صيدلية اونلاين

CIALIS TAB 20MG

$0.00 $68.20
CIALIS
Endocrines
Male Sexual Disorders
ACTIVE INGREDIENTS
= Additional active ingredients
Tadalafil.
TADALAFIL
PRESENTATION AND DOSSAGE
TABS: 28 x 2.5 mg.
TABS: 28 x 5 mg.
TABS: 28 x 10 mg.
TABS: 4 x 20 mg.
TABS: 8 x 20 mg.
RELATED INFORMATION


CONTAINS LACTOSE
INDICATIONS
In order for this product to be effective, sexual stimulation is required. Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). This product  is not indicated for use by women.

CONTRA-INDICATIONS
Co-administration with nitrates, nitric oxide donors, organic nitrites in any form. Cardiac disease including MI within last 90 days, unstable angina or angina during sexual intercourse, New York Heart Association Class 2 or greater heart failure in the last 6 months, uncontrolled arrhythmias, hypotension or uncontrolled hypertension, stroke within last 6 months. Use by women.

SPECIAL PRECAUTIONS
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Evaluation of erectile dysfunction and BPH should include an appropriate medical assesment to identify potential underlying causes, as well as treatment options. Prior to initiating treatment with this product for BPH, consideration should be given to other urological conditions which may cause similar symptoms. In addition, prostate cancer and BPH may coexist. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure and as such potentiate the hypotensive effect of nitrates. In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy. Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, tothis product, to sexual activity, or to a combination of these or other factors. Visual defects and cases of NAION have been reported in connection with the intake of this product and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking this productand consult a physician immediately. Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of this product is not recommended in patients with severe renal impairment for the treatment of ED. Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, this product for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min for the treatment of BPH and ED/BPH. In patients with creatinine clearance 30-50 mL/min, start dosing at 2.5 mg once daily, and increase the dose to 5 mg once daily based upon individual response for the treatment of ED/BPH  There is limited clinical data on the safety of single-dose administration in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency. If this product is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Agents for the treatment of erectile dysfunction, includingthis product , should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if this product is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. In patients who are taking alpha1 blockers, concomitant administration may lead to symptomatic hypotension in some patients. The combination of tadalafil and doxazosin is not recommended. The efficacy of the co-administration of an alpha-blocker and this product for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of this product and alpha-blockers is not recommended for the treatment of BPH.Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting this product for once daily use for the treatment of BPH. Caution should be exercised when prescribingthis product to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined. The safety and efficacy of combinations of this product and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. . The patients should be informed not to take this product with such combinations. Physicians should advise patients to stop taking PDE5 inhibitors, includingthis product, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, includingthis product. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. this product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 

SIDE EFFECTS
Frequency estimate: Very common (1/10), Common (1/100 to 1/10), Uncommon (1/1,000 to 1/100), Rare (1/10,000 and 1/1,000), Very Rare (<1/10,000) and Not known . For full details see prescribing information.

DRUG INTERACTIONS
Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.
Effects of other substances on tadalafil: Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10-mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20-mg) exposure (AUC) 4-fold and Cmax by 22%. Ritonavir, a protease inhibitor (200 mg dose given twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20-mg) exposure (AUC) 2-fold with no change in Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice, should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil. Consequently the incidence of the undesirable effects listed in section 4.8 might be increased. The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known. There is thus the potential of drug interactions mediated by inhibition of transporters. A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10 mg dose). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4, such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.
Effects of tadalafil on other medicinal products: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration to patients who are using any form of organic nitrate is contraindicated. Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of this product (2.5mg-20mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring. The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not recommended.
In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted. In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive agents was examined. Major classes of antihypertensive agents were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicines, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers – see above) is, in general, minor and not likely to be clinically relevant. Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicines. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicines. When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicines. Tadalafil has been demonstrated to produce an increase in the oral bioavailabilty of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain. Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol.Alcohol was administered in a manner to maximize the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol). Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg). Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicimal products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1 , CYP2C9 and CYP2C19. Tadalafil (10mg and 20mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin. Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid. Specific interaction studies with antidiabetic agents were not conducted.

DOSAGE
Use in adult men: Erectile Dysfunction: In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. In patients who anticipate a frequent use of Cialis (i.e., at least twice weekly) a once daily regimen with the lowest doses of Cialis might be considered suitable, based on patient choice and the physician’s judgement. In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed every 3 months by the prescribing physician.
CIALIS 5mg for once daily for Benign Prostatic Hyperplasia: The recommended dose for once daily use is 5 mg, taken at approximately the same time every day. 5mg for once daily for Erectile Dysfunction and Benign Prostatic Hyperplasia: The recommended dose for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
Use in elderly men: Dose adjustments are not required in elderly patients.

OVERDOSE
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes negligibly to tadalafil elimination.

PREGNANCY & LACTATION
This product is not indicated for use by women. There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use during pregnancy. Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. this product should not be used during breast feeding.

MANUFACTURER & DISTRIBUTER:
Manufacturer: Eli Lilly Israel Ltd.
License Holder: Eli Lilly Israel Ltd.

سياليس ® (كو) يعمل عن طريق تحسين تدفق الدم إلى القضيب. المعروفة باسم "حبة عطلة نهاية الأسبوع،" هذا الدواء يبقى في النظام لفترة أطول من منافسيها. لا تستخدم هذا الدواء إذا كنت على الأدوية التي تحتوي على النترات، وتجنب الإفراط في استهلاك الكحول.

Adult Dosing .

Dosage forms:  2.5,5,10,20

erectile dysfxn

[prn dosing regimen]
Dose: 5-20 mg PO x1 prior to sexual activity; Start: 10 mg PO x1, adjust based on individual response; Max: 20 mg/dose, 1 dose/24h; 10 mg/dose, 1 dose/72h if strong CYP3A4 inhibitor use; Info: effects may last 36h

[daily dosing regimen]
Dose: 2.5-5 mg PO qd; Start: 2.5 mg PO qd, adjust dose based on individual response; Max: 5 mg/day; 2.5 mg/day if strong CYP3A4 inhibitor use; Info: give without regard to sexual activity

BPH

[5 mg PO qd]
Info: for pts w/ or w/o erectile dysfxn

renal dosing

[erectile dysfxn prn dosing]
CrCl 30-50: start 5 mg x1 not more than qd, max 10 mg q48h; CrCl <30: max 5 mg q72h; HD: no supplement

[erectile dysfxn daily dosing]
CrCl <30: avoid use

[BPH daily dosing]
CrCl 30-50: start 2.5 mg qd, max 5 mg/day; CrCl <30: avoid use

hepatic dosing

[erectile dysfxn prn dosing]
Child-Pugh Class A or B: max 10 mg qd; Child-Pugh Class C: avoid use

[erectile dysfxn or BPH daily dosing]
Child-Pugh Class A or B: caution advised; Child-Pugh Class C: avoid use

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