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VIAGRA®Index Section (sildenafil citrate)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

2.2 Use with Food

2.3 Dosage Adjustments in Specific Situations

2.4 Dosage Adjustments Due to Drug Interactions

2.5 Dosage Adjustments in Special Populations

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Nitrates

4.2 Hypersensitivity Reactions

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular

5.2 Prolonged Erection and Priapism

5.3 Effects on the Eye

5.4 Hearing Loss

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

5.6 Adverse Reactions with the Concomitant Use of Ritonavir

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

5.8 Effects on Bleeding

5.9 Counseling Patients About Sexually Transmitted Diseases

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Nitrates

7.2 Alpha-blockers

7.3 Amlodipine

7.4 Ritonavir and other CYP3A4 inhibitors

7.5 Alcohol

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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