[See Dosage and Administration (2.4) and Warnings and Precautions (5).] .Moderate CYP3A4 inhibitorsErythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in C max when co administered with vardenafil hydrochloride tablets 5 mg in healthy volunteers.
Vardenafil dosing information
PDE5 inhibitors, including vardenafil hydrochloride tablets and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. [See Dosage and Administration (2.4), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2). ]Antihypertensives: Vardenafil hydrochloride tablets may add to the blood pressure lowering effects of antihypertensive agents. In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of blue tablets 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute.
Some side effects can be serious. If you experience any of the following symptoms , call your doctor immediately:
The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1.Alcohol: Vardenafil hydrochloride tablets (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight, approximately 40 mL of absolute alcohol in a 70 kg person). Alcohol and vardenafil plasma levels were not altered when dosed simultaneously.7.2 Effect of Other Drugs on VardenafilIn vitro studiesStudies in human liver microsomes showed that vardenafil is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9. Therefore, inhibitors of these enzymes are expected to reduce vardenafil clearance [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)] .In vivo studiesStrong CYP3A4 inhibitorsKetoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max) when co-administered with vardenafil hydrochloride tablets (5 mg) in healthy volunteers. A 5-mg vardenafil hydrochloride tablet dose should not be exceeded in a 24-hour period when used in combination with 200 mg once daily ketoconazole. It is recommended not to exceed a single 5 mg dose of vardenafil hydrochloride tablets in a 24-hour period when used in combination with erythromycin.
| Point | Explanation | Additional Advice |
|---|---|---|
| Take as prescribed | Usually 10 mg about 30-60 min before activity | Do not exceed recommended dose |
| Food interactions | High-fat meals may delay onset | Take on an empty stomach or low-fat meal |
| Alcohol consumption | May decrease effectiveness or increase side effects | Limit alcohol intake |
| Report side effects or adverse reactions | Such as vision changes, pain, prolonged erections | Seek medical attention immediately |
]Although specific interactions have not been studied, other CYP3A4 inhibitors,
- Vardenafil HCl 10mg improves erectile response by increasing blood flow.
- Avoid combining it with other ED medications unless prescribed.
- Potential for interactions with certain heart and blood pressure medicines.
- Use vardenafil with caution under doctor supervision if you have health issues.
- It’s not suitable for women, children, or individuals without ED diagnosis.
- Store in a cool, dry place away from direct sunlight.
- Do not take if you recently used nitric oxide donors.
- Be mindful of timing; take about an hour before intimacy.
- The medication does not produce an erection without sexual stimulation.
- Always adhere to your prescribed dose for best results.
including grapefruit juice would likely increase vardenafil exposure.Other Drug InteractionsNo
| Parameter | Value | Notes |
|---|---|---|
| Absorption Time | 30-60 minutes | After oral intake |
| Peak Plasma | 60 minutes | Approximate peak |
| Half-life | 4-5 hours | Duration of effect |
| Bioavailability | ~15% | Oral bioavailability |
pharmacokinetic interactions were observed between vardenafil and the following drugs:
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Gold | 50 mg | 20 Pills | 73.17€ 69.69€ | |
| Levitra Original | 20mg | 64 + 4 Pills | 298.45€ 284.24€ | |
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ | |
| Viagra Original | 100mg | 64 + 4 Pills | 264.15€ 251.57€ | |
| Cialis Generic | 40mg | 30 + 4 Pills | 74.97€ 71.40€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Levitra Original | 20mg | 76 + 4 Pills | 344.39€ 327.99€ | |
| Viagra Oral Jelly | 100mg | 21 Sachets | 78.66€ 74.91€ | |
| Viagra Generic | 50mg | 120 + 6 Pills | 129.64€ 123.47€ | |
| Cialis Generic | 5mg | 90 + 6 Pills | 115.91€ 110.39€ |
glyburide, warfarin, digoxin, an antacid based on magnesium-aluminum hydroxide, and ranitidine.
Renal Dose Adjustments
In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo. When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1). Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets. All Vardenafil Studies: Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide.
Pharmacological Class
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 hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo. The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil 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 pain Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis The following adverse reactions have been identified during post approval use of vardenafil hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters.Cimetidine
| Storage Parameter | Recommended Condition | Notes |
|---|---|---|
| Temperature | Below 25°C (77°F) | Store in a cool, dry place |
| Humidity | Avoid excessive moisture | Keep away from water |
| Light exposure | Keep in original container, protect from light | Prevent degradation |
| Shelf life | 2-3 years from manufacturing date | Check expiration date |
(400 mg b.i.d.) had no effect on vardenafil bioavailability (AUC) and maximum concentration (C max) of vardenafil
What special precautions should I follow?
Since higher doses of ketoconazole (400 mg daily) may result in higher increases in C max and AUC, a single 2.5 mg dose of vardenafil hydrochloride tablets should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily. [See Dosage and Administration (2.4) and Warnings and Precautions (5). ]Indinavir (800 mg t.i.d.) co-administered with vardenafil hydrochloride tablets 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil C max and a 2-fold increase in vardenafil half-life. It is recommended not to exceed a single 2.5 mg vardenafil hydrochloride tablets dose in a 24-hour period when used in combination with indinavir. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2).
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]Ritonavir (600 mg b.i.d.) co-administered with vardenafil hydrochloride tablets 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13 fold increase in vardenafil C max. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a HIV protease inhibitor and a highly strong CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. Consequently, it is recommended not to exceed a single 2.5 mg vardenafil hydrochloride tablets dose in a 72-hour period when used in combination with ritonavir. [See Dosage and Administration (2.4) and Warnings and Precautions (5.2).] .Cobicistat with vardenafil hydrochloride tablets can result in increased plasma concentrations, therefore it is recommended that a single 2.5 mg dose of vardenafil hydrochloride tablets should not be exceeded in a 72-hour period. when co-administered with 20 mg vardenafil hydrochloride tablets in healthy volunteers.7.3 Effects of Vardenafil on Other
Brand names
Ophthalmologic: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.4) and Patient Counseling Information (17)] . Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil. Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.
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Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride TabletsNitrates: Concomitant use of vardenafil hydrochloride tablets and nitrates and nitric oxide donors is contraindicated. The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours after vardenafil were potentiated by a 20 mg dose of vardenafil hydrochloride tablets in healthy middle-aged subjects. These effects were not observed when vardenafil hydrochloride tablets 20 mg were taken 24 hours before the nitroglycerin (NTG). Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of vardenafil hydrochloride tablets and nitrates is contraindicated [see Contraindications (4.1) and Clinical Pharmacology (12.2).Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. DrugsIn vitro studiesVardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar).
- Vardenafil 10mg should be used only under medical supervision.
- Overdose may cause serious side effects like priapism or sudden vision loss.
- The medication is available by prescription and not for recreational use.
- Male patients with heart issues should consult a doctor before use.
- Vardenafil may interact with other medications like antibiotics or antifungals.
- Alcohol consumption can increase the risk of side effects when taking vardenafil.
- It’s important to follow the prescribed dosage strictly for safety.
- Use caution if you have liver or kidney problems while taking vardenafil.
- Women and children should avoid using vardenafil, as it's designed for men.
- Discuss all health conditions and medications with your healthcare provider first.