Description

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Special instructions

With extreme caution and only if absolutely necessary, it is possible to use tadalafil in patients with severe renal insufficiency (CC < 30 ml / min) and severe hepatic insufficiency.

Against the background of treatment with tadalafil, patients with moderate renal insufficiency (CC from 31 to 50 ml/min) had back pain more often compared with patients with mild renal insufficiency (CC from 51 to 80 ml/min) or healthy volunteers. In patients with CC <50 ml / min, tadalafil should be used with caution.

Therefore, treatment of erectile dysfunction, including with the use of tadalafil, should not be carried out in men with such heart diseases in which sexual activity is not recommended.

The potential risk of complications during sexual activity in patients with diseases of the cardiovascular system should be taken into account: myocardial infarction within the last 90 days; unstable angina or angina pectoris occurring during sexual intercourse; chronic heart failure (II functional class and higher according to the NYHA classification) that has developed over the past 6 months; uncontrolled cardiac arrhythmias; arterial hypotension (blood pressure less than 90/50 mmHg) or uncontrolled hypertension; stroke, rescheduled within the last 6 months.

Tadalafil should be used with caution in patients with a predisposition to priapism (for example, with sickle cell anemia, multiple myeloma or leukemia) or in patients with anatomical deformity of the penis (for example, with angulation, cavernous fibrosis or Peyronie’s disease).

The patient should be informed of the need for immediate medical attention in case of an erection lasting 4 hours or more. Untimely treatment of priapism leads to damage to the tissues of the penis, as a result of which a long-term loss of potency may occur.

Against the background of the use of tadalafil, no cases of priapism have been reported.

It is not recommended to use tadalafil in combination with other types of erectile dysfunction treatment.

Drug interaction

Tadalafil is mainly metabolized with the participation of the enzyme CYP3A4. The selective CYP3A4 inhibitor ketoconazole increases AUC by 107%, and rifampicin reduces it by 88%.

Despite the fact that specific interactions have not been studied, it can be assumed that protease inhibitors such as ritonavir and saquinavir, as well as CYP3A4 inhibitors such as erythromycin and itraconazole, increase the activity of tadalafil.

With simultaneous administration of antacid (magnesium hydroxide / aluminum hydroxide) and tadalafil, the rate of absorption of the latter decreases without changing its AUC.

Tadalafil enhances the hypotensive effect of nitrates. This occurs as a result of the additive action of nitrates and tadalafil on the metabolism of nitric oxide and cGMP. Therefore, the use of tadalafil in patients receiving nitrates is contraindicated.