ing). ( 2.4, 5.6) • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using LEVITRA. ( 5.7, 12.2)
ADVERSE REACTIONS
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 BayerHealthCare Pharmaceuticals1-888-84-BAYER or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• LEVITRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. ( 7.1)
USE IN SPECIFIC POPULATIONS
• LEVITRA is not indicated for use in pediatric patients. ( 8.4) • Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C). ( 8.6) • Do not use LEVITRA in patients on renal dialysis. ( 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dose Information
2.2 Use with Food
2.3 Use in Specific Populations
2.4 Concomitant Medications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Nitrates
4.2 Guanylate Cyclase (GC) Stimulators
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Effects
5.2 Potential for Drug Interactions with Potent or Moderate CYP3A4 Inhibitors
5.3 Risk of Priapism
5.4 Effects on the Eye
5.5 Sudden Hearing Loss
5.6 Alpha-Blockers
5.7 Congenital or Acquired QT Prolongation
5.8 Hepatic Impairment
5.9 Renal Impairment
5.10 Combination with Other Erectile Dysfunction Therapies
5.11 Effects on Bleeding
5.12 Sexually Transmitted Disease
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Potential for Pharmacodynamic Interactions with LEVITRA
7.2 Effect of Other Drugs on Vardenafil
7.3 Effects of Vardenafil on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
