Diclofenac Misoprostol

Diclofenac Misoprostol Brand Name– Arthrotec

What is Diclofenac Misoprostol

Arthrotec is a combination of diclofenac sodium and misoprostol.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), and misoprostol is a synthetic prostaglandin of the E series that inhibits gastric acid secretion and stimulates mucus secretion in the digestive tract.

Misoprostol has been shown to reduce the risk of NSAID-induced gastric ulcers, but all NSAIDs including diclofenac cause 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 thrombotic events, myocardial infarction, and stroke.

The lowest effective diclofenac; misoprostol dose for the shortest possible duration is recommended, as the risk for adverse effects may increase with duration of use.

Diclofenac misoprostol was approved by the FDA December 24, 1997 for the treatment of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

Due to the abortifacient properties of misoprostol, this combination is contraindicated in women who are pregnant.

The combination product is also available by the same brand name in Canada and Europe.

Indications

1. osteoarthritis
2. rheumatoid arthritis

NOTE: Misoprostol 0.2 mg PO 3—4 times a day are therapeutically equivalent for gastric ulcer prevention. Misoprostol 0.2 mg PO 4 times a day is more protective than administration of the dose 2—3 times a day for duodenal ulcer prevention. No more than 0.2 mg of misoprostol should be given at one time.

For the treatment of the signs and symptoms of osteoarthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications

Side Effects

1. abdominal pain
2. acne vulgaris
3. agranulocytosis
4. alopecia
5. amniotic fluid embolism
6. anaphylactoid reactions
7. anemia
8. angioedema
9. anxiety
10. aplastic anemia
11. appetite stimulation
12. arrhythmia exacerbation
13. arthralgia
14. aseptic meningitis
15. asthenia
16. atrial fibrillation
17. azotemia
18. blurred vision
19. bullous rash
20. chills
21. coma
22. conjunctivitis
23. cough
24. cystitis
25. dehydration
26. depression
27. diarrhea
28. diplopia
29. dizziness
30. drowsiness
31. dysgeusia
32. dysmenorrhea
33. dyspepsia
34. dysphagia
35. dysuria
36. ecchymosis
37. edema
38. elevated hepatic enzymes
39. eosinophilia
40. epistaxis
41. eructation
42. erythema multiforme
43. esophageal ulceration
44. esophagitis
45. exfoliative dermatitis
46. fatigue
47. fetal death
48. flatulence
49. fluid retention
50. gastritis
51. gastroesophageal reflux
52. GI bleeding
53. GI perforation
54. glomerulonephritis
55. glossitis
56. glycosuria
57. gout
58. hallucinations
59. headache
60. hearing loss
61. heart failure
62. hematemesis
63. hematuria
64. hemolytic anemia
65. hemorrhoids
66. hepatic failure
67. hepatic necrosis
68. hepatitis
69. hypercholesterolemia
70. hyperesthesia
71. hyperglycemia
72. hyperhidrosis
73. hypertension
74. hypertonia
75. hyperuricemia
76. hyperventilation
77. hypoesthesia
78. hypoglycemia
79. hyponatremia
80. hypotension
81. impaired cognition
82. impotence (erectile dysfunction)
83. increased urinary frequency
84. infection
85. insomnia
86. interstitial nephritis
87. iritis
88. irritability
89. jaundice
90. lacrimation
91. leukocytosis
92. leukopenia
93. leukorrhea
94. lymphadenopathy
95. malaise
96. melena
97. menorrhagia
98. menstrual irregularity
99. migraine
100. myalgia
101. myocardial infarction
102. nausea
103. nephrotic syndrome
104. night blindness
105. nocturia
106. oliguria
107. palpitations
108. pancreatitis
109. pancytopenia
110. paranoia
111. paresthesias
112. pemphigus
113. peptic ulcer
114. perineal pain
115. peripheral edema
116. phlebitis
117. photosensitivity
118. platelet dysfunction
119. polyuria
120. porphyria
121. postmenopausal bleeding
122. premature labor
123. premature ventricular contractions (PVCs)
124. proteinuria
125. pruritus
126. pruritus ani
127. psychosis
128. pulmonary embolism
129. purpura
130. pyrosis (heartburn)
131. rash
132. renal failure (unspecified)
133. renal papillary necrosis
134. respiratory depression
135. sinus tachycardia
136. skin ulcer
137. spontaneous fetal abortion
138. Stevens-Johnson syndrome
139. stomatitis
140. stroke
141. syncope
142. tenesmus
143. teratogenesis
144. thrombocytopenia
145. thromboembolism
146. tinnitus
147. toxic epidermal necrolysis
148. tremor
149. urticaria
150. uterine contractions
151. uterine perforation
152. uterine rupture
153. vaginal bleeding
154. vaginitis
155. vasculitis
156. vertigo
157. visual impairment
158. vomiting
159. weight gain
160. weight loss
161. xerostomia

Monitoring Parameters

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

Contraindications

• acute bronchospasm
• acute myocardial infarction
• alcoholism
• anemia
• angina
• anticoagulant therapy
• asthma
• bone marrow suppression
• breast-feeding
• cardiac arrhythmias
• cardiac disease
• cerebrovascular disease
• chemotherapy
• children
• coagulopathy
• coronary artery bypass graft surgery (CABG)
• coronary artery disease
• corticosteroid therapy
• dehydration
• dental disease
• dental work
• diabetes mellitus
• geriatric
• GI bleeding
• GI disease
• GI perforation
• heart failure
• hematological disease
• hemophilia
• hepatic disease
• hypertension
• hypovolemia
• immunosuppression
• inflammatory bowel disease
• intramuscular injections
• jaundice
• labor
• lactase deficiency
• myocardial infarction
• nasal polyps
• neutropenia
• NSAID hypersensitivity
• peptic ulcer disease
• peripheral vascular disease
• porphyria
• pregnancy
• 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

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