Cialis, 5 mg 28 pcs

Sialis is a treatment for erectile dysfunction (impotence, erectile dysfunction) in men and is part of a group of drugs called FDE-5 (phosphodiesterase type 5) inhibitors.

The drug dilates blood vessels of the penis during sexual arousal. As a result, blood circulation in the penis increases, and this, in turn, contributes to the onset of a stable erection.

Indications

• Erectile dysfunction.
• Lower urinary tract symptoms in patients with benign prostatic hyerplasia.
• Erectile Dysfunction in Patients with Lower Urinary Tract Symptoms with Benign Prostatic Hyerplasia

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Active ingredient

Tadalafil

Composition

1 film-coated tablet contains:

Tadalafil 5 mg

Excipients:

Lactose monohydrate 109.65 mg

Lactose monohydrate (spray-dried) 17.50 mg

Lactose monohydrate (spray-dried) 17.50 mg/p>

Hyprolose 1.22 mg

Hyprolose (extra fine) 2.80 mg

Hyprolose (extra fine)/p>

Sodium lauryl sulfate 0.49 mg

Microcrystalline cellulose 26.25 mg

Sodium croscarmellose 11.20 mg

Magnesium stearate (vegetable) 0.88 mg.

Composition of the shell:

Opadray yellow (Y-30-12863-A) 8.75 mg (lactose monohydrate 3.72 mg, hypromellose 2.59 mg, titanium dioxide 1.54 mg, triacetin 0.74 mg, iron oxide yellow dye 0.16).

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How to take, the dosage

For oral administration.

• For patients with frequent sexual activity (more than twice a week), the recommended frequency of administration is daily, once daily, 5 mg, at the same time, regardless of food intake. The daily dose may be reduced to 2.5 mg, depending on individual sensitivity.
• For patients with infrequent sexual activity (less than twice a week), a dose of 20 mg, immediately before sexual activity, is recommended according to the instructions for medical use of the drug. The maximum daily dose is 20 mg.

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Interaction

Influence of other drugs on tadalafil

Tadalafil is mainly metabolized with participation of CYP3A4 isoenzyme. The selective CYP3A4 isoenzyme inhibitor ketoconazole (400 mg daily) increases single-dose tadalafil exposure (AUC) by 312% and C mah by 22%, while ketoconazole (200 mg daily) increases single-dose tadalafil exposure (AUC) by 107% and C mah by 15% relative to AUC and C mah values for tadalafil alone.

Ritonavir (200 mg twice daily), an inhibitor of the CYP3A4, 2C9, 2C19 and 2D6 isoenzymes, increases single-dose tadalafil exposure (AUC) by 124% without changing C mah. Although specific interactions have not been studied, it can be assumed that other HIV protease inhibitors, such as saquinavir, as well as CYP3A4 isoenzyme inhibitors such as erythromycin and intraconazole, increase tadalafil activity.

The selective CYP3A4 isoenzyme inducer, rifampicin (600 mg daily), reduces single-dose tadalafil exposure (AUC) by 88% and C mah by 46%, relative to the AUC and C mah values for tadalafil alone. It can be assumed that concomitant use of other CYP3A4 isoenzyme inducers should also reduce plasma concentrations of tadalafil.

The simultaneous use of antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduces the rate of absorption of tadalafil without changing the area under the pharmacokinetic curve for tadalafil.

An increase in gastric pH due to administration of the H2-histamine receptor blockers nizatidine had no effect on the pharmacokinetics of tadalafil.

The safety and effectiveness of combinations of tadalafil with other treatments for erectile dysfunction have not been studied, so the use of such combinations is not recommended. Tadalafil does not potentiate the increase in bleeding time caused by taking acetylsalicylic acid.

Influence of tadalafil on other drugs

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

Tadalafil has no clinically significant effect on the clearance of drugs whose metabolism involves cytochrome P450. Studies have confirmed that tadalafil neither inhibits nor induces CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1 isoenzymes.

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

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

Tadalafil has systemic vasodilator properties and may increase the effect of hypotensive drugs to reduce blood pressure. Additionally, a slightly greater reduction in blood pressure was observed in patients taking multiple hypotensive agents in whom blood pressure was poorly controlled. In the vast majority of patients, this decrease was not associated with hypotensive symptoms.

Patients treated with hypotensive medications and taking tadalafil should be given appropriate clinical advice.

There was no significant decrease in blood pressure when tadalafil was used by persons taking the selective alpha 1A-adrenoblocker tamsulosin.

The concomitant use of tadalafil with doxazosin is contraindicated. When tadalafil was used by healthy volunteers who were taking doxazosin (4-8 mg daily), an alpha 1-adrenoblocker, an increase in the hypotensive effect of doxazosin was observed. Some patients experienced dizziness. No fainting was observed. The use of doxazosin in lower doses has not been studied.

Tadalafil had no effect on alcohol concentration, nor did alcohol affect tadalafil concentration. At high doses of alcohol (0.7 g/kg), tadalafil administration did not cause a statistically significant decrease in mean blood pressure. Postural dizziness and orthostatic hypotension were observed in some patients. When tadalafil was taken in combination with lower doses of alcohol (0.6 g/kg), no reduction in blood pressure was observed, and dizziness occurred with the same frequency as when alcohol alone was taken.

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

Special Instructions

Caution should be exercised when prescribing Cialis to patients taking alpha1-adrenoblockers, because concomitant use may lead to symptomatic arterial hypotension in some patients.

In a clinical pharmacology study of 18 healthy volunteers taking a single dose of tadalafil, no symptomatic arterial hypotension was observed with concomitant administration of tamsulosin, an alpha 1-adrenoblocker. Diagnosis of erectile dysfunction should include identification of a potential underlying cause, appropriate physical examination, and determination of treatment tactics.

Sexual activity has potential risks for patients with cardiovascular disease. Therefore, treatment of erectile dysfunction, including with Cialis, should not be performed in men with heart conditions in which sexual activity is not recommended. There have been reports of the occurrence of priapism when using FDE-5 inhibitors, including tadalafil.

Patients should be informed to seek immediate medical attention if an erection lasts 4 hours or more. Failure to treat priapism in a timely manner leads to penile tissue damage, which may result in permanent impotence.

The safety and effectiveness of combinations of the drug Cialis with other treatments of disorders have not been studied. Therefore, the use of such combinations is not recommended. Like other FDE-5 inhibitors, tadalafil has systemic vasodilator properties, which may lead to a transient decrease in blood pressure.

Before prescribing Cialis, physicians should carefully consider whether patients with cardiovascular disease would be adversely affected by such vasodilatory effects. Nonarterial anterior ischemic optical neuropathy (NAPION) causes visual impairment, including total vision loss.

There are rare post-marketing reports of cases of the development of NAPION that are temporally associated with the ingestion of FDE-5 inhibitors. At this time, it is not possible to determine whether there is a direct association between the development of NAPION and the intake of FDE-5 inhibitors_ or other factors.

Physicians should advise patients to discontinue tadalafil and seek medical attention in the event of sudden vision loss. Physicians should also advise patients that people who have had NAPION are at increased risk of developing NAPION again.

The efficacy of Cialis in patients who have undergone pelvic surgery or radical neurosurgical prostatectomy is unknown.

Application in hepatic impairment: As no data are available for patients with severe hepatic impairment (Child-Pugh class C), caution should be exercised when prescribing the drug in this group of patients.

Influence on driving and operating ability: Even though the incidence of dizziness is similar between placebo and tadalafil, caution should be exercised during treatment when driving motor vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

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Contraindications

• High sensitivity to tadalafil or to any substance in the drug.
• In case of taking drugs containing any organic nitrates.
• Age under 18 years of age.
• Cardiovascular disorders: myocardial infarction within the last 90 days, unstable angina, occurrence of angina attack during sexual intercourse, chronic heart failure NYHA classes II-IV, uncontrolled arrhythmias, arterial hypotension (BP less than 90/50 mm Hg).hypertension, uncontrolled arterial hypertension, ischemic stroke within the last 6 months.
• Vision loss due to nonarterial anterior ischemic optic neuropathy (regardless of association with taking FDE-5 inhibitors).
• Simultaneous use of doxazosin as well as medications for erectile dysfunction.
• Frequent (more than 2 times per week) use in patients with chronic renal insufficiency (creatinine clearance less than 30 ml/min).
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Cautions:

• Severe hepatic impairment (Child-Pugh class C).
• Patients taking alpha 1 -adrenoblockers.
• Predisposition to priapism (in case of sickle cell anemia, multiple myeloma or leukaemia).
• Simultaneous use with potent CYP3A4 isoenzyme inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), hypotensive drugs.

Overdose

Symptoms: When administered once to healthy volunteers at a dose of up to 500 mg and repeatedly to patients with erectile dysfunction up to 100 mg/day, adverse effects were the same as when the drug was used at lower doses.

Treatment: conduct standard symptomatic therapy. In hemodialysis tadalafil is practically not excreted.

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Similarities

Dynamico Long, Tadalafil-SZ, Framitus