Lansoprazole Naproxen

Lansoprazole Naproxen Brand Names

Prevacid NapraPac

What is Lansoprazole Naproxen

Naproxen tablets and lansoprazole delayed-release capsules are packaged together for the treatment of arthritic symptoms in patients at risk for GI ulceration.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid chemical class and like all NSAIDs, carries an increased risk of serious gastrointestinal adverse effects including bleeding, ulceration, and perforation of the stomach or intestines.

Lansoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid release and thus acts to prevent NSAID-induced GI injury.

Lansoprazole naproxen is the second FDA-approved combination product for the treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric ulcers.

No comparative data of Arthrotec (diclofenac sodium; misoprostol, see separate monograph) and Prevacid NapraPac (lansoprazole; naproxen) for this indication were identified.

However, a double-blind trial has demonstrated the efficacy of lansoprazole in comparison with misoprostol and placebo in preventing gastric ulceration due to NSAID use in patients without H. pylori and a history of endoscopically documented gastric ulcer.

The percentage of patients that remained free of gastric ulcers after 12 weeks of lansoprazole 15 mg daily was 80% as compared with 93% of patients that received misoprostol 200 mcg four times daily; only 51% of 112 placebo-treated patients remained free of a gastric ulcer. In this trial, treatment with lansoprazole 15 mg or 30 mg daily was similarly efficacious.

This combination will not negate the risk of other NSAID-related adverse events and may not protect all patients from serious GI ADRs. The FDA approved the Prevacid NapraPac in November 2003.

Indications

1. ankylosing spondylitis
2. osteoarthritis
3. rheumatoid arthritis

Side Effects

1. abdominal pain
2. agranulocytosis
3. alopecia
4. anaphylactic shock
5. anaphylactoid reactions
6. angioedema
7. anorexia
8. aplastic anemia
9. aseptic meningitis
10. bezoar
11. blurred vision
12. bone fractures
13. cholelithiasis
14. colitis
15. confusion
16. constipation
17. cough
18. depression
19. diaphoresis
20. diarrhea
21. dizziness
22. drowsiness
23. dyspepsia
24. dysphagia
25. dyspnea
26. elevated hepatic enzymes
27. eosinophilia
28. epistaxis
29. eructation
30. erythema multiforme
31. esophageal stricture
32. esophageal ulceration
33. esophagitis
34. fatigue
35. flatulence
36. GI bleeding
37. GI perforation
38. glomerulonephritis
39. headache
40. hearing loss
41. heart failure
42. hematemesis
43. hematuria
44. hemolysis
45. hemolytic anemia
46. hemoptysis
47. hepatic failure
48. hepatitis
49. hiccups
50. hyperbilirubinemia
51. hyperkalemia
52. hypertension
53. hypomagnesemia
54. infection
55. insomnia
56. interstitial nephritis
57. jaundice
58. leukopenia
59. malaise
60. melena
61. myasthenia
62. myocardial infarction
63. nausea
64. nephrotic syndrome
65. neutropenia
66. odynophagia
67. palpitations
68. pancreatitis
69. pancytopenia
70. peptic ulcer
71. peripheral edema
72. pernicious anemia
73. pharyngitis
74. photophobia
75. photosensitivity
76. platelet dysfunction
77. pneumonitis
78. pruritus
79. pseudomembranous colitis
80. pseudoporphyria
81. pulmonary edema
82. purpura
83. pyrosis (heartburn)
84. rash
85. renal failure (unspecified)
86. renal papillary necrosis
87. rhinitis
88. sinusitis
89. Stevens-Johnson syndrome
90. stomatitis
91. stroke
92. tenesmus
93. thrombocytopenia
94. thromboembolism
95. thrombotic thrombocytopenic purpura (TTP)
96. tinnitus
97. toxic epidermal necrolysis
98. urticaria
99. vasculitis
100. vertigo
101. visual impairment
102. vitamin B12 deficiency
103. vomiting
104. xerophthalmia
105. xerostomia

Monitoring Parameters

• CBC
• LFTs
• serum creatinine/BUN
• serum magnesium
• stool guaiac

Contraindications

• acute bronchospasm
• acute myocardial infarction
• alcoholism
• anemia
• angina
• anticoagulant therapy
• asthma
• bone fractures
• bone marrow suppression
• breast-feeding
• cardiac arrhythmias
• cardiac disease
• cardiomyopathy
• chemotherapy
• children
• coagulopathy
• coronary artery bypass graft surgery (CABG)
• coronary artery disease
• corticosteroid therapy
• dehydration
• dental disease
• dental work
• diabetes mellitus
• diarrhea
• edema
• gastric cancer
• geriatric
• GI bleeding
• GI disease
• GI perforation
• heart failure
• hematological disease
• hemophilia
• hepatic disease
• hypertension
• hypoalbuminemia
• hypomagnesemia
• hypovolemia
• immunosuppression
• infants
• 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
• rheumatoid arthritis
• salicylate hypersensitivity
• stroke
• systemic lupus erythematosus (SLE)
• tachycardia
• thrombocytopenia
• thromboembolism
• tobacco smoking
• ulcerative colitis
• urticaria
• visual disturbance
• vitamin B12 deficiency

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