Vardenafil Hydrochloride
Generic Name: vardenafil hydrochloride
Brand Names:
Vardenafil Hydrochloride
11 DESCRIPTION Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Overview
11 DESCRIPTION Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Uses
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 )
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.
Side Effects
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.
Interactions
7 DRUG INTERACTIONS Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. ( 7.1 ) 7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets Nitrates: 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).
Warnings
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. 4 CONTRAINDICATIONS Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4 , 4.2 ) 4.1 Nitrates Administration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2) ] .
Pregnancy
8.1 Pregnancy Pregnancy Category B vardenafil hydrochloride tablets are not indicated for use in women. There are no studies of vardenafil hydrochloride tablets use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20 mg.
Storage
Store at 25°C (77°F); excursions permitted within15-30°C (59-86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Vardenafil Hydrochloride used for?▼
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 )
What are the side effects of Vardenafil Hydrochloride?▼
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.
Can I take Vardenafil Hydrochloride during pregnancy?▼
8.1 Pregnancy Pregnancy Category B vardenafil hydrochloride tablets are not indicated for use in women. There are no studies of vardenafil hydrochloride tablets use in pregnant women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20 mg.
What are the important warnings for Vardenafil Hydrochloride?▼
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. 4 CONTRAINDICATIONS Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4 , 4.2 ) 4.1 Nitrates Administration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.