Esomeprazol Naproxen Brand Name– Vimovo
What is Esomeprazol Naproxen
Esomeprazole Naproxen (Vimovo) is a fixed-dose combination of an immediate release proton pump inhibitor (PPI) and an enteric coated nonsteroidal anti-inflammatory drug (NSAID) formulated as a single tablet.
The combination tablet provides an option for the management of pain and inflammation with the potential for fewer gastrointestinal side effects and complications, as compared to an NSAID taken alone; the inclusion of a PPI does not negate all NSAID-associated GI adverse effects.
Although similar combination products exist (e.g., Prevacid Naprapac Therapy Kit; see lansoprazole; naproxen monograph), this is the first manufactured as a single tablet.
All NSAID containing products, including esomeprazole; naproxen, carry an increased risk of serious gastrointestinal adverse effects including bleeding, ulceration, and perforation of the stomach or intestines, and may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke.
In April 2010, the FDA approved esomeprazole; naproxen for treatment of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Indications
- ankylosing spondylitis
- juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA)
- osteoarthritis
- rheumatoid arthritis
- Esomeprazole; naproxen is not recommended for initial therapy of acute pain because the absorption of the naproxen component is delayed compared to other naproxen-containing products.
For the treatment of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis in patients at risk of developing NSAID-associated gastric ulcers
Side Effects
- abdominal pain
- agitation
- agranulocytosis
- alopecia
- anaphylactic shock
- anaphylactoid reactions
- anemia
- angioedema
- anorexia
- aplastic anemia
- appetite stimulation
- arthralgia
- arthropathy
- aseptic meningitis
- blurred vision
- bone fractures
- bronchospasm
- bullous rash
- candidiasis
- chest pain (unspecified)
- colitis
- confusion
- conjunctivitis
- constipation
- corneal opacification
- cough
- cystitis
- depression
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dysgeusia
- dysmenorrhea
- dyspepsia
- dysphagia
- dyspnea
- dysuria
- ecchymosis
- edema
- elevated hepatic enzymes
- eosinophilia
- epistaxis
- eructation
- erythema multiforme
- erythema nodosum
- esophageal stricture
- esophageal ulceration
- esophagitis
- exfoliative dermatitis
- fatigue
- fever
- flatulence
- fluid retention
- flushing
- gastric polyps
- gastritis
- gastroesophageal reflux
- GI bleeding
- GI obstruction
- GI perforation
- glomerulonephritis
- glycosuria
- goiter
- gynecomastia
- hallucinations
- headache
- hearing loss
- heart failure
- hematemesis
- hematuria
- hemolytic anemia
- hepatic encephalopathy
- hepatic failure
- hepatitis
- hiccups
- hot flashes
- hyperbilirubinemia
- hyperglycemia
- hyperkalemia
- hypertension
- hypertonia
- hyperuricemia
- hypocalcemia
- hypoglycemia
- hypokalemia
- hypomagnesemia
- hyponatremia
- impaired cognition
- impotence (erectile dysfunction)
- infection
- infertility
- insomnia
- interstitial nephritis
- jaundice
- leukocytosis
- leukopenia
- lichen planus-like eruption
- lupus-like symptoms
- lymphadenopathy
- maculopapular rash
- malaise
- melena
- migraine
- muscle cramps
- myalgia
- myasthenia
- myocardial infarction
- nausea
- nephrotic syndrome
- optic neuritis
- otalgia
- palpitations
- pancreatitis
- pancytopenia
- papilledema
- paresthesias
- parosmia
- peptic ulcer
- peripheral edema
- pernicious anemia
- pharyngitis
- photophobia
- photosensitivity
- platelet dysfunction
- pneumonitis
- polyuria
- pruritus
- pseudomembranous colitis
- pseudoporphyria
- pulmonary edema
- purpura
- pyrosis (heartburn)
- rash
- renal failure (unspecified)
- renal papillary necrosis
- renal tubular necrosis
- rhinitis
- sinus tachycardia
- sinusitis
- Stevens-Johnson syndrome
- stomatitis
- stroke
- thrombocytopenia
- thromboembolism
- tinnitus
- toxic epidermal necrolysis
- tremor
- urticaria
- vaginitis
- vasculitis
- vertigo
- visual impairment
- vitamin B12 deficiency
- vomiting
- weight gain
- weight loss
Monitoring Parameters
- CBC
- hemoglobin/hematocrit
- LFTs
- serum creatinine/BUN: in chronic use or acute toxicity
- serum magnesium
- stool guaiac
Contraindications
- acute bronchospasm
- acute myocardial infarction
- alcoholism
- anemia
- angina
- anticoagulant therapy
- Asian patients
- asthma
- bleeding
- bone fractures
- bone marrow suppression
- breast-feeding
- cardiac arrhythmias
- cardiac disease
- cardiomyopathy
- cerebrovascular disease
- chemotherapy
- children
- coagulopathy
- coronary artery bypass graft surgery (CABG)
- coronary artery disease
- corticosteroid therapy
- Crohn’s disease
- dehydration
- dental disease
- dental work
- diabetes mellitus
- diarrhea
- driving or operating machinery
- edema
- gastric cancer
- geriatric
- GI bleeding
- GI disease
- GI perforation
- heart failure
- hematological disease
- hemophilia
- hepatic disease
- hypertension
- hypomagnesemia
- hyponatremia
- hypovolemia
- immunosuppression
- infection
- infertility
- inflammatory bowel disease
- intramuscular injections
- jaundice
- labor
- long QT syndrome
- myocardial infarction
- nasal polyps
- neutropenia
- NSAID hypersensitivity
- obstetric delivery
- osteopenia
- osteoporosis
- peptic ulcer disease
- peripheral vascular disease
- pregnancy
- proton pump inhibitors (PPIs) hypersensitivity
- pseudomembranous colitis
- rebound acid hypersecretion
- renal disease
- renal failure
- renal impairment
- reproductive risk
- rheumatoid arthritis
- salicylate hypersensitivity
- stroke
- surgery
- systemic lupus erythematosus (SLE)
- tachycardia
- thrombocytopenia
- thromboembolism
- tobacco smoking
- ulcerative colitis
- urticaria
- vitamin B12 deficiency
- White patients
Interactions
- Abciximab
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Research Facts
A literature review summarizes the pharmacokinetics, benefits, safety, and tolerability of PN400.
Phase I trials demonstrated pharmacokinetics consistent with its formulation, and at different esomeprazole combination doses, PN400 containing esomeprazole 20 mg was the lowest dose that still resulted in substantial sustained increases of gastric pH > 4.
In two Phase III trials (Study 301 and Study 302), PN400 resulted in a significant reduction in gastric ulcers relative to enteric-coated naproxen (4.1% to 23.1% in Study 301, 7.1% to 24.3% in Study 302).
Discontinuation due to NSAID-associated upper gastrointestinal adverse events or duodenal ulcers was significantly less in PN400 patients (3.2% to 12%, P < 0.001, in Study 301; 4.8% to 11.9%, P = 0.009, in Study 302).
Two subjective patient indices were utilized to assess tolerability, ie, the Severity of Dyspepsia Assessment (SODA) and Overall Treatment Evaluation of Dyspepsia (OTE-DP).
Patients with PN400 had significantly better upper gastrointestinal tolerability compared with those treated with enteric-coated naproxen in terms of SODA scores, proportion of heartburn-free patients, and OTE-DP response.
While no formal recommendations are available at this time for use of this new combination medication, it will likely become an important treatment option with application for many patients.