International Nonproprietary Name: Tadalafil

Registration number: P No 014761/01-2003 on 02/17/2003
Trade name of drug: Cialis.
International (nonproprietary) name: Tadalafil
Chemical name: pirazinol [1 ', 2', '1, 6] pyrido [3.4-b] indole-1 ,4-dione, 6 – (1,3-benzodioksol-5-yl) -2,3,6, 7,1-2,12 a-hexahydro-2-methyl-, (6R, 12aR) -
Pharmaceutical form: Tablets, film-coated.
Composition
Active ingredient of brand cialis: Tadalafil. Each tablet of Brand Cialis contains 20 mg of Tadalafil.
Excipients: lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, a mixture of yellow dye Opadri II.

Pharmacotherapeutic group: a treatment for erectile dysfunction, PDE5 inhibitor.
Code ATX [G04BE08].

Pharmacological properties

Cialis brand name – Pharmacodynamics

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

In vitro studies have shown that cialis brand name is a selective inhibitor of PDE5. PDE5 is an enzyme found in smooth muscles of cavernous bodies in vascular smooth muscle of the internal organs, skeletal muscle, platelets, kidney, lung, and cerebellum. The action of Brand Cialis on PDE5 is more active than other phosphodiesterase. Brand Cialis is 10 000 times more potent for PDE5 than for FDE1, FDE2, FDE4 and FDE7, which are located in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle and other organs. Brand Cialis 10 000 times more active blocks PDE5 than FDE3 – an enzyme that is found in the heart and blood vessels. This selectivity for PDE5 compared to FDE3 is important because FDE3 is an enzyme participating in the reduction of the heart muscle. In addition, Brand Cialis, approximately 700 times more potent for PDE5 than for FDE6 found in the retina and is responsible for fotoperedachu. Brand Cialis is also showing the action in 9000 times more potent for PDE5 compared with its effect on FDE8, 9 and 10 and 14 times more potent for PDE5 compared to FDE11. Tissue distribution and physiological effects of inhibiting FDE8 – FDE11 so far not been clarified. Cialis brand name improves erection and the possibility of successful sexual intercourse. The drug acts within 36 hours. The effect is already apparent 16 minutes after taking the drug in the presence of sexual arousal.

Brand Cialis in healthy individuals does not cause significant changes in systolic and diastolic blood pressure compared with placebo in the prone position (mean maximum decrease of 1,6 / 0,8 mm Hg. Art., Respectively) and standing (mean maximum decrease of 0, 2 / 4, 6 mm Hg. Art., respectively). Brand Cialis does not cause significant changes in heart rate. Brand Cialis does not cause changes in the recognition of colors (blue / green), due to its low affinity to FDE6. In addition, no observed effect of Brand Cialis on visual acuity, electroretinogram, the intraocular pressure and pupil size.

Brand Cialis does not cause changes in testosterone, luteinizing hormone and follicle-stimulating hormone in blood plasma.

There were no clinically significant effect on the characteristics of sperm in men who took daily doses of Brand Cialis for 6 months in placebo-controlled studies.

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Brand Cialis – Pharmacokinetics

Suction

After oral administration, Brand Cialis is rapidly absorbed. The average maximum concentration (Cmax) in plasma is reached after an average of 2 hours after ingestion.

The speed and extent of absorption of Brand Cialis is not dependent on food intake, and the drug Cialis may be taken without regard to meals. Hours (morning or evening) had no clinically significant effect on the rate and extent of absorption.

Brand Cialis pharmacokinetics in healthy subjects is linear with respect to time and dose. In the dose range from 2.5 to 20 mg of the area under the curve “concentration-time» (AUC) increased proportionally to dose. Equilibrium plasma concentrations are reached within 5 days while taking the drug one time and day.

Pharmacokinetics of Brand Cialis in patients with erectile dysfunction is similar to the pharmacokinetics of the drug in patients without erectile dysfunction.

Distribution

The average volume of distribution is about 63 liters, indicating that Brand Cialis is distributed in body tissues. At therapeutic concentrations, 94% of Brand Cialis in plasma is associated with proteins. Protein binding does not change with impaired renal function.

In healthy persons less than 0.0005% of the administered dose was found in semen.

Metabolism

Brand Cialis is mainly metabolized by CYP3A4 isoenzyme, with the participation of cytochrome P450. Main circulating metabolite is metilkateholglyukuronid. This metabolite, at least 13 000 times less active against PDE5 than Brand Cialis. Consequently, the concentration of this metabolite is not clinically significant.

Breeding

In healthy individuals the average clearance of Brand Cialis ingestion of 2,5 l / h, and the average half-life – 17.5 hours. Brand Cialis is excreted mainly as inactive metabolites mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (about 36% of the dose).

Cialis brand name – Special Populations

Elderly patients

Healthy elderly (65 years and over) had a lower clearance of Brand Cialis when taken orally, which was reflected in the increase in the area under the curve “concentration-time” by 25% compared with healthy people aged 19 to 45 years. This difference is not clinically significant and does not require dose adjustment.

Patients with renal insufficiency

In patients with renal insufficiency, including patients on hemodialysis, the area under the curve “concentration-time was greater than in healthy individuals.

Patients with liver failure

Pharmacokinetics of Brand Cialis in patients with mild to moderate to severe hepatic impairment is comparable with that in healthy individuals. With regard to patients with severe hepatic impairment (classified Child-Pugh class C) is not available.

Patients with diabetes

Patients with diabetes mellitus during treatment with Brand Cialis area under the curve “concentration-time was less than about 19% higher than in healthy individuals. This difference does not require dose adjustment.

Brand Cialis – Indications for Use

Erectile dysfunction.

Brand Cialis – Contraindications

* Installed hypersensitivity to Brand Cialis or any substance that is part of the drug;
* In the case of the drugs containing any organic nitrates;
* The use of persons under 18 years of age.

Cialis brand name – Precautions

Since there is no data in patients with severe hepatic insufficiency (classified Child-Pugh Class C), caution must be exercised in the appointment of Cialis to this group of patients.

Caution must be exercised in the appointment of Cialis to patients taking alpha [1]-blockers such as doxazosin, as the simultaneous use can lead to symptomatic hypotension in some patients. In a study of clinical pharmacology in 18 healthy volunteers who received a single dose of Brand Cialis, there was no symptomatic hypotension while the introduction of tamsulosin, an alpha [1A]-blocker (see “Interaction with other drugs).

Brand Cialis – Dosing and Administration

For ingestion.

The recommended maximum dose of Cialis is 20 mg. Cialis is taken before anticipated sexual activity, regardless of the meal. The drug should be taken at least 16 minutes prior to anticipated sexual activity.

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

The maximum recommended frequency of administration – one time per day.

Cialis brand name – Side effect

The most frequently reported adverse events were headache and dyspepsia (11 and 7%, respectively). Adverse events associated with taking Brand Cialis were generally mild or moderate in severity, transient and diminished with continued use of the drug.

Other common adverse effects include back pain, myalgia, nasal congestion and “tides” of blood to the face.

Rarely – edema of the eyelids, eye pain, conjunctival hyperemia, and dizziness.

Very rarely – hypersensitivity reactions (including rash, urticaria and facial edema, Stevens-Johnson syndrome and exfoliative dermatitis); hypotension (in patients who have already taken antihypertensive drugs); hypertension and syncope, abdominal pain and gastroesophageal reflux, hyperhidrosis (excessive sweating), and the delay in erection priapism, blurry vision, no arterial anterior ischemic optic neuropathy, retinal vein occlusion; violation of the visual fields.

Myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations and tachycardia were observed in patients who previously had cardiovascular risk factors. However, it is impossible to pinpoint whether these phenomena directly with these risk factors with Brand Cialis, sexual excitement, or a combination of these or other factors.

Brand Cialis – Overdose

With a single appointment healthy individuals cialis brand name at a dose of 500 mg and patients with erectile dysfunction (many times up to 100 mg / day), adverse effects were the same as when using lower doses. In case of overdose should be carried out standard symptomatic treatment. When dialysis nearly Brand Cialis is not displayed.

Cialis brand name – Interaction with other drugs

The influence of other drugs on Brand Cialis

Brand Cialis is mainly metabolized with participation of the enzyme CYP3A4. Selective inhibitor of CYP3A4, ketoconazole (400 mg / day) increases the impact of a single dose of Brand Cialis (AUC) at 312% and Cmax by 22% and ketokonazop (200 mg / day) increases the impact of a single dose of Brand Cialis (AUC) by 107% and Cmax by 15% with respect to AUC and Cmax values for only one of Brand Cialis.

Ritonavir (200 mg twice daily), an inhibitor of CYP3A4, 2C9, 2S1E and 2D6, increases the impact of a single dose of Brand Cialis (AUC) by 24% without changing the C max. Despite the fact that the specific interactions were not investigated, suggests that other HIV protease inhibitors such as saquinavir, as well as SURZA4 inhibitors such as erythromycin and intrakonazol, increases the activity of Brand Cialis.

Selective inducer of CYP3A4, rifampin (rifampicin, 600 mg / day), reduces the impact of a single dose of Brand Cialis (AUC) by 88% and Cmax by 46% with respect to AUC and Cmax values for only one of Brand Cialis. We can assume that the simultaneous administration of other inducers of CYP3A4 should also reduce the concentration of Brand Cialis in plasma.

Simultaneous treatment with an antacid (magnesium hydroxide / aluminum hydroxide) and cialis brand name reduced the rate of absorption of Brand Cialis without altering the area under the pharmacokinetic curve for Brand Cialis.

Increasing the pH of the stomach as a result of receiving H2-antagonist nizatidina, had no effect on the pharmacokinetics of Brand Cialis.

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Cialis brand name – Effect of Brand Cialis on other drugs

It is known that Brand Cialis enhances the hypotensive effect of nitrates. This is due to the additive effect of nitrates and Brand Cialis on the metabolism of nitric oxide and cGMP. Therefore, use of Brand Cialis on the background of the use of nitrates is contraindicated.

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

Brand Cialis has no clinically significant effect on the pharmacokinetics of 5-warfarin or R-warfarin. Brand Cialis does not affect the action of warfarin on prothrombin time.

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

Brand Cialis has a systemic vasodilating properties and may exacerbate the effects of antihypertensive drugs to lower blood pressure. Additionally, patients taking multiple antihypertensive agents that have hypertension, poorly controlled, we observed a somewhat larger reduction in blood pressure. The vast majority of these patients reduction was not associated with hypotensive symptoms. Patients treated with antihypertensive drugs and receiving Brand Cialis, should be given appropriate clinical advice.

There were no significant reduction in blood pressure when using Brand Cialis makers selective alpha [1A]-blocker, tamsulosin.

In the application of Brand Cialis in healthy volunteers who took doxazosin (8 mg / day), alpha [1]-blocker, were increased hypotensive action of doxazosin. Some patients experienced dizziness. Cases of syncope were not observed. Lower doses of doxazosin were not studying. Brand Cialis does not affect the concentration of alcohol, as well as alcohol does not affect the concentration of Brand Cialis. At high doses of alcohol (0.7 g / kg), receiving Brand Cialis does not cause a statistically significant reduction in average blood pressure. Some patients experienced postural dizziness and orthostatic hypotension. The introduction of Brand Cialis in combination with lower doses of alcohol (0.6 g / kg), hypotension was not observed, and dizziness occurred at the same frequency as in the admission of only one alcohol.

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

Brand Cialis – Cautions

Sexual activity is a potential risk for patients with cardiovascular disease. Therefore, treatment of erectile dysfunction, including those using Cialis, you should not hold for men with heart disease, for whom sexual activity is not recommended. Should take into account the potential risk of complications in sexual activity in patients with cardiovascular disease:

* Myocardial infarction within the last 90 days
* Unstable angina or angina occurring during sexual intercourse
* Heart failure class 2 and higher NYHA, evolved during the last 6 months
* Uncontrolled cardiac arrhythmias, hypotension (with BP <90/50 mmHg. Cent.) Or uncontrolled hypertension
* A stroke, moved in the past 6 months.

Cialis should be used with caution in patients predisposed to priapism (eg sickle cell anemia, multiple myeloma, leukemia FPI) or patients with anatomical deformation of the penis (such as angulations, cavernous fibrosis or Peyronie’s disease). There are reports of occurrence of priapism using PDE5 inhibitors, including Brand Cialis. Patients should be informed of the need for immediate treatment for medical assistance in the event of an erection lasts for 4 hours or more. Delayed treatment leads to priapism penile tissue damage, resulting in a loss may occur long-term potency.

Safety and efficacy of a combination of Cialis with other treatments erectile dysfunction was not investigated. Therefore, the use of such combinations is not recommended.

As with other PDE5 inhibitors, Brand Cialis has a systemic vasodilating properties, which can lead to transient reduction in blood pressure. Prior to the appointment of Cialis, physicians should carefully consider the question – not whether the patients with their existing cardiovascular disease undergo undesirable effects due to these vasodilator effects.

Cialis brand name – Impact on the ability of driving and using machinery

No special requirements.

Brand Cialis – Use during pregnancy and lactation

Cialis is not intended for use in women.

Form release

Tablets, film-coated 20 mg and 1, 2, 4 or 8 tablets per pack.

Cialis brand name – Storage conditions

Store at temperatures below 30 ° C in the original packaging.
Keep out of reach of children.

Brand Cialis – Expiration date

3 years. Do not use later than the date on the package.

Manufacturer (Brand Cialis)

: Eli Lilly and Company Limited. (United Kingdom / USA)

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Cialis (generic name Tadalafil) is the most modern of the three PDE5 drugs, with the medication receiving FDA approval in November 2003.

Manufacturer Lilly launched Cialis into the pop culture vocabulary with a nickname of “The Weekender”, due to its unique property of having an effect that lasts up to 36 hours. More conservative advertising used the slogan, “When the moment is right, will you be ready?”

Cialis is shown to be effective, both in the short term and in the long term, with the original clinical trials still showing results at 24 weeks when the study was completed [Ref]. Among five randomized control trials with 1,112 erectile dysfunction patients, intercourse was successful with 10mg (61% success rate) and 20mg (75% success rate) of Cialis, compared to only a 32% success rate with placebo.

Cialis Dosage and usage

Cialis is packaged as yellow, almond-shaped coated tablets in 5mg, 10mg or 20mg strengths.

Men should be advised that a starting dose allows them to evaluate the drug for both side-effects and efficacy. The starting dose varies by clinical indication and other comorbid conditions. Normally, the starting dose of Cialis is 10mg, though for certain cases, a starting dose of 5mg is recommended. If the starting dose is well-tolerated, but insufficient to achieve results, a subsequent dose increase can be considered. A patient should try the drug at least four times before considering a higher dose.

Ingestion of food neither impacts the absorption rate nor impacts the absorption extent of Cialis. In contrast to the other PDE5 inhibitor medications, fatty-meals are not an issue in planning when to take the drug [Ref]. There is no difference whether the pill is taken in the morning or in the evening.

Cialis is taken as needed prior to anticipated sexual activity. It is effective as soon as 30 minutes within taking the tablet. The medication’s effect lasts as long as 36 hours after ingestion.

A male with erectile dysfunction requires sexual stimulation in order to produce an erection after taking Cialis. Taking Cialis without the accompanying sensual and/or physical arousal will not achieve the expected results.

The maximum recommended frequency of Cialis is one dose per 24 hour period.

Cialis Side-effects

The side-effects of Cialis are usually mild. The commonest ones reported are: headache (11%), dyspepsia (7%), back pain (4%), myalgia (4%), nasal congestion (4%) and flushing (4%) [Ref]. Most of these side-effects are similar to other PDE5 inhibitor medications.

All side-effects are PDE5 class-related, except for the back pain [Ref]. This back pain is only rarely severe enough to cause discontinuation.

There are other rare side-effects including priapism, due to the length of time that the drug stays in the body. Rare possible side-effects in which causality is unclear include: dizziness (1.7%), swollen eyelids (0.3%) and ocular discomfort (0.3%).

Cialis has good selectivity for PDE5 versus other PDE enzymes around the body. The drug is 700-fold more selective for PDE5 in the penis than the PDE6 in the retina, which likely accounts for its very low numbers of visual side-effects. Among all clinical trials of Cialis at doses of 10-20mg, reports of colour vision abnormalities were under 0.1%.

Cialis Contraindications, drug interactions and cautions

Contraindications and cautions are mostly similar to other PDE5 inhibitor agents.

Men who use nitrates should not take Cialis. This includes nitrates in any form: inhaled, oral, sublingual or transdermal. Coadministration of the two medications can lead to a dangerous hypotension.

Patients taking many alpha-blocker medications (such as prazosin) should also be aware that Cialis can cause an additive hypotension [Ref]. However, the manufacturer reports that Cialis can be safely used with some selective alpha-1 blocker medications including tamsulosin.

Cialis is not recommended to be combined with other oral erectile dysfunction medications, since the risk of priapism increases.

Since it is metabolized in the liver, caution should be used when using other drugs which slow down the metabolism, such as some antivirals, some antibiotics or some antifungals. Specific drugs include ketoconazole and ritonavir. This slowed metabolism can result in higher levels of Cialis in the bloodstream. Conversely, some drugs such as rifampicin speed up the liver metabolism, dropping the plasma levels of Cialis to an ineffective dose.

The clinical trials for Cialis did not include some groups of patients, and thus caution is required if using the drug in those patients. These include men with unstable angina, severe renal insufficiency, severe hepatic insufficiency, hypotension below 90/50 mmHg, hypertension greater than 170/100, uncontrolled arrhythmias, a myocardial infarction within the last 3 months, a stroke in the last 6 months, or heart failure worse than New York Heart Association Class 2 in the last 6 months

Cialis has neither an impact on cardiac exercise tolerance nor on reproductive abilities [Ref]. Cialis can be used safely in stable cardiac patients without other contraindications. For some cardiac patients, sexual activity–with or without Cialis–may be inappropriate [Ref]. Patients with renal impairment should not use Cialis on a daily basis.

Finally, caution should be used in patients with conditions which predispose to priapism, or with an anatomical deformity of the penis.

Strengths and weaknesses

One of the most prominent strengths of Cialis is the relatively long half-life. A 36 hours, Cialis lasts significantly longer, as compared to the 4 hour half-life or either Viagra or Levitra. This extended half-life can allow the patient to have increased spontaneity of intercourse, especially those less likely to predict when they will have intercourse. There is some evidence in comparison studies that Cialis may be preferred to Viagra, perhaps because of this extended length of action.

With regards to flexibility with meals, Cialis does hold the advantage versus the other PDE5 inhibitor medications. Viagra and Levitra can’t be taken effectively following a high fat meal, but Cialis still has the expected effect regardless of whether or not a fatty meal was recently consumed.

Among the PDE5 inhibitor medications, Cialis has the least effect on PDE6 in the eye. Whereas Viagra has only a 10-fold specificity for PDE5 in the penis versus PDE6 in the retina, Cialis has a 700-fold specificity. Current case reports of retinal problems from Viagra are very uncommon, though the long-term effects are unknown.

The long-term effects of the extended 36 hours of systemic exposure to Cialis are unknown, though there is no evidence to show that it more harmful versus other agents.

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