Naproxen and Sumatriptan

Naproxen and Sumatriptan Brand Name– Treximet

What is Naproxen and Sumatriptan

Naproxen and Sumatriptan is a combination oral product for the acute treatment of migraine attacks with or without aura.

The tablets are manufactured with RT Technology, which enhances the dispersion and dissolution of oral tablets in the stomach even in the presence of gastric stasis. Administration of both naproxen and sumatriptan appears to provide pain relief after 2 hours in more patients as compared with either drug administered alone.

Receipt of naproxen; sumatriptan also appears to be beneficial for patients who have migraine recurrence with sumatriptan monotherapy.

For example, among 67 adults who had efficacy with sumatriptan, the migraine recurrence rate fell from 62.5% to 14% with concurrent naproxen administration.

In 2 large trials, more patients who took the combination had sustained pain free responses 2—24 hours after the dose; the recurrence rate was 13% for the combination, 19—24% with sumatriptan monotherapy, 16—22% with naproxen monotherapy, and 25—31% with placebo.

In a separate long-term study of 362 adults who had at least 2 migraine attacks per month for 12 months, 69% of the attacks did not require a rescue medication after the initial naproxen; sumatriptan dose.

Further, among the 30% of attacks that were treated with a second naproxen; sumatriptan dose, 94% did not require use of another rescue medication.

Naproxen and sumatriptan tablets were FDA-approved in April 2008 for use in adult patients.

In May 2015, naproxen and sumatriptan became the first FDA-approved combination therapy to treat migraines in pediatric patients 12—17 years of age.

Indications

  • migraine

Limitations of Use:

  • Naproxen; sumatriptan should NOT be administered to patients with a history of hemiplegic or basilar migraine.
  • Safety and effectiveness of naproxen; sumatriptan have not been established for cluster headache.
  • Naproxen; sumatriptan is not intended for the prophylactic therapy of migraine.
  • Naproxen; sumatriptan should only be used where a clear diagnosis of migraine headache has been established. Exclude other potentially serious neurologic conditions before treating headaches in patients not previously diagnosed with migraine headache or in patients who experience a headache that is atypical for them

Side Effects

  1. abdominal pain
  2. anaphylactic shock
  3. anemia
  4. angina
  5. angioedema
  6. arrhythmia exacerbation
  7. aseptic meningitis
  8. blurred vision
  9. bowel ischemia
  10. bronchospasm
  11. chest pain (unspecified)
  12. chest pressure syndrome
  13. colitis
  14. constipation
  15. coronary vasospasm
  16. diarrhea
  17. dizziness
  18. drowsiness
  19. dyspepsia
  20. edema
  21. elevated hepatic enzymes
  22. eosinophilia
  23. erythema multiforme
  24. exfoliative dermatitis
  25. GI bleeding
  26. GI perforation
  27. hearing loss
  28. heart failure
  29. hematemesis
  30. hematuria
  31. hepatic failure
  32. hepatic necrosis
  33. hepatitis
  34. hot flashes
  35. hyperkalemia
  36. hypertension
  37. hyponatremia
  38. interstitial nephritis
  39. intracranial bleeding
  40. jaundice
  41. melena
  42. myocardial infarction
  43. nausea
  44. nephrotic syndrome
  45. pancreatitis
  46. paresthesias
  47. peptic ulcer
  48. peripheral edema
  49. peripheral vasoconstriction
  50. platelet dysfunction
  51. renal failure (unspecified)
  52. renal papillary necrosis
  53. seizures
  54. serotonin syndrome
  55. sinus tachycardia
  56. Stevens-Johnson syndrome
  57. stroke
  58. syncope
  59. thrombocytopenia
  60. thromboembolism
  61. tinnitus
  62. toxic epidermal necrolysis
  63. ventricular fibrillation
  64. ventricular tachycardia
  65. visual impairment
  66. vomiting
  67. weight loss
  68. withdrawal
  69. xerostomia

Monitoring Parameters

  • blood pressure
  • CBC
  • ECG
  • hemoglobin/hematocrit
  • LFTs
  • serum creatinine/BUN

Contraindications

  • acute bronchospasm
  • acute myocardial infarction
  • alcoholism
  • anemia
  • angina
  • anticoagulant therapy
  • arteriosclerosis
  • asthma
  • basilar/hemiplegic migraine
  • bone marrow suppression
  • breast-feeding
  • cardiac arrhythmias
  • cardiac disease
  • cardiomyopathy
  • cerebrovascular disease
  • chemotherapy
  • coagulopathy
  • colitis
  • coronary artery bypass graft surgery (CABG)
  • coronary artery disease
  • corticosteroid therapy
  • Crohn’s disease
  • dehydration
  • dental disease
  • dental work
  • diabetes mellitus
  • driving or operating machinery
  • edema
  • geriatric
  • GI bleeding
  • GI disease
  • GI perforation
  • heart failure
  • hematological disease
  • hemophilia
  • hepatic disease
  • hypercholesterolemia
  • hypertension
  • hypovolemia
  • immunosuppression
  • inflammatory bowel disease
  • intracranial bleeding
  • intramuscular injections
  • labor
  • MAOI therapy
  • myocardial infarction
  • nasal polyps
  • neutropenia
  • NSAID hypersensitivity
  • obesity
  • peptic ulcer disease
  • peripheral vascular disease
  • pregnancy
  • Raynaud’s phenomenon
  • renal disease
  • renal failure
  • renal impairment
  • rheumatoid arthritis
  • salicylate hypersensitivity
  • seizure disorder
  • seizures
  • stroke
  • systemic lupus erythematosus (SLE)
  • tachycardia
  • thrombocytopenia
  • thromboembolism
  • tobacco smoking
  • ulcerative colitis
  • urticaria
  • vasospastic angina
  • Wolff-Parkinson-White syndrome

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