sildenafil | Vizarsin tablets 100 mg, 4 pcs.
Special Price
$27.16
Regular Price
$35.00
In stock
SKU
BID471046
Latin name
VIZARSIN
VIZARSIN
Latin name
VIZARSIN
Release form
Tablets.
Packaging
In the package 4 pcs.
Indications
Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.
Effective only with sexual stimulation.
Contraindications
Hypersensitivity to sildenafil or any other component of the
drug Concomitant use with NO donors (such as amyl nitrite) or nitrates in any form (given the known effect of sildenafil on NO / cGMP, sildenafil may enhance the hypotensive effect of Men sexual activity is not recommended (e.g. patients with severe cardiovascular diseases such as unstable angina or severe heart failure)
Patients with decreased nnym impaired due anterior ischemic optic neuropathy nearterialnogo genesis (NAION), regardless of whether the whether or not it is associated with the use of PDE-5 inhibitors
Severe liver dysfunction
Arterial hypotension (blood pressure less than 90/50 mmHg)
Recently suffered a stroke or myocardial infarction
Established congenital retinal degeneration (including retinitis pigmentosa) (retinitis pigmentosa)
Age under 18.
According to the registered indication, the drug Visarsin® is not intended for use in women.
Precautions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome CCC syndrome multiple systemic atrophy anatomical deformation of the penis priapism sickle cell anemia multiple myeloma leukemia concomitant use of alpha-blockers.
Use during pregnancy and lactation
According to the registered indication, the drug VizarsinВ® is not intended for use in women.
Composition
1 tab.
sildenafil citrate 35.12 mg,
? which corresponds to the content of sildenafil 25 mg
Excipients: microcrystalline cellulose (Avicel PH101) - 36.88 mg, calcium dihydrogen phosphate - 51 mg, Croscarmellose sodium - 6 mg, Hypromellose - microcellulose PH10 10 microcrystal cellulose 4.5 mg, ) - 15 mg, magnesium stearate - 1.5 mg.
Shell composition: Opadry II 31K58875 white - 5 mg (hypromellose - 28%, lactose monohydrate - 40%, titanium dioxide - 24%, triacetin - 8%).
Side effects
Classification of the incidence of side effects. WHO: very often - 1/10 often - from 1/100 to
From the immune system: rarely - hypersensitivity reactions.
From the nervous system: very often - headache often - dizziness infrequently - drowsiness, hypesthesia rarely - cerebrovascular events, fainting frequency unknown - transient ischemic attacks, convulsions.
On the part of the organs of vision: often - visual impairment, transient color perception disorders (chromatopsy) infrequently - conjunctival damage, impaired lacrimal formation frequency unknown - NAION, occlusion of the blood vessels of the fibers, narrowing of the visual fields.
On the part of the organ of hearing and the labyrinth: infrequently - dizziness, tinnitus rarely - deafness *.
From the CCC side: often - flushing of the face skin infrequently - palpitations, tachycardia rarely - arterial hypertension, arterial hypotension, myocardial infarction, atrial fibrillation frequency unknown - ventricular arrhythmia, unstable angina pectoris, sudden cardiac arrest.
From the respiratory system: often - nasal congestion rarely - nosebleeds.
From the digestive system: often - dyspepsia infrequently - vomiting, nausea, dry mouth.
From the skin: infrequently - a skin rash.
From the side of the musculoskeletal system: infrequently - myalgia.
From the reproductive system: frequency is unknown - priapism, prolonged erection.
General disorders and changes at the injection site: infrequently - chest pain, general weakness.
* Sudden hearing loss or loss was noted in a small number of cases during post-marketing use or during clinical trials of all PDE-5 inhibitors, including sildenafil.
Drug interaction
Effect of other drugs on the pharmacokinetics of sildenafil
In vitro studies. Sildenafil metabolism occurs mainly under the action of cytochrome P450 (CYP) 3A4 (main pathway) and 2C9 (additional pathway) isoenzymes, so inhibitors of these isoenzymes may decrease sildenafil clearance, and inducers increase sildenafil clearance accordingly.
In vivo studies. Co-administration of CYP3A4 isoenzyme inhibitors (such as ketoconazole, erythromycin, cimetidine) and sildenafil reduces its clearance.
Ritonavir increases sildenafil AUC 11-fold, co-administration of these drugs is not recommended.
When sildenafil (100 mg 1 time / day) and HIV protease inhibitor and CYP3A4 isoenzyme inhibitor saquinavir are administered concomitantly with a sustained blood saquinavir concentration (1200 mg 3 times daily), sildenafil Cmax is increased by 140% and AUC is increased by 140% - 210%. Sildenafil has no effect on the pharmacokinetics of saquinavir. More potent CYP3A4 isoenzyme inhibitors, such as ketoconazole and itraconazole, may presumably cause more pronounced changes in the pharmacokinetics of sildenafil.
Using 100 mg of sildenafil 1 time / day with erythromycin, specific inhibitor of CYP3A4, against the background of achieving a constant concentration of erythromycin in the blood (500 mg 2 times / day for 5 days) leads to an increase in AUC of sildenafil by 182%. In healthy male volunteers, azithromycin (500 mg / d for 3 days) did not affect AUC, Cmax, Tmax, excretion rate constant, and T1 / 2 of sildenafil or its major circulating metabolite. Cimetidine (800 mg), a nonspecific CYP3A4 inhibitor, when co-administered with sildenafil (50 mg) in healthy volunteers caused a 56% increase in plasma sildenafil concentration.
Grapefruit juice, a weak CYP3A4 inhibitor, can moderately increase plasma concentrations of sildenafil.
Single use of antacids (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil. srdk srpc While no special pharmacokinetic studies have been performed, the population pharmacokinetic analysis did not reveal any changes in the pharmacokinetics of sildenafil, such as tolbutide , loop and potassium-sparing diuretics, ACE inhibitors, BPCs, beta-blockers or isoenzyme inducersCYP450 (such as rifamp ycin, barbiturates).
Nicorandil is a hybrid of nitrate and potassium channel activator. Due to the presence of the nitrate component, it can enter into serious interactions with sildenafil.
Effect of sildenafil on other drugs
In vitro studies. Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IR50 150 μmol). When sildenafil is used at the recommended doses, its Cmax in the blood plasma is about 1 μmol, so it is unlikely that Vizarsin® can affect the clearance of substrates of these isoenzymes.
There are no data on the interaction of sildenafil with non-specific PDE inhibitors, such as theophylline or dipyridamole.
In vivo studies. Given the known effect of sildenafil on NO / cGMP, it may potentiate the hypotensive action of nitrates, so its concomitant use with NO donors or nitrates in any form is contraindicated.
The concomitant use of sildenafil and alpha-blockers may lead to symptomatic arterial hypotension in selected susceptible patients. Arterial hypotension usually develops 4 hours after taking sildenafil.
In three special studies on drug interactions in patients with benign prostatic hyperplasia with stable hemodynamics, sildenafil (25, 50 or 100 mg) was used concomitantly with doxazosin (4 and 8 mg). In all three studies, an average additional decrease in BP in the lying position by 7/7 mm Hg was observed. in., 9/5 mm Hg. Art. and 8/4 mm Hg. Art., and additional reduction in blood pressure in the standing position at 6/6 mm Hg. in., 11/4 mm Hg. Art. and 4/5 mm Hg. Art. respectively. With the concomitant use of sildenafil and doxazosin in patients with stable hemodynamics, rare cases of symptomatic postural hypotension have been observed on the background of doxazosin administration. In these described cases, dizziness or a feeling of lightness developed, but without the development of fainting states.
No significant interactions were observed with sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg) co-metabolized with CYP2C9.
Sildenafil (50 mg) does not potentiate the increase in bleeding time caused by acetylsalicylic acid (150 mg).
Sildenafil (50 mg) does not potentiate the antihypertensive effect of alcohol in healthy volunteers with a maximum blood alcohol content of 80 mg / dL.
Summary of available data on the following drugs: diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, vasodilators and antihypertensive agents of central action, blockers of adrenergic neurons, BKKi alpha-blockers found no difference in adverse reaction profile in patients taking sildenafil or placebo at the same time. In a specially conducted study, sildenafil (100 mg) was used concomitantly with amlodipine in patients with hypertension and further reduced SAD in the supine position by an average of 8 mm Hg. and DBP - by 7 mm Hg. Art. This additional reduction in blood pressure turned out to be the same as when using only sildenafil in healthy volunteers.
Overdose
Symptoms: headache, blood tides to skin, dizziness, dyspepsia, nasal congestion, visual impairment.
Treatment: symptomatic. Hemodialysis is not effective.
Storage conditions
At a temperature not exceeding 30 РC, in the original packaging.
Keep out of the reach of children.
Expiration
5 years.
Active substances
sildenafil
Pharmacy
Pharmacy Prescription
dosage form
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
VIZARSIN
Release form
Tablets.
Packaging
In the package 4 pcs.
Indications
Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.
Effective only with sexual stimulation.
Contraindications
Hypersensitivity to sildenafil or any other component of the
drug Concomitant use with NO donors (such as amyl nitrite) or nitrates in any form (given the known effect of sildenafil on NO / cGMP, sildenafil may enhance the hypotensive effect of Men sexual activity is not recommended (e.g. patients with severe cardiovascular diseases such as unstable angina or severe heart failure)
Patients with decreased nnym impaired due anterior ischemic optic neuropathy nearterialnogo genesis (NAION), regardless of whether the whether or not it is associated with the use of PDE-5 inhibitors
Severe liver dysfunction
Arterial hypotension (blood pressure less than 90/50 mmHg)
Recently suffered a stroke or myocardial infarction
Established congenital retinal degeneration (including retinitis pigmentosa) (retinitis pigmentosa)
Age under 18.
According to the registered indication, the drug Visarsin® is not intended for use in women.
Precautions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome CCC syndrome multiple systemic atrophy anatomical deformation of the penis priapism sickle cell anemia multiple myeloma leukemia concomitant use of alpha-blockers.
Use during pregnancy and lactation
According to the registered indication, the drug VizarsinВ® is not intended for use in women.
Composition
1 tab.
sildenafil citrate 35.12 mg,
? which corresponds to the content of sildenafil 25 mg
Excipients: microcrystalline cellulose (Avicel PH101) - 36.88 mg, calcium dihydrogen phosphate - 51 mg, Croscarmellose sodium - 6 mg, Hypromellose - microcellulose PH10 10 microcrystal cellulose 4.5 mg, ) - 15 mg, magnesium stearate - 1.5 mg.
Shell composition: Opadry II 31K58875 white - 5 mg (hypromellose - 28%, lactose monohydrate - 40%, titanium dioxide - 24%, triacetin - 8%).
Side effects
Classification of the incidence of side effects. WHO: very often - 1/10 often - from 1/100 to
From the immune system: rarely - hypersensitivity reactions.
From the nervous system: very often - headache often - dizziness infrequently - drowsiness, hypesthesia rarely - cerebrovascular events, fainting frequency unknown - transient ischemic attacks, convulsions.
On the part of the organs of vision: often - visual impairment, transient color perception disorders (chromatopsy) infrequently - conjunctival damage, impaired lacrimal formation frequency unknown - NAION, occlusion of the blood vessels of the fibers, narrowing of the visual fields.
On the part of the organ of hearing and the labyrinth: infrequently - dizziness, tinnitus rarely - deafness *.
From the CCC side: often - flushing of the face skin infrequently - palpitations, tachycardia rarely - arterial hypertension, arterial hypotension, myocardial infarction, atrial fibrillation frequency unknown - ventricular arrhythmia, unstable angina pectoris, sudden cardiac arrest.
From the respiratory system: often - nasal congestion rarely - nosebleeds.
From the digestive system: often - dyspepsia infrequently - vomiting, nausea, dry mouth.
From the skin: infrequently - a skin rash.
From the side of the musculoskeletal system: infrequently - myalgia.
From the reproductive system: frequency is unknown - priapism, prolonged erection.
General disorders and changes at the injection site: infrequently - chest pain, general weakness.
* Sudden hearing loss or loss was noted in a small number of cases during post-marketing use or during clinical trials of all PDE-5 inhibitors, including sildenafil.
Drug interaction
Effect of other drugs on the pharmacokinetics of sildenafil
In vitro studies. Sildenafil metabolism occurs mainly under the action of cytochrome P450 (CYP) 3A4 (main pathway) and 2C9 (additional pathway) isoenzymes, so inhibitors of these isoenzymes may decrease sildenafil clearance, and inducers increase sildenafil clearance accordingly.
In vivo studies. Co-administration of CYP3A4 isoenzyme inhibitors (such as ketoconazole, erythromycin, cimetidine) and sildenafil reduces its clearance.
Ritonavir increases sildenafil AUC 11-fold, co-administration of these drugs is not recommended.
When sildenafil (100 mg 1 time / day) and HIV protease inhibitor and CYP3A4 isoenzyme inhibitor saquinavir are administered concomitantly with a sustained blood saquinavir concentration (1200 mg 3 times daily), sildenafil Cmax is increased by 140% and AUC is increased by 140% - 210%. Sildenafil has no effect on the pharmacokinetics of saquinavir. More potent CYP3A4 isoenzyme inhibitors, such as ketoconazole and itraconazole, may presumably cause more pronounced changes in the pharmacokinetics of sildenafil.
Using 100 mg of sildenafil 1 time / day with erythromycin, specific inhibitor of CYP3A4, against the background of achieving a constant concentration of erythromycin in the blood (500 mg 2 times / day for 5 days) leads to an increase in AUC of sildenafil by 182%. In healthy male volunteers, azithromycin (500 mg / d for 3 days) did not affect AUC, Cmax, Tmax, excretion rate constant, and T1 / 2 of sildenafil or its major circulating metabolite. Cimetidine (800 mg), a nonspecific CYP3A4 inhibitor, when co-administered with sildenafil (50 mg) in healthy volunteers caused a 56% increase in plasma sildenafil concentration.
Grapefruit juice, a weak CYP3A4 inhibitor, can moderately increase plasma concentrations of sildenafil.
Single use of antacids (magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability of sildenafil. srdk srpc While no special pharmacokinetic studies have been performed, the population pharmacokinetic analysis did not reveal any changes in the pharmacokinetics of sildenafil, such as tolbutide , loop and potassium-sparing diuretics, ACE inhibitors, BPCs, beta-blockers or isoenzyme inducersCYP450 (such as rifamp ycin, barbiturates).
Nicorandil is a hybrid of nitrate and potassium channel activator. Due to the presence of the nitrate component, it can enter into serious interactions with sildenafil.
Effect of sildenafil on other drugs
In vitro studies. Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IR50 150 μmol). When sildenafil is used at the recommended doses, its Cmax in the blood plasma is about 1 μmol, so it is unlikely that Vizarsin® can affect the clearance of substrates of these isoenzymes.
There are no data on the interaction of sildenafil with non-specific PDE inhibitors, such as theophylline or dipyridamole.
In vivo studies. Given the known effect of sildenafil on NO / cGMP, it may potentiate the hypotensive action of nitrates, so its concomitant use with NO donors or nitrates in any form is contraindicated.
The concomitant use of sildenafil and alpha-blockers may lead to symptomatic arterial hypotension in selected susceptible patients. Arterial hypotension usually develops 4 hours after taking sildenafil.
In three special studies on drug interactions in patients with benign prostatic hyperplasia with stable hemodynamics, sildenafil (25, 50 or 100 mg) was used concomitantly with doxazosin (4 and 8 mg). In all three studies, an average additional decrease in BP in the lying position by 7/7 mm Hg was observed. in., 9/5 mm Hg. Art. and 8/4 mm Hg. Art., and additional reduction in blood pressure in the standing position at 6/6 mm Hg. in., 11/4 mm Hg. Art. and 4/5 mm Hg. Art. respectively. With the concomitant use of sildenafil and doxazosin in patients with stable hemodynamics, rare cases of symptomatic postural hypotension have been observed on the background of doxazosin administration. In these described cases, dizziness or a feeling of lightness developed, but without the development of fainting states.
No significant interactions were observed with sildenafil (50 mg) and tolbutamide (250 mg) or warfarin (40 mg) co-metabolized with CYP2C9.
Sildenafil (50 mg) does not potentiate the increase in bleeding time caused by acetylsalicylic acid (150 mg).
Sildenafil (50 mg) does not potentiate the antihypertensive effect of alcohol in healthy volunteers with a maximum blood alcohol content of 80 mg / dL.
Summary of available data on the following drugs: diuretics, beta-blockers, ACE inhibitors, angiotensin receptor blockers, vasodilators and antihypertensive agents of central action, blockers of adrenergic neurons, BKKi alpha-blockers found no difference in adverse reaction profile in patients taking sildenafil or placebo at the same time. In a specially conducted study, sildenafil (100 mg) was used concomitantly with amlodipine in patients with hypertension and further reduced SAD in the supine position by an average of 8 mm Hg. and DBP - by 7 mm Hg. Art. This additional reduction in blood pressure turned out to be the same as when using only sildenafil in healthy volunteers.
Overdose
Symptoms: headache, blood tides to skin, dizziness, dyspepsia, nasal congestion, visual impairment.
Treatment: symptomatic. Hemodialysis is not effective.
Storage conditions
At a temperature not exceeding 30 РC, in the original packaging.
Keep out of the reach of children.
Expiration
5 years.
Active substances
sildenafil
Pharmacy
Pharmacy Prescription
dosage form
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
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