VARDENAFIL 5 mg/1

VARDENAFIL · TABLET, FILM COATED · Zydus Pharmaceuticals USA Inc.

4 Recalls on Record

Plain English

Vardenafil is a prescription tablet used to treat erectile dysfunction in men. It works by increasing blood flow to help achieve and maintain an erection.

Key Facts

Brand Name: VARDENAFIL
Generic Name: VARDENAFIL
NDC Code (Product): 70710-1069
Manufacturer: Zydus Pharmaceuticals USA Inc.
Strength: 5 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: ANDA208960
Marketing Start: 11/01/2018

Recall History

4 Recalls on Record

Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated

Class II02/19/2018

Kalchem International, Inc.

cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated

Class II07/02/2020

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

TerminatedVoluntary: Firm initiated

Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective31 reports

dizziness29 reports

drug interaction29 reports

chronic kidney disease28 reports

fatigue27 reports

enterocolitis infectious26 reports

headache26 reports

hypotension24 reports

acute kidney injury23 reports

nausea19 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 used for?

Vardenafil is a prescription tablet used to treat erectile dysfunction in men. It works by increasing blood flow to help achieve and maintain an erection.

Is VARDENAFIL a controlled substance?

VARDENAFIL is not classified as a controlled substance by the DEA.

What is the generic name for VARDENAFIL?

The generic name for VARDENAFIL is VARDENAFIL. There are 11 other brand versions of VARDENAFIL.

What is the NDC code for VARDENAFIL 5 mg/1?

The NDC (National Drug Code) for VARDENAFIL 5 mg/1 is 70710-1069, listed by Zydus Pharmaceuticals USA Inc..

Product NDC

70710-1069

Package NDC

70710-1069-1

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