General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Vardenafil Hydrochloride
VARDENAFIL HYDROCHLORIDE
1 INDICATIONS AND USAGE Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )
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Brand names:Vardenafil Hydrochloride
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- VARDENAFIL HYDROCHLORIDE
- Medicine class
- General Medicine
- Brand names
- Vardenafil Hydrochloride
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours
- FDA approved
- Yes
What Is Vardenafil Hydrochloride?
1 INDICATIONS AND USAGE Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 )
Vardenafil Hydrochloride (VARDENAFIL HYDROCHLORIDE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Vardenafil Hydrochloride. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Vardenafil Hydrochloride with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Vardenafil Hydrochloride is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. ( 2.1 ) A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. ( 2.3 ) Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. ( 2.1 ) The maximum recommended dosing frequency is one tablet per day. ( 2.1 ) Vardenafil hydrochloride tablets may be taken with or without food. ( 2.2 ) If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4 , 5.2 , 7.2 ): Ritonavir: No more than 2.5 mg in a 72-hour period Cobicistat: No more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period Ketocon
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) 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) ] Effects on Eye [see Warnings and Precautions (5.4) ] Sudden Hearing Loss [see Warnings and Precautions (5.5) ] QT Prolongation [see Warnings and Precautions (5.7) ] Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.
- at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because 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 tablets were administered to over 4430 men (mean age 56, range 18-89 years;
- 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide.
- Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.
- 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.
Serious
- 5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.
- Before prescribing vardenafil hydrochloride tablets, it is important to note the following: Cardiovascular Effects : Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status.
- ( 5.1 ) Risk of Priapism : In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
- ( 5.3 ) Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION).
- Vardenafil hydrochloride tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing vardenafil hydrochloride tablets, it is important to note the following: Cardiovascular Effects : Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due t
How Vardenafil Hydrochloride Works
12.1 Mechanism of Action Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesteras
Pharmacokinetics
Absorption
Absorption Mean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 8
Half-Life
half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours
Metabolism
metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1)
Excretion
Excretion The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Vardenafil Hydrochloridewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Vardenafil Hydrochloride side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Vardenafil Hydrochloride
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.