Cialis Lilly medicine for erectile dysfunction (1 blister x 2 tablets)

Dosage form Box of 1 blister x 2 tablets
Specifications Tadalafil
Ingredient Lilly del Caribbe

Ingredient

Composition informationContent
Tadalafil20mg

Uses

Indications

Cialis medicine is indicated in the following cases:

  • Treatment of erectile dysfunction.

    Tadalafil is a selective inhibitor, with restoration of Guanosine monophosphate (CGMP) - Specialized on enamel phosphodiesterase tube 5 (PDE5). When sexual stimulation leads to local oxide nitric release, PDE5 inhibitors due to the effects of tadalafil increases the CGMP level in the cave. This leads to smooth muscle relaxation and increases blood flow into the penis tissue, thereby causing penis. When there is no sexual stimulation, Tadalafil does not work.

    Pharmacological effects

    In vitro studies show that Tadalafil inhibits PDE5 selective. PDE5 is a yeast found in the caves smooth, blood vessel muscles and organs, skeletal muscles, platelets, kidneys, lungs and cerebellum. The impact of Tadalafil on PDE5 is stronger on other phosphodiesterases. Tadalafil has a strong impact on PDE5> 10,000 times more than PDE1, PDE2 and PDE4, which are found in the heart, brain, blood vessels, liver and other organs. The impact of Tadalafil on PDE5 is stronger> 10,000 times more on PDE3, which is found in the heart and blood vessels. More selective for PDE5 compared to PDE3 is important because PDE3 is an enamel related to myocardial contraction. In addition, Tadalafil has an impact on PDE5 about 700 times stronger than PDE6, which is a yeast found in the retina and has a role in re -loading images. Tadalafil has a stronger impact on PDE5 more than 10,000 times compared to enzymes from PDE7 to PDE10.

    Safety and clinical effectiveness

    Three research works have been carried out over 1054 patients at home to determine the Cialis response time. Tadalafil has proven that statistically improving the erection function and the ability to succeed in sexual activity for up to 36 hours after taking the drug, as well as the ability to achieve and maintain early erection at 16 minutes to help intercourse successfully compared to placebo.

    Research Cialis in healthy people, compared to placebo does not see significant differences in systolic blood pressure and diastolic blood pressure measured in the back position (maximum value reduced average 1.6/0.8mmHg), when measured in the posture of systolic blood pressure and diastolic blood pressure (maximum decrease in average value of 0.2/4.6 mmHg) and no significant changes on the heart rhythm.

    In a study to survey the effects of Tadalafil on the vision, by Farnsworth - Munsell 100 color test, there is no disorder of color distinction (blue/green) detected. This finding is suitable for Tadalafil's low humanity for PDE6 compared to PDE5. In all clinical trials, reports on visual changes in color are very rare (

    Three studies were conducted in male patients to assess the ability to affect the sperm of Cialis 10mg (research for 6 months) and 20mg (research for 6 months and 9 months) with daily dosage. Two of these three studies showed a decrease in sperm quantity and density related to Tadalafil treatment but not clinical significance. These effects are not related to changes in other parameters such as movement, morphology and FSH.

    Tadalafil with doses of 2 to 100 mg was assessed in 16 clinical trials with 3,250 patients including patients with erectile dysfunction of different levels (mild, medium and severe), different causes, ages from 21 to 86 years old and of different ethnic groups. The majority of patients reported at least 1 year. In the research on the majority of patients to assess mainly this effect, 81% of patients reported that Cialis has improved the erection function compared to the placebo -use group of only 35%. In addition, in patients with erectile dysfunction with different severity reported that they have improved the function when using Cialis (sequentially 86%, 83%, and 72% for medium, medium and heavy levels compared to 45%, 42% and 19% in the placebo group). In the main research works, 75% of successful intercourse when using Cialis compared to 32% in the placebo group.

    A 12 -week study conducted on 186 patients (142 Tadalafil users, 44 placebo users) with erectile dysfunction accompanied by spinal cord damage, Tadalafil improved the erection function significantly to bring success in patients treated with Tadalafil 10 mg or 20 mg (adjustable dose according to demand) of 48% compared to 17% in the placebo group.

    Children

    The European Health Agency has abandoned the research results in all research in children in the treatment of erectile dysfunction.

    pharmacokinetic

    absorption

    Tadalafil is quickly absorbed after drinking and the average maximum plasma concentration (CMAX) is about 2 hours after drinking. Tadalafil's absolute bioavailability has not been established.

    Tadalafil's speed and absorption level are not influenced by food, so the Cialis can be taken when not eaten or eaten. The time to use the drug (in the morning compared to the afternoon) does not affect significantly on clinically for the speed and level of drug absorption.

    distribution

    The average distribution of the drug is about 63 l, proving that Tadalafil is distributed to tissues. At the treatment concentration, 94% of Tadalafil in plasma is bound to protein. The cohesion with protein is not affected by kidney function.

    Under 0,0005% of the drug dose appears in the semen of healthy people.

    transformation

    Tadalafil is metabolized mainly by Cytochrome P450 (CYP) 3A4. The metabolites are mainly methylcatecholl glucuronide. This metabolites have an less impact of at least 13,000 times compared to Tadalafil on PDE5. So there is no clinical impact in the observed concentrations of the changes.

    Elimination

    The average clearance when used by Tadalafil's oral by 2.5 L/hour and the average semi -cancellation period is 17.5 hours on healthy people. Tadalafil is excreted mainly in the form of non -effective metabolites, mainly in stool (about 61% of the drug) and with less than the urine (about 36% of the drug).

    linear/no - linear

    Tadalafil's pharmacokinetics on healthy people is a relevant performance line of time and dosage. When the dosage exceeds the threshold between 2.5 to 20 mg, the area under the curve (AUC) will increase corresponding to the dose. The concentration of drugs in plasma is stable within 5 days when taking the drug once a day. Pharmacokinetics are identified in patients with erectile dysfunction similar to pharmacokinetics on people without erectile dysfunction.

    Special patient groups

    Elderly

    Healthy elderly people (65 years old) have a lower Tadalafil clearance, resulting in an area under the curve (AUC) larger than 25% compared to healthy people aged 19 to 45. The impact of this age does not have a significant clinical impact, so there is no need to adjust the dose.

    kidney failure

    In a clinical trial of pharmacology using a single dose of Tadalafil (5 - 20 mg), the area under the curve of Tadalafil (AUC) is doubled on mild kidney failures (Creatinine clearance is 51 to 80 ml/min) or medium (creatinine clearance is 31 to 50 ml/minute) and in people with renal insufficiency at the end of the reception stage. In patients who are separating CMAX 41% higher than healthy people. Hematopsisa is negligible for the elimination of Tadalafil.

    Hepatic failure

    The area under the curve of Tadalafil (AUC) in patients with mild or medium liver failure (group A and B of Child-Pugh) is equivalent to the area under the curve of healthy people when using the 10 mg dose. Clinical data on Cialis safety is not much in patients with severe hepatic impairment (group C of Child-Pugh); When appointing Cialis for these patients, physicians should consider each case between benefits and risks to decide. Currently there is no data on the Tadalafil dose that is higher than 10 mg for patients with liver failure.

    Diabeten patient

    The area under the curve (AUC) of Tadalafil in diabetics is about 19% lower than the area under the curve of a healthy normal person. However, this difference does not need to adjust the dose.

  • Before taking Cialis Lilly medicine for erectile dysfunction (1 blister x 2 tablets)

    How to use

    Oral drugs.

    Dosage

    for adult men

    Maximum dosage is recommended for 20 mg, used before planning sexual activity, applied when the tadalafil 10 mg dose is not effective.

    The maximum number of drug use is recommended once a day. Can be used at least 30 minutes before sexual activity and do not recommend daily use.

    Tadalafil has been shown to be effective up to 36 hours after taken and works early at 16 minutes after taking the drug.

    Used for elderly patients

    No need to adjust the dose in elderly patients.

    Used for patients with renal failure

    No dose adjustment in patients with mild or medium renal failure. 20mg tadalafil tablets are not for patients with severe renal failure.

    Used for patients with liver failure

    Cialis safety data in patients with severe liver failure (group C Child - Pugh); If prescribed, the treating doctor needs to consider carefully between the benefits and risks of each case.

    Used for diabetics

    No need to adjust the dose in diabetics.

    Children

    Do not use Cialis in children to treat erectile dysfunction.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose? The side effects occur similarly to the lower dose side effects.

    In case of overdose, the standard support measures should be taken as required. Hematopsisa is negligible to eliminate Tadalafil.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Cialis drug, you may experience unwanted effects (ADR).

    Summary of safety

    The most common side effects reported in patients using Cialis are headache, indigestion, back pain and muscle pain and the level of increased occurrence with increased dose. Side effects are often fleeting and generally light or medium.

    Summary table of side effects

    Side reactions are recorded from spontaneous reports and in placebo clinical tests (including a total of 7116 patients using Cialis and 3718 patients using placebo) are listed in the table below.

    Conventions on frequency: Very common (≥ 1/10), common (≥ 1/100 to

    very

    Common

    Common

    Less

    Rare

    immune system disorders

    Feng shui 3

    dizziness

    Stroke 1 (including the phenomenon of mucus), fainting, open ischemic anemia 1, migraine, infarction, temporary forgetting.

    Feelings described as pain in the eye

    Smart visual defects, eyelid swelling, conjunctiva, neurological disease ischemic anemia without arteritis in the front (NAOon) 3, retinal veins.

    Myocardial infarction, unstable angina 3, ventricular arrhyths 3

    Hypotension 4, Hypertension

    Difficulty breathing, nosebleeds

    Abdominal pain.

    urticaria, Stevens - Johnson syndrome, flaking dermatitis.

    Face 3, sudden cardiac arrest 1.3

    (2) The phenomenon of loss or loss of hearing ability has been reported in a few cases through after -sales monitoring and clinical trials when using PDE5 inhibitors including Tadalafil.

    (3) Side reactions are reported through after -sales monitoring are not recorded in placebo clinical trials.

    (4) is more often recorded in patients taking Tadalafil when taking antihypertensive drugs.

    Describe the selective side effects.

    There is a slight increase in the incidence of irregular electrocardioma, primary sinus slow heart rate, which has been reported in patients treated with Tadalafil once a day compared to placebo. Most ECG abnormalities do not combine with side effects.

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Cialis medicine is contraindicated in the following cases:

  • Hypersensitivity to the active ingredient or any ingredient of the drug. In clinical studies, Tadalafil shows signs of increased hypotension of nitrates. This is probably due to the coordination effects of nitrates and tadalafil on the nitric oxide/CGMP cycle. Therefore, contraindicated use of Cialis at the same time with organic nitrates in any form.
  • All agents used to treat erectile dysfunction, including Cialis, are not used for male patients with cardiovascular disease without having sexual activity. Doctors should pay attention to the potential risk of heart disease due to sexual activity in patients with cardiovascular disease in advance.
  • The following groups of patients with cardiovascular disease are not included in clinical trials and thus contraindicated to use Tadalafil with:

  • Patients with myocardial infarction within 90 days.
  • Patients with unstable angina or angina occur during intercourse.

  • Patients of Group 2 according to the New York Heart Association or the heart failure worse within the past 6 months.
  • Patients with uncontrolled arrhythmia, low blood pressure (
  • Patients with stroke in the past 6 months.
  • Cialis is contraindicated for patients with visual losses one eye due to ischemic neurological anemia non -inflammatory artery (Naion), regardless of whether or not it is related to PDE5 inhibitor exposure.

    Precautions when using

    need to ask the history and physical examination to diagnose erectile dysfunction as well as identify the hidden causes, before prescribing the use of pharmaceuticals.

    Before starting any treatment for erectile dysfunction, physicians should pay attention to the patient's cardiovascular condition because there is a degree of cardiovascular risk associated with sexual activity. Tadalafil has vascular stretch properties, resulting in a decrease in blood pressure but at a mild and transient level. This will increase the potential of hypotension of nitrate.

    Erectile dysfunction assessment needs to consider the hidden causes attached to determine the appropriate treatment after evaluating the patient's pathology. Currently, whether the Cialis is effective or not in patients with spinal cord lesions and patients with pelvic surgery or prostate surgery thoroughly without nervous preservation.Heart

    Meet when bringing the drug to the market and/or in clinical trials, serious cardiovascular phenomena, including myocardial infarction, sudden death from heart disease, unstable angina, ventricular arrhythmia, stroke, transient ischemic attack, chest pain, drum pain and tachycardia. Most patients who have the above phenomena have previous cardiovascular risk factors. However, it is difficult to determine definitely to see if the above phenomena are directly related to these risk factors, to use Cialis, to sexual activity or due to the coordination of these factors or other factors.

    Patients who are taking alpha 1 blockers, monkeys simultaneously with Cialis may have symptomatic hypotension in some patients. Therefore, it is not recommended to simultaneously use Tadalafil and Doxazosin.

    vision

    Blinds and cases of non -inflammatory anemic anemic anemia (Naion) have been reported when using Cialis simultaneously with other PDE5 inhibitors. In the case of sudden blind appearance, patients should stop the drug and consult a doctor immediately.

    kidney failure

    Due to the increase in the concentration of the Curve (AUC) of Tadalafil, the clinical experience is limited, and is not able to eliminate the impact by the separation; If prescribing the Cialis, the doctor should consider carefully assess the benefits and risks for each patient, in patients with severe renal impairment, the maximum recommended dose is 10 mg. 20 mg tadalafil tablets are not for patients with severe renal failure.

    Hepatic failure

    Clinical data on the safety of single-dose Cialis use in patients with severe liver failure (C Child-Pugh group) is limited; If the prescription is indicated for this patient, the physician needs to consider carefully between the benefits and the risk of each case. There is no data on doses higher than 10 mg Tadalafil in patients with liver failure.

    Penis and anatomical deformation

    Patients with penis that lasts 4 hours or longer, need to recommend medical assistance immediately. If the penis is not treated immediately, the penis tissue damage can be damaged and permanently lost its ability.

    Medicines to treat erectile dysfunction, including Cialis, need to be cautious when prescribing patients with penis anatomy (such as an angle folding penis, cave fibroids or Peyronie disease) or in patients with diseases that can cause penis pain (such as sickle cell anemia, multiple marrow, leukemia).

    Use with CYP3A4 inhibitors

    Be cautious when prescribing Cialis for patients who are using strong CYP3A4 inhibitors (such as ritonavir, saquinavir, ketoconazole, iTraconazole, and erythromycin) for receiving the area under the curve (AUC) of Tadalafil when used in combination with these drugs.

    Cialis and other erectile dysfunctions

    Safety and effectiveness when coordinating Cialis with PDE5 inhibitors or other drugs to treat erectile dysfunction has not been studied. Therefore recommendations should not be used in combination with cialis with these drugs.

    lactose

    Cialis contains lactose monohydrate. Do not use Cialis for patients with genetic problems related to galactose intolerance, lapp lactase or glucose - galactose absorption disorder.

    The ability to drive and operate machines

    Cialis has negligible effects on the ability to drive or operate machinery.

    Despite the clinical trials, the rate of dizziness reports in groups of placebo and Tadalafil is similar, patients should still be aware of the reaction of Cialis drugs for them before driving or operating machinery.

    Pregnancy

    There is no Cialis appointment for women.

    There is not much data on the use of Tadalafil in pregnant women. Animal studies show that the drug is not directly or indirectly harmful to pregnancy, the development of embryos or fetuses, the birth or postpartum process. The most cautious is to avoid using Cialis during pregnancy.

    Breastfeeding period

    Data on toxic, pharmacological energy in animals shows that Tadalafi is excreted in milk, the risk for breastfed babies is not excluded. Do not use Cialis during breastfeeding.

    Drug interaction

    Many studies on drug interaction with Tadalafil 10mg and/or 20mg have been done and described below. In these buildings, Tadalafil dose is only 10mg, so clinical symptoms related to higher doses to assess drug interactions cannot be completely listed.

    The impact of other drugs on Tadalafil

    Cytochrome p450 inhibitors

    Tadalafil is metabolized mainly by CYP3A4. A selective inhibitor CYP3A4, Ketoconazole (200mg per day) when used in combination with Tadalafil increases the area under the curve (AUC) of Tadalafil (10mg) double and 15% CMAX when compared to the AUC and CMAX value of Tadalafil (10mg) only used alone. Ketoconazole (400mg per day) increases the area under the curve (AUC) of Tadalafil (20mg) 4 times and 22%CMAX. Ritonavir, a protease inhibitor (200mg used twice daily), is CYP3A4, CYP2C9, CYP2C9, and CYP2D6 inhibitors, increasing the area under the curve (AUC) of Tadalafil (20mg) twice without changing CMAX. Although specialized interactions have not been studied, some protease inhibitors, such as Saquinavir, and other CYP3A4 inhibitors, such as Erythromycin, Clarithromycin, iTraconazole and grapefruit juice when used simultaneously with Tadalafil should be cautious because they can increase Tadalafil concentration in plasma. Thus, the rate of unwanted effects can also increase.

    Transport substances

    The role of transport substances (such as P - Glycoprotein) with Tadalafil is not known. Therefore there is a potential drug interaction if these substances are inhibited.

    Cytochrome P450 induction substances

    A CYP3A4, Rifampidn induction, reducing the area under the curve (AUC) Tadalafil to 88% when compared to the AUC value of Tadalafil (10mg) only used alone. Reducing the area under the curve may reduce the effect of Tadalafi, but the reduction level is not known. Other CYP3A4 induction substances such as phenobarbital, phenytoin and carbamazepine can also reduce the concentration of Tadalafil in plasma.

    Tadalafil's influence on other drugs

    nitrates

    The results of clinical research tests show that Tadalafil (5 mg, 10 mg and 20 mg) shows signs of increasing the lowering effects of nitrates. Therefore, contraindicated use of Cialis for patients is taking any form of organic nitrate. Based on the results of a clinical trial, of which 150 subjects are assigned daily doses of Tadalafil 20mg for 7 days and 0.4mg nitroglycerin under the tongue at different times, the drug interaction lasts more than 24 hours and no more interaction 48 hours after taking Tadalafil the last dose. Therefore, in the case of patients who have used Cialis (2.5 mg - 20 mg), and nitrate indications are thought to be an essential solution in life -threatening situations, note that the use of nitrate needs at least 48 hours after the last dose of Cialis use. In such cases, nitrate is only used with strict supervision by appropriate machines for hemodynamic monitoring.

    Anti -blood pressure medications (including calcium channel blockers)

    Concomitance the use of doxazosin (4 and 8 mg daily) with Tadalafil (single dose 5 mg and 20 mg daily) increases the hypotension effect of this alpha blocker significantly. This impact lasts at least 12 hours and may have symptoms of fainting. Therefore, recommendations must not be combined with tadalafil and Alpha inhibitors. In drug interactive studies conducted on a limited number of healthy volunteers, these effects have not been reported to alfuzosin or tamsulosin. However, be careful when using Tadalafil for patients who are taking any alpha blockers, especially for the elderly. Should start treatment with the lowest dose and increase gradually.

    In Tadalafil clinical experimental studies, the characteristics that increase the hypotension of hypotension drugs have also been surveyed.

  • The main groups of antihypertensive drugs have been studied, including Calcium inhibitors (Amlodipine) inhibiting Angiotensin (ACE) (Enalapril), Beta - adrenergic receptor inhibitors (metoprolol), thiazide diuretic (Bendrofluazide), and Angiotensin II receptor (including different types and doses Prefers often in combination with thiazides, inhibit calcium channels, inhibit beta receptors, and/or inhibit alpha receptors).
  • In other clinical pharmacological research, Tadalafil (20 mg) in combination with 4 drugs for high blood pressure treatment. In those who use a variety of antihypertensive drugs, the fluctuations in transient blood pressure appear to be related to blood pressure control. In this respect, the research subjects with good blood pressure are controlled, the hypotension is minimal and similar to in healthy people, in research subjects that blood pressure is not well controlled, more blood pressure lower, although this blood pressure is not accompanied by symptoms of blood pressure. Clinical changes (except in the case of alpha inhibitors - please read the following section). However, it is necessary to have appropriate advice for patients about the possibility of hypotension when treated with hypotension drugs.
  • CYP1A2 substrates (such as theophylline)

    In clinical pharmacological research, when using Tadalafil 10 mg with theophylline (an unstable phosphodiesterase inhibitor), there is no pharmacokinetic interaction. There is only one effect of pharmacological force is a slight increase of heart rate (3.5 beats/minute). Although this impact is insignificant and does not cause a clear clinical effect in this test, it should also be noted when used with the above drugs.

    ethinylestradiol and terbutaline

    Tadalafil has been shown to increase the bioavailability of EthinyleLestradiol oral use; The results are the same for oral terbutaline, although it is not sure to have a clinical impact.

    alcohol

    Alcohol concentration (the average concentration of the blood in the blood is 0.08%) is not affected when used simultaneously with Tadalafil (10 mg and 20 mg). In addition, there is no change in the concentration of Tadalafil observed 3 hours after taking the drug simultaneously with alcohol. Alcohol has been used in experiments with a way to maximize the speed of alcohol absorption (drinking at night and eating 2 hours later). Tadalafil (20mg) does not increase the average level of hypoglycemia due to alcohol (drink for 0.7 g/kg or about 180 ml or 40% wine [vodka] in men weighing 80 kg) but in some research subjects, observing dizziness and lower posture hypotension. When using Tadalafil with a small amount of alcohol (0.6 g/kg), observing no hypotension and the rate of dizziness occurs at the same frequency as when the object only drinks alcohol. The impact of alcohol on cognitive function does not change when using Tadalafil (10 mg).

    Metabolic drugs by Cytochrome P450

    Tadalafil does not cause inhibition or reduction of clinical significance of metabolic drugs by CYP450 similarities. Studies have confirmed that the Tadalafil does not inhibit or the CYP450 homogeneous touch includes CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9, and CYP2C19.

    CYP2C9 (such as R-Warfarin)

    Tadalafil (10 mg and 20 mg) has no clinical significance related to the area under the curve (AUC) when used with S - Warfarin or R - Warfarin (CYP2C9) as well as Tadalafil does not change the prothrombin time when used with Warfarin.

    aspirin

    Tadalafil (10 mg and 20 mg) does not add bleeding time when used with acetyl salicylic acid.

    Diabetes treatments

    Specific studies on interaction with diabetes drugs have not been conducted.

    Storage

    Store in the original packaging to avoid moisture. No storage at a temperature of over 30 ° C.

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