16 HOW SUPPLIED/STORAGE AND HANDLING

In patients taking potent inhibitors of CYP3A4 and CIALIS for once daily use, the dose of CIALIS should not exceed 2.5 mg [see Dosage and Administration (2.4)].

5.6 Alpha blockers and Antihypertensives

CIALIS for once daily use has not been extensively evaluated in patients with mild or moderate hepatic insufficiency. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)]. Patients should be made aware that both alcohol and CIALIS, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that 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 [see Dosage and Administration (2.4) and Clinical Pharmacology (12.2)]. CIALIS is metabolized predominantly by CYP3A4 in the liver. The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied.

Therefore, the use of such combinations is not recommended.

7.2 Potential for Other Drugs to Affect CIALIS

Therefore, physicians should inform patients that 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 [see Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)CIALIS is metabolized predominantly by CYP3A4 in the liver. The dose of CIALIS should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole [see Drug Interactions (7.2)]. In patients taking potent inhibitors of CYP3A4 and CIALIS for once daily use, the dose of CIALIS should not exceed 2.5 mg [see Dosage and Administration (2.4)].5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction TherapiesThe safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.5.12 Effects on BleedingStudies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone.

Generic version

CIALIS has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although CIALIS has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.5.13 Counseling Patients About Sexually Transmitted DiseasesThe use of CIALIS offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing CIALIS, it is important to note the following: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

Although CIALIS has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

17.5 Priapism

Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. [See Contraindications (4.1) and Patient Counseling Information (17.1)]. Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for CIALIS, and therefore until further information is available, CIALIS is not recommended for the following groups of patients: myocardial infarction within the last 90 days unstable angina or angina occurring during sexual intercourse New York Heart Association Class 2 or greater heart failure in the last 6 months uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg) As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure.

Cialis and foods

Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors. Physicians should be aware that CIALIS for once daily use provides continuous plasma tadalafil levels and should consider this when evaluating the potential for interactions with medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial consumption of alcohol [see Drug Interactions (7.1), (7.2), (7.3)]. There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. CIALIS should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). The use of CIALIS offers no protection against sexually transmitted diseases.

6 ADVERSE REACTIONS 6.1 Clinical Studies ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly

• The 20mg dose is usually prescribed for most men.
• Cialis works by relaxing blood vessels in the penis.
• It can also treat symptoms of benign prostatic hyperplasia.
• Store Cialis in a cool, dry place away from children.
• Do not split or crush the pills.

compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Tadalafil was administered to over 6550 men during clinical trials worldwide.

In trials of CIALIS for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively.

• Benign Prostatic Hyperplasia (BPH) symptoms include frequent urination and weak stream.
• Tadalafil 5mg daily is approved for the treatment of BPH.
• It can also be used for men who have both BPH and ED.
• The combination pill with tamsulosin is for BPH, not specifically for ED.
• Improvement in BPH symptoms may take a few weeks to become noticeable.
• It does not reduce the size of the prostate but relaxes smooth muscle.
• For BPH, it is taken at the same time every day, without regard to sexual activity.
• Do not take 20mg on-demand for BPH; use the dose prescribed for that condition.
• Discuss all urinary symptoms with your doctor for proper diagnosis.
• Other BPH medications include alpha-blockers and 5-alpha reductase inhibitors.
• Tadalafil can be used in combination with some of these other drugs.
• Your urologist will determine the best regimen for your specific case.

For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.CIALIS for Use as NeededIn eight primary placebo-controlled Phase 3 studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the

Can erectile dysfunction be a sign of another health condition?

In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs. [See Dosage and Administration (2.4) and Drug Interactions (7.1)]. CIALIS should be limited to 5 mg not more than once in every 72 hours in patients with severe renal insufficiency or end-stage renal disease on hemodialysis.

Higher dosages of Cialis

No dose adjustment is required in patients with mild renal insufficiency [see Use in Specific Populations (8.7)]. Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, CIALIS for once daily use is not recommended in patients with severe renal insufficiency. No dose adjustment is required in patients with mild or moderate renal insufficiency [see Use in Specific Populations (8.7)]. In patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 10 mg. Because of insufficient information in patients with severe hepatic impairment, use of CIALIS in this group is not recommended [see Use In Specific Populations (8.6)]. 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 taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 1) for CIALIS for use as needed:CIALIS

• Cialis Tadalafil 20mg is a phosphodiesterase inhibitor.
• It may interact with certain medications like alpha-blockers.
• Inform your doctor of your medical history before use.
• Avoid heavy drinking while taking Cialis.
• The medication can be taken daily or as needed.

for Once Daily UseIn three placebo-controlled Phase 3 clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.The following

• Cialis 20mg is generally well-tolerated under medical supervision.
• Overdose symptoms include severe hypotension and priapism.
• Priapism requires prompt medical treatment.
• Do not combine Cialis with other ED medications.
• Regular check-ups are recommended if prescribed long-term.

adverse events were reported (see Table 2) in clinical trials of 12 weeks duration:The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study:Back pain or myalgia was reported at incidence rates described in Tables 1 and 2.

Are All Tadalafil Prescriptions the Same?

Physicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the 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 [see Adverse Reactions (6.2)]. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended. Physicians should advise patients to stop taking PDE5 inhibitors, including CIALIS, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1) and (6.2)].

Erectile dysfunction explained

Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha blockers and antihypertensive medications [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at canadian pharmacy cialis 20mg increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.