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Brand Cialis

Brand Cialis
Cialis (Tadalafil) is a medicine used to treat erectile dysfunction, which is the inability to achieve and maintain an erection necessary for intercourse.

Brand: Tadalafil

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: November 2023
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Product description

Composition of Cialis

Buy Cialis in Canada

active substance: 1 tablet contains tadalafil 20 mg;

excipients: lactose monohydrate, lactose monohydrate (dry spray), hydroxypropyl cellulose (EF very fine), croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose (granulate 102), magnesium stearate (vegetable), Opadry II yellow dye mixture) (32K1288 ... 

Description

Yellow, almond-shaped tablets with the designation "C 20" applied to them on one side. 

Pharmacological action

Tadalafil is a reversible selective inhibitor of specific PDE-5 cGMP. When sexual arousal causes local release of nitric oxide, inhibition of PDE5 by tadalafil leads to an increase in the concentration of cGMP in the cavernous body of the penis. The consequence is relaxation of the smooth muscles of the arteries and blood flow to the tissues of the penis, which causes an erection. Tadalafil has no effect in the absence of sexual arousal.

Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE-5 is an enzyme found in the smooth muscles of the corpus cavernosum, in the smooth muscles of the vessels of the internal organs, in skeletal muscles, platelets, kidneys, lungs and cerebellum. The effect of tadalafil on PDE-5 is more active than on other PDEs. Tadalafil is 10,000 times more potent for PDE-5 than for PDE-1, PDE-2, PDE-4 and PDE-7, which are localized in the heart, brain, blood vessels, liver, leukocytes, skeletal muscles and in other organs. Tadalafil is 10,000 times more active in 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, since 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, which is found in the retina and is responsible for phototransmission. Tadalafil also exhibits an effect 9000 times more potent in relation to PDE-5 in comparison with its effect on PDE-8, PDE-9 and PDE-10 and 14 times more potent in relation to PDE-5 compared to PDE-11. Tissue distribution and physiological effects of inhibition of PDE-8 - PDE-11 have not yet been clarified.

Tadalafil improves erection and increases the ability to have a full sexual intercourse.

Tadalafil in healthy individuals does not cause significant changes in SBP and DBP in comparison with placebo in the prone position (the average maximum decrease is 1.6 / 0.8 mm Hg, respectively) and in the standing position (the average maximum decrease is 0.2 / 4.6 mm Hg, respectively). Tadalafil does not cause a significant change in heart rate.

Tadalafil does not cause changes in color recognition (blue / green), which is explained by the low affinity for PDE-6. In addition, there is no effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.

Several studies have been conducted to evaluate the effect of daily tadalafil intake on spermatogenesis. None of the studies observed an undesirable effect on sperm morphology and motility. One study found a decrease in mean sperm concentration compared to placebo. A decrease in sperm concentration was associated with a higher frequency of ejaculation. In addition, there was no undesirable effect on the mean concentration of sex hormones, testosterone, LH and FSH when taking tadalafil compared with placebo.

The efficacy and safety of Cialis® (in doses of 2.5 mg and 5 mg) was studied in clinical trials. An improvement in erection was noted in patients with erectile dysfunction of all severity when taking tadalafil 1 time per day. In the primary efficacy studies of tadalafil 5 mg, 62% and 69% of attempts at intercourse were successful compared to 34% and 39% of patients taking placebo. Taking tadalafil 5 mg significantly improved erectile function for 24 hours between doses.

The mechanism of action of tadalafil in patients with BPH - inhibition of PDE-5 by tadalafil, leading to an increase in the concentration of cGMP in the cavernous body of the penis, is also observed in the smooth muscles of the prostate gland, bladder and vessels that supply them with blood. Relaxation of vascular smooth muscles leads to an increase in blood perfusion in these organs and, as a consequence, to a decrease in the severity of BPH symptoms. Relaxation of smooth muscle of the prostate and bladder can further enhance vascular effects.

Pharmacokinetics

Treatment of Sexua lAttraction with Cialis

Absorption. After oral administration, tadalafil is rapidly absorbed. Average Cmax in plasma is reached on average 2 hours after oral administration. The speed and degree of absorption of tadalafil do not depend on food intake, therefore Cialis® can be used regardless of food intake. The time of intake (morning or evening) had no clinically significant effect on the rate and extent of absorption.

The pharmacokinetics of tadalafil in healthy individuals is linear with respect to time and dose. In the dose range from 2.5 to 20 mg, AUC increases in proportion to the dose.

The pharmacokinetics of tadalafil in patients with erectile dysfunction is similar to the pharmacokinetics of the drug in patients without erectile dysfunction.

Distribution. Css in plasma are reached within 5 days when taking the drug once a day.

The averageVd is about 63 liters, which indicates that tadalafil is distributed in body tissues.

At therapeutic concentrations, 94% of tadalafil in plasma binds to proteins.

In healthy individuals, less than 0.0005% of the administered dose is found in semen.

Metabolism. Tadalafil is mainly metabolized with the participation of the isoenzyme CYP3A4 of cytochrome P450. The main circulating metabolite is methylcatechol glucuronide. This metabolite is at least 13,000 times less active against PDE-5 than tadalafil. Therefore, the concentration of this metabolite is not clinically relevant.

Excretion. In healthy individuals, the average clearance of tadalafil when taken orally is 2.5 l / h, and the average T1/2 is 17.5 hours.Tadalafil is excreted mainly in the form of inactive metabolites, mainly with feces (about 61% of the dose) and less degree with urine (about 36% of the dose).

Special populations

Elderly patients. Healthy elderly patients (65 years of age or more) had a lower oral clearance of tadalafil, which was expressed in an increase in AUC by 25% compared with healthy individuals aged 19 to 45 years. This difference is not clinically significant and does not require dose adjustment.

Patients with renal impairment. In persons with mild to moderate renal insufficiency, dose adjustment is not required. Due to the increased exposure of tadalafil (AUC), patients with severe renal insufficiency are not recommended to use Cialis®.

Patients with hepatic impairment. The pharmacokinetics of tadalafil in individuals with mild and moderate hepatic impairment is comparable to that in healthy individuals. For patients with severe hepatic impairment (Child-Pugh class C), no data are available. When prescribing the drug Cialis® to patients with severe hepatic impairment, it is necessary to first assess the risks and benefits of using the drug.

Patients with diabetes mellitus. In patients with diabetes mellitus during the use of tadalafil, the AUC was approximately 19% less than in healthy individuals. This difference does not require dose adjustment.

Indications for use Cialis

Cialis packaging

  • erectile dysfunction (ED);
  • lower urinary tract symptoms in patients with benign prostatic hyperplasia;
  • erectile dysfunction in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.


Contraindications

Hypersensitivity to tadalafil or any substance that is part of the drug;

  • taking medications containing any organic nitrates;
  • use in persons under 18 years of age;

the presence of contraindications to sexual activity in patients with CVS diseases (myocardial infarction within the last 90 days, unstable angina pectoris, the occurrence of an attack of angina pectoris during intercourse, chronic heart failure of classes II-IV according to 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 neuropathy of the optic nerve (regardless of the connection with the use 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 <30 ml / min);

lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution: since there is no data on patients with severe hepatic impairment (class C according to the Child-Pugh classification), caution must be exercised when prescribing Cialis® to this group of patients.

Care must be taken when prescribing Cialis® to patients taking alpha1-blockers, since concurrent use can lead to symptomatic hypotension in some patients. In a clinical pharmacology study in 18 healthy volunteers who took a single dose of tadalafil, no symptomatic arterial hypotension was observed with the simultaneous administration of tamsulosin alpha1A-blocker (see "Interaction").

Diagnosis of erectile dysfunction should include identification of the potential underlying cause, appropriate medical examination, and treatment.

Cialis® should be used with caution in patients with a predisposition to priapism (with sickle cell anemia, multiple myeloma or leukemia) or with anatomical deformity of the penis (angular curvature, cavernous fibrosis or Peyronie's disease). You should also be careful while taking it with potent inhibitors of the CYP3A4 isoenzyme (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), antihypertensive drugs.

Pregnancy and lactation

Cialis® is not intended for use in women.

Overdose

With a single appointment of tadalafil to healthy individuals at a dose of up to 500 mg and patients with ED - repeatedly up to 100 mg / day, the undesirable effects were the same as when using lower doses.

Treatment: in case of overdose, it is necessary to carry out standard symptomatic treatment. With hemodialysis, tadalafil is practically not excreted.

Interaction with other drugs

The effect of other drugs on tadalafil

Tadalafil is mainly metabolized with the participation of the isoenzyme CYP3A4. Selective inhibitor of the isoenzyme CYP3A4 ketoconazole (400 mg / day) increases the AUC of tadalafil in a single dose by 312% and Cmax by 22%, and ketoconazole (200 mg / day) increases the AUC of tadalafil in a single dose by 107% and Cmax by 15% relative to AUC and Cvaluesmaxfor tadalafil alone. Ritonavir (200 mg 2 times a day), an inhibitor of isoenzymes CYP3A4, 2C9, 2C19 and 2D6, increases the AUC of tadalafil in a single dose by 124% without changing Cmax. Despite the fact that specific interactions have not been studied, it can be assumed that other inhibitors of HIV protease, such as saquinavir, as well as inhibitors of the CYP3A4 isoenzyme, such as erythromycin and itraconazole, increase the activity of tadalafil.

A selective inducer of the CYP3A4 isoenzyme, rifampicin (600 mg / day), reduces the exposure of a single dose of tadalafil (AUC) by 88% and Cmax by 46% relative to AUC and Cvaluesmaxfor tadalafil alone. It can be assumed that the simultaneous use of other inducers of the isoenzyme CYP3A4 should also reduce plasma concentrations of tadalafil.

The simultaneous administration of an antacid (magnesium hydroxide / aluminum hydroxide) and tadalafil reduces the rate of absorption of tadalafil without changing the area under the pharmacokinetic curve for tadalafil. An increase in gastric pH as a result of taking theHblocker2histaminereceptornizatidine did not affect the pharmacokinetics of tadalafil.

The safety and effectiveness of the combination of tadalafil with other treatments for erectile dysfunction have not been studied, so the use of such combinations is not recommended.

Tadalafil does not potentiate the increase in bleeding time caused by the intake of acetylsalicylic acid.

The effect of tadalafil on other drugs

It is known that tadalafil enhances the hypotensive effect of nitrates. This is due to the additive effect of nitrates and tadalafil on the metabolism of nitric oxide (NO) and cGMP. Therefore, the use of tadalafil while taking nitrates is contraindicated.

Tadalafil does not have a clinically significant effect on the clearance of drugs, the metabolism of which occurs with the participation of cytochrome P450. Studies have confirmed that tadalafil does not inhibit or induce isoenzymes CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1.

Tadalafil has no clinically significant effect on the pharmacokinetics of S-warfarin or R-warfarin. Tadalafil does not affect the effect of warfarin on PT.

Tadalafil does not increase the duration of bleeding caused by acetylsalicylic acid.

Tadalafil has systemic vasodilating properties and can enhance the effect of antihypertensive drugs aimed at lowering blood pressure.

Additionally, in patients taking several antihypertensive drugs in whom arterial hypertension was poorly controlled, a slightly greater decrease in blood pressure was observed. In the vast majority of patients, this decrease was not associated with hypotensive symptoms. Patients receiving treatment with antihypertensive drugs and taking tadalafil should be given appropriate clinical guidelines.

There was no significant decrease in blood pressure with the use of tadalafil in healthy individuals taking the selective alpha1A-blocker tamsulosin according to the results of two clinical trials.

The simultaneous use of tadalafil with doxazosin is contraindicated. When tadalafil was used by healthy volunteers who took doxazosin (4–8 mg / day), an alpha1-adrenergic blocker, an increase in the hypotensive effect of doxazosin was observed. Some patients have experienced BP-related symptoms, including fainting.

Tadalafil did not affect the concentration of alcohol, as well as alcohol did not affect the concentration of tadalafil. At high doses of alcohol (0.7 g / kg), taking tadalafil did not cause a statistically significant decrease in the mean blood pressure. In some patients, postural dizziness and orthostatic hypotension were observed. When taking tadalafil in combination with lower doses of alcohol (0.6 g / kg), a decrease in blood pressure was not observed, and dizziness occurred with the same frequency as when taking alcohol alone.

Tadalafil has no clinically significant effect on the pharmacokinetics or pharmacodynamics of theophylline.

Application Features

Sexual activity has a potential risk for patients with cardiovascular diseases. Therefore, the treatment of ED, incl. the drug Cialis®should not be carried out in men with heart diseases in which sexual activity is not recommended.

There have been reports of the occurrence of priapism with the use of PDE-5 inhibitors, including tadalafil. Patients should be informed of the need for immediate medical attention in case of an erection lasting 4 hours or more. Late treatment of priapism leads to damage to the tissues of the penis, resulting in irreversible impotence.

The safety and effectiveness of the combination of Cialis® with other PDE-5 inhibitors and treatments for ED have not been studied. Therefore, the use of such combinations is not recommended.

Like other PDE-5 inhibitors, tadalafil has systemic vasodilating properties, which can lead to a transient decrease in blood pressure. Before prescribing Cialis®, doctors should carefully consider whether patients with cardiovascular disease will be exposed to unwanted effects due to such vasodilating effects.

NAPION causes visual impairment, including complete loss of vision. There are rare post-marketing reports of cases of NAPION development, in time associated with the intake of PDE-5 inhibitors. It is currently impossible to determine whether there is a direct relationship between the development of NAPION and the use of PDE-5 inhibitors or other factors. Physicians should advise patients in case of sudden loss of vision to stop taking tadalafil and seek medical attention. Physicians should also advise patients that people who have had NAPION are at increased risk of re-developing NAPION.

Patients suspected of having BPH should be screened to rule out prostate cancer.

The efficacy of Cialis® in patients who have undergone surgery on the pelvic organs or radical neuro-sparing prostatectomy is unknown.

Influence on the ability to drive a car and perform work requiring an increased speed of psychomotor reactions. Despite the fact that the incidence of dizziness on the background of placebo and tadalafil is the same, during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.


Side Effects

The most common adverse events in ED patients are headache and dyspepsia, as well as back pain, myalgia, flushing, and nasal congestion.

The most common adverse events in patients with ED / BPH are headache and dyspepsia, pain in the extremities, gastroesophageal reflux, myalgia.

From the immune system: infrequently (≥0.1%, <1%) - hypersensitivity reactions.

From the nervous system: very often (≥10%) - headache; often (≥1%, <10%) - dizziness; rarely (≥0.01%, <0.1%) - stroke (including acute cerebrovascular accident (ACVA) of hemorrhagic type), fainting1, transient ischemic attacks1, migraine3, epileptic seizure, transient amnesia ...

From the side of the organs of vision: infrequently (≥0.1%, <1%) - blurred vision, pain in the eyeball; rarely (≥0.01%, <0.1%) - visual field disturbance, swelling of the eyelids, injection of the scleral vessels of the eyeball, non-arterial anterior ischemic optic neuropathy (NAPION)3, occlusion of retinal vessels3.

On the part of the organ of hearing and labyrinth disorders: rarely (≥0.01%, <0.1%) - sudden hearing loss2.

From the: CVSinfrequently (≥0.1%, <1%) - palpitations, tachycardia, lowering blood pressure (in patients who have already taken antihypertensive drugs), increased blood pressure; rarely (≥0.01%, <0.1%) - myocardial infarction, ventricular arrhythmias3, unstable angina pectoris3.

Respiratory system: infrequently (≥0.1%, <1%) - nasal congestion, shortness of breath; rarely (≥0.01%, <0.1%) - epistaxis.

From the gastrointestinal tract: often (≥1%, <10%) - dyspepsia; infrequently (≥0.1%, <1%) - abdominal pain, gastroesophageal reflux.

Skin and subcutaneous tissue: disordersinfrequently (≥0.1%, <1%) - rash, hyperhidrosis (excessive sweating); rarely (≥0.01%, <0.1%) - urticaria, Stevens-Johnson syndrome3, exfoliative dermatitis3.

Musculoskeletal and connective tissue disorders: often (≥1%, <10%) - back pain, myalgia.

From the genitals and mammary gland: rarely (≥0.01%, <0.1%) - prolonged erection, priapism3.

General disorders: infrequently (≥0.1%, <1%) - chest pain1; rarely (≥0.01%, <0.1%) - facial edema3, sudden cardiac death1.3.

  1. Observed in patients with previous cardiovascular risk factors. However, it is impossible to determine with certainty whether these events are directly related to these risk factors, tadalafil, sexual arousal, or a combination of these or other factors.
  2. Sudden hearing loss has been reported in a small number of post-marketing and clinical studies with all PDE5 inhibitors, including tadalafil.
  3. Adverse reactions detected in post-marketing studies that were not observed in clinical placebo-controlled studies.