Naproxen and Pseudoephedrine

Naproxen and Pseudoephedrine Brand Names

Aleve Cold and Sinus | Aleve Sinus Headache | Aleve-D 12 Hour Sinus & Cold | Aleve-D 12 Hour Sinus & Headache | Sudafed 12 hour Pressure + Pain | Sudafed Sinus and Pain 12 hour

What is Naproxen and Pseudoephedrine

Naproxen and Pseudoephedrine is a non-prescription combination product used for the temporary relief of cold, sinus, or flu symptoms including mild pain, sinus and nasal congestion, headache, sinus pressure, and fever.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used in this product for its antipyretic and analgesic properties.

All NSAIDs, including naproxen, carry an increased risk of serious gastrointestinal (GI) adverse effects (see Contraindications/Precautions) and may carry an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke.

A retrospective review by CDER of short-term efficacy trials of non-prescription strength naproxen indicated that an increase in CV events was not apparent during the studies.

However, it is important to note that CV risk was not the focus of the studies, and further information is needed to determine if a cause and effect relationship exists between non-prescription strength NSAID use and adverse cardiovascular outcomes.

FDA-approved labeling of OTC naproxen and pseudoephedrine products advises patients to not exceed recommended dose or duration, as the risk for adverse effects may increase with increased use.

Further, if such a product is needed for longer than 10 days, the patient should consult their health care provider.

Indications

• common cold
• fever
• headache
• mild pain
• nasal congestion

For the temporary relief of common cold, sinus, and flu symptoms including mild pain, sinus and nasal congestion, headache, sinus pressure, and fever

Side Effects

1. abdominal pain
2. agranulocytosis
3. alopecia
4. anaphylactic shock
5. anaphylactoid reactions
6. angina
7. angioedema
8. anorexia
9. anxiety
10. aplastic anemia
11. arrhythmia exacerbation
12. aseptic meningitis
13. blurred vision
14. colitis
15. confusion
16. constipation
17. contact dermatitis
18. depression
19. diaphoresis
20. diarrhea
21. dizziness
22. drowsiness
23. dyspepsia
24. dysphagia
25. dyspnea
26. dysuria
27. ecchymosis
28. edema
29. elevated hepatic enzymes
30. eosinophilia
31. erythema
32. erythema multiforme
33. esophageal stricture
34. esophageal ulceration
35. esophagitis
36. fatigue
37. fluid retention
38. gastritis
39. GI bleeding
40. GI perforation
41. glomerulonephritis
42. hallucinations
43. headache
44. hearing loss
45. heart failure
46. hematemesis
47. hematuria
48. hemolytic anemia
49. hepatic failure
50. hepatitis
51. hyperkalemia
52. hypertension
53. hypertensive crisis
54. insomnia
55. interstitial nephritis
56. jaundice
57. leukopenia
58. malaise
59. melena
60. myasthenia
61. myocardial infarction
62. nausea
63. nephrotic syndrome
64. neutropenia
65. ocular hypertension
66. odynophagia
67. palpitations
68. pancreatitis
69. peptic ulcer
70. peripheral edema
71. photophobia
72. photosensitivity
73. platelet dysfunction
74. pneumonitis
75. premature ventricular contractions (PVCs)
76. pruritus
77. pseudoporphyria
78. psychosis
79. purpura
80. pyrosis (heartburn)
81. rash
82. renal failure (unspecified)
83. renal papillary necrosis
84. restlessness
85. seizures
86. sinus tachycardia
87. Stevens-Johnson syndrome
88. stomatitis
89. stroke
90. supraventricular tachycardia (SVT)
91. thrombocytopenia
92. tinnitus
93. toxic epidermal necrolysis
94. urticaria
95. vasculitis
96. vertigo
97. visual impairment
98. vomiting

Monitoring Parameters

• laboratory monitoring not necessary

Contraindications

• acute bronchospasm
• acute myocardial infarction
• anemia
• angina
• anticoagulant therapy
• asthma
• breast-feeding
• cardiac arrhythmias
• cardiac disease
• cardiomyopathy
• children
• closed-angle glaucoma
• coagulopathy
• coronary artery bypass graft surgery (CABG)
• coronary artery disease
• corticosteroid therapy
• dehydration
• diabetes mellitus
• ethanol ingestion
• geriatric
• GI bleeding
• GI perforation
• heart failure
• hepatic disease
• hypertension
• hyperthyroidism
• hypoalbuminemia
• hypovolemia
• infants
• infertility
• labor
• laboratory test interference
• MAOI therapy
• myocardial infarction
• nasal polyps
• NSAID hypersensitivity
• obstetric delivery
• peptic ulcer disease
• peripheral vascular disease
• pregnancy
• prostatic hypertrophy
• renal disease
• renal failure
• renal impairment
• reproductive risk
• salicylate hypersensitivity
• stroke
• tachycardia
• tobacco smoking
• urinary retention
• urticaria

Interactions

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