My Medical Blog http://mymedblog.com/ ru My Medical Blog DataLife Engine CIALIS for Once Daily Use http://mymedblog.com/cialis/37-cialis-for-once-daily-use.html http://mymedblog.com/cialis/37-cialis-for-once-daily-use.html CIALIS for Once Daily Use

The efficacy and safety of CIALIS for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. CIALIS, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). CIALIS was studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively.

One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. CIALIS was taken once daily at doses ranging from 2.5 to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis.]]> support Mon, 06 Oct 2008 03:43:17 +0400 CIALIS: CLINICAL STUDIES http://mymedblog.com/cialis/36-cialis-clinical-studies.html http://mymedblog.com/cialis/36-cialis-clinical-studies.html CIALIS: CLINICAL STUDIES

CIALIS for Use as Needed

The efficacy and safety of CIALIS in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. CIALIS, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

CIALIS was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.

In these 7 trials, CIALIS was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted.]]> support Mon, 06 Oct 2008 03:26:42 +0400 CIALIS: Pharmacokinetics http://mymedblog.com/cialis/35-cialis-pharmacokinetics.html http://mymedblog.com/cialis/35-cialis-pharmacokinetics.html CIALIS: Pharmacokinetics

Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects. Steady-state plasma concentrations are attained within 5 days of once per day dosing and exposure is approximately 1.6-fold greater than after a single dose. Mean tadalafil concentrations measured after the administration of a single oral dose of 20 mg and single and once daily multiple doses of 5 mg, from a separate study, to healthy male subjects are depicted.]]> support Mon, 06 Oct 2008 03:17:25 +0400 CIALIS: CLINICAL PHARMACOLOGY http://mymedblog.com/cialis/34-cialis-clinical-pharmacology.html http://mymedblog.com/cialis/34-cialis-clinical-pharmacology.html CIALIS: CLINICAL PHARMACOLOGY

 Mechanism of Action

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.

The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. CIALIS inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by CIALIS has no effect in the absence of sexual stimulation.

Studies in vitro have demonstrated that CIALIS is a selective inhibitor of PDE5. PDE5 is found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.

In vitro studies have shown that the effect of CIALIS is more potent on PDE5 than on other phosphodiesterases. These studies have shown that CIALIS is >10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. CIALIS is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Additionally, CIALIS is 700-fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. CIALIS is >9,000-fold more potent for PDE5 than for PDE8, PDE9, and PDE10. CIALIS is 14-fold more potent for PDE5 than for PDE11A1 and 40-fold more potent for PDE5 than for
PDE11A4, two of the four known forms of PDE11. PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues. In vitro, CIALIS inhibits human recombinant PDE11A1 and, to a lesser degree, PDE11A4 activities at concentrations within the therapeutic range. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined.
]]> support Mon, 06 Oct 2008 03:09:59 +0400 CIALIS: USE IN SPECIFIC POPULATIONS http://mymedblog.com/cialis/25-cialis-use-in-specific-populations.html http://mymedblog.com/cialis/25-cialis-use-in-specific-populations.html USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B — CIALIS (tadalafil) is not indicated for use in women. There are no adequate and well controlled studies of CIALIS use in pregnant women. Animal reproduction studies in rats and mice revealed no evidence of fetal harm.

Non-teratogenic effects — Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In one of two perinatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance.

]]> support Sun, 24 Aug 2008 21:11:21 +0400 CIALIS: DRUG INTERACTIONS http://mymedblog.com/cialis/24-cialis-drug-interactions.html http://mymedblog.com/cialis/24-cialis-drug-interactions.html DRUG INTERACTIONS

7.1 Potential for Pharmacodynamic Interactions with CIALIS

Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.

Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. PDE5 inhibitors, including CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When asodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin.

]]> support Sun, 24 Aug 2008 21:09:36 +0400 CIALIS: ADVERSE REACTIONS http://mymedblog.com/cialis/23-cialis-adverse-reactions.html http://mymedblog.com/cialis/23-cialis-adverse-reactions.html ADVERSE REACTIONS

6.1 Clinical Studies Experience

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.

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. 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 Needed

 In eight primary placebo-controlled Phase 3 studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and 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.

]]> support Sun, 24 Aug 2008 20:50:30 +0400 CIALIS: WARNINGS AND PRECAUTIONS http://mymedblog.com/cialis/22-cialis-warnings-and-precautions.html http://mymedblog.com/cialis/22-cialis-warnings-and-precautions.html 5 WARNINGS AND PRECAUTIONS

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:

5.1 Cardiovascular

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. 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. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention.

]]> support Sun, 24 Aug 2008 17:49:16 +0400 CIALIS : INDICATIONS AND USAGE http://mymedblog.com/cialis/20-cialis-indications-and-usage.html http://mymedblog.com/cialis/20-cialis-indications-and-usage.html 1 INDICATIONS AND USAGE

1.1 Erectile Dysfunction

CIALIS is indicated for the treatment of erectile dysfunction.

CIALIS (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:

 

The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a- hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

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