Treximet

Treximet is a prescription medication used to treat migraines, with or without aura. 

It is a single product containing 2 medications: sumatriptan and naproxen. Sumatriptan belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain. Naproxen belongs to a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs. These work by stopping substances in your body that cause inflammation and pain.

This medication comes in tablet form and is taken at the first sign of a migraine headache. Treximet may be taken with or without food. Treximet should be swallowed whole; the tablet should not be crushed, divided, or chewed. 

Common side effects of Treximet include dizziness, tiredness, burning or prickling feeling in the hands, arms, legs, or feet (paresthesia), nausea, stomach upset, dry mouth, chest discomfort, and pain in the neck, throat, or jaw. 

Treximet can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Treximet affects you.

Treximet is a prescription medication used to treat migraines, with or without aura. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pernix Therapeutics, LLC

Serious side effects have been reported with Treximet. See the “Treximet Precautions” section.

Common side effects of Treximet include the following:

• dizziness
• tiredness
• burning or prickling feeling in the hands, arms, legs, or feet (paresthesia)
• nausea
• stomach upset
• dry mouth
• chest discomfort
• pain in the neck, throat, or jaw

This is not a complete list of Treximet side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Zestril, Prinivil), ramipril (Altace), quinapril (Accupril), captopril (Capoten), benazepril (Lotensin), and enalapril (Vasotec)
• angiotensin receptor blockers (ARBs) such as losartan (Cozaar), irbesartan (Avapro), olmesartan (Benicar), candesartan (Atacand), and valsartan (Diovan)
• beta-blockers such as propranolol (Inderal), timolol (Timoptic), atenolol (Tenormin), and metoprolol (Lopressor, Toprol)
• antacids such as Tums, Citrical, or Rolaids
• sucralfate (Carafate)
• aspirin (Ecotrin)
• diuretics such as furosemide (Lasix), hydrochlorothiazide (Microzide), and chlorthalidone (Thalitone)
• cholestyramine (Questran)
• lithium
• methotrexate (Trexall)
• warfarin (Coumadin, Jantoven)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), sertraline (Zoloft), and escitalopram (Lexapro)
• serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) and venlafaxine (Effexor)
• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as sumatriptan (Imitrex), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan(Maxalt), and zolmitriptan (Zomig)

This is not a complete list of Treximet drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Treximet including the following:

• Heart attack or stroke: Tell your healthcare provider right away if you have some or all of the following symptoms: 
  • shortness of breath
  • chest pain
  • weakness
  • slurring of speech

• New hypertension or worsening of preexisting hypertension: Have your blood pressure watched by your doctor closely if taking Treximet, especially if you have a history of hypertension or are taking medications to treat hypertension.

• Congestive heart failure: Tell your healthcare provider right away if you have some or all of the following symptoms: 
  • swelling in the arms or legs
  • shortness of breath
  • unexplained weight gain
  • fatigue

• Serious and sometimes fatal skin reaction: Tell your healthcare provider right away if you have some or all of the following symptoms: 
  • rash
  • blistering
  • itching
  • fever

• Stomach bleeding and ulceration (holes or sores of your stomach or intestines): Tell your healthcare provider right away if you have some or all of the following symptoms: 
  • pain
  • blood in stools (black or tarry stools)
  • coughing up of blood
  • indigestion or general stomach discomfort

• Medication overuse headaches: Some people who take/use too much sumatriptan (one of two active ingredients in Treximet), may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment.

• Seizures: Seizures have happened in people taking sumatriptan (one of the two active ingredients in Treximet) who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan.

• Serotonin syndrome: Serotonin syndrome is a serious and life-threatening problem that can happen in people taking sumatriptan (one of two active ingredients in Treximet), especially if sumatriptan is used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

  • Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
    • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
    • fast heartbeat
    • changes in blood pressure
    • high body temperature
    • tight muscles
    • trouble walking
    • nausea, vomiting, or diarrhea
    • Liver toxicity: Tell your healthcare provider right away if you have some or all of the following symptoms: 
    • flu-like symptoms
    • itchiness
    • fatigue
    • nausea
    • yellow tinting of the skin or eyes
• Kidney injury: Patients at greatest risk of this are those who already have renal dysfunction, heart failure, liver injury, those taking diuretics or ACE inhibitors, and the elderly.
• Anaphylactoid reaction: Tell your healthcare provider right away if you have some or all of the following symptoms:
  • swelling of the face or throat or trouble swallowing
  • difficulty breathing, coughing, chest tightness, wheezing
  • dizziness, fainting, rapid or weak heartbeat
  • flushing, itching, hives or a feeling of warmth
• Pregnancy: In late pregnancy, Treximet should be avoided since one of the ingredients (naproxen) may cause premature closure of the ductus arteriosus.
• Pre-existing asthma: Treximet should not be taken in patients with aspirin-sensitive asthma and should be used with caution in patients with preexisting asthma.
• Anemia: Tell your healthcare provider right away if you have some or all of the following symptoms:
  • Shortness of breath
  • Dizziness
  • Headache
  • Coldness in the hands and feet
  • Pale skin
  • Chest pain

Treximet can cause dizziness or drowsiness.  Do not drive or operate heavy machinery until you know how Treximet affects you.

Do not take Treximet if you have a history of:

• a hypersensitivity (allergic) reaction to Treximet
• asthma, hives, or other allergic-type reactions after taking NSAIDs (including naproxen, one of the two active ingredients in Treximet) other aspirin
• coronary artery bypass graft (CABG) surgery; naproxen is not to be used for treating pain before or after this surgery
• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• taken any of the following medicines in the last 24 hours:
  • almotriptan (Axert)
  • eletriptan (Relpax)
  • frovatriptan (Frova)
  • naratriptan (Amerge)
  • rizatriptan (Maxalt, Maxalt-MLT)
  • ergotamines (Cafergot, Ergomar, Migergot)
  • dihydroergotamine (D.H.E. 45, Migranal)
• an allergy to Treximet or any of the ingredients in Treximet. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before you take Treximet, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to Treximet or any of its ingredients
• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• are a female who has gone through menopause
• have heart disease or a family history of heart disease or stroke
• have liver problems
• have kidney problems
• have clotting problems or are taking anticoagulation medications
• have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
• have asthma
• have had epilepsy or seizures
• are not using effective birth control
• are pregnant or plan to become pregnant
• become pregnant while taking sumatriptan (one of two active ingredients in Treximet)
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Treximet should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. There is a Treximet Pregnancy Registry that monitors fetal outcomes of pregnant women exposed to Treximet. Talk to your healthcare provider about how to get on the Treximet Pregnancy Registry if you take Treximet while breastfeeding. 

In addition, naproxen (one of the ingredients of Treximet) is known to cause heart defects on the developing fetus. Use during pregnancy, especially during late pregnancy, should be avoided.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

You should not take Treximet if you are breastfeeding. It may be excreted in your breast milk and may harm your nursing child.

Take Treximet exactly as prescribed.

Treximet comes in tablet form and is taken is taken once at the first sign of a migraine headache. Treximet may be taken with or without food. Treximet should be swallowed whole; do not split, crush, or chew Treximet. A second tablet may be taken after 2 hours if your migraine is not successfully treated. The dosing of tablets should be at least 2 hours apart. 

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 this medication so you can talk with your healthcare provider about how Treximet is working for you.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose is 1 tablet (85 mg of sumatriptan and 500 mg of naproxen) taken at the first sign of a migraine headache. A second tablet may be taken after 2 hours if your migraine is not successfully treated. The tablets should be dosed at least 2 hours apart. 

If you take too much Treximet, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Treximet at room temperature (25°C or 77°F). Excursions are permitted to 15°-30°C or 59°-86°F.
• Do not repackage Treximet; dispense and store Treximet in its original container. 
• Keep this and all medicines out of the reach of children.

WARNINGS