Esomeprazol Naproxen

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

  1. ankylosing spondylitis
  2. juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA)
  3. osteoarthritis
  4. 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

  1. abdominal pain
  2. agitation
  3. agranulocytosis
  4. alopecia
  5. anaphylactic shock
  6. anaphylactoid reactions
  7. anemia
  8. angioedema
  9. anorexia
  10. aplastic anemia
  11. appetite stimulation
  12. arthralgia
  13. arthropathy
  14. aseptic meningitis
  15. blurred vision
  16. bone fractures
  17. bronchospasm
  18. bullous rash
  19. candidiasis
  20. chest pain (unspecified)
  21. colitis
  22. confusion
  23. conjunctivitis
  24. constipation
  25. corneal opacification
  26. cough
  27. cystitis
  28. depression
  29. diaphoresis
  30. diarrhea
  31. dizziness
  32. drowsiness
  33. dysgeusia
  34. dysmenorrhea
  35. dyspepsia
  36. dysphagia
  37. dyspnea
  38. dysuria
  39. ecchymosis
  40. edema
  41. elevated hepatic enzymes
  42. eosinophilia
  43. epistaxis
  44. eructation
  45. erythema multiforme
  46. erythema nodosum
  47. esophageal stricture
  48. esophageal ulceration
  49. esophagitis
  50. exfoliative dermatitis
  51. fatigue
  52. fever
  53. flatulence
  54. fluid retention
  55. flushing
  56. gastric polyps
  57. gastritis
  58. gastroesophageal reflux
  59. GI bleeding
  60. GI obstruction
  61. GI perforation
  62. glomerulonephritis
  63. glycosuria
  64. goiter
  65. gynecomastia
  66. hallucinations
  67. headache
  68. hearing loss
  69. heart failure
  70. hematemesis
  71. hematuria
  72. hemolytic anemia
  73. hepatic encephalopathy
  74. hepatic failure
  75. hepatitis
  76. hiccups
  77. hot flashes
  78. hyperbilirubinemia
  79. hyperglycemia
  80. hyperkalemia
  81. hypertension
  82. hypertonia
  83. hyperuricemia
  84. hypocalcemia
  85. hypoglycemia
  86. hypokalemia
  87. hypomagnesemia
  88. hyponatremia
  89. impaired cognition
  90. impotence (erectile dysfunction)
  91. infection
  92. infertility
  93. insomnia
  94. interstitial nephritis
  95. jaundice
  96. leukocytosis
  97. leukopenia
  98. lichen planus-like eruption
  99. lupus-like symptoms
  100. lymphadenopathy
  101. maculopapular rash
  102. malaise
  103. melena
  104. migraine
  105. muscle cramps
  106. myalgia
  107. myasthenia
  108. myocardial infarction
  109. nausea
  110. nephrotic syndrome
  111. optic neuritis
  112. otalgia
  113. palpitations
  114. pancreatitis
  115. pancytopenia
  116. papilledema
  117. paresthesias
  118. parosmia
  119. peptic ulcer
  120. peripheral edema
  121. pernicious anemia
  122. pharyngitis
  123. photophobia
  124. photosensitivity
  125. platelet dysfunction
  126. pneumonitis
  127. polyuria
  128. pruritus
  129. pseudomembranous colitis
  130. pseudoporphyria
  131. pulmonary edema
  132. purpura
  133. pyrosis (heartburn)
  134. rash
  135. renal failure (unspecified)
  136. renal papillary necrosis
  137. renal tubular necrosis
  138. rhinitis
  139. sinus tachycardia
  140. sinusitis
  141. Stevens-Johnson syndrome
  142. stomatitis
  143. stroke
  144. thrombocytopenia
  145. thromboembolism
  146. tinnitus
  147. toxic epidermal necrolysis
  148. tremor
  149. urticaria
  150. vaginitis
  151. vasculitis
  152. vertigo
  153. visual impairment
  154. vitamin B12 deficiency
  155. vomiting
  156. weight gain
  157. 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

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  • Vincristine
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  • Vorapaxar
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Warfarin

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.

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