• Hepatic Insufficiency: VIMOVO should be avoided in patients with severe hepatic insufficiency (2, 4, 5.11, 8.6, 12.3)

• Renal Insufficiency: VIMOVO is not recommended in patients with moderate or severe renal insufficiency (2, 5.6, 5.7, 8.7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 

Revised: 07/2011
 

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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

Recent Major Changes
Cardiovascular Risk
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Thrombotic Events
5.2 Hypertension
5.3 Congestive Heart Failure and Edema
5.4 Gastrointestinal Effects — Risk of Ulceration, Bleeding, and Perforation
5.5 Active Bleeding
5.6 Renal Effects
5.7 Advanced Renal Disease
5.8 Anaphylactoid Reactions
5.9 Skin Reactions
5.10 Pregnancy
5.11 Hepatic Effects
5.12 Hematological Effects
5.13 Pre-existing Asthma
5.14 Concomitant NSAID Use
5.15 Corticosteroid Treatment
5.16 Bone Fracture
5.17 Masking of Inflammation and Fever
5.18 Laboratory Tests
5.19 Hypomagnesemia
5.20 Concomitant use of St John's Wort or Rifampin with VIMOVO
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 ACE-inhibitors
7.2 Aspirin
7.3 Cholestyramine
7.4 Cyclosporin
7.5 Tacrolimus
7.6 Diuretics
7.7 Lithium
7.8 Methotrexate
7.9 Anticoagulants
7.10 Selective Serotonin Reuptake Inhibitors (SSRIs)
7.11 Other Information Concerning Drug Interactions
7.12 Interactions With Investigations of Neuroendocrine Tumors
7.13 Drug/Laboratory Test Interaction
7.14 Interactions Related to Absorption
7.15 Antiretroviral Agents
7.16 Effects on Hepatic Metabolism/Cytochrome P-450 pathways
7.17 Other Pharmacokinetic-based Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Insufficiency
8.7 Renal Insufficiency
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
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
MEDICATION GUIDE
PACKAGE LABEL - VIMOVO 375 / 20 MG TABLET
 

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FULL PRESCRIBING INFORMATION
Cardiovascular Risk
• Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular di