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Index
Index
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Before using this drug, tell your doctor your medical history, including any allergies (especially drug allergies), any penis conditions such as fibrosis/scarring, history of painful/prolonged erection (priapism), sickle cell anemia, blood system cancers (such as leukemia or myeloma), or Peyronie's disease, eye problems (retina diseases). kidney or liver disease, bleeding disorders or active stomach ulcers, heart diseases, stroke or severe high or low blood pressure. Limit alcohol intake, as it may aggravate side effects of this drug. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. The elderly may be more sensitive to the side effects of this drug, therefore caution is advised in this group.
Pharmacotherapeutic group: medicines used in erectile dysfunction. cialas is a potent, selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by cialas 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. cialas has no effect in the absence of sexual stimulation. Patient Confidence and Sexual Satisfaction The IIEF also measures patients' confidence that they can attain and keep an erection sufficient for sexual intercourse. cialas statistically significantly improved patient confidence. Analysis of the Intercourse Satisfaction and Overall Satisfaction domains of the IIEF showed that cialas treatment provided statistically significant enhancement of sexual satisfaction measured by both domains. Additionally, cialas improved the proportion of sexual encounters that were satisfying for both the patient and the partner. Period of Responsiveness cialas 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 activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including cialas, 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. Patients who experience cardiovascular symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and should report the episode to their physician. The following groups of patients with cardiovascular disease were not included in clinical trials: patients with a 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. Carcinogenicity, Mutagenesis, Impairment of Fertility Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic potential, and toxicity to reproduction. There was no impairment of fertility in male and female rats. In dogs given cialas daily for 6 to 12 months at doses of 25 mg/kg/day and above, there were alterations to the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs. There were 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. In men, cialas 10 or 20 mg given daily for 6 months had no significant effect compared to placebo on serum levels of testosterone, luteinising hormone, or follicle stimulating hormone. Absorption cialas is rapidly absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing. Absolute bioavailability of cialas following oral dosing has not been determined. The rate and extent of absorption of cialas are not influenced by food, thus cialas may be taken with or without food. The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption. Elderly Healthy elderly subjects (65 years or over), had a lower oral clearance of cialas, resulting in 25% higher exposure (AUC) relative to healthy subjects aged 19 to 45 years. This effect of age is not clinically significant and does not warrant a dose adjustment. Renal Impairment In a clinical pharmacology study in subjects with mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min) renal impairment, cialas exposure (AUC) was higher than in healthy subjects after administration of a 10-mg dose. In another clinical pharmacology study in subjects with end-stage renal failure undergoing haemodialysis, the cialas exposure (AUC) after a 10-mg dose was comparable to the exposure in healthy subjects (see Warnings and Precautions). cialas 20 mg tablets are blister packed and are presented in cartons containing 1, 4, or 8 tablets. |
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