Each tablet contains 5 mg Tadalafil
Cipalafil(tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
blood flow resulting from the relaxation of penile arteries and corpus cavernosalsmooth 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. Tadalafil inhibits PDE5.
•Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.
The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply
•Healthy male elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) with no effect on Cmaxrelative to that observed in healthy subjects 19 to 45 years of age.
•No dose adjustment is warranted based on age alone.
Use in Specific Populations
•Creatinine clearance less than 30 mL/min or on hemodialysis:
Cipalafil for once daily use is not recommended
•Mild or moderate (Child Pugh Class A or B): Cipalafilfor once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if Cipalafilfor once daily use is prescribed to these patients.
•Severe(Child Pugh Class C): The use of Cipalafilis not recommended
•NitratesConcomitant use of nitrates in any form is contraindicated.
•CYP3A4 InhaibitorsFor patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg.
•Nitrates Administration of Cipalafilto patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Cipalafilwas shown to potentiate the hypotensive effect of nitrates.
•Hypersensitivity Reactions Cipalafilis contraindicated in patients with a known serious hypersensitivity to tadalafil.
WARNINGS AND PRECAUTIONS
-Cipalafil is not recommended for the following groups of patients:
•myocardial infarction within the last 90 days
•unstable angina or angina occurring during sexual intercourse
•New York Heart Association Class 2 or greater heart failure in the last 6 months
•uncontrolled arrhythmias, hypotension(<90/50 mm Hg), or uncontrolled hypertension
•strokewithin the last 6 months.
WARNINGS AND PRECAUTIONS
There have been rare reports of prolonged erections greater than 4 hours, can result in irreversible damage to the erectile tissue.
•Physicians should advise patients to stop use of all PDE5 inhibitors, including Cipalafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes.
Sudden Hearing Loss
•Physicians should advise patients to stop taking PDE5 inhibitors, including Cipalafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Lower urinary tract symptoms associated to Benign prostatic hyperplasia with or without Erectile Dysfunction
Dosage and Administration
Cipalafil 5 mg daily