Other ingredients:
lactose monohydrate, sodium croscarmellose, use of cialis hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, a mixture of the Opadry II dye, talc.
Cialis
tadalafil 20 mg in one tablet
Pharmacokinetics of the drug Cialis:
Absorption of the drug Cialis.
After ingestion, Cialis is rapidly absorbed. Cmax is achieved on average after 2 hours. The speed and degree of absorption do not depend on the intake of food. The time of taking Cialis (morning or evening) has no clinically significant effect on speed and degree of absorption.
The pharmacokinetics of the drug Cialis in healthy individuals is linear with respect to time and dose. In the dose range of 2.5 to 20 mg, the AUC increases use of cialis in proportion to the dose. Css in the plasma are reached within 5 days with the administration of the drug 1 time / day.
The pharmacokinetics of the drug Cialis in patients with impaired function of erection is similar to the pharmacokinetics of the drug in individuals without a violation of the function of erection.
The distribution of the drug Cialis:
Vd is about 63 liters, which indicates that the Cialis is distributed in the tissues of the body. In therapeutic concentrations, 94% of tadalafil binds to plasma proteins. In healthy individuals, less than 0.0005% of the administered dose is found in the sperm.
Metabolism of the drug Cialis:
Metabolized with the participation of the isoenzyme CYP3A4. The main use of cialis circulating metabolite is methylcatechol glucuronide. It is 13,000 times less active against PDE5 than tadalafil.
Therefore, this metabolite is unlikely to be clinically significant.
Excretion of the drug Cialis:
In healthy individuals, the average clearance of the drug Cialis for ingestion is 2.5 l / h, and the average T1 / 2 is 17.5 h. Cialis is excreted mostly in the form of inactive metabolites, mainly with feces (about 61%) and to a lesser extent with urine (about 36%).
Pharmacokinetics in special clinical situations of the drug Cialis:
Healthy elderly people (65 years and over) have a lower clearance of the drug Cialis, which is expressed in an AUC increase of 25% compared with healthy individuals aged 19 to 45 years. This difference is not clinically significant and does not require dose selection.
In patients with renal insufficiency mild (KK 51-80 ml / min) or moderate severity (CK = 31-50 ml / min), AUC is greater than in healthy individuals. Binding to proteins does not change if the kidney function is impaired. In patients with severe renal insufficiency (KK <= 30 ml / min), the use of Cialis has not been studied.
The pharmacokinetics of the drug Cialis in patients with mild or moderate disorders of liver function is comparable to that of healthy individuals.
In patients with diabetes mellitus, when the drug was used, the Cialis AUC was less by about 19% than in healthy individuals. This difference is not clinically significant use of cialis and does not require a dose change.
Indications for the use of the drug Cialis:
– erectile dysfunction.
Dosing regimen of the drug Cialis:
Middle-aged men are recommended to take the drug Cialis in a dose of 20 mg. Cialis is taken at least 16 minutes before the alleged sexual activity, regardless of food intake.
Patients can attempt to have intercourse at any time within 36 hours after taking the drug in order to establish the optimal response time for taking the drug.
The maximum recommended frequency of reception is 1 time / day.
For older men, a special dose is not required. Recommendations for taking medication for middle-aged men are also applicable for elderly patients.
Patients with impaired renal function (CK> = 30 ml / min) and a special dose selection are not required.
Side effect of the drug Cialis:
Most often: headache (11%), dyspepsia (7%).
Side effects are usually minor or moderate in severity, transient and decrease with continued use of the drug.
Perhaps: pain in the back, myalgia, stuffy nose, flush of blood to the face.
Rarely: edema of the eyelids, pain in the eyes, congestion use of cialis hyperemia, dizziness.
Contraindications to the use of the drug Cialis:
– simultaneous administration of drugs containing any organic nitrates;
– children and adolescence under 18;
– established hypersensitivity to tadalafil and other components of the drug.
Pregnancy and lactation
Cialis is not intended for use in women.
Special instructions for the use of the drug Cialis:
Since there are no data from controlled clinical trials on the safety and efficacy of Cialis in patients with severe renal insufficiency (CC <= 30 ml / min) and severe hepatic insufficiency, the drug should be used in this category of patients with extreme caution and only in case of emergency. Against the backdrop of treatment with Cialis in patients with moderate renal insufficiency (CK 31-50 ml / min), back pain was more common compared with patients with mild renal insufficiency (KK 51-80 ml / min) or healthy volunteers. Patients with CC <= 50 ml / min should be given caution.
Sexual activity has a potential risk for patients with cardiovascular disease. Therefore, the treatment of erectile dysfunction, incl. with the use of generic cialis, should not be performed in men with heart diseases in which sexual activity is not recommended.
The potential risk of developing complications associated with sexual activity in patients with cardiovascular diseases should be considered:
– myocardial infarction within the last 90 days;
– unstable angina or angina arising during sexual intercourse;
– Chronic heart failure (II functional class and higher according to the NYHA classification), developed during the last 6 months;
Uncontrolled disturbances of the heart rhythm;
– arterial hypotension (blood pressure less than 90/50 mm Hg) or uncontrolled hypertension;
– A stroke that has been postponed for the last 6 months.
Cialis should be used with caution in patients with predispositions to priapism (eg, sickle cell anemia, multiple myeloma or leukemia) or in patients with anatomical deformation of the penis (eg, with angulation, cavernous fibrosis or Peyronie’s disease).
The patient should be informed of the need to seek immediate medical attention in the event 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 Cialis, no cases of priapism have been reported.
The safety and effectiveness of the combination of Cialis with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Use in Pediatrics
Cialis is not used in patients younger than 18 years of age.
Impact on the ability to drive vehicles and manage machinery There are no
specific recommendations.
Overdose of the drug Cialis:
With a single appointment to healthy volunteers at a dose of 500 mg / day and patients with erectile dysfunction – repeatedly up to 100 mg / day, the undesirable use of cialis effects were the same as with the use of the drug in lower doses.
Treatment: Conventional symptomatic therapy.
Drug interaction of the drug Cialis with other drugs:
The effect of other drugs on Cialis.