Compound
1 film-coated tablet contains:
active substance:
tadalafil 20 mg;
Excipients:
lactose monohydrate;
lactose monohydrate (spray dried);
hyprolosis;
hyprolosis (extra thin);
sodium lauryl sulfate;
microcrystalline cellulose”;
MCC;
croscarmellose sodium;
magnesium stearate (vegetable);
film sheath:
Opadry yellow (Y-30-12863-A) (lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow)
Pharmacologic effect
Tadalafil is a reversible selective inhibitor of specific PDE-5 cGMP. When sexual arousal causes the local release of nitric oxide, inhibition of PDE-5 by tadalafil leads to an increase in the concentration of cGMP in the cavernous body of the penis. The consequence of this is the relaxation of the smooth muscles of the arteries and the flow of blood to the tissues of the penis, which causes an erection. Tadalafil has no effect in the absence of sexual arousal.
In vitro studies have shown that tadalafil is a selective PDE-5 inhibitor. PDE-5 is an enzyme found in cavernous body smooth muscle, visceral vascular smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The action of tadalafil on PDE-5 is more active than on other PDEs. Tadalafil is 10,000 times more potent against PDE-5 than against PDE-1, PDE-2, PDE-4, and PDE-7, which are localized in the heart, brain, blood vessels, liver, and leukocytes, skeletal muscle, and in other organs.
Tadalafil is 10,000 times more active at blocking PDE-5 than PDE-3, an enzyme found in the heart and blood vessels. This selectivity for PDE-5 over PDE-3 is important because PDE-3 is an enzyme involved in cardiac muscle contraction. In addition, tadalafil is about 700 times more active against PDE-5 than against PDE-6, found in the retina and responsible for photo transmission.
Tadalafil is also 9000 times more potent against PDE-5 than its effect on PDE-8, PDE-9 and PDE-10 and 14 times more potent against PDE-5 than PDE-11. Distribution in tissues and physiological effects of inhibition of PDE-8 – PDE-11 has not yet been elucidated.
Tadalafil improves erection and increases the possibility of full-fledged sexual intercourse.
Indications
- erectile dysfunction (ED);
- lower urinary tract symptoms in patients with benign prostatic hyperplasia;
- erectile dysfunction in patients with lower urinary tract symptoms on the background of benign prostatic hyperplasia.
Use during pregnancy and lactation
Cialis is not intended for use in women.
Contraindications
- hypersensitivity to tadalafil or any substance that is part of the drug Cialis;
- taking medications containing any organic nitrates;
- use in persons under 18 years of age;
- the presence of contraindications to sexual activity in patients with cardiovascular diseases (myocardial infarction within the last 90 days, unstable angina pectoris, the occurrence of an angina attack during intercourse, chronic heart failure II-IV classes according to the NYHA classification, uncontrolled arrhythmias, arterial hypotension (BP 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 (regardless of the connection with the intake of PDE-5 inhibitors);
- simultaneous administration of doxazosin, as well as drugs for the treatment of erectile dysfunction;
- frequent (more than 2 times a week) use in patients with chronic renal failure (Cl creatinine
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution: since there are no data on patients with severe hepatic insufficiency (Child-Pugh class C), caution should be exercised when prescribing Cialis to this group of patients.
Caution must be exercised when prescribing the drug to Cialis patients taking alpha1-blockers since simultaneous use can lead to symptomatic arterial hypotension in some patients. In a clinical pharmacology study in 18 healthy volunteers taking a single dose of tadalafil, symptomatic arterial hypotension was not observed with the simultaneous administration of tamsulosin alfa1A-blocker (see “Interaction”).
Diagnosis of erectile dysfunction should include identification of a potential underlying cause, appropriate medical evaluation, and determination of treatment tactics.
Cialis should be used with caution in patients with a predisposition to priapism (with sickle cell anemia, multiple myeloma, or leukemia) or with an anatomical deformity of the penis (angular curvature, cavernous fibrosis, or Peyronie’s disease). Caution should also be exercised when taken simultaneously with potent inhibitors of the CYP3A4 isoenzyme (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), antihypertensive drugs.
How to take, course of administration and dosage
The use of the drug Cialis according to the indication of ED. For patients with frequent sexual activity (more than 2 times a week): the recommended frequency of administration is daily, 1 time per day, 5 mg, at the same time, regardless of food intake. The daily dose may be reduced to 2.5 mg depending on individual sensitivity.
For patients with infrequent sexual activity (less than 2 times a week): it is recommended to prescribe Cialis at a dose of 20 mg, immediately before sexual activity, according to the instructions for the medical use of the drug. The maximum daily dose of Cialis is 20 mg.
Use of Cialis for BPH or ED/BPH. The recommended dose of Cialis when used once a day is 5 mg; the drug should be taken at approximately the same time of day, regardless of the time of sexual activity. The duration of treatment is determined by the doctor individually. In patients with mild renal insufficiency (Cl creatinine from 51 to 80 ml/min) and moderate severity (Cl creatinine from 31 to 50 ml/min), dose adjustment is not required.
In patients with severe renal insufficiency (Cl creatinine, the use of Cialis once a day is not recommended.
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