What Factors Affect Vardenafil Dosage?

Vardenafil hydrochloride tablets, the indication is to treat male penile erectile dysfunction.

Vardenafil hydrochloride tablets, the indication is to treat male penile erectile dysfunction.

Drug Name

Vardenafil hydrochloride tablets

Drug type

prescription

Use classification

Erectile dysfunction medication

Vardenafil Hydrochloride Tablets Ingredients

The main ingredient of this product is vardenafil hydrochloride.
Its chemical name: 2- [2-ethoxy-5- (4-ethyl-piperazine-1-sulfonyl) -phenyl] -5-methyl-7-propyl-3H-imidazole [5 The structural formula of 1,1-f]-[1,2,4] triazine-4-one monohydrochloride is:

Molecular formula: C ₂₃ H ₃₂ N ₆ O ₄ S · HCl · 3H ₂ O
Molecular weight: 579.1

Vardenafil Tablet Properties

This product is a light orange to dark orange film-coated tablet, which appears white after removing the film coating.

Vardenafil hydrochloride indications

Treatment of erectile dysfunction in men.

Vardenafil Hydrochloride Tablets Specifications

5mg, 10mg, 20mg

Vardenafil hydrochloride tablets dosage

Usage: Oral <br brRecommended dosage:
The recommended starting dose is 10 mg, taken approximately 25-60 minutes before intercourse. In clinical trials, it was taken 4-5 hours before intercourse and still showed efficacy. The maximum recommended dosage is once a day. Vardenafil can be taken with or without food. Sexual stimulation is needed as an instinctive response for treatment.
Dosage range:
Depending on the efficacy and tolerance, the dose can be increased to 20 mg or reduced to 5 mg. The maximum recommended dose is 20 mg daily.
Liver damage:
Patients with mild liver damage (Child-Pugh A) do not need to adjust the dose; patients with moderate liver damage (Child-Pugh B), due to reduced clearance of vardenafil, the recommended starting dose is 5mg, and then based on tolerance The pharmacokinetics of vardenafil in patients with severe liver damage (Child-Pugh C) have not yet been studied.
Renal damage:
Patients with mild, moderate, or severe renal impairment do not require dose adjustment. Vardenafil pharmacokinetic studies in dialysis patients have not been performed.
Combination therapy:
Some patients taking vardenafil and alpha-blockers together may cause symptomatic hypotension. Concomitant medication should only be used when the patient is stable with alpha-blockers. For patients receiving stable treatment with alpha-blockers, the minimum recommended starting dose of vardenafil is 5 mg, and tamsulosin can be taken at any time. When vardenafil is combined with other alpha-blockers, there should be a certain interval between medications. For patients who have already taken the optimal dose of vardenafil, the use of alpha-blockers should start with the lowest dose. For patients taking PDF5 inhibitors (including vardenafil), increased alpha-blocker doses may cause patients to have a further drop in blood pressure.
Patients taking certain CYP3A4 inhibitors may need to adjust the dose of vardenafil (eg, ketoconazole, itraconazole, ritonavir, indinavir, and erythromycin).
When erythromycin is used concurrently, the maximum dose of vardenafil does not exceed 5 mg. When taking ketoconazole and itraconazole, the maximum dose of vardenafil should not exceed 5 mg. When the doses of ketoconazole and itraconazole exceed 200 mg, vardenafil cannot be taken. Avoid taking indinavir and ritonavir, both potent CYP3A4 inhibitors at the same time.

Adverse reactions of vardenafil hydrochloride tablets

In global clinical trials (as of March 2004), more than 9,500 patients have taken vardenafil and are well tolerated. Adverse events that occur are usually transient, mild to moderate.
Placebo-controlled clinical trials:
When taking vardenafil at the recommended dose, the following adverse reactions have been reported in placebo-controlled clinical trials (as of March 2004):

Global clinical trials:
Global clinical trials have reported the following adverse reactions in patients taking vardenafil (as of March 2004). Includes critical terms specified by WHO (which may be related to serious diseases and should be given special attention) or other clinically relevant adverse reactions:

Myocardial infarction (MI) has been reported when taking vardenafil for sexual activity after marketing, but myocardial infarction and vardenafil, or sexual activity, or potential cardiovascular disease in patients, or The comprehensive effect of factors is directly related.
After PDE5 inhibitors were marketed (including Elida), very few patients have reported nonarteritic anterior ischemic optic neuropathy (NAION). NAION is a disease that can cause vision loss or even permanent blindness. Most, but not all, of these patients have anatomical or vascular risk factors that are prone to NAION, including: small cup-to-disk ratio (papillary papilla), age over 50 years, diabetes, hypertension, coronary heart disease, hyperlipidemia , Smoking. Whether the above events are related to the use of PDE5 inhibitors or the patient's potential vascular risk factors or anatomical defects, or a combination of these factors, or other factors are not directly determined.
After the market for PDE5 inhibitors (including Elidad), very few patients have reported visual impairment, including blindness (temporary or permanent). Whether these events are related to the use of PDE5 inhibitors, the patient's potential vascular risk factors or anatomical defects, or a combination of these factors, or whether they are directly related to other factors, has not been determined.
After marketing of PDE5 inhibitors (including Elida) and in clinical trials, it has been reported that a small number of patients can cause sudden deafness or hearing loss. Whether these events are related to the use of Elida, the patient's potential risk factors for hearing loss, or a combination of these factors, or whether they are directly related to other factors, has not been determined.

Vardenafil hydrochloride taboo

1. Patients with allergic symptoms to any ingredient (active or inactive ingredient) of the drug are contraindicated.
2. In the same way that PDE inhibits the NO / cGMP pathway, PDE5 inhibitors may enhance the antihypertensive effect of nitrate drugs. Therefore, patients taking nitrate or nitric oxide donor treatment should avoid concurrent use of vardenafil.
3. Avoid HIV protein kinase inhibitors indinavir or ritonavir and vardenafil at the same time because they are potent CYP3A4 inhibitors.

Precautions for vardenafil hydrochloride tablets

Because sexual activity is associated with a certain degree of cardiac risk, physicians should first consider their heart condition before taking any treatment for erectile dysfunction. The vasodilator properties of vardenafil may cause a temporary, mild reduction in blood pressure. Patients with left ventricular outflow disorders such as aortic stenosis and idiopathic hypertrophic subaortic stenosis may be sensitive to vasodilator drugs, including PDE5 inhibitors. Because of the potential cardiac risk, intercourse is not recommended for patients with heart disease, so medications for erectile dysfunction are generally not available.
A study of the effects of vardenafil on QT intervals in 59 healthy male subjects showed that therapeutic doses (10 mg) and overdose (80 mg) of vardenafil resulted in prolonged QTc intervals. A post-marketing study showed that when vardenafil is combined with another drug that affects the QT interval, it has a cumulative effect on the QT interval compared with the use of each drug alone. Therefore, for patients with a history of prolonged QT interval or taking QT interval prolonged drugs, this must be taken into account in the clinical application of vardenafil. Patients with congenital prolonged QT interval (long QT syndrome) and taking antiarrhythmic drugs in class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) Taking vardenafil.
For patients with anatomical deformities of the penis (eg, angulation, cavernous fibrosis, Peyronie's disease), or patients with penile erections that cannot be resolved (eg, sickle cell disease, multiple myeloma, and leukemia), treatment of their erectile dysfunction needs Use with caution.
When combined with other erectile dysfunction treatments, the safety and efficacy of vardenafil have not been studied, so it is not recommended.
The safety of vardenafil has not been studied in patients with the following conditions: vardenafil is recommended unless further information is available: severe liver disease, advanced renal disease requiring dialysis, hypotension (resting systolic blood pressure [90 mmHg), Recently suffered a stroke or myocardial infarction (within 6 months), unstable angina, and a family of degenerative eye diseases such as retinitis pigmentosa.
Transient blindness and non-arteritic anterior ischemic optic neuropathy have been reported to be associated with the use of Elida and other PDE5 inhibitors. Patients should be advised to stop taking Eleda in the event of sudden blindness and seek medical attention immediately.
Vardenafil is not used in patients with abnormal bleeding or active peptic ulcers, so it should only be used after a careful benefit-risk assessment.
Vardenafil has no effect on bleeding time when used alone or in combination with aspirin.
Human platelet in vitro tests have shown that vardenafil alone does not inhibit platelet aggregation induced by multiple platelet factors. During overdose treatment, vardenafil was observed to slightly enhance the anticoagulant effect of sodium nitroprusside and nitric oxide donors in a concentration-dependent manner. Vardenafil combined with heparin had no effect on bleeding time in rats, but its interaction has not been studied in humans.
Ability to drive and operate machinery:
Patients should consider their own response to vardenafil before driving and operating machinery.

Vardenafil hydrochloride tablets for pregnant and lactating women

Not applicable

Vardenafil hydrochloride tablets for children

Children (born to 16 years): Vardenafil is not suitable for children.

Vardenafil hydrochloride tablets for elderly

Elderly patients (65 years of age) have reduced clearance of vardenafil with a starting dose of 5 mg considered.

Vardenafil hydrochloride drug interactions

CYP inhibitor:
Vardenafil is mainly metabolized by the liver enzyme system via the cytochrome P450 (CYP) isoenzyme 3A4, and CYP3A5 and CYP2C isoenzymes play a certain role in their metabolism. Therefore, inhibitors of these enzymes can reduce the clearance of vardenafil.
Cimetidine: The combination of vardenafil (20 mg) and the non-specific cytochrome P450 inhibitor cimetidine (400 mg, twice daily) in healthy volunteers does not affect the AUC of vardenafil And Cmax.
Erythromycin: In healthy volunteers, the combined use of vardenafil (5mg) and the CYP3A4 inhibitor erythromycin (500 mg three times a day) can increase the AUC and Cmax of vardenafil by 300% and 200, respectively. %.
Ketoconazole: In healthy volunteers, the combined use of vardenafil (5 mg) and the strong CYP3A4 inhibitor ketoconazole (200 mg) increased AUC and Cmax of vardenafil by 900% and 300%, respectively.
Indinavir: The combination of vardenafil (10 mg) and the HIV protease inhibitor indinavir (800 mg three times a day) resulted in a 1500% increase in vardenafil AUC and a 600% increase in Cmax. After 24 hours of combined administration, the plasma concentration of vardenafil is approximately 4% of its maximum plasma concentration (Cmax).
Ritonavir: (600 mg, twice a day) and vardenafil 5mg used simultaneously, resulting in a 13-fold increase in vardenafil Cmax and a 49-fold increase in AUC _0-24 . The strong CYP3A4 inhibitor ritonavir (also inhibits the CYP2C9 enzyme) can block hepatic metabolism of vardenafil, and ritonavir significantly prolongs the half-life of vardenafil to 25.7 hours.
Concomitant use of the P450 (CYP) 3A4 inhibitors ketoconazole, itraconazole, indinavir, and ritonavir significantly increased plasma levels of vardenafil. When erythromycin is used concurrently, the maximum dose of vardenafil does not exceed 5 mg.
When taking ketoconazole and itraconazole, the maximum dose of vardenafil should not exceed 5 mg. When ketoconazole and itraconazole exceed 200 mg, vardenafil cannot be taken. Avoid taking indinavir and ritonavir, both potent CYP3A4 inhibitors at the same time.
Nitrate, nitric oxide donor:
A study of 18 healthy subjects showed that vardenafil (10 mg) was not found potent when administered sublingually before taking nitroglycerin (0.4 mg) for a certain period of time (24 to 1 hour) Blood pressure lowering effect.
One to four hours after taking vardenafil in healthy middle-aged subjects, the hypotensive effect of nitroglycerin (0.4 mg) sublingually increased. This effect was not observed with vardenafil 20 mg 24 hours before taking nitroglycerin.
At present, there is no data to confirm that the combined use of vardenafil and nitrates has a potential hypotensive effect, and the combined use should be avoided.
other:
When vardenafil (20 mg) is used in combination with glibenclamide (3.5 mg), it does not affect the relative bioavailability of glibenclamide (it does not affect the AUC and Cmax of glibenclamide). There is no data showing that the combined application of glibenclamide affects the pharmacokinetics of vardenafil.
When vardenafil (20 mg) was used in combination with warfarin (25 mg), no interactions between pharmacokinetics and pharmacodynamics (prothrombin time and factor II, VII, and X) were found. The combined use of warfarin did not affect the pharmacokinetics of vardenafil.
When vardenafil (20 mg) was used in combination with nifedipine (30 or 60 mg), no related pharmacokinetic interactions and no pharmacodynamic interactions were found (compared with placebo, Vardenafil caused additional reductions in blood pressure, with an average reduction in supine systolic and diastolic blood pressure of 5.9 mmHg and 5.2 mm Hg, respectively).
Alpha-blockers:
Because alpha-blockers can significantly reduce blood pressure, which can cause orthostatic hypotension and syncope, the interaction of alpha-blockers and vardenafil has been investigated. Volunteers with normal blood pressure who take terazosin 10 mg or tamsulosin 0.4 mg and vardenafil 10 mg and 20 mg daily for a short period of time. Both drugs reach Cmax at the same time, which can cause orthostatic systolic blood pressure in some cases. [85mmHg, or decrease 30mmHg with orthostatic hypotension. This occurs less frequently when Cmax is 6 hours apart, especially when taken with tamsulosin. When combined with vardenafil and tamsulosin, orthostatic systolic and diastolic blood pressures decreased by 8 mmHg and 7 mmHg, respectively (regardless of the length of the medication interval). Further studies were performed on patients receiving benign prostatic hyperplasia (BPH) who received long-term treatment with alpha-blockers (tanlocin 0.4 mg or terazosin 5 mg, 10 mg) taking vardenafil 5 mg, orthostatic systolic blood pressure and diastole. The average pressure was reduced by 6 mmHg and 3 mmHg (regardless of the length of the medication interval or the type of -blocker). Three patients had combined tamsulosin and vardenafil and had at least one transient orthostatic systolic blood pressure [85 mmHg, but no symptoms of hypotension; patients receiving terazosin were taking vardenafil 5mg at the same time, Five patients had an orthostatic systolic blood pressure drop of 30 mmHg (2 patients in the placebo group), and one had an orthostatic systolic blood pressure of 85 mmHg with dizziness. However, vardenafil 5mg and terazosin are not taken when taken 6 hours apart.
When local glycoxin (0.375 mg) reached steady state, vardenafil (20 mg) was used in combination, once every other day, and continued to be used for more than 14 days. No relevant pharmacokinetic interactions were found.
A single dose of Maalox (antacid, magnesium hydroxide / aluminum hydroxide) does not affect the bioavailability (AUC) or maximum blood concentration (Cmax) of vardenafil.
The combined use of the H2-receptor antagonist ranitidine (150 mg twice daily) and cimetidine (400 mg twice daily) did not affect the bioavailability of vardenafil (20 mg).
When used alone or in combination with low-dose aspirin (2 x 81 mg tablets), vardenafil (10 mg and 20 mg) did not affect bleeding time.
Vardenafil does not enhance the antihypertensive effect of alcohol (0.5 g / kg by weight). Its pharmacokinetics have not changed.
Pharmacokinetic data from phase III clinical trials show that aspirin, ACE-inhibitors, -receptor blockers, weak CYP 3A4-inhibitors, diuretics, and therapeutic drugs for diabetes (sulfonylureas and metformin) There was no significant effect on the pharmacokinetics of vardenafil.
Food and daily diet:
When vardenafil was taken simultaneously with a high-fat diet (57% fat content), the absorption rate of vardenafil decreased, Tmax was prolonged for 60 minutes, and Cmax decreased by an average of 20%, but AUC was not affected. When vardenafil is ingested with the normal diet (30% fat content), its pharmacokinetic parameters (Cmax, Tmax, and AUC) are not affected. Therefore, vardenafil can be taken with or without food.

Vardenafil hydrochloride overdose

In single-dose subject studies, the highest test dose reached 80 mg per day. The highest test dose (80 mg daily) was well tolerated without any serious adverse drug reactions. The same result was confirmed in another clinical trial using 40 mg vardenafil (once a day) for 4 weeks of continuous medication.
When vardenafil was taken at a dose of 40 mg twice daily, several more severe back pains were observed, but no muscular or neurotoxic effects were confirmed.
When overdose, general symptomatic treatment should be given as needed. Since vardenafil has a high binding rate to plasma proteins and is not primarily cleared by urine, renal dialysis does not increase its clearance in vivo.

Vardenafil hydrochloride clinical trials

A placebo-controlled, double-blind, adjustable-dose clinical trial in patients with spinal cord injury shows that vardenafil has significant clinical value and statistics for improving erectile function in patients with erectile dysfunction caused by traumatic spinal cord injury. significance. Compared with the placebo group, vardenafil significantly improved erectile function scores, successful erections, successful intercourse rates, and cervical stiffness. 53% of patients in the vardenafil group returned to normal IIEF scores (26) compared to 9% in the placebo group. After three months of treatment, patients who took vardenafil had successful erection rates and successful intercourse rates of 76% and 59%, respectively, compared with 41% and 22% in the placebo group, with clinically and statistically significant differences (p <0.001). In this group of people who did not respond well to conventional treatment, after completing three months of treatment, the efficiency of erectile function improvement based on GAQ in patients taking vardenafil was 83%, compared to 26% in the placebo group.
QT interval extension An independent post-marketing study of 44 healthy volunteers showed that when a single dose of vardenafil 10 mg or a single dose of sildenafil 50 mg was used in combination with gatifloxacin 400 mg that extended the QT interval Compared with monotherapy, QTc interval (Fridericia method) prolonged cumulative effect in both vardenafil and sildenafil (Vardenafil: 4 ms, Sildenafil: 5 ms). The clinical impact of QT changes is unclear (see [Cautions]).
Impact on vision In another double-blind, placebo-controlled clinical trial, subjects took at least 15 20 mg vardenafil or placebo for more than 8 weeks, and were checked with ERG and FM-100 after dosing 2 Retina function at 6 and 24 hours did not have a significant effect on retinal function in healthy men compared to placebo.
Effects on sperm motility and morphology In a placebo-controlled clinical trial of vardenafil 20 mg daily for six months, no effects of vardenafil on sperm concentration, number, motility or morphology were found. In addition, vardenafil had no effect on serum levels of testosterone, luteinizing hormone, or follicle stimulating hormone.

Vardenafil hydrochloride pharmacology and toxicology

Pharmacological effects <br /> Erectile penis erection is a hemodynamic process involving the relaxation of corpus cavernosum and related arteriolar smooth muscle. During sexual stimulation, nitric oxide (NO) is released from the neuron tips in the cavernous body of the penis. NO activates the guanylate cyclase of smooth muscle cells, which increases the level of intracellular cyclic guanylate (cGMP), eventually leading to smooth muscle relaxation. Increase blood flow in the penis. The actual level of cGMP is regulated by the rate of guanylate cyclase synthesis and the rate of phosphodiesterase (PDEs degradation) cGMP.
cGMP-specific phosphodiesterase 5 (PDE5) is the main PDE present in the corpora cavernosa of the human body.
Vardenafil inhibits the degradation of cGMP phosphodiesterase type 5 (PDE5) in the human penile sponge and increases the local endogenous nitric oxide release of the cavernous body under sexual stimulation, thereby enhancing the natural response of sexual stimulation.
Enzymatic purification tests showed that vardenafil is a highly efficient and highly selective PDF5 inhibitor with an IC50 of 0.7 nM for human PDE5.
Vardenafil's inhibitory effect on PDE5 is much higher than that on other PDEs (15 times that of PDE6, 130 times that of PDE1, 300 times that of PDE11, and 1000 times that of PDE2, 3, 4, 7, 8, 9, 10 Times). In in vitro tests, vardenafil relaxes smooth muscle by increasing cGMP levels in isolated human penile cavernous bodies.
In conscious rabbit experiments, the effect of vardenafil on erectile dysfunction depends on the level of endogenous nitric oxide synthase, and this effect can be enhanced by a nitric oxide donor.
Erectile Response A placebo-controlled Rigiscan study showed that some subjects had a full penile erection and insertion (60% hardness) after taking vardenafil 20mg for 15 minutes.All subjects taking vardenafil Compared with the placebo group, the erectile response of the penis was significantly different after 25 minutes of administration.
Toxicology study <br Acute toxicity: The LD50 of rats is 190 mg / kg, and the light, electron and visual inspections did not reveal the effect of the drug on vision.
Long-term toxicity: The maximum non-toxic dose (NOEL) of rats and dogs is 3 mg / kg. In addition, animals showed cardiovascular toxicity related to PDE5, and rats also exhibited pancreatic, exocrine, and thyroid toxicity related to PDE.
Genotoxicity : isolated Salmonella typhimurium reverse mutation test, HPRT mutation test in mammalian cells, chromosome aberration test, and micronucleus test in vivo mouse, no vardenafil was found to be genotoxic and mutagenic.
Reproductive toxicity : Vardenafil was orally administered to rats and rabbits, and vardenafil did not affect animal fertility and embryo development.
Carcinogenicity : Rats and mice were orally given vardenafil for 24 consecutive months. The doses were calculated based on body surface area and were 225 times and 450 times the maximum recommended clinical dose of 20 mg. The area under the curve (AUC) ) Conversions are 360 times and 25 times the maximum clinically recommended dose of 20 mg, respectively. At this time, vardenafil is not carcinogenic.

Pharmacokinetics of vardenafil hydrochloride tablets

absorb:
Vardenafil was quickly absorbed after oral administration, and reached the maximum blood concentration ( _Cmax ) in the fastest 15 minutes under fasting state, and the peak time ( _Tmax ) was 90% for 30-120 minutes (average 60 minutes). Due to the significant first-pass effect, the average absolute bioavailability of oral vardenafil is approximately 15%. Within the recommended dose range of 5-20 mg, the increase in AUC (area under the drug concentration-time curve) and Cmax after oral vardenafil is almost proportional to the dose increase. When vardenafil was taken simultaneously with a high-fat diet (57% fat content), the absorption rate of vardenafil decreased, Tmax was prolonged for 60 minutes, and Cmax decreased by an average of 20%, but AUC was not affected. When vardenafil was ingested with the normal diet (fat content 30%), its pharmacokinetic parameters (C _max , T _max , and AUC) were not affected. Therefore, vardenafil can be taken with or without food.
distributed:
When vardenafil reached steady state, the average volume of distribution was 208 L. Vardenafil and its main active metabolite, M1, are highly bound to human plasma proteins (approximately 95%), and this combination is independent of and reversible with the total drug concentration. 90 minutes after taking vardenafil in healthy volunteers, the drug concentration in semen did not exceed 0.00012% of the dose.
metabolism:
Vardenafil is mainly metabolized by the liver enzyme CYP3A4 type, and a small part is metabolized by CYP3A5 and CYP2C9 isoenzymes. Vardenafil's plasma elimination half-life is approximately 4-5 hours. Vardenafil's main circulating metabolite (M1) in the body comes from piperazine citrate deethylation, and then M1 continues to metabolize. The plasma elimination half-life of M1 is similar to that of the original drug, about 4 hours. In the systemic circulation, part of M1 is bound glucuronide. Non-glucuronide M1 in plasma accounts for about 26% of the original drug component. The metabolite M1 has a similar phosphodiesterase selectivity to vardenafil. In in vitro tests, M1 inhibits PDE5 by about 28% of vardenafil, accounting for 7% of its efficacy.
excretion:
The total clearance of vardenafil in the body is 56 liters / hour, and its terminal half-life is 4-5 hours. After oral administration, vardenafil is excreted in the form of metabolites, most of which are excreted in feces (91-95%), and a small part is excreted in urine (2-6%).
Specific population pharmacokinetics:
elderly:
Vardenafil liver clearance in elderly volunteers (65 years) was significantly lower than in young volunteers (45 years). The AUC of older men was 52% higher than that of young men, which was within the range of variation in clinical trials. In placebo-controlled clinical trials, there was no difference in the safety and effectiveness of vardenafil in elderly and young people.
Renal insufficiency:
In patients with mild (creatinine clearance CLcr: 50-80 ml / min) and moderate (CLcr: 30-50 ml / min) renal impairment, vardenafil's pharmacokinetics were similar to those of normal renal function control group. Volunteers with severe renal impairment (CLcr [30 ml / min) had an average AUC increase of 21% and an average Cmax decrease of 23% compared with volunteers without renal impairment.
There was no significant correlation between creatinine clearance (CLcr) and vardenafil plasma exposure (AUC and _Cmax ). For patients with renal impairment requiring dialysis treatment, pharmacokinetic studies of vardenafil have not been performed.
Liver insufficiency:
Reduced clearance of vardenafil in patients with mild to moderate liver damage (Child-PughA) is directly proportional to the degree of liver damage.
Compared with healthy controls, patients with mild liver damage (Child-PughA) had a 17% increase in AUC and 22% increase in _Cmax . Patients with moderate liver damage (Child-PughB) had a 160% increase in AUC and 130% increase in _Cmax .
In patients with severe liver damage (Child-PughC), the pharmacokinetics of vardenafil have not been studied.

Storage of vardenafil hydrochloride tablets

Keep it tightly closed below 25 ° C. Keep the medicine out of the reach of children.

Vardenafil Hydrochloride Tablets Packaging

Aluminum-plastic packaging
5mg: 1 tablet / box, 4 tablets / box;
10mg: 1 tablet / box, 4 tablets / box;
20mg: 1 tablet / box, 2 tablets / box, 4 tablets / box.

Vardenafil hydrochloride tablet expiration date

36 months.

Standards for vardenafil hydrochloride tablets

Import drug registration standard JX20030240 ^[1]