Sumatriptan and naproxen sodium

What is Sumatriptan and naproxen sodium?

• Sumatriptan and naproxen sodium (Treximet) is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug used to treat migraines attacks.

Sumatriptan

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Naproxen

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What are the uses of this medicine?

• Sumatriptan and naproxen sodium (Treximet) used to treat acute migraine headaches with or without aura in patients 12 years of age and older.

Limitations of use:

• Treximet is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.
• Treximet is not used to prevent or decrease the number of migraine headaches you have.
• It is not known if Treximet is safe and effective to treat cluster headaches.

How does this medicine work?

• Treximet contains sumatriptan and naproxen.

Sumatriptan:

• Sumatriptan - a sulfonamide triptan with vasoconstrictor activity.
• Sumatriptan selectively binds to and activates serotonin 5-ht1d receptors in the central nervous system (cns), thereby constricting cerebral blood vessels.
• This may lead to a relief in pain from vascular headaches.
• Sumatriptan may also relieve vascular headaches by decreasing the release of vasoactive neuropeptides from perivascular trigeminal axons in the dura mater during a migraine, by reducing extravasation of plasma proteins, and by decreasing the release of other mediators of inflammation from the trigeminal nerve.

Naproxen:

• Naproxen (na prox' en) belongs to the propionic acid class of NSAIDs similar to fenoprofen, ibuprofen, ketoprofen and oxaprozin.
• The antiinflammatory and analgesic properties of NSAIDs such as naproxen are mediated by inhibition of tissue cyclo-oxygenases (Cox-1 and -2), which results in a decrease in pro-inflammatory prostaglandins, important mediators in inflammatory and pain pathways.
• Naproxen has analgesic as well as antipyretic and anti inflammatory activity.
• Treximet has analgesic, anti-inflammatory, and antipyretic properties.

• The mechanism of action of Treximet, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• heart problems, history of heart problems, or right before or after heart bypass surgery
• had a stroke, transient ischemic attack (TIAs), or problems with your blood circulation
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• narrowing of blood vessels to your legs and arms (peripheral vascular disease), stomach (ischemic bowel disease), or kidneys
• uncontrolled high blood pressure
• taken any medicines in the last 24 hours that are called 5-HT1 agonists that are triptans or contain ergotamine. Ask your healthcare provider for a list of these medicines if you are not sure.
• taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Ask your healthcare provider for a list if you are not sure.
• had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• an allergy to sumatriptan, naproxen, or any of the ingredients in Treximet.
• liver problems.

What drug interactions can this medicine cause?

• Monitor patients for bleeding who are concomitantly taking Treximet with drugs that interfere with hemostasis. Concomitant use of Treximet and analgesic doses of aspirin is not generally recommended.
• Concomitant use of ACE Inhibitors and ARBs with Treximet in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.
• NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
• Concomitant use of Digoxin with Treximet can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.
• NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. During concomitant use of Treximet and lithium, monitor patients for signs of lithium toxicity.
• Concomitant administration of some NSAIDs with high-dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels. During concomitant use of Treximet and methotrexate, monitor patients for methotrexate toxicity.

Is this medicine FDA approved?

• Treximet (sumatriptan and naproxen sodium) tablets, for oral use was approved in the year of 2008.

How should this medicine be used?

Recommended dosage: Adults:

• Recommended dosage: 1 tablet of 85/500 mg.
• Maximum dosage in a 24-hour period: 2 tablets of 85/500 mg; separate doses by at least 2 hours.

Pediatric Patients 12 to 17 years of Age:

• Recommended dosage: 1 tablet of 10/60 mg.
• Maximum dosage in a 24-hour period: 1 tablet of 85/500 mg.

Mild to Moderate Hepatic Impairment:

• Recommended dosage: 1 tablet of 10/60 mg.

Administration:

• Take Treximet exactly as your healthcare provider tells you to take it.
• Take Treximet tablets whole with water or other liquids.
• Treximet can be taken with or without food.
• If you do not get any relief after your first dose, do not take a second dose without first talking with your healthcare provider.
• If your headache comes back or you only get some relief from your headache:
• For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 2 doses of Treximet 85/500 mg in a 24-hour period.
• For children 12 to 17 years of age: it is not known if taking more than 1 dose of Treximet in 24 hours is safe and effective. Talk to your healthcare provider about what to do if your headache does not go away or comes back.
• If you take too much Treximet, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take Treximet so you can talk with your healthcare provider about how Treximet is working for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 85 mg sumatriptan / 500 mg naproxen sodium

This medicine is available in fallowing brand namesː

• Treximet

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• pain, discomfort, or stiffness in your neck, throat, jaw, or chest
• tingling or numbness in your fingers or toes
• dry mouth
• heartbeat problems
• feeling weak, drowsy, or tired
• nausea
• heartburn
• feeling hot
• muscle tightness

Treximet may cause serious side effects include:

• heart attack or stroke
• ulcers and bleeding in the stomach and intestines
• serious allergic reactions or serious skin reactions
• changes in color or sensation in your fingers and toes (Raynaud's syndrome)
• new or worse high blood pressure
• heart failure from body swelling (fluid retention)
• kidney problems including kidney failure
• low red blood cells (anemia)
• liver problems including liver failure
• asthma attacks in people who have asthma
• stomach and intestinal problems (gastrointestinal and colonic ischemic events)
• peripheral vascular ischemia
• headaches
• serotonin syndrome
• seizures

What special precautions should I follow?

• The use of Treximet is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS. Perform cardiac evaluation in patients with cardiovascular risk factors.
• Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported . Discontinue Treximet if occurs.
• Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan and are usually non-cardiac in origin. Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists. Discontinue Treximet if occurs.
• Sumatriptan may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud′s syndrome. Discontinue Treximet if non-coronary vasospastic reaction occurs.
• Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
• Avoid use of Treximet in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Detoxification may be necessary.
• Serotonin syndrome may occur with Treximet. Discontinue Treximet if occurs. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Treximet in patients with advanced renal disease.
• Treximet should not be given to patients with the aspirin triad. Seep emergency help if an anaphylactic reaction occurs.
• Anaphylactic reactions may occur in patients without known prior exposure to either component of Treximet. Discontinue Treximet at first sign of rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Treximet. Discontinue and evaluate clinically.
• Limit use of NSAIDs, including Treximet, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
• Anemia has occurred in patients receiving NSAIDs. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
• Treximet is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdose of sumatriptan may cause convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation
• Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare.

Management of overdosage:

• Manage patients with symptomatic and supportive care following an NSAID overdosage.
• There are no specific antidotes.
• Consider emesis and/or activated charcoal and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).
• Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding.
• It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
• Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
• For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

Can this medicine be used in pregnancy?

• Use of NSAIDs, including Treximet, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Use of NSAIDs, including Treximet, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Can this medicine be used in children?

• Safety and effectiveness of Treximet in pediatric patients under 12 years of age have not been established.
• The safety and efficacy of Treximet for the acute treatment of migraine in pediatric patients 12 to 17 years of age was established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: sumatriptan succinate and naproxen sodium.
• Inactive ingredients in all strengths: croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, and titanium dioxide.
• 85/500-mg tablets also contain: hypromellose and triacetin.
• 10/60-mg tablets also contain: polyethylene glycol and polyvinyl alcohol.

Who manufactures and distributes this medicine?

• Treximet is a registered trademark of Currax Pharmaceuticals LLC.
• Distributed by Currax™ Pharmaceuticals LLC; Morristown, NJ.

What should I know about storage and disposal of this medication?

• Store Treximet at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Treximet and all medicines out of the reach of children.

• Dailymed label info on Sumatriptan and naproxen sodium
• FDA Sumatriptan and naproxen sodium

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