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
- abdominal pain
- anaphylactic shock
- anemia
- angina
- angioedema
- arrhythmia exacerbation
- aseptic meningitis
- blurred vision
- bowel ischemia
- bronchospasm
- chest pain (unspecified)
- chest pressure syndrome
- colitis
- constipation
- coronary vasospasm
- diarrhea
- dizziness
- drowsiness
- dyspepsia
- edema
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- exfoliative dermatitis
- GI bleeding
- GI perforation
- hearing loss
- heart failure
- hematemesis
- hematuria
- hepatic failure
- hepatic necrosis
- hepatitis
- hot flashes
- hyperkalemia
- hypertension
- hyponatremia
- interstitial nephritis
- intracranial bleeding
- jaundice
- melena
- myocardial infarction
- nausea
- nephrotic syndrome
- pancreatitis
- paresthesias
- peptic ulcer
- peripheral edema
- peripheral vasoconstriction
- platelet dysfunction
- renal failure (unspecified)
- renal papillary necrosis
- seizures
- serotonin syndrome
- sinus tachycardia
- Stevens-Johnson syndrome
- stroke
- syncope
- thrombocytopenia
- thromboembolism
- tinnitus
- toxic epidermal necrolysis
- ventricular fibrillation
- ventricular tachycardia
- visual impairment
- vomiting
- weight loss
- withdrawal
- 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
Interactions
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