Drugplain

Vardenafil Hydrochloride 10 mg/1

Vardenafil Hydrochloride · TABLET · Macleods Pharmaceuticals Limited

No Recall History
Plain English

Vardenafil hydrochloride is a prescription medication in tablet form used to treat erectile dysfunction in men. It works by relaxing blood vessels and increasing blood flow to help achieve and maintain erections.

Key Facts

Brand Name
Vardenafil Hydrochloride
Generic Name
Vardenafil Hydrochloride
NDC Code (Product)
33342-153
Manufacturer
Macleods Pharmaceuticals Limited
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA204632
Drug Class
Phosphodiesterase 5 Inhibitor [EPC]
Marketing Start
10/24/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

enterocolitis infectious13 reports
overdose6 reports
visual impairment6 reports
blood pressure increased5 reports
dyschromatopsia5 reports
erectile dysfunction5 reports
hypotension5 reports
photophobia5 reports
retinal deposits5 reports
dizziness4 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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 Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochlorid…

Contraindications

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) ] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. 4.2 Guanylate Cyclase (GC) Stimulators Do not use vardenafil hydrochloride tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride tablets may potentiate the hypotensive effects of GC stimulators.

Drug 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). 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. PDE5 inhibitors, including vardenafil hydrochloride tablets and al…

Adverse Reactions

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; 8…

Frequently Asked Questions

What is Vardenafil Hydrochloride used for?

Vardenafil hydrochloride is a prescription medication in tablet form used to treat erectile dysfunction in men. It works by relaxing blood vessels and increasing blood flow to help achieve and maintain erections.

Is Vardenafil Hydrochloride a controlled substance?

Vardenafil Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Vardenafil Hydrochloride?

The generic name for Vardenafil Hydrochloride is Vardenafil Hydrochloride. There are 4 other brand versions of Vardenafil Hydrochloride.

What is the NDC code for Vardenafil Hydrochloride 10 mg/1?

The NDC (National Drug Code) for Vardenafil Hydrochloride 10 mg/1 is 33342-153, listed by Macleods Pharmaceuticals Limited.

Product NDC

33342-153

Package NDC

33342-153-07

Other Vardenafil Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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