Name:
Maxigame tab. p / o 50 mg in bl. in pack. No. 1×1
Description:
Film-coated tablets, blue, round, biconvex. The main active ingredient is sildenafil citrate Release form Tablets Dosage 50 mg Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformity of the penis (angulation, cavernous fibrosis, Peyronie’s disease) or in patients with risk factors for the development of priapism (sickle cell anemia, multiple myeloma, leukemia). If an erection persists for more than 4 hours, the patient should immediately seek medical help. If priapism therapy is not carried out in a timely manner, this can lead to damage to the tissues of the penis and irreversible loss of potency. Drugs intended for the treatment of erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable. Since sexual activity poses a certain risk in heart disease, before starting any therapy for erectile dysfunction, the doctor should conduct an examination of the patient’s cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina, myocardial infarction or stroke in the last 6 months, life-threatening arrhythmias, arterial hypertension (BP> 170/100 mm Hg) or hypotension (BP < 90/50 mm Hg). Art.). Clinical studies have shown no difference in the incidence of myocardial infarction (1.1 per 100 people per year) or the incidence of death from cardiovascular diseases (0.3 per 100 people per year) in patients treated with sildenafil compared with patients who received placebo. Cardiovascular complications During the post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina pectoris, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack) have been reported. , hypertension and hypotension) that had a temporal association with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular events. Many of these adverse events were observed shortly after sexual activity and some of them were noted after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct relationship between the observed adverse events and these or other factors. Hypotension Sildenafil has a systemic vasodilatory effect, leading to a transient decrease in blood pressure, which is not clinically significant and does not lead to any consequences in most patients. However, before prescribing sildenafil, the physician should carefully assess the risk of possible adverse vasodilatory effects in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators has been observed in patients with left ventricular outflow tract obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) and the rare multiple system atrophy syndrome, manifested by severe autonomic dysregulation of blood pressure. Sildenafil should be administered with caution to patients taking alpha-blockers, since their combined use may lead to symptomatic hypotension in some susceptible patients. The development of this effect is most likely within 4 hours after taking sildenafil. To minimize the risk of developing postural hypotension in patients taking alpha-blockers, treatment with sildenafil should be started after stabilization of hemodynamic parameters in these patients. Consideration should also be given to reducing the starting dose of sildenafil. The physician should inform patients what actions to take if symptoms of postural hypotension appear. Visual disturbances When using all PDE5 inhibitors, incl. sildenafil, rare cases of anterior ischemic optic neuropathy of non-inflammatory origin have been noted as a cause of deterioration or loss of vision. The majority of these patients had risk factors such as decreased cup-to-optic disc ratio ("congestive disc"), age over 50 years, diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. In the event of a sudden deterioration in vision, the patient should be advised to stop taking sildenafil and immediately consult a doctor. A small number of patients with hereditary retinitis pigmentosa have genetically determined disorders of the functions of retinal phosphodiesterases. There are no data on the safety of sildenafil in patients with retinitis pigmentosa. Hearing impairment Sudden worsening or loss of hearing has been reported in some post-marketing and clinical studies with all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden worsening or loss of hearing. A causal relationship between the use of PDE5 inhibitors and sudden worsening or loss of hearing has not been established. In the event of a sudden deterioration or loss of hearing while taking sildenafil, you should immediately consult your doctor. Bleeding Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donor, on human platelets in vitro. Data on the safety of the use of sildenafil in patients with a tendency to bleeding or exacerbation of gastric and duodenal ulcers are not available, so sildenafil should be used with caution in these patients. The incidence of epistaxis in patients with pulmonary hypertension associated with diffuse connective tissue disease was higher (sildenafil 12.9%, placebo 0%) than in patients with primary pulmonary hypertension (sildenafil 3%, placebo 2.4%). Patients receiving sildenafil in combination with a vitamin K antagonist had a higher incidence of epistaxis (8.8%) than patients not taking a vitamin K antagonist (1.7%). Use in conjunction with other treatments for erectile dysfunction The safety and efficacy of the combined use of sildenafil with other PDE5 inhibitors or other drugs for the treatment of pulmonary hypertension containing sildenafil, or other treatments for erectile dysfunction has not been studied, so the use of such combinations is not recommended. Influence on the ability to drive vehicles and control mechanisms The effect of sildenafil on the ability to drive a car and perform work that requires increased attention has not been studied. However, during the period of use of the drug, care must be taken when driving vehicles and engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, tk. possible dizziness and blurred vision. Pharmacological action Drug for the treatment of erectile dysfunction. Sildenafil is a potent selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5). With sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis. Sildenafil does not have a direct relaxing effect on the isolated corpus cavernosum, but actively enhances the relaxing effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the breakdown of cGMP in the corpus cavernosum. Upon activation of the NO/cGMP pathway, PDE5 inhibition under the influence of sildenafil leads to an increase in the level of cGMP in the cavernous body, resulting in relaxation of smooth muscle tissue and increased blood flow in the cavernous body. The activity of sildenafil against PDE5 is 10-10,000 times greater than the activity against other PDE isoenzymes (1-11). The pharmacological effect is achieved only in the presence of sexual stimulation. In clinical studies, the median time to achieve a 60% firm erection (enough for sexual intercourse) was shown to be 25 minutes (range 12 to 37 minutes). In some patients, 1 hour after taking the drug at a dose of 100 mg using the Farnsworth-Munsell 100 test, a mild and transient impairment of the ability to distinguish colors (blue / green) was detected, 2 hours after taking the drug, these changes were absent. It is believed that the violation of color vision is caused by inhibition of PDE6, which is involved in the process of light transmission in the retina. Sildenafil does not affect visual acuity, contrast perception, electroretinogram, intraocular pressure or pupil diameter. In healthy volunteers, after a single dose of sildenafil at a dose of 100 mg, no effect on sperm motility or morphology was noted. Pharmacokinetics Absorption After oral administration, sildenafil is rapidly absorbed. Absolute bioavailability averages 41% (25-63%). After a single dose of the drug inside on an empty stomach at a dose of 100 mg Cmax in plasma is 18 ng / ml (38 nM) and is achieved within 30-120 minutes (average 60 minutes). When taking sildenafil in combination with fatty foods, Cmax decreases by 20-40% and is reached after 1.5-3 hours. The distribution of Vd of sildenafil in the equilibrium state averages 105 liters. The binding of sildenafil and its main circulating N-desmethyl metabolite to plasma proteins is approximately 96% and is independent of the total concentration of sildenafil. In healthy volunteers receiving sildenafil (once at a dose of 100 mg), less than 0.0002% (mean 188 ng) of the administered dose was determined in the semen 90 minutes after ingestion. Metabolism Sildenafil is metabolized primarily in the liver by microsomal isoenzymes CYP3A4 (major pathway) and CYP2C9 (minor pathway). The main circulating metabolite is formed from sildenafil by N-desmethylation. In terms of selectivity of action on PDE, the metabolite is comparable to sildenafil, its activity against PDE5 in vitro is approximately 50% of the activity of sildenafil. The concentration of the main metabolite in plasma is approximately 40% of the concentration of sildenafil. The N-demethyl metabolite undergoes further metabolism, with its T1 / 2 being about 4 hours. Excretion The total clearance of sildenafil is 41 l / h, and the final T1 / 2 is 3-5 hours. After oral administration, sildenafil is excreted as metabolites mainly through intestines (approximately 80% of the dose) and, to a lesser extent, by the kidneys (approximately 13% of the dose). Pharmacokinetics in special groups of patients In elderly patients (over 65 years of age), the clearance of sildenafil is reduced, and the concentration of free active substance in plasma is approximately 40% higher than its concentration in young (18-45 years) patients. With mild renal failure (CC 50-80 ml / min) and moderate (CC 30-49 ml / min) severity, the pharmacokinetic parameters of sildenafil after a single oral dose of 50 mg do not change. In severe renal insufficiency (CC ≤30 ml / min), the clearance of sildenafil is reduced, which leads to an approximately twofold increase in AUC (100%) and Cmax (88%) compared with those with normal renal function in patients of the same age group. In patients with mild to moderate liver cirrhosis (Child-Pugh class A and B), sildenafil clearance is reduced, resulting in an increase in AUC (84%) and Cmax (47%) compared with those with normal liver function in patients in the same age group. The pharmacokinetic parameters of sildenafil have not been studied in patients with severe hepatic impairment. Indications for use Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse. Sildenafil is only effective with sexual stimulation. Dosage and administration The drug is taken orally, approximately 1 hour before the planned sexual activity. When taken simultaneously with a fatty meal, the onset of action of the drug may be delayed compared to taking it on an empty stomach. The recommended dose is 50 mg 1 time / day. Based on efficacy and tolerability, the dose may be increased to 100 mg or reduced to 25 mg. The maximum single dose is 100 mg. The maximum recommended frequency of use is 1 time / day. In elderly patients, dose adjustment is not required. With mild to moderate renal failure (CC 30-80 ml / min), dose adjustment is not required. In patients with severe renal insufficiency (CC <30 ml / min), the dose should be reduced to 25 mg. Based on efficacy and tolerability, the dose may be increased to 50 mg and 100 mg. In patients with impaired liver function, the dose should be reduced to 25 mg. Based on efficacy and tolerability, the dose may be increased to 50 mg and 100 mg. Co-administration with other drugs In patients receiving concomitant treatment with CYP3A4 inhibitors (with the exception of ritonavir, with which the simultaneous use of sildenafil is not recommended), the initial dose of sildenafil should be 25 mg. To minimize the possibility of developing orthostatic hypotension in patients taking alpha-blockers, treatment with sildenafil should be initiated after hemodynamic stabilization. The advisability of prescribing sildenafil at an initial dose of 25 mg should be considered. Use during pregnancy and lactationFor a registered indication, sildenafil is not intended for use in women. Interaction with other drugs The effect of other drugs on the metabolism of sildenafil The metabolism of sildenafil occurs mainly in the liver under the action of CYP3A4 isoenzymes (the main route) and CYP2C9, so inhibitors of these isoenzymes may reduce the clearance of sildenafil. With simultaneous use with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine), a decrease in the clearance of sildenafil was noted. A single dose of sildenafil at a dose of 100 mg together with erythromycin, a specific inhibitor of CYP3A4 (when taking erythromycin 500 mg 2 times / day for 5 days), in conditions of reaching an equilibrium concentration of erythromycin in the blood, leads to an increase in the AUC of sildenafil by 182%. Cimetidine (at a dose of 800 mg), which is a non-specific inhibitor of CYP3A4, when used together with sildenafil (at a dose of 50 mg) in healthy volunteers, caused an increase in plasma concentrations of sildenafil by 56%. Simultaneous use of sildenafil (once at a dose of 100 mg) and the HIV protease inhibitor ritonavir (500 mg 2 times / day), which is a potent inhibitor of the isoenzymes of the cytochrome P450 system, against the background of reaching an equilibrium concentration of ritonavir in the blood, led to an increase in Cmax of sildenafil by 300% (4 times), and AUC of sildenafil - by 1000% (11 times). After 24 hours, the concentration of sildenafil in the blood plasma was approximately 200 ng / ml (when using only sildenafil - approximately 5 ng / ml). Simultaneous use of sildenafil (once at a dose of 100 mg) and HIV protease inhibitor saquinavir (at a dose of 1200 mg 3 times / day), which is an inhibitor of CYP3A4, against the background of reaching an equilibrium concentration of saquinavir in the blood, led to an increase in Cmax of sildenafil by 140%, a AUC sildenafil - by 210%. Sildenafil had no effect on the pharmacokinetics of saquinavir. Stronger inhibitors of CYP3A4, such as ketoconazole and itraconazole, may cause more pronounced changes in the pharmacokinetics of sildenafil. CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin) influence on the pharmacokinetics of sildenafil. In studies involving healthy volunteers, the simultaneous use of the endothelin receptor antagonist bosentan (an inducer of the isoenzyme CYP3A4 (moderate), CYP2C9 and possibly CYP2C19) at an equilibrium concentration (125 mg 2 times / day) and sildenafil at an equilibrium concentration (80 mg 3 times / day) days) there was a decrease in AUC and Cmax of sildenafil by 62.6% and 52.4%, respectively. Sildenafil increased the AUC and Cmax of bosentan by 49/8% and 42%, respectively. It is assumed that the simultaneous use of sildenafil with potent inducers of the CYP3A4 isoenzyme, such as rifampicin, may lead to a greater decrease in the concentration of sildenafil in the blood plasma. A single dose of an antacid (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil. In healthy male volunteers, the simultaneous administration of azithromycin (500 mg / day for 3 days) does not affect the AUC, Cmax, Tmax, excretion rate constant and T1 / 2 of sildenafil or its main circulating metabolite. Grapefruit juice is a weak inhibitor of CYP3A4 and may cause a moderate increase in plasma levels of sildenafil. The effect of sildenafil on other medicinal products Sildenafil is a weak inhibitor of the isoenzymes of the cytochrome P450 system - 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 µmol). It is unlikely that sildenafil can affect the clearance of substrates of these isoenzymes. Sildenafil enhances the hypotensive effect of nitrates, so its combined use with nitric oxide donators or nitrates in any form is contraindicated. In preclinical studies, an additional (additive) decrease in blood pressure has been demonstrated with the combined use of PDE5 inhibitors and riociguat. In clinical trials, an increase in the hypotensive effect of PDE5 inhibitors was shown when they were prescribed in combination with riociguat. No positive clinical effect was found when using a combination of these drugs in the study population. The concomitant use of riociguat and PDE5 inhibitors, including sildenafil, is contraindicated. In selected sensitive patients receiving alpha-blockers, the simultaneous use of sildenafil may lead to symptomatic hypotension. With the simultaneous administration of the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg and 100 mg) in patients with benign prostatic hyperplasia with stable hemodynamics, the average additional decrease in systolic / diastolic blood pressure in the supine position was 7/7 mmHg, 9/5 mmHg and 8/4 mm Hg. respectively, and in the standing position – 6/6 mm Hg, 11/4 mm Hg. and 4/5 mm Hg. respectively. Rare cases of symptomatic orthostatic hypotension, manifested as dizziness (without syncope), have been reported in such patients. Signs of a significant interaction of sildenafil (50 mg) with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP2C9, have not been identified. Sildenafil at a dose of 100 mg does not affect the pharmacokinetic parameters of HIV protease inhibitors at their constant concentration in the blood, such as saquinavir and ritonavir, which are both CYP3A4 substrates. Sildenafil at a dose of 50 mg does not cause an additional increase in bleeding time caused by taking acetylsalicylic acid at a dose of 150 mg. Sildenafil at a dose of 50 mg does not increase the hypotensive effect of ethanol in healthy volunteers with a maximum blood ethanol concentration of 80 mg/dL on average. In patients with arterial hypertension, there were no signs of the interaction of sildenafil (at a dose of 100 mg) with amlodipine. The average additional decrease in blood pressure in the prone position is 8 mm Hg. (systolic) and 7 mm Hg. (diastolic). The use of sildenafil in combination with antihypertensive drugs does not lead to additional side effects. Contraindications simultaneous use of nitric oxide donators or organic nitrates or nitrites in any form; co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulants such as riociguat; joint use with other means of treating erectile dysfunction; concomitant use of ritonavir; severe liver failure (Child-Pugh class C); severe cardiovascular disease (severe heart failure, unstable angina, stroke or myocardial infarction in the last 6 months, life-threatening arrhythmias, hypertension (BP> 170/100 mm Hg) or arterial hypotension (BP < 90/50 mm Hg)); patients with episodes of development of non-arteritic anterior ischemic optic neuropathy with loss of vision in one eye; hereditary retinitis pigmentosa; hypersensitivity to sildenafil or any of the components of the drug. For its registered indication, sildenafil is not intended for use in women and in children and adolescents under 18 years of age. With caution, the drug should be used for anatomical deformation of the penis (including with angulation, cavernous fibrosis or Peyronie's disease); diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia); diseases accompanied by bleeding; exacerbation of peptic ulcer of the stomach and duodenum; hereditary retinitis pigmentosa; heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, stroke, life-threatening arrhythmias, arterial hypertension (BP over 170/100 mm Hg) or hypotension (BP less than 90/50 mm Hg); in patients with episodes of development of anterior ischemic neuropathy of the optic nerve of non-inflammatory origin in history; with the simultaneous use of alpha-blockers. Composition of sildenafil citrate 70.24 mg, which corresponds to the content of sildenafil 50 mg - 3 mg. Shell composition: hypromellose - 4.13 mg, macrogol 6000 - 1.3 mg, titanium dioxide - 0.9 mg, talc - 0.43 mg, indigo carmine (E132) - 0.24 mg. OverdoseSymptoms: with a single dose of the drug at a dose of up to 800 mg in studies in healthy volunteers, adverse events were comparable to those when taking sildenafil at lower doses, but their frequency and severity increased. The use of the drug at a dose of 200 mg did not lead to an increase in efficiency, but the frequency of adverse events (headache, flushing of the face, dizziness, dyspepsia, nasal congestion, visual impairment) increased. Treatment: symptomatic therapy. Sildenafil is not excreted by hemodialysis. Side effect The frequency of side effects is defined as follows: very often (≥1 / 10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1 / 10,000, <1/1000), very rarely (<1/10,000), the frequency is unknown (it was not possible to establish the frequency of occurrence according to the available data). From the immune system: rarely - hypersensitivity reactions (including skin rash), allergic reactions. From the hemopoietic system: infrequently - anemia, leukopenia. From the side of metabolism and nutrition: infrequently - a feeling of thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia. From the nervous system: very often - headache; often - dizziness; infrequently - drowsiness, migraine, ataxia, hypertonicity, neuralgia, neuropathy, paresthesia, tremor, vertigo, symptoms of depression, insomnia, unusual dreams, increased reflexes, hypoesthesia; rarely - cerebrovascular accident, transient ischemic attack, convulsions *, repeated convulsions *, fainting. On the part of the organ of vision: often - blurred vision, blurred vision, cyanopsia; infrequently - conjunctivitis, eye pain, photophobia, photopsia, chromatopsia, redness of the eyes / scleral injections, changes in the brightness of light perception, mydriasis, hemorrhage in the eye tissue, cataracts, disruption of the lacrimal apparatus; rarely - swelling of the eyelids and adjacent tissues, a feeling of dryness in the eyes, the presence of iridescent circles in the field of view around the light source, increased eye fatigue, seeing objects in yellow (xanthopsia), seeing objects in red (erythropsia), conjunctival hyperemia, irritation of the mucosa membranes of the eyes, discomfort in the eyes; frequency unknown - non-arteritic anterior ischemic optic neuropathy, retinal vein occlusion, visual field defects, diplopia *, temporary loss of vision or decreased visual acuity, increased intraocular pressure, retinal edema, retinal vascular disease, vitreous detachment / vitreal traction. On the part of the organ of hearing: infrequently - a sudden decrease or loss of hearing, ear pain, tinnitus, ringing in the ears. From the side of the cardiovascular system: often - "tides"; infrequently - palpitations, tachycardia, increased blood pressure, decreased blood pressure, increased heart rate, unstable angina, AV blockade, myocardial infarction, cerebral thrombosis, cardiac arrest, heart failure, abnormal ECG readings, cardiomyopathy; rarely - atrial fibrillation, ventricular arrhythmia *, sudden cardiac death. From the respiratory system: often - nasal congestion; infrequently - epistaxis, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum volume, increased cough; rarely - a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa. From the digestive system: often - nausea, dyspepsia; infrequently - gastroesophageal reflux disease, vomiting, pain in the abdomen, dryness of the oral mucosa, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding; rarely hypesthesia of the oral mucosa. From the skin and subcutaneous tissues: infrequently - skin rash, urticaria, herpes simplex, pruritus, increased sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis. From the musculoskeletal system: often - back pain; infrequently - myalgia, pain in the extremities, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis. From the urinary system: infrequently - cystitis, nocturia, urinary incontinence, hematuria. On the part of the genital organs and the mammary gland: infrequently - an increase in the mammary glands, impaired ejaculation, swelling of the genitals, anorgasmia, hematospermia, damage to the tissues of the penis; rarely - bleeding from the penis, priapism and / or prolonged erection. Others: infrequently - a feeling of heat, swelling of the face, photosensitivity reaction, shock, asthenia, fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rarely - irritability. * Side effects identified during post-marketing studies. Cardiovascular complications During the post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina pectoris, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack) have been reported. , hypertension and hypotension) that had a temporal association with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular events. Many of these adverse events were observed shortly after sexual activity, and some of them were noted after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct relationship between the observed adverse events and these or other factors. Visual disturbances In rare cases, during the post-registration use of all PDE5 inhibitors, incl. sildenafil, reported non-arteritic anterior ischemic optic neuropathy (NPINZN) - a rare disease and the cause of reduced or loss of vision. Most of these patients had risk factors, in particular, a reduced cup-to-optic disc diameter ratio ("congestive disc"), age over 50 years, diabetes mellitus, hypertension, CAD, hyperlipidemia, and smoking. An observational study assessed whether recent use of drugs of the PDE5 inhibitor class is associated with acute onset of NPINZN. The results indicate an approximately two-fold increase in the risk of NPINZN within 5 half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINZN is 2.5-11.8 cases per 100,000 men aged >50 years in the general population. Patients should be advised in the event of sudden loss of vision to discontinue sildenafil therapy and consult a physician immediately. Individuals who have already had a case of NPNDI have an increased risk of recurrent NINZN. Therefore, the physician should discuss this risk with these patients and also discuss with them the potential for adverse effects of PDE5 inhibitors. PDE5 inhibitors, incl. Sildenafil should be used with caution in such patients and only in situations where the expected benefit outweighs the risk. When using sildenafil in doses exceeding the recommended, adverse events were similar to those noted above, but usually more common. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Buy Maxigra tablets p/o 50mg №1×1 Price for Maxigra tablets p/o 50mg №1×1
INN | SILDENAFIL |
---|---|
The code | 81 655 |
Barcode | 5 903 060 017 573 |
Dosage | 50mg |
Active substance | Sildenafil |
Manufacturer | Pharm.z-d Polpharma SA, Poland |
Indications Applications | treatment of erectile dysfunction, characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse. Sildenafil is only effective with sexual stimulation. |
Contraindications | simultaneous use of nitric oxide donators or organic nitrates or nitrites in any form; co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulants such as riociguat; joint use with other means of treating erectile dysfunction; concomitant use of ritonavir; severe liver failure (Child-Pugh class C); severe cardiovascular disease (severe heart failure, unstable angina, stroke or myocardial infarction in the last 6 months, life-threatening arrhythmias, hypertension (BP> 170/100 mm Hg) or arterial hypotension (BP < 90/50 mm Hg)); patients with episodes of development of non-arteritic anterior ischemic optic neuropathy with loss of vision in one eye; hereditary retinitis pigmentosa; hypersensitivity to sildenafil or any of the components of the drug. For its registered indication, sildenafil is not intended for use in women and in children and adolescents under 18 years of age. With caution, the drug should be used for anatomical deformation of the penis (including with angulation, cavernous fibrosis or Peyronie's disease); diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia); diseases accompanied by bleeding; exacerbation of peptic ulcer of the stomach and duodenum; hereditary retinitis pigmentosa; heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, stroke, life-threatening arrhythmias, arterial hypertension (BP over 170/100 mm Hg) or hypotension (BP less than 90/50 mm Hg); in patients with episodes of development of anterior ischemic neuropathy of the optic nerve of non-inflammatory origin in history; with the simultaneous use of alpha-blockers. |
Side effects | The frequency of side effects is defined as follows: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1 / 10, 000, <1/1000), very rarely (<1/10, 000), the frequency is unknown (it was not possible to establish the frequency of occurrence according to the available data). From the immune system: rarely – hypersensitivity reactions (including skin rash), allergic reactions. From the hemopoietic system: infrequently – anemia, leukopenia. From the side of metabolism and nutrition: infrequently – a feeling of thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia. From the nervous system: very often – headache; often – dizziness; infrequently – drowsiness, migraine, ataxia, hypertonicity, neuralgia, neuropathy, paresthesia, tremor, vertigo, symptoms of depression, insomnia, unusual dreams, increased reflexes, hypoesthesia; rarely – cerebrovascular accident, transient ischemic attack, convulsions *, repeated convulsions *, fainting. On the part of the organ of vision: often – blurred vision, blurred vision, cyanopsia; infrequently – conjunctivitis, eye pain, photophobia, photopsia, chromatopsia, redness of the eyes / scleral injections, changes in the brightness of light perception, mydriasis, hemorrhage in the eye tissue, cataracts, disruption of the lacrimal apparatus; rarely – swelling of the eyelids and adjacent tissues, a feeling of dryness in the eyes, the presence of iridescent circles in the field of view around the light source, increased eye fatigue, seeing objects in yellow (xanthopsia), seeing objects in red (erythropsia), conjunctival hyperemia, irritation of the mucosa membranes of the eyes, discomfort in the eyes; frequency unknown – non-arteritic anterior ischemic optic neuropathy, retinal vein occlusion, visual field defects, diplopia *, temporary loss of vision or decreased visual acuity, increased intraocular pressure, retinal edema, retinal vascular disease, vitreous detachment / vitreal traction. On the part of the organ of hearing: infrequently – a sudden decrease or loss of hearing, ear pain, tinnitus, ringing in the ears. From the side of the cardiovascular system: often – "tides"; infrequently – palpitations, tachycardia, increased blood pressure, decreased blood pressure, increased heart rate, unstable angina, AV blockade, myocardial infarction, cerebral thrombosis, cardiac arrest, heart failure, abnormal ECG readings, cardiomyopathy; rarely – atrial fibrillation, ventricular arrhythmia *, sudden cardiac death. From the respiratory system: often – nasal congestion; infrequently – epistaxis, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum volume, increased cough; rarely – a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa. From the digestive system: often – nausea, dyspepsia; infrequently – gastroesophageal reflux disease, vomiting, pain in the abdomen, dryness of the oral mucosa, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding; rarely hypesthesia of the oral mucosa. From the skin and subcutaneous tissues: infrequently – skin rash, urticaria, herpes simplex, pruritus, increased sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis. From the musculoskeletal system: often – back pain; infrequently – myalgia, pain in the extremities, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis. From the urinary system: infrequently – cystitis, nocturia, urinary incontinence, hematuria. On the part of the genital organs and the mammary gland: infrequently – an increase in the mammary glands, impaired ejaculation, swelling of the genitals, anorgasmia, hematospermia, damage to the tissues of the penis; rarely – bleeding from the penis, priapism and / or prolonged erection. Others: infrequently – a feeling of heat, swelling of the face, photosensitivity reaction, shock, asthenia, fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rarely – irritability. * Side effects identified during post-marketing studies. Cardiovascular complications During the post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina pectoris, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack) have been reported., hypertension and hypotension) that had a temporal association with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular events. Many of these adverse events were observed shortly after sexual activity, and some of them were noted after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct relationship between the observed adverse events and these or other factors. Visual disturbances In rare cases, during the post-registration use of all PDE5 inhibitors, incl. sildenafil, reported non-arteritic anterior ischemic optic neuropathy (NPINZN) – a rare disease and the cause of reduced or loss of vision. Most of these patients had risk factors, in particular, a reduced cup-to-optic disc diameter ratio ("congestive disc"), age over 50 years, diabetes mellitus, hypertension, CAD, hyperlipidemia, and smoking. An observational study assessed whether recent use of drugs of the PDE5 inhibitor class is associated with acute onset of NPINZN. The results indicate an approximately two-fold increase in the risk of NPINZN within 5 half-lives after the use of a PDE5 inhibitor. According to published literature data, the annual incidence of NPINZN is 2.5-11.8 cases per 100, 000 men aged >50 years in the general population. Patients should be advised in the event of sudden loss of vision to discontinue sildenafil therapy and consult a physician immediately. Individuals who have already had a case of NPNDI have an increased risk of recurrent NINZN. Therefore, the physician should discuss this risk with these patients and also discuss with them the potential for adverse effects of PDE5 inhibitors. PDE5 inhibitors, incl. Sildenafil should be used with caution in such patients and only in situations where the expected benefit outweighs the risk. When using sildenafil in doses exceeding the recommended, adverse events were similar to those noted above, but usually occurred more often. |
Use during pregnancy and lactation | Forbidden to use |
Age category | 18+ |
Application Gender | Male |
Release Form | tablets |
Main Active Substances | sildenafil citrate |
Composition Means | sildenafil citrate 70.24 mg, which corresponds to the content of sildenafil 50 mg – 3 mg. Shell composition: hypromellose – 4.13 mg, macrogol 6000 – 1.3 mg, titanium dioxide – 0.9 mg, talc – 0.43 mg, indigo carmine (E132) – 0.24 mg. |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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