Cialis
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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
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 Warnings
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
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.
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