Sumatriptan and naproxen

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• It is used to treat migraine headaches.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how sumatriptan and naproxen affects you.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this medicine. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
• Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with sumatriptan and naproxen. Call your doctor right away if you have a change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• NSAIDs like sumatriptan and naproxen may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this medicine is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking sumatriptan and naproxen, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Very bad headache or if headache is not better after the first dose.
• Very bad belly pain or bloody loose stools.
• Change in eyesight, eye pain, or very bad eye irritation.
• Loss of eyesight. This can be long-lasting.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Feeling very tired or weak.
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take sumatriptan and naproxen with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Treximet 10/60: Sumatriptan 10 mg and naproxen sodium 60 mg [contains sodium ~20 mg/tablet]

Treximet 85/500: Sumatriptan 85 mg and naproxen sodium 500 mg [contains sodium ~60 mg/tablet]

Note: Use care when prescribing; there are 2 different Treximet tablet strengths available.

Migraine headache: Oral: Sumatriptan 85 mg/naproxen 500 mg. If a satisfactory response has not been obtained at 2 hours, a second dose may be administered (maximum: Sumatriptan 170 mg/naproxen 1,000 mg in 24 hours). Note: The safety of treating an average of >5 migraine headaches in a 30-day period has not been established.

Refer to adult dosing.

1% to 10%:

Cardiovascular: Chest discomfort (≤3%), chest pain (≤3%)

Central nervous system: Dizziness (4%), drowsiness (3%), paresthesia (2%)

Gastrointestinal: Nausea (3%), sore throat (≤3%), dyspepsia (2%), xerostomia (2%)

Neuromuscular & skeletal: Jaw pain (≤3%), jaw pressure (≤3%), jaw tightness (≤3%), neck pain (≤3%), neck pressure (≤3%), neck tightness (≤3%)

Respiratory: Pharyngeal edema (≤3%; tightness and pressure)

<1% (Limited to important or life-threatening): Gastric ulcer (including recurrence)

Migraine relief; occult blood loss; periodic liver function test, hematocrit and hemoglobin (in patients with signs or symptoms suggestive of anemia); platelets and bleeding time (in patients who may be affected by changes in platelet function), urine output; blood pressure; renal function (in patients with dehydration, mild to moderate renal impairment, or preexisting kidney disease), signs/symptoms suggestive of angina; perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD), monitor ECG with first dose in patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation and consider periodic cardiovascular evaluation in such patients if they are intermittent long-term users; signs/symptoms of serotonin syndrome and hypersensitivity reactions.

Administration advice:
-Take orally with or without food
-Tablets should not be split, crushed, or chewed
-For patients with multiple cardiovascular risk factors who have had a negative CV evaluation, consider administering the first under close medical supervision, follow with an ECG.

Storage requirements:
-Do not repackage; dispense and store in original container with desiccant

General:
-Use of acute migraine drugs for 10 more days per month may lead to medication overuse headache.
-This drug should not be used within 24 hours of another triptan or an ergot-type medication.

Monitoring:
Renal: Monitor renal function in patients with mild to moderate renal impairment, dehydration, or preexisting kidney disease.
Cardiovascular: Monitor blood pressure; periodically evaluate patients for cardiovascular risks.
Hematologic: Closely monitor patients with coagulation disorders or those patients receiving anticoagulants for potential effects on platelet function.

Patient advice:
-Patients should understand the risk of cardiovascular and cerebrovascular events and seek medical advice promptly in the event of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness and slurring of speech.
-Patients should be aware that this product contains a NSAID; they should be instructed to watch for and report any unexplained weight gain or edema, signs or symptoms of hepatotoxicity, or gastrointestinal toxicity.
-Inform patients about the signs and symptoms of serious skin manifestations and instruct patients to contact their health care professional at first appearance of a skin rash or any other sign of hypersensitivity.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.

Although limited data suggests naproxen levels in breastmilk are low and adverse effects in breastfed infants uncommon, the long half-life of this drug and potentially serious adverse reactions that may occur make other agents preferable.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with Sumatriptan and Naproxen Sodium Tablets and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events, Prinzmetal's Angina, Other Vasospasm-Related Events, Arrhythmias and Cerebrovascular Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for signs and symptoms of chest pain, shortness of breath, weakness, irregular heartbeat, significant rise in blood pressure, weakness and slurring of speech, and should be advised to report any of these symptoms to their health care provider immediately. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.3, 5.5, 5.6, 5.8)].

Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop Sumatriptan and Naproxen Sodium Tablets and seek immediate medical therapy [see Warnings and Precautions (5.7)].

Anaphylactic Reactions

Inform patients that anaphylactic reactions have occurred in patients receiving the components of Sumatriptan and Naproxen Sodium Tablets. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Contraindications (4), Warnings and Precautions (5.13)].

Serious Skin Reactions

Inform patients that Sumatriptan and Naproxen Sodium Tablets, like other NSAID-containing products, may increase the risk of serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their healthcare providers as soon as possible [see Warnings and Precautions (5.14)].

Fetal Toxicity

Inform patients that Sumatriptan and Naproxen Sodium Tablets should not be used during the third trimester of pregnancy because NSAID-containing products have been shown to cause premature closure of the ductus arteriosus. Inform patients that Sumatriptan and Naproxen Sodium Tablets should be used during the first and second trimester of pregnancy only if the potential benefit justifies the potential risk to the fetus [see Contraindications (4), Warnings and Precautions (5.15), Use in Specific Populations (8.1)].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.9)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.13)].

Concomitant Use with Other Triptans or Ergot Medications

Inform patients that use of Sumatriptan and Naproxen Sodium Tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of Sumatriptan and Naproxen Sodium Tablets or other triptans, particularly during concomitant use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.11), Drug Interactions (7.1)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.10)].

Ability to Perform Complex Tasks

Treatment with Sumatriptan and Naproxen Sodium Tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan and Naproxen Sodium Tablets [see Adverse Reactions (6.1)].

Asthma

Advise patients with preexisting asthma to seek immediate medical attention if their asthma worsens after taking Sumatriptan and Naproxen Sodium Tablets. Patients with a history of aspirin-sensitive asthma should not take Sumatriptan and Naproxen Sodium Tablets [see Contraindications (4), Warnings and Precautions (5.17)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of Sumatriptan and Naproxen Sodium Tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.

Use of NSAIDS and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with Sumatriptan and Naproxen Sodium Tablets until they talk to their healthcare provider [see Drug Interactions (7)].

The other brands listed are trademarks of their respective owners and are not trademarks of Pernix Ireland Limited. The makers of these brands are not affiliated with and do not endorse Pernix Ireland Limited or its products.

Pernix Ireland Limited, distributed by Macoven Pharmaceuticals, LLC
Morristown, NJ 07960

©2017, Pernix Ireland Limited. All rights reserved.

May 2017
SUM-LC070.00

Sumatriptan and Naproxen may be found in some form under the following brand names:

• Treximet