Table Of Contents
- Cialis Price Comparison Table
- Cialis Information
- Cialis Ingredients and Composition
- How Does Cialis Work?
- How To Take Cialis and Cialis Dosage and Administration
- If you suspect a Cialis Overdose
- Cialis Side Effects
- Cialis Warnings
- Cialis Precautions and Contraindications
- Taking Cialis during Pregnancy or Breast-feeding
- Cialis Clinical Trials and Studies
- Cialis Drug Interactions
- Storing Cialis
- Articles and information related to Cialis
- Credits for Cialis Information
Brand names: Cialis, Regalis, Apcalis
Cialis Price Comparison Table
| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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Cialis 20mg| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
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Cialis Information
Brand Name: Cialis
Generic Name: Tadalafil
Cialis (tadalafil) is a drug used to treat erectile dysfunction.
Cialis (tadalafil) is a potent, selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Cialis Ingredients and Composition
Along with 10mg of tadalafil, each Cialis tablet for oral administration contains:
- lactose monohydrate
- croscarmellose sodium
- hydroxypropylcellulose
- microcrystalline cellulose
- sodium laurylsulphate
- magnesium stearate.
Cialis tablet for oral administration film-coating contains:
- lactose monohydrate
- hypromellose
- triacetin
- titanium dioxide (E171)
- iron oxide (E172)
- talc
The active ingredient in Cialis is tadalafil.
How Does Cialis Work?
When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Cialis (tadalafil) has no effect in the absence of sexual stimulation.
Cialis (tadalafil) pharmacodynamics
Studies in vitro have shown that Cialis (tadalafil) is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of Cialis (tadalafil) is more potent on PDE5 than on other phosphodiesterases. Cialis (tadalafil) is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs. Cialis (tadalafil) is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility. Additionally, Cialis (tadalafil) is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction. Cialis (tadalafil) is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
How To Take Cialis and Cialis Dosage and Administration
Cialis tablets are for oral use.
Use in Adult Men
The recommended dose of Cialis is 20 mg, taken prior to anticipated sexual activity. The maximum recommended Cialis dosing frequency is once per day. Cialis may be taken between 30 minutes and 36 hours prior to anticipated sexual activity. Patients may initiate sexual activity at varying time points relative to Cialis dosing in order to determine their own optimal window of responsiveness. The Cialis dose may be lowered to 10 mg based on individual response and tolerability. Cialis may be taken without regard to food.
Cialis Use in Elderly Men
Cialis Dosage adjustments are not required in elderly patients. Dosage recommendations described in "Use in adult men" apply to elderly men.
Cialis Use in Men with Impaired Renal Function
Cialis dosage adjustments are not required in patients with renal impairment.
Cialis Use in Men with Impaired Hepatic Function
Cialis dosage adjustments are not required in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) (see Pharmacokinetics).
Cialis Use in men with diabetes
The presence of diabetes does not require a Cialis dose reduction.
Use in children
Cialis should not be used in individuals below 18 years of age.
If you suspect a Cialis Overdose
Single Cialis doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of Cialis overdose, standard supportive measures should be adopted as required.
Cialis Side Effects
Cialis was administered to over 4000 subjects (aged 19 to 86 years) during clinical trials worldwide. Over 230 patients were treated for longer than one year and over 720 patients were treated for over 6 months. In controlled phase 2/3 clinical trials, the discontinuation rate due to Cialis side effects (1.7%) was not significantly different from placebo-treated patients (1.1%). In these studies, the side effects reported with Cialis were generally mild or moderate, transient, and decreased with continued dosing.
The following Cialis side effects have been reported:
- Headache
- Dyspepsia
- Back pain
- Myalgia
- Nasal congestion
- Flushing
There may be additional unreported Cialis side effects.
Cialis Warnings
Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including Cialis, should not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. The following groups of patients with cardiovascular disease were not included in clinical trials:
- patients with myocardial infarction within the last 90 days;
- patients with unstable angina or angina occurring during sexual intercourse;
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months;
- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension;
- patients with a stroke within the last 6 months.
Additionally, there is limited clinical trial data on the safety of Cialis in the following groups; if Cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician
- patients with severe renal insufficiency (creatinine clearance = 30 mL/min);
- patients with severe hepatic insufficiency (Child-Pugh Class C).
Cialis (tadalafil) 10 mg has been the highest dose studied in patients with mild (creatinine clearance 51 to 80 mL/min), and moderate (creatinine clearance 31 to 50 mL/min) renal failure and in patients with end stage renal failure undergoing haemodialysis.
Priapism was not reported in clinical trials with Cialis. owever, priapism has been reported with another PDE5 inhibitor, sildenafil. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
The safety and efficacy of combinations of Cialis and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
In a clinical pharmacology study, administration of Cialis (tadalafil) 10 mg to patients with moderate renal impairment (creatinine clearance 31 to 50 mL/min) was determined to be safe but appeared to be less well tolerated in terms of back pain than in patients with mild renal impairment (creatinine clearance 51 to 80 mL/min) and healthy subjects. Cialis (tadalafil) 10 mg has been the highest dose studied in patients with mild (creatinine clearance 51 to 80 mL/min), and moderate (creatinine clearance 31 to 50 mL/min) renal failure and in patients with end stage renal failure undergoing haemodialysis. Cialis (tadalafil) exposure was increased by 107% when co-administered (10 mg dose) with ketoconazole. Although specific interactions have not been studied, some protease inhibitors, such as ritonavir and saquinavir, and other CYP3A4 inhibitors, such as erythromycin and itraconazole, would also be likely to increase Cialis (tadalafil) exposure.
Cialis (tadalafil) exposure was reduced by 88% when co-administered (10 mg dose) with rifampicin. It can be expected that concomitant administration of other CYP3A4 inducers will also decrease plasma concentrations of tadalafil.
Cialis Precautions and Contraindications
In clinical studies, Cialis (tadalafil) 10 mg was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Cialis to patients who are using any form of organic nitrate is contraindicated. Cialis should not be used in patients with a known hypersensitivity to tadalafil or to any of the excipients.
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Taking Cialis during Pregnancy or Breast-feeding
Preclinical data reveal no special hazard for humans based on conventional Cialis studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Cialis Clinical Trials and Studies
Two Cialis clinical studies were conducted in 571 patients in an at-home setting to define the period of responsiveness to Cialis (tadalafil). Cialis (tadalafil) demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing. Sexual Encounter Profile (SEP) diary data collected in Clialis clinical studies supports this period of responsiveness. In these studies patients were free to choose the time interval between Cialis dose administration and the time of sexual attempts.
Cialis (tadalafil) administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate. When Cialis (tadalafil) and certain oral antihypertensive medications were assessed in medicine interaction studies, Cialis (tadalafil) did not result in clinically significant augmentation of the antihypertensive effects of those medications.
In a study to assess the effects of Cialis (tadalafil) on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test. This finding is consistent with the low affinity of Cialis (tadalafil) for PDE6 compared to PDE5. In addition, no effects were observed on visual acuity, electroretinograms, intraocular pressure, or pupillometry. Across all Clialis clinical studies, reports of changes in colour vision were rare (< 0.1%).
Cialis had no clinically relevant effects on sperm concentration, sperm count, motility, or morphology in 103 men in a study of daily doses of 10 mg for 6 months or 111 men in a study of daily doses of 20 mg for 6 months. Cialis (tadalafil) at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), aetiologies, ages (range 21-86 years), and ethnicities. Most patients reported erectile dysfunction of at least 1 year in duration. In the primary efficacy studies of general populations, 81% of patients reported that Cialis (tadalafil) improved their erections. Also, patients with erectile dysfunction in all severity categories reported improved erections while taking Cialis (tadalafil) (86%, 83% and 72% for mild, moderate, and severe, respectively). In the primary efficacy studies, 75% of intercourse attempts were successful in Cialis (tadalafil)-treated patients.
Cialis Drug Interactions
Tadalafil, the active ingredient in Cialis, is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole, increased tadalafil AUC by 107% and a CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil (10 mg) alone (see Warnings and Precautions). Simultaneous administration of an antacid (magnesium hydroxide/aluminium hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil (10 mg). An increase in gastric pH resulting from administration of nizatidine, an H2 antagonist had no significant effect on tadalafil (10 mg) pharmacokinetics. In clinical studies, tadalafil (10 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see Contraindications). CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of medicines metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1 and CYP2C9.
Tadalafil, the active ingredient in Cialis, (10 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Tadalafil (10 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive agents was examined. Major classes of antihypertensive agents were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. Analysis of phase 3 clinical trial data also showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medications.
Tadalafil, the active ingredient in Cialis, (10 and 20 mg) had no clinically significant effect on blood pressure changes due to tamsulosin, an alpha-adrenergic receptor blocking agent.
Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg). The effects of alcohol on cognitive function and on blood pressure were not augmented by tadalafil (20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol. Tadalafil (10 mg) had no clinically significant effect on the pharmacokinetics or pharmacodynamics of theophylline, a CYP1A2 substrate.
Storing Cialis
Store Cialis below 25°C. Store in the original package.
Articles and information related to Cialis
Credits for Cialis Information
Cialis information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include Cialis.