美国FDA批准葛兰素史克及其合作伙伴Pozen公司联合开发的偏头痛复方制剂Treximet/Trexima，这也是首种将曲坦类及镇痛药结合起来针对偏头痛多种发病机制的复方药物。Treximet（舒马普坦85毫克+萘普生钠500毫克）用于紧急治疗有或无先兆的成人偏头痛发作。
Treximet是惟一将曲坦类药和抗炎止痛剂结合在同一片剂中的药物，具有靶向多种偏头痛机制的作用。这项批准是基于有2900多名偏头痛患者参加的两项相同的双盲、随机、安慰剂对照、平行分组的多中心研究，研究显示，与单用85毫克舒马普坦或500毫克萘普生钠或安慰剂相比，用Treximet治疗可使更多的患者在两小时和4小时时的偏头痛得到缓解。
在此研究中，Treximet可有效缓解偏头痛发作并可持续2~24小时，同时有效缓解其相关症状如恶心、畏光等。服用Treximet24小时内最常见的不良反应有眩晕、恶心、嗜睡、胸部不适及胸痛，颈、喉及下巴疼痛，紧张，反胃及口干等。

TREXIMET

Generic Name: sumatriptan and naproxen (soo ma TRIP tan and na PROX en)
Brand Names: Treximet

What is Treximet?
Treximet is a tablet containing a combination of sumatriptan and naproxen.

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Treximet is used to treat migraine headaches.

Treximet will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. Treximet should not be used to treat a migraine that causes visual aura (such as flickering lights) with weakness on one side of the body, speech problems, ringing in your ears.

Treximet may also be used for other purposes not listed in this medication guide.

Important information about Treximet
Do not take more than 2 Treximet tablets in 24 hours.

You should not use Treximet if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs).

Do not take Treximet if you have liver disease, uncontrolled high blood pressure, or a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery.

Do not take Treximet if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days. Do not take Treximet within 24 hours before or after taking any of the following medications: almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig), or ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine).

Before taking Treximet
You should not use Treximet if you are allergic to sumatriptan (Imitrex), naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

Do not take Treximet if you have:
liver disease;
untreated or uncontrolled high blood pressure; ora history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery (also called coronary artery bypass graft, or CABG).

Do not take Treximet if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days. Do not take Treximet within 24 hours before or after taking any of the following medicines:
almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig); or
ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine).

If you any of these other conditions, you may need a dose adjustment or special tests to safely use Treximet:
high blood pressure;
congestive heart failure;
epilepsy or other seizure disorder;
liver disease;
kidney disease; orcoronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. Treximet may be harmful to an unborn baby. Tell your doctor if you are pregnant before you take this medication. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take Treximet during pregnancy without your doctor's advice. Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. Do not use Treximet without telling your doctor if you are breast-feeding a baby.

How should I take Treximet?
Use Treximet exactly as it was prescribed for you. Follow the instructions on your prescription label.

Never use more than the recommended dose of Treximet. Overuse of migraine headache medicine can actually make your headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Take one (1) Treximet tablet as soon as you notice headache symptoms, or after an attack has already begun.

Do not crush, chew, or break the tablet. Swallow the pill whole.

You may take Treximet with or without food.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, you may take a second tablet two (2) hours after the first.

You must wait at least 2 hours before taking a second tablet. Do not take more than 2 Treximet tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Contact your doctor if you have more than five headaches in one month (30 days).

If you take Treximet every now and then over a long period of time, your doctor may want to check you on a regular basis to make sure the medication is not causing harmful effects. Do not miss any scheduled appointments.

Naproxen can cause you to have unusual results with certain medical tests. Tell any doctor who treats you if you have taken Treximet within the past 72 hours.

Store Treximet at room temperature away from moisture and heat.

What happens if I miss a dose?
Since Treximet is taken only when needed, it does not have a daily dosing schedule.

Do not take more than 2 Treximet tablets in 24 hours.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a Treximet overdose are unknown, but may include dizziness, drowsiness, heartburn, stomach pain, nausea, vomiting, breathing problems, black or bloody stools, coughing up blood, and seizure (convulsions).

What should I avoid while taking Treximet?
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Medicines available over the counter contain aspirin, naproxen, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking Treximet. Alcohol can increase the risk of stomach bleeding caused by naproxen. Treximet can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Treximet side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Treximet: runny or stuffy nose; hives; wheezing or trouble breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you a serious side effect such as:
chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;
sudden numbness or weakness, confusion, problems with vision, speech, or balance;
bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
urinating less than usual or not at all;
pale skin, weakness, easy bruising, flu symptoms;
swelling or rapid weight gain;
numbness, tingling, pale or blue-colored appearance in your fingers or toes;
severe blistering, peeling, and red skin rash;
seizure (convulsions); oranxiety, restlessness, high fever, sweating, memory problems, trouble concentrating, loss of coordination, vomiting, diarrhea, fast heart rate, hallucinations, or fainting.

Less serious Treximet side effects may include:
dizziness, drowsiness;
constipation, dizziness, indigestion, dry mouth;
warmth, numbness, or tingly feeling;
redness in your face;
tight muscles; or
mild pressure or heavy feeling in any part of your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Treximet?
Many drugs can interact with Treximet. Below is just a partial list. Tell your doctor if you are using:
a blood thinner such as warfarin (Coumadin);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
probenecid (Benemid);
a diuretic (water pill) such as furosemide (Lasix);
steroids (prednisone and others);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), meloxicam (Mobic), and others;
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others;
a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others; oran antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and there may be other drugs that can interact with Treximet. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about Treximet.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

原产地英文商品名:TREXIMET (85/500)mg/tab 9tabs/box

中文参考商品译名:TREXIMET (85/500)毫克/片 9片/盒

中文参考药品译名:琥珀酸舒马普坦/萘普生钠
生产厂家中文参考译名:葛兰素史克
生产厂家英文名:GLAXOSMITHKLINE