Product Name: Staxyn
Common Brand Names: Levitra Orodispersable
Pharmaceutical Category: Men's Health
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There is an additional general information about this medication active ingredient vardenafil:
Staxyn is a medication for the treatment of erectile dysfunction, an inhibitor of PDE5.
Penile erection is a hemodynamic process, based on the relaxation of smooth muscles of cavernous bodies and located in its arterioles. During sexual stimulation of the nerve endings of cavernous bodies released nitric oxide (NO), activates the enzyme guanylate cyclase, which leads to higher content in the cavernous bodies of cyclic guanosine monophosphate (cGMP). The result is relaxation of smooth muscles of cavernous bodies, which increases blood flow to the penis.
Vardenafil blocks PDE5, which is under the influence of the splitting of cGMP, as a result of the action of endogenous NO in the cavernous bodies during sexual stimulation is enhanced, resulting in the ability of vardenafil to strengthen the natural response to sexual stimulation.
The clinical effect is realized before reaching Cmax. After taking oral doses of 20 mg and 10 mg onset of action is after 10 minutes, which allows an erection sufficient for penetration and successful intercourse in 34% and 40% of patients with mild to moderate erectile dysfunction, respectively. After 25 min the effect occurs in 53% and 50% of patients respectively, which coincides with the beginning of the emergence of the active substance in the blood and the rapid increase of its concentration. The duration of effect is 8-12 hours.
After oral administration Staxyn is rapidly absorbed from the gastrointestinal tract. Cmax is achieved, usually after an average of 60 minutes (from 30 to 120 min). The absolute bioavailability of approximately 15%. When receiving vardenafil at the same time with a diet containing large amounts of fat, the absorption rate decreases: time to Cmax in plasma (Tmax) is increased to 60 min, Cmax on average reduced by 20% without significant change in AUC. When taking a normal diet containing no more than 30% fat, vardenafil pharmacokinetic parameters (Cmax, Tmax, AUC) are not changed.
Vardenafil and its major metabolite are highly bound to plasma proteins (95%), and this property is reversible and not dependent on the total concentration of the drug.
After 90 min of this medicine administration in semen inside of healthy men found no more than 0.00012% of the administered dose.
Staxyn is metabolized primarily in the liver, with the participation of isozymes CYP3A4, and CYP3A5 and CYP2C9.
The average T1/2 of vardenafil is 4-5 hours, and the main metabolite is about 4 hours.
The total clearance of vardenafil is 56 L / h, the final T1/2 is about 4-5 hours. After oral administration of vardenafil in the form of metabolites are excreted primarily through the intestine (91-95% of dose), to a lesser extent by the kidneys (2-6% dose).
In patients with mild (creatinine clearance 80-50 ml / min), moderate (creatinine clearance 50-30 ml / min) and severe (creatinine clearance < 30 ml / min) impaired renal function the pharmacokinetic parameters of vardenafil were comparable to those in healthy subjects. There was no significant correlation between QA and the concentration of vardenafil in the plasma (AUC and Cmax).
In patients with mild and moderate hepatic impairment decreases clearance of vardenafil is proportional to the degree of liver dysfunction.
Compared with healthy men, in patients with mild hepatic impairment, may be increase in AUC and Cmax on 20%, and with moderate hepatic dysfunction in 2.6 times.
Why is Staxyn prescribed?
Erectile dysfunction (inability to achieve and maintain an erection necessary for sexual intercourse).
Dosage and administration
At the beginning of treatment recommended dose is 10 mg. Staxyn is taken orally if necessary for about 25-60 minutes before sexual intercourse. Along with this you can take vardenfil at any time during the period from 4-5 hours to 25 minutes before sexual activity. The maximum recommended frequency of administration is 1 time / day.
Vardenafil can be taken irrespective of ingestion. To be effective of treatment a sufficient level of sexual stimulation is required.
Depending on the efficacy and tolerability of treatment the dose can be increased to 20 mg or decreased to 5 mg / day.
The maximum recommended dose is 20 mg 1 time / day.
In elderly patients the dosage changes is not required.
In patients with moderate hepatic impairment there is a decrease of clearance of vardenafil, so the initial dose is 5 mg / day. In the future, depending on the efficacy and tolerability the dose may be increased to 10 mg and then to 20 mg.
Staxyn side effects, adverse reactions
CNS and peripheral nervous system: headache, dizziness; rarely - increased muscle tone.
Cardiovascular system: facial flushing; rarely - increased blood pressure, lower blood pressure.
Digestive system: dyspepsia, nausea.
Respiratory system: nasal congestion.
Dermatological reactions: rarely - photosensitivity.
Reproductive system: rarely - priapism.
Simultaneous treatment with nitrates or drugs, which are nitric oxide donators, childhood and adolescence to 16 years; hypersensitivity to vardenafil.
With caution use Staxyn in patients with anatomical deformation of the penis (curved, cavernous fibrosis or Peyronie's disease), as well as in patients with diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, or leukemia).
Safety of vardenafil has not been studied and the drug is not recommended in patients with severe hepatic impairment; kidney disease in the terminal stage, requiring dialysis, with hypotension (systolic blood pressure at rest less than 90 mm Hg); recent stroke or myocardial infarction (within the last 6 months); unstable stenocardia; with hereditary degenerative retinal diseases (such as retinitis pigmentosa).
Since vardenafil is not used in patients with a propensity for bleeding in patients with exacerbation of peptic ulcer disease, use of the drug in these cases is possible only after careful assessment of the risks and benefits of therapy.
In studies in humans, while the use of vardenafil as monotherapy were not observed changes in bleeding time. Due to the fact that sexual activity is associated with some degree of cardiac risk before prescribing vardenafil on erectile dysfunction is necessary to evaluate the cardiovascular system of the patient.
Staxyn is not suitable for use in children.
Before use in patients whose activities are related to driving and work with the mechanisms necessary to determine their individual response to this drug.
Staxyn drug interactions
When this drug applied simultaneously with:
- CYP3A4 inhibitor erythromycin it did not exceed the recommended maximum dose of vardenafil 10 mg / day.
- alpha-blockers it may been developed symptomatic hypotension. Therefore, vardenafil in dosing 5 mg, 10 mg and 20 mg should be administered no earlier than 6 hours after taking alpha-blocker.
- with the simultaneous introduction of heparin and vardenafil to rats the bleeding time did not change. The influence of this combination on bleeding time in humans has not been studied.
Since the PDE inhibitors affect nitric oxide system / cGMP, PDE5 inhibitors may increase the hypotensive effects of nitrates.
In studies on human platelets in vitro showed that vardenafil monotherapy does not inhibit platelet aggregation induced by various platelet agonists.
In the use of vardenafil at doses exceeding therapeutic, there was a slight dose-dependent increase antiagregatsionnogo effect of sodium nitroprusside - a drug that is a donor of nitric oxide.
Because the safety and efficacy of Staxyn in combinations with other drugs to treat erectile dysfunction has not been studied, the use of such combinations is not recommended.
Vardenafil is metabolized primarily in the liver, with the participation of isoenzyme CYP3A4, and also with the participation of some isozymes CYP3A5 and CYP2C9. As potent inhibitors of these isoenzymes (cimetidine, ketoconazole, itraconazole, indinavir, ritonavir) may decrease the clearance of vardenafil, while the use of these drugs should not exceed a maximum dose of vardenafil 5 mg / day.
Staxyn in case of emergency / overdose
Symptoms: studies in 8 healthy volunteers for at once daily to 120 mg in the majority of them there were observed reversible back pain / myalgia and / or blurred vision.
Treatment: maintenance therapy. It is not expected that dialysis will be effective due to increased clearance, as vardenafil is characterized by a high degree of binding to plasma proteins and does not appear in significant quantities in the urine.