Cialis 20 mg tablets 4- instructions, composition, analogs, reviews.

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Cialis 20 mg tablets 4- instructions, composition, analogs, reviews. healthy individuals

Cialis 20 mg tablets No. 4- manual, composition, analogs, reviews. Low Price Pharmacy Good Day | (Europe)

Cialis 20 mg tablets # 4 CODE: 89979 ✅ Available. Buy at a price of 2153.00 UAH. ⚡ Tel. ☎ 0 (800) 500-129. ✅ Low prices ✅ Always available | Instructions for the drug, composition, reviews, indications for use – Pharmacy Good Day

Composition

One tablet contains

active ingredient – tadalafil 20 mg,

excipients: lactose monohydrate, lactose monohydrate (dry spray), hydroxypropylcellulose (very fine), sodium croscarmellose, hydroxypropylcellulose, sodium lauryl sulfate, microcrystalline cellulose (granulate 102), magnesium stearate.

shell composition: Opadry II Yellow 32K12884 ink mixture (lactose monohydrate, hydroxypropyl methylcellulose 2910, hypromellose 15cP (E464), titanium dioxide (E171), triacetin (glycerol triacetate / triacetin), iron (III) yellow oxide (E172),

polishing: talc.

Description

Almond-shaped tablets with a biconvex surface, coated with a yellow color, labeled «C 20» on one side.

Pharmacotherapeutic group

Preparations for the treatment of urological diseases. Drugs for the treatment of erectile dysfunction. Tadalafil.

ATX code G04BE08

Pharmacological properties

Pharmacokinetics

Suction

After ingestion tadalafil is rapidly absorbed. The average maximum concentration (Cmax) in plasma is achieved on average 2 hours after ingestion.

The speed and extent of absorption of tadalafil does not depend on food intake, so the drug Cialis can be taken regardless of food intake. The time of administration (in the morning or in the evening) did not have a 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, the area under the concentration-time curve (AUC) increases in proportion to the dose. Equilibrium plasma concentrations are achieved within 5 days while taking the drug once a day.

The pharmacokinetics of tadalafil in patients with impaired erection is similar to the pharmacokinetics of the drug in individuals without impaired erection.

Distribution

The average volume of distribution is about 63 liters, which indicates that tadalafil is distributed in the tissues of the body. At therapeutic concentrations, 94% plasma tadalafil binds to proteins. Protein binding does not change with impaired renal function. In healthy individuals, less than 0.0005% of the injected dose is found in semen.

Metabolism

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Tadalafil is mainly metabolized with the participation of the cytochrome P450 CYP3A4 isoenzyme. The main circulating metabolite is methylcateholglucuronide, which is at least 13,000 times less active against PDE5 than tadalafil. Consequently, the concentration of this metabolite is not clinically significant.

Removal

In healthy individuals, the average clearance of tadalafil when taken orally is 2.5 l / h, and the average half-life is 17.5 hours. Tadalafil is excreted mainly in the form of inactive metabolites, mainly with feces (about 61% of the dose) and, to a lesser extent, with urine (about 36% of the dose).

Special Populations

Elderly patients

Healthy elderly people (65 years and older) had a lower clearance of tadalafil when taken orally, which resulted in an increase in the area under the concentration-time curve (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 failure

In patients with renal insufficiency, including patients on hemodialysis, the area under the concentration-time curve (AUC) was larger than in healthy individuals. In patients on hemodialysis, Cmax was 41% higher than in healthy individuals. Hemodialysis has little effect on the elimination of tadalafil.

Patients with hepatic impairment

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The pharmacokinetics of tadalafil in patients with weak and moderate hepatic insufficiency is comparable to that in healthy individuals. For patients with severe hepatic impairment (Child-Pugh class C), no data are available.

Patients with diabetes

In patients with diabetes mellitus with the use of tadalafil, the area under the concentration-time curve (AUC) was less by about 19% than in healthy individuals. This distinction does not require dose selection.

Pharmacodynamics

Cialis is an effective, reversible selective inhibitor of specific phosphodiesterase type 5 (PDE5) cyclic guanosine monophosphate (cGMP). When sexual arousal causes local release of nitric oxide, inhibition of PDE5 by Cialis leads to an increase in cGMP levels in the cavernous body of the penis. The result is a relaxation of smooth muscles of the arteries and blood flow to the tissues of the penis, which causes an erection. Cialis has no effect in the absence of sexual stimulation.

In vitro studies have shown that Cialis is a selective PDE5 inhibitor. PDE5 is an enzyme found in the smooth muscles of the cavernous body, in the smooth muscles of the vessels of the internal organs, in skeletal muscles, platelets, kidneys, lungs and cerebellum. The effect of Cialis on PDE5 is more active than on other phosphodiesterase. Cialis is 10,000 times more potent with PDE5 than with PDE1, PDE2, PDE4 and PDE7, which are located in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Cialis is 10,000 times more active in blocking PDE5 than PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac muscle contraction. In addition, Cialis is approximately 700 times more active in relation to PDE5 than in relation to PDE6, which is found in the retina and is responsible for photo transmission. Cialis also has an effect of 9000 times more potent against PDE5 compared with its effect on PDE8, 9 and 10, and 14 times more potent against PDE5 compared with PDE11. The distribution in tissues and the physiological effects of inhibition of PDE8 – PDE11 have not yet been elucidated.

Cialis improves erection and the possibility of successful sexual intercourse. The drug is valid for 36 hours. The effect appears already after 16 minutes after taking the drug in the presence of sexual arousal.

Cialis in healthy individuals does not cause significant changes in systolic and diastolic pressure in comparison with placebo in the prone position (the average maximum decrease is 1.6 / 0.8 mmHg, respectively) and in the standing position (the average maximum decrease is 0, 2 / 4.6 mmHg, respectively). Cialis does not cause a significant change in heart rate.

Cialis does not cause color recognition changes (blue / green), which is explained by its low affinity for PDE6. In addition, there is no effect of Cialis on visual acuity, electroretinogram, intraocular pressure and pupil size.

In order to assess the effect of daily intake of Cialis on spermatogenesis, several studies have been conducted. None of the studies observed an undesirable effect on the morphology of spermatozoa and their mobility. One study found a decrease in the average sperm concentration compared to placebo. A decrease in sperm concentration was associated with a higher frequency of ejaculation. In addition, no adverse effect on the average concentration of sex hormones, testosterone, luteinizing hormone and follicle-stimulating hormone was observed when taking Cialis, compared with placebo.

Indications for use

erectile dysfunction

Dosage and administration

For reception inside.

The recommended maximum dose of Cialis is 20 mg. Cialis is taken before the intended sexual activity, regardless of the meal. The maximum recommended frequency of admission – once a day.

The drug should be taken at least 16 minutes before the intended sexual activity.

Patients can attempt sexual intercourse at any time within 36 hours after taking the drug in order to establish the optimal response time for taking the drug.

Special Populations

Dose adjustment is not required in elderly patients (65 years and older), patients with mild to moderate renal insufficiency, patients with diabetes mellitus.

The maximum recommended dose of Cialis in patients with liver failure and severe renal insufficiency is 10 mg. There is limited clinical data on the safety of Cialis in patients with severe hepatic insufficiency (Child-Pugh class C). In the case of the appointment of Cialis in this group, it is necessary to conduct a thorough analysis of the benefit / risk individually for each patient. There are no relevant data on prescribing a dose of more than 10 mg in patients with hepatic impairment.

Side effects

Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (≥ 10%); often (≥ 1%, 10%); sometimes (≥ 0.1%, 1%); rarely (≥ 0.01%, 0.1%); extremely rarely (0.01%), the frequency is unknown (it is impossible to estimate the frequency of occurrence of reactions from the available data).

Often

headache

nasal congestion

dyspepsia, gastroesophageal reflux

back pain, myalgia, pain in the limbs

tide / blood flow

Sometimes

hypersensitivity reactions

dizziness

blurred vision, pain in the eyeball

tinnitus

tachycardia, heart palpitations, hypotension2, hypertension

shortness of breath, nosebleeds

abdominal pain

rash, hyperhidrosis (excessive sweating)

hematuria, bleeding from the penis, hemospermia

chest pain1

Seldom

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Cialis 20 mg tablets 4- instructions, composition, analogs, reviews. clinically significant

angioedema

stroke (including stroke in hemorrhagic type), syncope, transient ischemic attacks (TIA) 1, migraine3, seizures / convulsions, transient amnesia

visual disturbances, eyelid swelling, conjunctival hyperemia

anterior ischemic optic neuropathy, non-arteritis, retinal vascular occlusion 3

sudden hearing loss

myocardial infarction, unstable stenocardia3, ventricular arrhythmia3

urticaria, Stevens-Johnson syndrome 3, exfoliative dermatitis 3

prolonged erection, priapism3

swelling of the face3, sudden cardiac death1,3

1 Observed in patients with previous cardiovascular risk factors. However, it is impossible to determine whether these phenomena are directly related to these risk factors, Cialis, sexual arousal, or a combination of these or other factors.

2 In most cases, it was observed in patients who have already taken antihypertensive drugs.

3 Adverse reactions found during post-marketing studies that were not observed in clinical placebo-controlled studies.

Contraindications

hypersensitivity to tadalafil or to any substance included in the preparation

taking drugs containing any organic nitrates

the presence of contraindications to sexual activity in patients with diseases of the cardiovascular system: myocardial infarction in the last 90 days, unstable angina, the occurrence of angina during sexual intercourse, heart failure II-IV classes according to the classification of the New York Heart Association (NYHA), developed during the last 6 months, uncontrolled arrhythmia, arterial hypotension (BP less than 90/50 mm Hg), uncontrolled arterial hypertension, ischemic stroke during the last 6 months

loss of vision due to non-arteritis-associated anterior ischemic optic neuropathy (NAPION) (regardless of the connection with taking PDE5 inhibitors)

simultaneous administration of doxazosin, as well as medicines for the treatment of erectile dysfunction

frequent (more than 2 times a week) use in patients with chronic renal failure (CC less than 30 ml / min)

hereditary intolerance to galactose, Lapp-lactase deficiency and glucose-galactose malabsorption

children and adolescents up to 18 years

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Drug interactions

Effect of other drugs on Cialis

Cialis is mainly metabolized with the participation of the CYP3A4 enzyme. A selective CYP3A4 inhibitor, ketoconazole (400 mg per day), increases the effects of a single dose of Cialis (AUC) by 312% and Cmax by 22%, and ketoconazole (200 mg per day), increases the effects non prescription cialis of a single dose of Cialis (AUC) by 107% and Cmax by 15% relative to AUC and Cmax values ​​for Cialis alone.

Ritonavir (200 mg twice a day), an inhibitor of CYP3A4, 2C9, 2C19 and 2D6, increases the effects of a single dose of Cialis (AUC) by 124% without changing Cmax. Although specific interactions have not been studied, it can be assumed that other protease inhibitors, such as saquinavir, as well as CYP3A4 inhibitors, such as erythromycin, clarithromycin, intraconazole and grapefruit juice, increase plasma Cialis concentration.

There is the potential for drug interactions between Cialis and transport proteins (for example, p-glycoprotein) mediated by inhibition of transporters.

The selective inducer CYP3A4, rifampin (rifampicin, 600 mg per day), reduces the effects of a single dose of Cialis (AUC) by 88% and Cmax by 46%, relative to AUC and Cmax values ​​for Cialis alone. Such a reduction in exposure may reduce the effectiveness of Cialis; the magnitude of the decrease in efficacy is unknown.

It can be assumed that the simultaneous introduction of other inducers of CYP3A4, such as phenobarbital, phenytoin and carbamazepine, should also reduce the concentration of Cialis in the plasma.

The simultaneous use of antacids (magnesium hydroxide / aluminum hydroxide) and Cialis reduces the rate of absorption of the drug without changing the area under the pharmacokinetic curve (AUC) for Cialis.

An increase in the pH of the stomach as a result of taking a H2-antagonist of nizatidine did not affect Cialis pharmacokinetics.

The safety and efficacy of Cialis combination with other types of treatment of erectile dysfunction have not been studied, so the use of such combinations is not recommended.

Effect of Cialis on other drugs

It is known that Cialis enhances the hypotensive effect of nitrates. This occurs as a result of the additive effect of nitrates and Cialis on the metabolism of nitric oxide and cGMP. Therefore, the use of Cialis against the use of nitrates is contraindicated. In the case of a life-threatening condition, when the prescription of nitrates is clinically justified, it is necessary to withstand the 48 hour interval after taking the last dose of Cialis. In such conditions, nitrates should be used only under strict medical supervision with appropriate hemodynamic monitoring.

Cialis has no clinically significant effect on the clearance of drugs, the metabolism of which proceeds with the participation of the cytochrome P450 isoenzyme. Studies have confirmed that Cialis does not inhibit and does not induce isoenzymes CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1.

Cialis has no clinically significant effect on the pharmacokinetics of S-warfarin or R-warfarin. Cialis does not affect the effect of warfarin on prothrombin time.

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

Cialis has systemic vasodilating properties and may enhance the action of antihypertensive drugs aimed at lowering blood pressure. Additionally, in patients taking several antihypertensive agents in whom hypertension was poorly controlled, there was a slightly greater decrease in blood pressure. In the vast majority of patients, these decreases were not associated with hypotensive symptoms. Patients receiving antihypertensive medication and receiving Cialis should be given appropriate clinical guidelines.

When Cialis was used by healthy volunteers taking alpha1-adrenergic blocker doxazosin (4-8 mg per day), a significant increase in the hypotensive effect of doxazosin was observed. Some patients experienced symptoms associated with a decrease in blood pressure, including syncope. This effect lasts at least twelve hours and may be symptomatic. Therefore, the simultaneous use of Cialis and doxazosin is not recommended. According to the results of two clinical studies, no significant reduction in blood pressure was observed when Cialis was used by healthy individuals who took tamsulosin and alfuzosin alpha1-blockers. Nevertheless, caution should be exercised when applying Cialis to patients taking any alpha-blockers, especially in old age. Treatment should begin with minimal doses and gradually adjust.

Cialis did not affect the concentration of alcohol, nor did alcohol affect the concentration of Cialis. The use of Cialis did not cause a statistically significant reduction in the average blood pressure caused by alcohol intake at a dose of 0.7 g / kg. Some patients had postural dizziness and orthostatic hypotension. When taking Cialis in combination with lower doses of alcohol (0.6 g / kg), arterial hypotension was not observed, and dizziness occurred with the same frequency as when taking alcohol alone.

Cialis has no clinically significant effect on the pharmacokinetics or pharmacodynamics of theophylline, a non-selective phosphodiesterase inhibitor, with the exception of a slight increase in heart rate (3.5 beats per minute). Despite the insignificant nature of this phenomenon, the possibility of an increase in heart rate should be considered while simultaneously prescribing Cialis and theophylline.

An increase in the bioavailability of ethinyl estradiol has been noted with Cialis. A similar effect can be expected with oral administration of terbutaline, although the clinical consequences have not been precisely established.

special instructions

Cialis is not intended for use in women!

Before the start of drug therapy, it is necessary to study the medical history and physical examination of the patient to diagnose erectile dysfunction and determine the potential causes of this condition.

Sexual activity has a potential risk for patients with cardiovascular disease. Therefore, treatment of erectile dysfunction, including using Cialis, should not be carried out in men with heart diseases for which sexual activity is not recommended.

Like other PDE5 inhibitors, Cialis has systemic vasodilating properties, which can lead to a transient decrease in blood pressure, and, thus, enhances the hypotensive effect of nitrates.

Before initiating erectile dysfunction therapy, physicians should take into account the patient’s cardiovascular status due to the presence of a certain degree of risk of developing cardiovascular pathology associated with sexual activity.

The effectiveness of Cialis in patients who have undergone non-nerve-saving radical prostatectomy or pelvic cavity surgery.

Myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, heart palpitations and tachycardia were observed in patients with previously cardiovascular risk factors. However, it is impossible to determine whether these phenomena are directly related to these risk factors, Cialis, sexual arousal, or a combination of these or other factors.

Care must be taken when prescribing Cialis to patients taking alpha1-blockers, such as doxazosin, since simultaneous use may lead to symptomatic hypotension in some patients. In a clinical pharmacology study in 18 healthy volunteers who took a single dose of Cialis, no symptomatic hypotension was observed with the simultaneous administration of tamsulosin, alpha1A-adrenergic blocker. Simultaneous administration of doxazosin and Cialis is not recommended.

Visual impairment and cases of development of anterior ischemic optic neuropathy (NAPION) not associated with arteritis, were observed with the use of Cialis and PDE5 inhibitors. NAPION causes visual impairment, including total loss of vision. At present it is impossible to determine whether there is a direct link between the development of NAPION and the intake of PDE5 inhibitors or other factors. Doctors should recommend patients to stop taking Cialis in the event of a sudden loss of vision and seek medical help. Physicians should also inform patients that people who have had a NAPION are at increased risk of re-developing NAPION.

Cialis should be used with caution in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), chronic renal failure (CRF) (creatinine clearance less than 50 ml / min). Since clinical data on patients with severe hepatic impairment (Child-Pugh class C) are limited, care must be taken when prescribing Cialis to this group of patients.

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There are reports of the occurrence of priapism when using PDE5 inhibitors, including Cialis. Patients should be informed of the need to immediately seek medical help in the event of an erection lasting 4 hours or more. Late treatment of priapism leads to damage to the tissues of the penis, which can result in long-term loss of potency. Cialis should be used with caution in patients with a predisposition to priapism (for example, in sickle cell anemia, multiple myeloma, or leukemia) or in patients with anatomical deformity of the penis (eg, angular curvature, cavernous fibrosis, or Peyronie’s disease).

Care should be taken when prescribing Cialis to patients using potent inhibitors of CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin) due to a marked increase in Cialis exposure (AUC) with combination therapy with these drugs.

The safety and efficacy of Cialis combination with other PDE5 inhibitors and treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Cialis contains lactose in its composition. Patients with rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take Cialis.

Data on the use of the drug in patients over 65 years old, receiving Cialis in clinical trials for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, is limited.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

Despite the fact that the incidence of dizziness on the background of placebo and Cialis is the same, care must be taken during the period of treatment when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and psychomotor reactions.

Overdose

Symptoms: With a single appointment to healthy individuals of Cialis in a dose of up to 500 mg and patients with erectile dysfunction – many times up to 100 mg / day, undesirable effects were the same as when using lower doses.

Treatment: In case of overdose, standard symptomatic treatment is necessary. With hemodialysis, Cialis is practically not excreted.

Release form and packaging

1, 2 or 4 tablets are placed in a blister packaging made from polyvinyl chloride film (PVC / PE / PCTFE) and aluminum foil.

On 1, 2 or 4 tablets together with the instruction for medical application in the state and Russian languages ​​place in a folding cardboard pack.

Storage conditions

Store at temperatures below 30 ° C in the original packaging.

Keep out of the reach of children!

Shelf life

3 years

Do not use later than the date indicated on the package.

Pharmacy sales terms

On prescription

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