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AXERT- almotriptan malate tablet, coated


  1. Patient Information
  2. Tell Your Doctor If You Take:
  3. Risk Factors For Heart Disease, Such As:
  4. "who Should Not Take Axert?
  5. What To Do In Case Of An Overdose?
  6. What Is A Migraine And How Does It Differ From Other Headaches?
  7. Certain Things May Trigger Migraine Attacks In Some People. Some Of These Triggers Are:
  8. Revised: 10/2012document Id:

Patient Information 

AXERTis a medication used to treat migraine attacks in adults and adolescents age 12 to 17 years. AXERTis a member of a class of drugs called selective serotonin receptor agonists.

Use AXERTonly for a migraine attack. Do not use AXERTto treat headaches that might be caused by other conditions. Tell your doctor about your symptoms. Your doctor will decide if you have migraine.

There is more information about migraine at the end of this leaflet.

Who should not take AXERT?1

Do not take AXERTif you:

  • have ever had heart disease.
  • have uncontrolled high blood pressure.
  • have hemiplegic or basilar migraine. If you are not sure, ask your doctor.
  • have taken another serotonin receptor agonist (e.g., another triptan) in the last 24 hours. These include naratriptan (AMERGE), rizatriptan (MAXALT), sumatriptan (IMITREX, TREXIMET), or zolmitriptan (ZOMIG).
  • have taken ergotamine-type medicines in the last 24 hours. These include ergotamine (BELLERGAL-S, CAFERGOT, ERGOMAR, WIGRAINE), dihydroergotamine (D.H.E. 45), or methysergide (SANSERT).
  • had an allergic reaction to AXERTor any of its ingredients. The active ingredient is almotriptan malate. Ask your doctor or pharmacist about inactive ingredients.

Tell Your Doctor If You Take: 

  • monoamine oxidase (MAO) inhibitors, such as phenelzine sulfate (NARDIL) or tranylcypromine sulfate (PARNATE) for depression or another condition, or if it has been less than two weeks since you stopped taking an MAO inhibitor.
  • ketoconazole (NIZORAL), itraconazole (SPORANOX), ritonavir (NORVIR), or erythromycin (EMYCIN), or if it has been less than one week since you stopped taking one of these drugs.
  • selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types 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 fluvoxamine. Common SNRIs are CYMBALTA(duloxetine) and EFFEXOR(venlafaxine).

These medicines may affect how AXERTworks, or AXERTmay affect how these medicines work.

To help your doctor decide if AXERTis right for you or if you need to be checked while taking AXERT, tell your doctor about any:

  • past or present medical problems.
  • past or present high blood pressure, chest pain, shortness of breath, or heart disease.
  • liver or kidney problems.

Risk Factors For Heart Disease, Such As: 

high blood pressure
diabetes
high cholesterol
overweight
smoking
family members with heart disease
you are past menopause
you are a male over 40 years old.
  • allergic reactions to sulfonamides, also known as sulfa drugs (ask your doctor if you are not sure what sulfonamide drugs are).
  • medicines you take or plan to take, including prescription and non-prescription medicines and herbal supplements. Be sure to include medicines you normally take for a migraine.
  • Talk to your doctor about using AXERTif you are pregnant, planning to become pregnant, or breastfeeding.

    How should I take AXERT?

    • When you have a migraine headache, take your medicine as directed by your doctor.
    • If your headache comes back after your first dose, you may take a second dose 2 hours or more after the first dose. If your pain continues after the first dose, do not take a second dose without first checking with your doctor.
    • Do not take more than two AXERTTablets in a 24-hour period.
    • If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

    What should I avoid while taking AXERT?

    Check with your doctor before you take any new medicines, including prescription and non-prescription medicines and supplements. There are some medicines that you should not take during the period 24 hours before and 24 hours after taking AXERT. Some of them are listed in the section

    "who Should Not Take Axert? 

    "

    What are the possible side effects of AXERT?

    The side effects are usually mild and do not last long. The following isnota complete list of side effects. Ask your doctor to tell you about the other side effects.

    Themost commonside effects in adults are:

    • Nausea
    • Sleepiness
    • Tingling or burning feeling (paresthesia)
    • Headache
    • Dry mouth

    Themost commonside effects in adolescents are:

    • Dizziness
    • Sleepiness
    • Nausea
    • Headache
    • Tingling or burning feeling (paresthesia)
    • Vomiting

    If you experience sleepiness, you should evaluate your ability to perform complex tasks, such as driving or operating heavy machinery.

    Tell your doctor about any other symptoms that you develop while taking AXERT. If the symptoms continue or worsen, get medical help right away. Also, tell your doctor if you develop a rash or itching after taking AXERT. You may be allergic to the medicine.

    In very rare cases, patients taking this class of medicines experience serious heart problems, stroke, or increased blood pressure. Extremely rarely, patients have died. Therefore, tell your doctor right away if you feel tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw after taking AXERT. Do not take AXERTagain until your doctor has checked you.

    Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use AXERT. In particular, this reaction may occur when they use AXERTtogether with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (hallucinations, agitation, or coma), fast heartbeat, changes in blood pressure, high body temperature or sweating, tight muscles, trouble walking, nausea, vomiting, or diarrhea. Call your doctor immediately if you have any of these symptoms after taking AXERT.

    This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

    What To Do In Case Of An Overdose? 

    Call your doctor or poison control center or go to the ER.

    What Is A Migraine And How Does It Differ From Other Headaches? 

    A migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. The pain and symptoms from a migraine headache may be worse than the pain and symptoms of a common headache.

    Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.

    Migraine attacks typically last for hours or, rarely, for more than a day. They can return often. The strength and frequency of migraine attacks may vary.

    Based on your symptoms, your doctor will decide whether you have a migraine.

    Migraine headaches tend to occur in members of the same family. Both men and women get migraines, but it is more common in women.

    Certain Things May Trigger Migraine Attacks In Some People. Some Of These Triggers Are: 

    • certain foods or drinks, such as cheese, chocolate, citrus fruit (oranges, grapefruit, lemons, limes, and others), caffeine, and alcohol.
    • stress.
    • a change in behavior, such as too much or too little sleep, missing a meal, or a change in diet.
    • hormone changes in women, such as during monthly menstrual periods.

    You may be able to prevent migraine attacks or make them come less often if you understand what triggers your attacks. Keeping a headache diary may help you identify and monitor the possible triggers that cause your migraine. Once you identify the triggers, you and your doctor can change your lifestyle to avoid those triggers.

    How does AXERTwork during a migraine attack?

    Treatment with AXERT:

    • reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack.
    • blocks the release of substances from nerve endings that cause more pain and other symptoms of migraine.
    • interrupts the sending of specific pain signals to your brain.

    It is thought that each of these actions contributes to relief of your symptoms by AXERT.

    How should I store AXERT?

    Keep your medicine in a safe place where children cannot reach it. It may be harmful to children. Store your medicine away from heat, light, or moisture at a controlled room temperature. If your medicine has expired, throw it away as instructed. If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to do so. Throw away your medicine as instructed. Be sure that discarded tablets are out of the reach of children.

    General advice about prescription medicines

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use AXERTfor a condition for which it was not prescribed. Do not give AXERTto other people even if they have the same symptoms you have. People may be harmed if they take medicines that have not been prescribed for them.

    This leaflet provides a summary of information about AXERT. If you have any questions or concerns about either AXERTor migraines, talk to your doctor. In addition, talk to your pharmacist or other healthcare provider.

    AXERTTablets are manufactured by:
    Janssen-Ortho, LLC
    Gurabo, Puerto Rico 00778

    AXERTTablets are manufactured for:
    Ortho-McNeil Neurologics,
    Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
    Titusville, NJ 08560

    Licensed from: Almirall, S.A.
    U.S.Patent No. 5,565,447

    Revised April 2011


    1
    The brands listed are the trademarks of their respective owners and are not the trademarks of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

    PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton

    NDC 54868-5527-1

    Axert
    (almotriptan malate) Tablets

    equivalent to
    12.5 mg
    almotriptan

    12 tablets

    Rx only

    PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Carton
    AXERT
    almotriptan malate tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5527(NDC:0062-2085)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    almotriptan malate(UNII: PJP312605E) (almotriptan - UNII:1O4XL5SN61)almotriptan12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    mannitol(UNII: 3OWL53L36A)
    powdered cellulose(UNII: SMD1X3XO9M)
    sodium starch glycolate type A potato(UNII: 5856J3G2A2)
    sodium stearyl fumarate(UNII: 7CV7WJK4UI)
    titanium dioxide(UNII: 15FIX9V2JP)
    hypromelloses(UNII: 3NXW29V3WO)
    polyethylene glycols(UNII: 3WJQ0SDW1A)
    propylene glycol(UNII: 6DC9Q167V3)
    ferric oxide red(UNII: 1K09F3G675)
    carnauba wax(UNII: R12CBM0EIZ)
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint CodeA
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5527-112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02100102/09/2006
    Labeler -Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-5527)

    Revised: 10/2012document Id: 

    496c5df0-d2c8-4bd8-8eb3-7293863db328Set id: 886c13fa-4547-4411-88aa-8e23a7a698f6Version: 2Effective Time: 20121010Physicians Total Care, Inc.



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