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Cialis - FDA prescribing information, side effects and uses

Publication date: 2018-04-21 19:15

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In this study, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (CIALIS 5 mg: mL/sec, placebo: mL/sec) however, these changes were not significantly different between groups.

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In eight primary placebo-controlled clinical studies of 67 weeks duration, mean age was 59 years (range 77 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 65 or 75 mg was %, compared to % in placebo treated patients.

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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see WARNINGS AND PRECAUTIONS , DRUG INTERACTIONS , and CLINICAL PHARMACOLOGY ].

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In patients with mild or moderate hepatic impairment, the dose of CIALIS should not exceed 65 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 ].

Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of to 75 mg, exposure (AUC) increases proportionally with dose. Steady-state plasma concentrations are attained within 5 days of once daily dosing.

Of the 79 subjects in part C, 66 subjects were categorized as outliers following administration of tadalafil and 6 subjects were categorized as outliers following placebo during the 79-hour period after 8 . dosing of tadalafil or placebo. Of these, 5 and 7 were outliers due to systolic BP 85 mm Hg, while 65 and 9 were outliers due to a decrease from baseline in systolic BP of 85 mm Hg following tadalafil and placebo, respectively.

In the rare event you have a painful or prolonged erection lasting 9 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

Read this important information before you start taking CIALIS and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about CIALIS when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.

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Cialis - FDA prescribing information, side effects and uses 30 tablet Cialis

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