Label: VARDENAFIL HYDROCHLORIDE tablet

  • NDC Code(s): 33342-151-07, 33342-151-11, 33342-151-12, 33342-152-07, view more
  • Packager: Macleods Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 10, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS & USAGE
    Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
  • 2 DOSAGE & ADMINISTRATION
    2.1 General Dose Information - For most patients, the recommended starting dose of vardenafil hydrochloride is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The ...
  • 3 DOSAGE FORMS & STRENGTHS
    Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side, 5 mg ...
  • 4 CONTRAINDICATIONS
    4.1 Nitrates - Administration of vardenafil - hydrochloride tabletswith nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology ...
  • 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 ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions with the use of vardenafil hydrochloride tablets are discussed elsewhere in the labeling: Cardiovascular Effects [see Contraindications (4.1) and ...
  • 7 DRUG INTERACTIONS
    7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets - Nitrates:Concomitant use of vardenafil hydrochloride tablets and nitrates and nitric oxide donors is ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Vardenafil hydrochloride tablets are not indicated for use in females. There are no data with the use of Vardenafil hydrochloride tablets in pregnant women to ...
  • 10 OVERDOSAGE
    The maximum dose of vardenafil hydrochloride tablets for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced ...
  • 11 DESCRIPTION
    Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine ...
  • 12 CLINICAL PHARMACOLOGY
    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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis & Mutagenesis & Impairment of Fertility - Carcinogenesis - Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic ...
  • 14 CLINICAL STUDIES
    Vardenafil was evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Vardenafil Hydrochloride tablets 2.5 mg - 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side and are ...
  • 17 PATIENT COUNSELING INFORMATION
    PATIENT COUNSELING INFORMATION - “See FDA-approved patient labeling (Patient Information)” Nitrates - Inform patients that vardenafil hydrochloride tablets is contraindicated with regular ...
  • PATIENT INFORMATION
    Vardenafil Hydrochloride Tablets -  (varDEN a fil) Read the Patient Information about vardenafil hydrochloride tablets before you start taking it and again each time you get a refill. There ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Vardenafil Hydrochloride tablets 2.5 mg - Bottles of 30 tablets                  NDC 33342-151-07 - Bottles of 100 tablets                NDC 33342-151-11 - Unit dose blister ...
  • INGREDIENTS AND APPEARANCE
    Product Information