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Vardenafil Tablets

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Even one glass may alter metabolism; consistent, limited intake or complete avoidance is advisable to maintain predictable exposure. Are over-the-counter sexual enhancers safe with vardenafil?

Section snippets

Current FDA guidance on reproduction-development toxicity testing stipulates that embryo-fetal development studies in at least two species (usually rats and rabbits) inform labeling when systemic maternal exposure approximates or exceeds anticipated clinical exposure. Safety extrapolation to humans relies on allometric scaling, placental transfer kinetics, and species-specific pharmacodynamics; therefore, absent positive human data, vardenafil should be avoided throughout pregnancy, and effective contraception is advised for women of reproductive potential participating in investigational protocols. Store vardenafil tablets at controlled room temperature, 20-25 °C (68-77 °F), with permissible excursions between 15 °C and 30 °C. Vardenafil for the treatment of erectile dysfunction: A critical review. Phosphodiesterase 5: Structure-function regulation and selectivity.

What should I do if I accidentally take too much vardenafil?

PubChem compound summary for CID 135400189, vardenafil. Risk of death in patients with coronary artery disease taking phosphodiesterase 5 inhibitors. Journal of the American College of Cardiology, 82(12), 1123-1135. Evaluation of vardenafil on cenforce professional 100 cardiac repolarization in healthy men. The American Journal of Cardiology, 93(9), 1378-1383.

How long before sex should I take vardenafil?

Pharmacology and drug-interaction effects of phosphodiesterase 5 inhibitors. International Journal of Clinical Practice, 59(9), 1165-1170. Ocular side effects of vardenafil: Results of a double-blind study. The Journal of Sexual Medicine, 17(11), 2057-2065. Cardiac safety in clinical trials of PDE5 inhibitors. Many contain undeclared PDE5 analogues or nitrates, posing serious interaction risks; avoid concurrent use.

Brand Name Price per Pack Dosage Options Over-the-counter (OTC) Prescription Required
Levitra $40-$60 5, 10, 20 mg No Yes
Vardenafil Generic $10-$25 5, 10, 20 mg No Yes
Other Brands Varies 5-20 mg No Yes

What if I experience dizziness after dosing?

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Sit or lie down until symptoms pass; if severe or persistent, seek medical attention as this may indicate significant hypotension. No evidence supports physical dependence, but psychological reliance on performance medications can develop, warranting periodic assessment.

4.1 Nitrates

Cardiology in Review, 13(4), 213-220. Simultaneous administration of vardenafil and tamsulosin in benign prostatic hyperplasia. Optimization of factors affecting vardenafil absorption using β-cyclodextrin. Pharmaceutical Development and Technology, 24(3), 354-364. Korean Journal of Urology, 47(9), 1001-1008.

J. Chromatogr. A

Interactions between grapefruit juice and cardiovascular drugs. American Journal of Cardiovascular Drugs, 4(5), 281-297. American Journal of Cardiology, 92(8), 1048-1053. Clinical pharmacology review of vardenafil NDA 21-400. Simultaneous administration of vardenafil and tamsulosin does not cause hypotension. How effective is vardenafil compared with other PDE5 inhibitors?

GPhC Regulated Pharmacy

Grapefruit juice-drug interactions: A practical review. Co-administration is possible, but only after the α-blocker dose is stabilized; otherwise, symptomatic hypotension may occur. If I am already on tamsulosin, how long should I wait before taking vardenafil? Clinical studies suggest dosing vardenafil at least two hours after tamsulosin minimizes additive blood-pressure effects. Yes; grapefruit compounds inhibit CYP3A4 and can unpredictably raise drug levels, increasing side-effect risk. Trials report 70-80 % successful intercourse attempts versus 50-60 % with placebo, comparable to sildenafil and tadalafil. Macrolides such as clarithromycin inhibit CYP3A4 and can raise vardenafil levels, necessitating dose adjustment.

8.5 Geriatric Use

Absolute contraindications include concurrent use of organic nitrates (e.g., nitroglycerin, isosorbide dinitrate) in any form. Co-administration may lead to severe, potentially life-threatening hypotension owing to additive increases in cGMP-mediated vasodilation. Similarly, patients receiving riociguat, a soluble guanylate-cyclase stimulator, should avoid vardenafil because the combination can produce profound systemic blood-pressure reductions unresponsive to vasopressors. Prescribers must inquire specifically about intermittent nitrate use for angina prior to initiating therapy. Individuals with inherited degenerative retinal disorders such as retinitis pigmentosa, although representing less than one percent of the population, were excluded from pivotal trials; theoretical PDE6 cross-reactivity raises concerns about exacerbating photoreceptor degeneration.

Important Disclaimer

Vardenafil should also be withheld in patients with known hypersensitivity to the drug or its excipients. Electrocardiographic studies revealed small, dose-dependent increases in QTc (approximately 4-6 ms) at supratherapeutic exposures; consequently, vardenafil is contraindicated in men taking class IA or class III anti-arrhythmic agents (e.g., quinidine, procainamide, amiodarone, sotalol) or in those with congenital long-QT syndrome. Additional caution is warranted following recent (< 6 months) myocardial infarction, stroke, or life-threatening arrhythmia, and in patients with uncontrolled hypertension (≥ 170/100 mm Hg), severe hypotension (< 90/50 mm Hg), or severe hepatic impairment (Child-Pugh C). Data from pooled cardiovascular safety analyses indicate that men with stable coronary artery disease who are not taking nitrates do not experience an increased incidence of major adverse cardiac events when treated with PDE5 inhibitors; however, clinical judgment should prevail for each patient’s risk-benefit assessment. Pharmacokinetic interactions largely stem from vardenafil’s metabolism by CYP3A4.

General drug facts

For example, concomitant ketoconazole 400 mg once daily increased vardenafil area under the curve (AUC) nearly ten-fold; under such circumstances, dosing should not exceed 2.5 mg in 24 hours. Combined use with α-adrenergic blockers (e.g., doxazosin, terazosin) may potentiate orthostatic hypotension due to overlapping vasodilatory effects. Titrate the α-blocker to a stable maintenance dose and ensure hemodynamic stability before introducing vardenafil at the lowest feasible dose. Clinical pharmacology trials evaluating co-administration with tamsulosin 0.4 mg daily demonstrated no clinically significant blood-pressure reductions when vardenafil was given two hours after the α-blocker, underscoring the importance of temporal separation and dose adjustment. Additional interactions include moderate CYP3A4 inducers (e.g., rifampin, carbamazepine), which can lower systemic exposure, potentially requiring dosage escalation if clinically justified. Daily use is not approved; the safety database supports on-demand dosing only, with insufficient data on chronic daily administration.

Dosage (mg) Typical Usage Onset of Action Duration of Effect
10 Mild to moderate ED 30-60 minutes Up to 4 hours
20 Moderate to severe ED 30-60 minutes Up to 4-5 hours
5 Lower dose for less side effects 30-60 minutes Up to 4 hours
25 Off-label use, clinical trials 30-60 minutes Up to 4 hours

503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider.

Overdose/Missed Dose

Grapefruit juice inhibits enteric CYP3A4 and may unpredictably increase vardenafil bioavailability; patients should be advised to avoid large quantities or to maintain consistent intake patterns to minimize variability. Pharmacodynamic synergy with other vasodilators, antihypertensives, or alcohol could accentuate blood-pressure reductions, warranting patient counseling on positional dizziness and syncope risk. In randomized controlled trials, the most frequently reported adverse reactions included headache (up to 15 %), facial flushing (10 %), nasal congestion (7 %), dyspepsia (4 %), and dizziness (2 %). These events were generally mild to moderate, transient, and self-limiting, correlating with peak plasma levels and attenuating upon repeated, intermittent use. Visual disturbances, predominantly a blue-green tinge or increased light sensitivity, occurred in ≤ 2% of subjects and resolved within hours of dosing cessation, consistent with transient PDE6 inhibition.

Solid electrodes in electroanalytical chemistry: Present applications and prospects for high throughput screening of drug compounds

Although rare, priapism-painful erections persisting beyond four hours-has been associated with PDE5 inhibitors, including vardenafil. Post-marketing pharmacovigilance identified fewer than 1 case per 50,000 prescriptions, yet the potential for irreversible tissue ischemia necessitates prompt medical intervention for prolonged erections. Counsel patients to seek emergency care if tumescence exceeds four hours. Additional serious but uncommon adverse events comprise sudden sensorineural hearing loss, non-arteritic anterior ischemic optic neuropathy, and myocardial infarction in predisposed individuals; establishing causality is challenging due to confounding vascular risk factors inherent to the target population. Cardiac electrophysiology investigations have shown small QTc prolongations that generally lack clinical consequence but underscore the need to avoid concomitant class IA or III anti-arrhythmic agents.

Does vardenafil interact with foods or drinks?

Similarly, isolated reports of ventricular arrhythmias are confounded by underlying structural heart disease. Post-authorization safety studies continue to monitor hepatic toxicity, hypersensitivity reactions, and potential drug-drug interactions, reinforcing the importance of ongoing pharmacovigilance in commercial preparations. Vardenafil is not indicated for use in women and carries no established therapeutic role during pregnancy. Animal reproduction studies conducted with doses generating exposures up to 18-fold higher than typical human AUC did not reveal teratogenicity, but delayed ossification and decreased neonatal survival were observed at maternally toxic doses, signifying class-related hemodynamic effects on uteroplacental perfusion. Because mechanistic data suggest theoretical impacts on vascular tone, the risk-benefit ratio for any off-label maternal use (e.g., pulmonary hypertension) remains uncertain. 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices.

Our team of experts has the answers you're looking for.

A clinical pharmacist cannot recommend a specific doctor. Because we are licensed in all 50 states*, we can accept prescriptions from many licensed prescribers if the prescription is written within their scope of practice and with a valid patient-practitioner relationship.

Side Effect Frequency Severity Recommended Action
Headache Common Mild Take analgesics, hydration
Flushing Common Mild Cool environment, hydrate
Nasal Congestion Moderate Mild Use decongestants if needed
Dizziness Less common Mild Sit or lie down immediately
Muscle Pain Rare Mild Consult doctor if persists

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