Axert

Generic Name: almotriptan (Oral route)

al-moe-TRIP-tan

Commonly used brand name(s):

In the U.S.

• Axert

Available Dosage Forms:

• Tablet

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Axert

Almotriptan is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take almotriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Almotriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Almotriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Almotriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

Almotriptan is available only with your doctor's prescription.

Before Using Axert

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in patients 18 years of age and older, and there is no specific information comparing use of almotriptan in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of almotriptan in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Avitriptan
• Dihydroergotamine
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Frovatriptan
• Linezolid
• Methylergonovine
• Methysergide
• Naratriptan
• Rizatriptan
• Sumatriptan
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram
• Clovoxamine
• Desvenlafaxine
• Duloxetine
• Escitalopram
• Femoxetine
• Fluoxetine
• Fluvoxamine
• Milnacipran
• Nefazodone
• Paroxetine
• Reboxetine
• Sertraline
• Sibutramine
• St John's Wort
• Tapentadol
• Venlafaxine
• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Heart or blood vessel disease or
• High blood pressure or
• Kidney disease or
• Liver disease or
• Stroke (history of)—The chance of side effects may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use almotriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of Axert

Do not use almotriptan for a headache that is different from your usual migraines. Instead, check with your doctor.

To relieve your migraine as soon as possible, use almotriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using almotriptan. Using almotriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use almotriptan until your migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you feel much better after a dose of almotriptan, but your headache comes back or gets worse after 2 or more hours, you may use one additional dose of almotriptan.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of almotriptan or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For migraine headaches:
    • Adults—6.25 or 12.5 milligrams (mg) as a single dose. If the migraine comes back after being relieved, another dose be taken two hours or more after the first dose. Do not take more than 2 doses in any twenty-four-hour period.
    • Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Axert

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine, or after taking almotriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Axert Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain
• fast heartbeat
• palpitations
• shortness of breath
• tightness in throat

• Chest pain, severe
• cool, pale skin
• increased sweating
• tightness in chest

Check with your doctor as soon as possible if any of the following side effects occur:

• Discharge from eye
• eye irritation
• itching, redness, or swelling of skin
• neck pain or rigid neck
• redness of inner lining of eyelid
• skin rash

• Abdominal cramping or pain
• black, tarry stools
• blood in stools
• bringing back up of food
• diarrhea
• difficulty in swallowing
• earache
• eye pain
• fainting
• fever
• heartburn, repeated
• loss of appetite
• loss of vision
• rapid breathing
• weight loss

Other side effects may occur that usually do not need medical attention. Some of these effects, such as nausea, vomiting, drowsiness, dizziness, and general feeling of illness or tiredness, often occur during or after a migraine, even when almotriptan has not been used. Most of the side effects caused by almotriptan go away within a short time (less than 2 hours). However, check with your doctor if these side effects continue or are bothersome.

• Burning, numbness, prickly, or tingling feeling
• dizziness
• dry mouth
• headache
• nausea
• sleepiness

• Aching, fullness, or tension in sinuses
• anxious feeling
• back pain
• belching
• change in sense of taste
• chills
• cough producing mucus
• decreased sensitivity to touch
• fatigue
• feeling of constant movement of self or surroundings
• feeling of spinning
• feeling of warmth or heat
• flushing or redness of skin
• heartburn
• increased sense of hearing
• indigestion
• lack or loss of strength
• muscle aches
• muscle weakness
• nosebleed
• painful menstrual period
• quivering or trembling
• restlessness
• runny or stuffy nose
• sore throat
• trouble in sleeping
• vomiting

• Abnormal increase in reflexes
• abnormally increased feeling of mental and physical well-being
• buzzing or ringing in the ears
• change in dreams or nightmares
• change in sense of smell
• change in sense of touch
• clumsiness or unsteadiness
• continuous, uncontrolled, back-and-forth and/or rolling eye movements
• cough
• difficulty in concentrating
• difficulty in swallowing
• double vision
• drooling
• dry eyes
• dry throat
• feeling of pins and needles
• hoarseness
• increased sensitivity to sunlight
• increased thirst
• loss of voice
• muscle stiffness

• mental depression
• nervousness
• pain, redness, swelling, or warmth in joints
• sneezing
• stabbing pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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