–°ialis Daily is a drug aplied for the treatment of erectile dysfunction. It contains tadalafil. This substance belongs to a reversible selective inhibitor of specific phosphodiesterase type 5 (PDE-5) of cyclic guanosine monophosphate (cGMP). When sexual excited, it causes a local release of nitric oxide, inhibition of PDE5 by tadalafil leads to an increase in the concentration of cGMP in the corpus cavernosum of the penis. The consequence is relaxation of the smooth muscles of the arteries and blood flow to the penile tissues, which causes an erection. Tadalafil has no effect in the absence of sexual excitement.

Indications

Erectile dysfunction

Mode of administration and dosage

Oral administration. For patients with frequent sexual activity (more than 2 times a week), the recommended dosage is 5 mg daily, 1 time per day, at the same time, regardless of food intake. The daily dose can be reduced to 2.5 mg, depending on individual sensitivity.

Contraindications

  • Hypersensitivity to tadalafil or to any substance that is part of the drug;
  • Any organic nitrates;
  • Application for persons under 18 years of age;
  • The presence of contraindications to sexual activity in patients with diseases of the cardiovascular system: myocardial infarction within the last 90 days, unstable angina pectoris or the occurrence of an attack of angina pectoris during intercourse, chronic heart failure class II or higher according to the NYHA classification within the last 6 months, uncontrolled arrhythmias, arterial hypotension (blood pressure less than 90/50 mm Hg), uncontrolled arterial hypertension, ischemic stroke within the last 6 months;
  • Loss of vision due to non-arterial anterior ischemic optic neuropathy;
  • Concomitant use with doxazosin, with other PDE-5 inhibitors, other treatment options for erectile dysfunction, guanylag cyclase stimulants;
  • Use in patients with chronic renal failure;
  • Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Side effects

  • Immune system disorders: infrequently – hypersensitivity reactions; rarely – angioedema.
  • Nervous system disorders: often – headache; infrequently – dizziness; rarely – stroke (including stroke of hemorrhagic type), fainting, transient ischemic attacks, migraine, epileptic seizure, transient amnesia.
  • The organs of vision: infrequently – blurred vision, pain in the eyeball; rarely – disturbance of visual fields, swelling of the eyelids, injection of vessels of the eyeball sclera, non-arterial anterior ischemic optic neuropathy, occlusion of retinal vessels.
  • Hearing disorders and labyrinth disorders: infrequently – ringing in the ears; rarely – sudden hearing loss.
  • The cardiovascular system: often: “hot flushes” to the face; infrequently – a feeling of palpitations, tachycardia, a decrease in blood pressure (in patients who have already taken antihypertensive drugs), an increase in blood pressure; rarely – myocardial infarction, ventricular arrhythmias, unstable angina pectoris.
  • The respiratory system: often – nasal congestion; infrequently – shortness of breath, nosebleeds.
  • The gastrointestinal tract: often – dyspepsia; infrequently – abdominal pain, gastroesophageal reflux, diarrhea in patients over 65, vomiting, nausea.
  • Skin and subcutaneous tissue disorders: infrequently – rash; rarely – hyperhidrosis (excessive sweating), urticaria, Stevens-Johnson syndrome, exfoliative dermatitis.
  • The musculoskeletal and connective tissue disorders: often – back pain, myalgia, pain in the limbs.
  • The genitals and mammary gland: infrequently – prolonged erection; rarely – priapism, hematospermia, penile bleeding.
  • General disorders: infrequently – chest pain; rarely – facial edema, sudden cardiac death.

Overdose

With a single appointment of tadalafil to healthy individuals at a dose of up to 500 mg and patients with erectile dysfunction – repeatedly up to 100 mg/day, the undesirable effects were the same as when using lower doses. In case of overdose, it is necessary to carry out standard symptomatic treatment. Tadalafil is practically not excreted through hemodialysis.

Interactions

Tadalafil is mainly metabolized with the participation of the CYP3A4 enzyme. The selective inhibitor of CYP3A4 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 the simultaneous administration of an 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 is due to the additive effect of nitrates and tadalafil on the metabolism of nitric oxide and cGMP. Therefore, the use of tadalafil in patients receiving nitrates is contraindicated.