"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
(almotriptan malate) Tablets
Please read this information before you start taking AXERT® (almotriptan malate) Tablets. Also, read this leaflet each time you renew your prescription just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss AXERT® when you start taking your medication and at regular checkups.
What is AXERT® and what is it used for?
Use AXERT® only for a migraine attack. Do not use AXERT® to 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®?*
Do not take AXERT® if 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 AXERT® or 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).
*The brands listed are the trademarks of their respective owners and are not the trademarks of Janssen Pharmaceuticals, Inc.
These medicines may affect how AXERT® works, or AXERT® may affect how these medicines work.
To help your doctor decide if AXERT® is 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:
- 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 AXERT® if 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 AXERT® Tablets in a 24-hour period.
- Some people who take migraine medicines, like AXERT®, for 10 or more days every month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with AXERT® .
- 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 nonprescription 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 is not a complete list of side effects. Ask your doctor to tell you about the other side effects.
The most common side effects in adults are:
The most common side effects in adolescents are:
- Tingling or burning feeling (paresthesia)
If you feel dizzy or sleepy, or if you notice any changes in your vision, 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 any of the following after taking AXERT®:
- a swollen face, lips, mouth, tongue or throat
- difficulty swallowing or breathing
- an itchy rash (hives).
These may be a sign that you are 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 AXERT® again 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 AXERT® together 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.
What may trigger a migraine attack?
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.
- 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 AXERT® work 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 AXERT® for a condition for which it was not prescribed. Do not give AXERT® to 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 AXERT® or migraines, talk to your doctor. In addition, talk to your pharmacist or other healthcare provider.
Last reviewed on RxList: 8/21/2014
This monograph has been modified to include the generic and brand name in many instances.
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