12.1 Mechanism of Action 

 

12.2 Pharmacodynamics 

 

12.3 Pharmacokinetics 

 

13 NONCLINICAL TOXICOLOGY 

 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

 

14 CLINICAL STUDIES 

 

14.1 Trials in a General Erectile Dysfunction Population 

 

14.2 Trial in Patients with ED and Diabetes Mellitus 

 

14.3 Trial in Patients with ED after Radical Prostatectomy 

 

16 HOW SUPPLIED/STORAGE AND HANDLING 

 

17 PATIENT COUNSELING INFORMATION 

* Sections or subsections omitted from the full prescribing information are not listed. Close 

1 INDICATIONS AND USAGE

 

LEVITRA® is indicated for the treatment of erectile dysfunction.

 

2 DOSAGE AND ADMINISTRATION

2.1 General Dose Information 

 

For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.

2.2 Use with Food

 

LEVITRA can be taken with or without food.

 

2.3 Use in Specific Populations

 

Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age [see Use in Specific Populations (8.5)]. 

 

Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. 

 

Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

 

Renal Impairment: Do not use LEVITRA in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. 

2.4 Concomitant Medications 

 

Nitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)].

 

Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)]. 

 

CYP3A4 Inhibitors: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2)]. For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period.