Cialis, 5 mg 14 pcs
€159.94 €133.29
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Cialis is a treatment for erectile dysfunction (impotence, erectile dysfunction) in men and belongs to the group of drugs called FDE-5 (phosphodiesterase type 5) inhibitors.
The drug dilates blood vessels of the penis during sexual arousal.
Indications
- Erectile dysfunction
- Lower urinary tract symptoms in patients with benign prostatic hyerplasia.
- Erectile dysfunction in patients with lower urinary tract symptoms in patients with benign prostatic hyperplasia
.
Active ingredient
Tadalafil
Composition
1 film-coated tablet contains:
Tadalafil 5 mg.
Associates:
Lactose monohydrate 109.65 mg
Lactose monohydrate (spray-dried) 17.50 mg
Magnesium stearate (vegetable) 0.88 mg
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 a day, 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), it is recommended to prescribe the drug in a dose of 20 mg, immediately before sexual activity according to the instructions for medical use of the drug. The maximum daily dose is 20 mg.
Interaction
Influence of other drugs on tadalafil
Tadalafil is mainly metabolized with participation of CYP3A4 isoenzyme. The selective CYP3A4 isoenzyme inhibitor ketoconazole (400 mg per day) increases tadalafil single dose exposure (AUC) by 312% and C mah by 22%, and ketoconazole (200 mg per day) increases tadalafil single dose 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 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 per day), 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.
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 intake of H2-histamine receptor blockers nizatidine had no effect on tadalafil pharmacokinetics.
Safety and efficacy of combination 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.
The effect 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 against the background of taking nitrates is contraindicated.
Tadalafil has no clinically significant effect on 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 aimed at reducing blood pressure. Additionally, a slightly greater reduction in blood pressure was observed in patients who were taking multiple hypotensive agents in whom arterial hypertension 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 guidelines.
No significant decrease in blood pressure was observed when tadalafil was used by persons taking the selective alpha 1A-adrenoblocker tamsulosin.
Simultaneous use of tadalafil with doxazosin is contraindicated. When using tadalafil in healthy volunteers who were taking doxazosin (4-8 mg per day), alpha 1-adrenoblocker, an increase in 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 the mean value of 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 decrease in blood pressure was observed, and dizziness occurred with the same frequency as with alcohol alone.
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, since concomitant use may lead to symptomatic arterial hypotension in some patients.
In a clinical pharmacology study in 18 healthy volunteers taking a single dose of tadalafil, no symptomatic arterial hypotension was observed when tamsulosin, an alpha 1-adrenoblocker was administered simultaneously. Diagnosis of erectile dysfunction should include identification of the potential underlying cause, appropriate medical examination, and determination of treatment tactics.
Sexual activity has potential risks for patients with cardiovascular disease. Therefore, erectile dysfunction treatment, 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 of the need to seek immediate medical attention in the event of an erection lasting 4 hours or more.
Untimely treatment of priapism leads to penile tissue damage, which may result in irreversible impotence. Safety and effectiveness of combinations of the drug Cialis with other types of treatment 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. Non-arterial anterior ischemic optical neuropathy (NAPION) causes visual impairment, including total loss of vision.
There have been rare post-marketing reports of cases of the development of NAPION, temporally associated with the ingestion of FDE-5 inhibitors. At this time, it is not possible to determine whether there is a direct link 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 inform 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 liver dysfunction: Because there are no data regarding patients with severe hepatic impairment (class C according to the Child-Pugh classification), caution should be exercised when prescribing the drug to this group of patients.
Influence on driving and operating machinery: Despite the fact that the incidence of dizziness against placebo and tadalafil is the same, during treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.
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 diseases: 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.systolic), uncontrolled arterial hypertension, ischemic stroke within the last 6 months.
- Vision loss due to nonarterial anterior ischemic optic neuropathy (irrespective of association with FDE-5 inhibitors).
- Simultaneous use of doxazosin as well as medications for erectile dysfunction.
- Frequent (more than 2 times a week) use in patients with chronic renal insufficiency ( creatinine clearance less than 30 ml/min).
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution:
- Severe hepatic impairment (Child-Pugh class C).
- Patients taking alpha 1 -adrenoblockers.
- Predisposition to priapism (in sickle cell anemia, multiple myeloma or leukemia).
- Anatomic deformity of the penis (angular curvature, cavernous fibrosis or Peyronie’s disease).
- Simultaneous use with potent CYP3A4 isoenzyme inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), hypotensive drugs.
Side effects
Adverse events associated with tadalafil administration are usually mild to moderate in severity, transient, and diminished with continued use of the drug.
The most frequent (≥1%), headache, dyspepsia, back pain, myalgia, “rushes” of blood to the face, nasal congestion.
Disorders of the cardiovascular system:
- not infrequently- palpitations*, tachycardia*, decreased blood pressure (in patients who were already taking hypotensive agents), increased blood pressure
- frequently – myocardial infarction*
- not known – unstable angina pectoris*.
Nervous system disorders:
- very often – headache
- often – dizziness
- frequently – syncope, migraine, transient ischemic attacks, stroke.
Vision disorders:
- infrequent – blurred vision
- frequent – visual field disturbance
- not known – nonarterial anterior ischemic optical neuropathy of the optic nerve, retinal vein occlusion.
Respiratory system disorders: infrequent – nasal bleeding.
Disorders of the digestive system:
- often – abdominal pain
- infrequent – gastroesophageal reflux
Skin and subcutaneous tissue disorders:
- infrequent – rash, urticaria, hyperhidrosis (increased sweating)
- not known – Stevens-Johnson syndrome and exfoliative dermatitis.
General disorders:
- infrequently – chest pain*
- frequently – facial edema
- not known – sudden cardiac death*.
Immune system disorders: infrequent – hypersensitivity reactions.
Reproductive system disorders:
- often – prolonged erection
- not known – priapism.
* Observed in patients with previous cardiovascular risk factors. However, it is not possible to definitively determine whether these phenomena are directly related to these risk factors, to tadalafil, to sexual arousal, or to a combination of these or other factors.
Overdose
Symptoms: When administered once to healthy volunteers at a dose of up to 500 mg and to patients with erectile dysfunction many times up to 100 mg/day, adverse effects were the same as when using the drug at lower doses.
Treatment: Conducting standard symptomatic therapy. In hemodialysis tadalafil is practically not excreted.
Similarities
Dynamico Long, Tadalafil-SZ, Framitus
Weight | 0.017 kg |
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Shelf life | 3 years |
Conditions of storage | Store at a temperature not exceeding 30°C. |
Manufacturer | Lilly del Caribe Inc., Puerto Rico |
Medication form | pills |
Brand | Lilly del Caribe Inc. |
Other forms…
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