Full U.S. Prescribing Information

You should discuss AXERT^® with your doctor and read the Prescribing Information below before taking this medication. It is also important to review this information when you renew your prescription in the event that something has changed within your life that may affect how you take this medication.

To download the Full Prescribing Information, click on the appropriate link below:

Full Prescribing Information*
Use only Ortho-McNeil Neurologics^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. NDC codes to order AXERT^® until further notice.

These codes are:
AXERT^® 6.25 mg 6-tablet blister 0062-2080-06
AXERT^® 12.5 mg 12-tablet blister 0062-2085-12

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INDICATION

AXERT® tablets are indicated for the acute treatment of migraine with or without aura in adults. AXERT® tablets are indicated for the acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). In adolescents age 12-17 years, efficacy of AXERT® on migraine associated symptoms (nausea, photophobia and phonophobia) was not established.

AXERT® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of AXERT® have not been established for cluster headache which is present in an older, predominantly male population.

IMPORTANT SAFETY INFORMATION

AXERT® is a prescription medication for the acute treatment of migraine with or without aura in adults, and for the acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). If you have no response for the first migraine attack treated with AXERT®, then your doctor will need to see if you really have migraine before you take AXERT® to treat any future attacks. You should not take AXERT® if you have heart disease, uncontrolled high blood pressure or have ever had heart disease. If you have risk factors for heart disease (high blood pressure, high cholesterol, diabetes, obesity, smoking, family history of heart attack, menopause, or are a male over 40 years of age), or if you are pregnant, nursing, or thinking about becoming pregnant, talk with your doctor before taking AXERT®. You should also tell your doctor if you have had a stroke of any type or any transient ischemic attacks, or if you have circulation (blood flow) problems, as you should not use AXERT®. Contact your doctor immediately if you are experiencing symptoms of pain, tightness, pressure, or heaviness in your chest, throat, neck, or jaw, shortness of breath, weakness, or slurring of speech, if you experience abdominal pain or bloody diarrhea, or if your fingers or toes become cold or discolored. In very rare cases, serious heart problems have occurred in patients without known heart disease.

AXERT®, like other triptans, may be associated with a potentially life-threatening condition mainly when taken together with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two classes of drugs for depression or other disorders. Common SSRIs are Celexa® (citalopram HBr), Lexapro® (escitalopram oxalate), Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), Symbyax® (olanzapine/fluoxetine), Zoloft® (sertraline), and Luvox® (fluvoxamine). Common SNRIs are Cymbalta® (duloxetine) and Effexor® (venlafaxine). If you experience symptoms such as confusion, sweating, flushing, rapid heartbeat, diarrhea, muscle weakness, poor balance, or worsening headache, contact your doctor immediately.

Tell your doctor about all prescription and over-the-counter medications you are taking. Do not take AXERT® if you have taken an ergotamine-containing or ergot-type medication or another triptan in the last 24 hours. Do not take if you have had an allergic reaction to AXERT® or any of its ingredients. Tell your doctor if you have had an allergic reaction to a sulfonamide drug or if you are taking ketoconazole.

The most common AXERT® side effects in adults are nausea, sleepiness, tingling sensation, headache, and dry mouth.

The most common AXERT® side effects in adolescents are dizziness, sleepiness, headache, tingling sensation, nausea and vomiting.

Ask your doctor about side effects, possible drug interactions, and any other important questions you may have before taking AXERT®.

Celexa and Lexapro are registered trademarks of Forest Laboratories. Paxil is a registered trademark of GlaxoSmithKline. Symbyax, Prozac/Sarafem and Cymbalta are registered trademarks of Eli Lilly. Zoloft is a registered trademark of Pfizer. Luvox is a registered trademark of Solvay. Effexor is a registered trademark of Wyeth.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For full U.S. Prescribing Information, click here.

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Ortho-McNeil Neurologics®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc publishes this site and is solely responsible for its contents.

This information is intended for the use of our customers, patients and healthcare professionals in the United States and Puerto Rico only. Ortho-McNeil-Janssen Pharmaceuticals, Inc. recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States and Puerto Rico.

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This page was last updated on Aug 12 2009 at 22:50:14 EDT.