Precautions for the use of tadalafil

Before considering the treatment with tadalafil, you should first ask for a medical history and a physical examination of the patient to diagnose whether there is male erectile dysfunction and to identify possible unknown causes.

Because the incidence of cardiovascular disease has a certain degree of correlation with sexual behavior, doctors should consider the cardiovascular health status of patients before the treatment of male erectile dysfunction, including tadalafil. The characteristic of dilating blood vessels, which results in a mild, transient decrease in blood pressure, which may enhance the antihypertensive effect of nitrate.

Severe cardiovascular disease, including myocardial infarction, unstable angina, ventricular arrhythmia, shock, transient ischemic attack, etc., has been observed in clinical trials of tadalafil. In addition, hypertension and hypotension (including orthostatic hypotension) can also be seen occasionally in clinical trials. Most of the patients who have the above conditions have cardiovascular factors before taking the drug. However, it is not yet certain whether these events are related to these risk factors.

There is limited clinical safety information regarding the use of this product in patients with severe hepatic insufficiency (Child-Pugh grade C); if a prescription is given to such a patient, the prescribing physician is required to perform a serious benefit/risk assessment of each patient.

An abnormal erection occurred in a clinical trial of tadalafil. However, another PDE5 inhibitor, sildenafil, has reported an abnormal erection and should be told that the patient should be treated immediately if the erection time exceeds 4 hours or more. If the abnormal erection of the penis is not treated promptly, it may result in destruction of the penile tissue and permanent loss of erectile capacity.

The following patients should be careful with tadalafil: patients who are prone to abnormal erectile dysfunction (such as sickle cell anemia, multiple myeloma or leukemia), or patients with abnormal penile dissection (such as penile horns, malformed penis, and cavernous fibrosis) Or Peyronie's disease).

The diagnosis of penile erectile dysfunction should include identifying the underlying cause and determining the appropriate treatment after an appropriate assessment. It is unclear whether this product is effective for patients with spinal cord injury, patients with pelvic surgery, and patients undergoing prostatectomy.

Tadalafil cannot be used in the following patients: hereditary patients with galactose intolerance, or patients with galactase deficiency, or patients with glucose-galactose malabsorption.

Patients who are taking alpha-blocking retardants, such as doxazosin, such as a combination of this product, may cause symptomatic hypotension in some patients. Therefore, tadalafil is not recommended for use in combination with alpha-blocking retarders.

Special attention should be paid to patients who are taking a non-prescription of a drug that is using a potent CYP3A4 inhibitor (eg, ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin). Because he has been found to be used in combination with these drugs, it can enhance the exposure of tadalafil.

The safety and efficacy of this product in combination with other erectile dysfunction treatments have not been studied. Therefore, such a combination is not recommended.

In a dog test, a daily dose of 25 mg/kg/day of tadalafil is given for 6-12 months (at least 3 times higher than a single dose of 20 mg/kg/day for humans). Exposure rate [range 3.7-18.6]), found that some test dogs had degeneration of vas deferens epithelial cells and thus reduced sperm count. The results of six consecutive months of study in healthy volunteers in two groups showed that in humans The clinical phenomenon observed in the above dog test does not occur (see "Pharmacology and Toxicology").

The effect of the long-term continuous daily taking of tadalafil has not been determined, so continuous daily use is prohibited.
Tadalafil has no or no effect on the ability to drive and operate the machine. No special studies of this potential impact have been conducted. Although the frequency of vertigo reported by the placebo and tadalafil groups is similar in clinical trials, patients should be aware of their response to tadalafil before driving and operating the machine.

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