (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 a.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part B (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 p.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part C (N=24), subjects were titrated to doxazosin 8 mg administered daily at 8 a.m. In this part, tadalafil or placebo were administered at either 8 a.m. or 8 p.m.

The placebo-subtracted mean maximal decreases in systolic blood pressure over a 12-hour period after dosing in the placebo-controlled portion of the study (part C) are shown in the following table.

Table 9: Doxazosin Study 2 (Part C): Mean Maximal Decrease in Systolic Blood Pressure

Placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg)	Tadalafil 20 mg at 8 a.m.	Tadalafil 20 mg at 8 p.m.
Ambulatory Blood-Pressure Monitoring (ABPM)	7	8

Figure 4: Doxazosin Study 2 (Part C): Mean Change from Time-Matched Baseline in Systolic Blood Pressure

Blood pressure was measured by ABPM every 15 to 30 minutes for up to 36 hours after tadalafil or placebo. Subjects were categorized as outliers if one or more systolic blood pressure readings of < 85 mm Hg were recorded or one or more decreases in systolic blood pressure of > 30 mm Hg from a time-matched baseline occurred during the analysis interval.

Of the 24 subjects in part C, 16 subjects were categorized as outliers following administration of tadalafil and 6 subjects were categorized as outliers following placebo during the 24-hour period after 8 a.m. dosing of tadalafil or placebo. Of these, 5 and 2 were outliers due to systolic BP < 85 mm Hg, while 15 and 4 were outliers due to a decrease from baseline in systolic BP of > 30 mm Hg following tadalafil and placebo, respectively.

During the 24-hour period after 8 p.m. dosing, 17 subjects were categorized as outliers following administration of tadalafil and 7 subjects following placebo. Of these, 10 and 2 subjects were outliers due to systolic BP < 85 mm Hg, while 15 and 5 subjects were outliers due to a decrease from baseline in systolic BP of > 30 mm Hg, following tadalafil and placebo, respectively.

Some additional subjects in both the tadalafil and placebo groups were categorized as outliers in the period beyond 24 hours.

Severe adverse events potentially related to blood-pressure effects were assessed. In the study (N=72 subjects), 2 such events were reported following administration of tadalafil (symptomatic hypotension in one subject that began 10 hours after dosing and lasted approximately 1 hour, and dizziness in another subject that began 11 hours after dosing and lasted 2 minutes). No such events were reported following placebo. In the period prior to tadalafil dosing, one severe event (dizziness) was reported in a subject during the doxazosin run-in phase.

Alfuzosin ? A single oral dose of tadalafil 20 mg or placebo was administered in a 2-period, crossover design to healthy subjects taking once-daily alfuzosin HCl 10 mg extended-release tablets, an alpha[1]-adrenergic blocker (N=17 completed subjects). Tadalafil or placebo was administered 4 hours after alfuzosin following a minimum of seven days of alfuzosin dosing.

Table 10: Alfuzosin Study: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure

Placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg)	Tadalafil 20 mg
Supine	2.2 (-0.9, 5.2)
Standing	4.4 (-0.2, 8.9)

Blood pressure was measured manually at 1, 2, 3, 4, 6, 8, 10, 20, and 24 hours after tadalafil or placebo dosing. There was 1 outlier (subject with a standing systolic blood pressure < 85 mm Hg) following administration of tadalafil 20mg. There were no subjects with a decrease from baseline in standing systolic blood pressure of > 30 mm Hg at one or more time points. No severe adverse events potentially related to blood pressure effects were reported. No syncope was reported.

Other Anti-Hypertensive Agents

Amlodipine ? A study was conducted to assess the interaction of amlodipine (5 mg daily) and tadalafil 10 mg. There was no effect of tadalafil on amlodipine blood levels and no effect of amlodipine on tadalafil blood levels. The mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking amlodipine was 3/2 mm Hg, compared to placebo. In a similar study using tadalafil 20 mg, there were no clinically significant differences between tadalafil and placebo in subjects taking amlodipine.

Metoprolol ? A study was conducted to assess the interaction of sustained-release metoprolol (25 to 200 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking metoprolol was 5/3 mm Hg, compared to placebo.

Bendrofluazide ? A study was conducted to assess the interaction of bendrofluazide (2.5 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking bendrofluazide was 6/4 mm Hg, compared to placebo.

Enalapril ? A study was conducted to assess the interaction of enalapril (10 to 20 mg daily) and tadalafil 10 mg. Following dosing, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking enalapril was 4/1 mm Hg, compared to placebo.

Angiotensin II receptor blocker (and other anti-hypertensives) ? A study was conducted to assess the interaction of angiotensin II receptor blockers and tadalafil 20 mg. Subjects in the study were taking any marketed angiotensin II receptor blocker, either alone, as a component of a combination product, or as part of a multiple anti-hypertensive regimen. Following dosing, ambulatory measurements of blood pressure revealed differences between tadalafil and placebo of 8/4 mm Hg in systolic/diastolic blood pressure.

Aspirin

Tadalafil did not potentiate the increase in bleeding time caused by aspirin.

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† IMPORTANT INFORMATION REGARDING CIALIS AND PROCALIS. CIALIS® is prescribed to treat impotence (ED). If you take any medicines that have nitrates in them (like nitroglycerin for chest pain)—every day or even once in a while—you should NOT take CIALIS. Discuss your general health status with your doctor to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help. The most common side effects of CIALIS are headache, facial flushing, and upset stomach. Less commonly, bluish vision, blurred vision, or sensitivity to light may briefly occur. In rare instances, men taking PDE5 inhibitors (oral impotence medicines, including CIALIS) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, and call a doctor right away. Although erections lasting for more than 4 hours may occur rarely with all ED treatments in this drug class, to avoid long-term injuries, it is important to seek immediate medical help. If you are older than age 65, or have serious liver or kidney problems, your doctor may start you at the lowest dose (10 mg) of CIALIS. If you are taking protease inhibitors, such as for the treatment of HIV, your doctor may recommend a 10-mg dose and may limit you to a maximum single dose of 20 mg of CIALIS in a 48-hour period. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers, your doctor may start you on a lower dose of CIALIS. Remember to protect yourself and your partner from sexually transmitted diseases. CIALIS is one of many options for treating ED that you and your doctor can consider. ProCALIS an aid in impotence and erectile dysfunction (ED) . Generic Pro Calis is a generic formulation of herbal compounds that help, similar to the name brand Cialis, alleviate impotence, and achieve functional hard erections with longer duration, improved frequency, and more intensity. Discuss your general health status with your doctor to ensure that you are healthy enough to consume these compounds. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.

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