- Jun 21, 2018
Erasmo-25( Erasmo-50) instruction:
Operating substances Erasmo:
Form of release Erasmo:
- Film-coated tablets of 25 mg No. 1, No. 4.
- Film-coated tabletsthumbnail, 50 mg No. 1, No. 4.
To whom is Erasmo shown?
Treatment of men with impaired erectile function, namely: inability to achieve or maintain an erection of the penis necessary to ensure satisfactory sexual activity.
To achieve the desired effect of the drug requires sexual stimulation.
How to use Erasmo?
The recommended dose of Erasmo-50 is taken as necessary approximately one hour before the onset of sexual activity. Given the individual effectiveness and tolerability of the drug, the dose can be reduced to 25 mg or increased to 100 mg.
Before starting treatment, a physical examination of patients should be performed to diagnose erectile dysfunction and identify the potential causes of these disorders.
In addition, before the appointment of any treatment for erectile dysfunction, the doctor is obliged to assess the condition of the cardiovascular system. Since sildenafil has vasodilator properties, the physician should assess how these properties can cause undesirable effects in patients with certain disorders, especially in combination with sexual activity. Patients with hypersensitivity to vasodilators are those with obstruction of outflow from the left ventricle( eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as multiple systemic atrophy syndrome.
Sildenafil drugs should be used with caution in the treatment of patients with anatomical deformation of the penis( eg, with angulation, cavernous fibrosis or Peyronie's disease), as well as patients with a predisposition to developing priapism( eg, those suffering from serpoklatinic anemia, multiple myeloma or leukemia).Since the safety and effectiveness of the use of sildenafil in combination with other types of therapy for erectile dysfunction has not been investigated, therefore, the use of such combinations is not recommended.
The use of PDE5 inhibitor drugs is not recommended for patients who have suffered an episode of non-arterial ischemic neuropathy of the anterior part of the eye( NAION).
The drug should be given with caution to patients who regularly take alpha-blocker medications, since this combination in some individuals can cause symptomatic hypotension: most often this occurs within 4 hours after the application of Erasmo. To reduce the risk of developing orthostatic hypotension before starting the use of Erasmo, it is necessary to stabilize the hemodynamic state of patients with a course of therapy with alpha-blocker drugs, and start taking the drug with minimal doses of 25 mg. In addition, the doctor should advise patients in the case of developing symptoms of orthostatic hypotension.
Since in vitro, sildenafil potentiates the anti-aggregation effect of sodium nitroprusside, and individual studies of the use of the drug by patients with coagulation disorders or exacerbation of gastric and duodenal ulcers have not been carried out, such a patient should be prescribed only after a thorough assessment of the risk of such use.
Because Erasmo tablets contain lactose, they should not be used in men with rare hereditary lactose intolerance, lactase deficiency, or glucose-galactose absorption impairment.
Use in elderly patients
Treatment of elderly patients is performed without dose adjustment.
Usage in patients with renal insufficiency
Patients with mild to moderate renal insufficiency( creatinine clearance is 30-80 ml / min) are recommended to use usual doses of the drug.
For serious kidney damage( creatinine clearance <30 ml / min), the doctor should consider using a smaller dose of the drug( 25 mg), followed by a possible increase in the dose to 50 mg.
Use in patients with impaired liver function
In treating patients with impaired liver function( eg, cirrhosis), the doctor should consider using a smaller dose of the drug( 25 mg), followed by a possible increase in the dose to 50 mg.
Use in patients taking other medications.
It is not recommended to use sildenafil drugs simultaneously with ritonavir preparations.
For patients who are concurrently treated with other CYP3A4 inhibitors( eg saquinavir, ketoconazole, erythromycin, cimetidine), a reduction in the dose of sildenafil up to 25 mg should be considered.
To reduce the likelihood of developing arterial hypotension in patients undergoing treatment with alpha-blockers, a daily regular dose of alpha-blocker drugs should be established before starting Erasmo. After that, Erasmo-25 can be used as an initial dose.
The ability to influence the reaction rate when driving vehicles or other mechanisms.
Because Erasmo can cause dizziness and visual impairment, patients should first establish how they react to Erasmo application before starting to drive or operate machinery.
Use during pregnancy or lactation.
Erasmo is not intended for use in women.
Erasmo is not intended for the treatment of children under the age of 18 years.
Side Effects of Erasmo.
When conducting studies on the use of Erasmo, the incidence of side effects was 1%, with the vast majority of adverse reactions occurring in mild or moderate form. With an increase in the dose, the frequency and severity of side effects also increased. When used at a dose of 100 mg, the most common side effects were dyspepsia( 12%) and visual impairment( 11%).With frequent use of Erasmo, than it is recommended, there was also a pain in the muscles. At application of other doses the most widespread by-effects were a headache and a hyperemia. In the conduct of clinical and postmarketing studies, the following side effects were noted.
- tachycardia, ventricular arrhythmia, myocardial infarction, unstable angina, sudden cardiac arrest;
- hypotension, hypertension, epistaxis, loss of consciousness, cerebral hemorrhage, temporary ischemic attack.
Sensory organs( vision):
- effect on visual acuity( increased photosensitivity and blurred vision);
- chromatopsy( in light and temporal form, mainly expressed in a change in the color of objects);
- pain in the eyes, redness / rush of blood to the eyes, non-arterial ischemic neopathy of the anterior part of the eye( NAION), blockage of the vessels of the retina.
Central nervous system:
- headache, dizziness.
Respiratory and mediastinal system:
- occlusion of the nasal canal.
- hypersensitivity reactions( including rash on the skin).
- prolonged erection, priapism.
Who is contraindicated with Erasmo?
- Hypersensitivity to the active ingredient and any other components of the drug.
- Since sildenafil potentiates the hypotensive effect of nitrates, the simultaneous use of the drug together with nitrate preparations and nitric oxide donors is contraindicated.
- In the presence of contraindications for sexual activity per se( for example, serious diseases of the cardiovascular system).
- Serious violations of the liver, hypotension, recent myocardial infarction or stroke, congenital degenerative damage to the retina( pigmented retinitis pigmentosa).
Interaction of Erasmo.
Since the metabolism of sildenafil occurs mainly with the isoforms 3A4( main pathway) and 2C9 cytochrome P450( CYP), the inhibitors of these isoenzymes are able to reduce the clearance of sildenafil.
The use of single doses of antacids( magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil.
In a population pharmacokinetic analysis, no effect on the pharmacokinetics of sildenafil was demonstrated with concomitant therapy with CYP2C9 inhibitors( tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors( selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazides and thiazide-like diuretics, loop and potassium-sparingdiuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, beta-adrenergic receptor antagonistsDo inducers of CYP450 metabolism( rifampicin, barbiturates).
Since nicorandil is a combination of a potassium channel and nitrate inductor, it can significantly affect the pharmacokinetics of sildenafil.
No data on the interaction of sildenafil with nonspecific phosphodiesterase inhibitors, such as theophylline and dipyridamole, are available.
Given the effect of sildenafil on the mechanism of exchange of nitric oxide and cGMP( section "Pharmacodynamics") it was found that the drug enhances the hypotensive effect of nitrates, so the simultaneous use of these drugs is contraindicated.
When applying the drug to some sensitive patients who are being treated with drugs of alpha-blockers( eg, to xazosin), simtomatic hypotension may develop. This usually occurs within 4 hours after taking the dose of sildenafil.
Sildenafil in a dose of 50 mg did not cause an increase in bleeding time caused by the use of acetylsalicylic acid( 150 mg).
Sildenafil 50 mg did not increase the hypotensive effect of alcohol in healthy volunteers who had an average blood alcohol level of 80 mg / dL on average.
In the analysis of the following classes of antihypertensive drugs: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, vasodilators, as well as antihypertensive drugs of central action, neuronal adrenoblockers, calcium channel blockers, alpha-adrenergic blockers, there were no differences in side effects, which were observed in patients taking sildenafil and placebo.
When using doses of the drug, above 100 mg, its effectiveness does not increase. However, such a dose increase may lead to an increase in undesirable side effects. In case of an overdose of the drug, it is necessary to apply standard measures for the provision of medical care. Dialysis does not accelerate clearance, since sildenafil is bound to a considerable degree by plasma proteins and is not excreted by urine.