Vardenafil dosing information

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Vardenafil hydrochloride orally disintegrating tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

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Kamagra	100mg	180 + 6 Pills	436.79€ 415.99€
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Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.

Before Using

While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride orally disintegrating tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17).] There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Vardenafil hydrochloride orally disintegrating tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.

Medications & Supplements

Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥50. Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)]. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition. Vardenafil hydrochloride orally disintegrating tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.

What are the serious side effects of vardenafil?

Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)]. Consideration should be given to the following: · Patients should be stable vardenafil hcl 10mg on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. · In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥50.

Storage Condition	Recommended Temperature	Humidity	Additional Notes
Standard Storage	15-30°C (59-86°F)	< 70%	Keep away from light
Protect from moisture	-	Keep in a dry place	Keep in original container
Keep out of reach of children	-	-	Safety measure

Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)]. Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.

Contraindication	Reason	Alternative Action
Use with Nitrates	Severe hypotension risk	Seek alternative ED treatment
Severe Liver Impairment	Reduced metabolism, increased risk	Dose adjustment or avoidance
Hypotension (<90/60 mm Hg)	Risk of significant blood pressure drop	Monitor blood pressure
Concomitant Potent CYP3A4 Inhibitors	Increased Vardenafil levels	Dose reduction

Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition. Vardenafil hydrochloride orally disintegrating tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.

Other Comments

Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)]. Consideration should be given to the following: · Patients should be stable vardenafil hcl 10mg on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. · In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. · In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose.

The onset of vardenafil 10 mg is typically 30-60 minutes.
It can last up to 4-5 hours in some users.
Vardenafil is contraindicated with certain heart medications.
Use caution if you have a history of hypotension.
The tablet may cause mild gastrointestinal upset.
Do not consume large amounts of alcohol when taking vardenafil.
Inform your doctor if you experience sudden hearing loss.
Use only as directed by your healthcare provider.
Discontinue if you experience persistent erection issues.
The medication does not increase sexual desire.

Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval.

Brand Name	Manufacturer	Formulation Type	Price Range	Notes
Levitra	Bayer	Tablet	Moderate	Widely used
Staxyn	Bayer	Orally disintegrating tablet	Similar price	Alternative formulation
Generic Vendors	Multiple	Tablet	Lower	Cost-effective option

These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride orally disintegrating tablets. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].

What is the current market landscape for vardenafil hydrochloride?

· In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

Patient resources

Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride orally disintegrating tablets. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. The safety and efficacy of vardenafil hydrochloride orally disintegrating tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

How is vardenafil supplied (dosage forms)?

In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil hydrochloride orally disintegrating tablets should be administered to these patients after careful benefit-risk assessment. Vardenafil hydrochloride orally disintegrating tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria. Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contains 1.403 mg phenylalanine vigora 200 mg per tablet. Use of vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases. The safety and efficacy of vardenafil hydrochloride orally disintegrating tablets used in combination with other treatments for erectile dysfunction have not been studied.

Vardenafil 10 mg tablets treat erectile dysfunction in men.
The medication works by increasing blood flow to the penis.
Take vardenafil 10 mg about 30 minutes before activity.
It can be taken with or without food, but high-fat meals may delay effects.
Maximum recommended dose is one tablet per 24 hours.
Vardenafil may cause side effects like headache or flushing.
Do not use vardenafil if you take nitrates for chest pain.
Consult a doctor before using vardenafil if you have heart problems.
Store vardenafil tablets at room temperature, away from moisture.
Alcohol can increase side effects of vardenafil.

Therefore, the use of such combinations is not recommended. In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil hydrochloride orally disintegrating tablets should be administered to these patients after careful benefit-risk assessment. Vardenafil hydrochloride orally disintegrating tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria. Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contains 1.403 mg phenylalanine vigora 200 mg per tablet. Use of vardenafil hydrochloride orally disintegrating tablets offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling:· Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)]· Priapism [see Warnings and Precautions (5.3)]· QT Prolongation [see Warnings and Precautions (5.7)]· Effects on eye [see Warnings and Precautions (5.4)]· Sudden hearing loss [see Warnings and Precautions (5.5)]6.1 Clinical Studies ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old.

Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride orally disintegrating tablets are discussed elsewhere in the labeling:· Cardiovascular effects [see Contraindications (4.1) and Warnings and Precautions (5.1)]· Priapism [see Warnings and Precautions (5.3)]· QT Prolongation [see Warnings and Precautions (5.7)]· Effects on eye [see Warnings and Precautions (5.4)]· Sudden hearing loss [see Warnings and Precautions (5.5)]6.1 Clinical Studies ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Vardenafil Hydrochloride Orally Disintegrating Tablets: Safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old. Approximately 8% (n=29) were ≥75 years old. An integrated analysis of both studies included a total of 355 subjects that received vardenafil hydrochloride orally disintegrating tablets compared to 340 subjects that received placebo (mean age was 61.7, range 21 to 88; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for vardenafil hydrochloride orally disintegrating tablets compared to 0.6% for placebo.

Pregnancy and breastfeeding

Table 1 below details the most frequently reported adverse reactions.Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trialsAdverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.All Vardenafil Studies: Vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18 to 89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.In the placebo-controlled clinical trials for vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest painAuditory: tinnitus, vertigoCardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotensionDigestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminasesMusculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgiaNervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizureRespiratory: dyspnea, sinus congestionSkin and appendages: erythema, rashOphthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitisUrogenital: increase in erection, priapism6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation.

Pregnancy Categories

Approximately 8% (n=29) were ≥75 years old. An integrated analysis of both studies included a total of 355 subjects that received vardenafil hydrochloride orally disintegrating tablets compared to 340 subjects that received placebo (mean age was 61.7, range 21 to 88; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for vardenafil hydrochloride orally disintegrating tablets compared to 0.6% for placebo. Table 1 below details the most frequently reported adverse reactions.Table 1: Adverse drug reactions reported by ≥2% of the patients treated with vardenafil hydrochloride orally disintegrating tablets and more frequent on drug than placebo in controlled trialsAdverse drug reactions reported in the vardenafil hydrochloride orally disintegrating tablets placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.All Vardenafil Studies: Vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18 to 89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.In the placebo-controlled clinical trials for vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and vardenafil hydrochloride orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest painAuditory: tinnitus, vertigoCardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotensionDigestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminasesMusculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgiaNervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizureRespiratory: dyspnea, sinus congestionSkin and appendages: erythema, rashOphthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitisUrogenital: increase in erection, priapism6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation.

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