TREXIMET is indicated for the acute treatment of migraine attacks with or without aura in adults.

Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET.TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache.

---

Migraine Disorders -- neural condition characterized by a severe recurrent vascular headache, usually on one side of the head, often accompanied by nausea, vomiting, and photophobia, sometimes preceded by sensory disturbances; triggers include allergic reactions, excess carbohydrates or iodine in the diet, alcohol, bright lights or loud noises.

Cluster Headache -- A primary headache disorder that is characterized by severe, strictly unilateral PAIN which is orbital, supraorbital, temporal or in any combination of these sites, lasting 15-180 min. occurring 1 to 8 times a day. The attacks are associated with one or more of the following, all of which are ipsilateral: conjunctival injection, lacrimation, nasal congestion, rhinorrhea, facial SWEATING, eyelid EDEMA, and miosis. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

TREXIMET should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes.

In addition, patients with other significant underlying cardiovascular diseases should not receive TREXIMET, nor should patients who have had coronary artery bypass graft (CABG) surgery.

Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina, such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia.

Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks.

Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see WARNINGS: Cardiovascular Effects).

---

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Physical findings -- Objective evidence of disease perceptible to the examining physician.

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Cardiovascular Diseases -- Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Angina Pectoris -- The symptom of paroxysmal pain consequent to MYOCARDIAL ISCHEMIA usually of distinctive character, location and radiation. It is thought to be provoked by a transient stressful situation during which the oxygen requirements of the MYOCARDIUM exceed that supplied by the CORONARY CIRCULATION.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Stable Angina -- Angina pectoris which has not recently changed in frequency, duration or intensity. Stable angina pectoris is relieved by rest or administration or oral, sublingual or transdermal antianginal medications.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Transient Ischemic Attack -- Brief reversible episodes of focal, nonconvulsive ischemic dysfunction of the brain having a duration of less than 24 hours, and usually less than one hour, caused by transient thrombotic or embolic blood vessel occlusion or stenosis. Events may be classified by arterial distribution, temporal pattern, or etiology (e.g., embolic vs. thrombotic). (From Adams et al., Principles of Neurology, 6th ed, pp814-6)

Peripheral Vascular Diseases -- Pathological processes involving any one of the BLOOD VESSELS in the vasculature outside the HEART.

Gastrointestinal tract vascular insufficiency --

TREXIMET should only be used where a clear diagnosis of migraine headache has been established.