Almotriptan (Oral Route)

    Almotriptan (Oral Route)

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    Description and Brand Names of Almotriptan (Oral Route)

    US Brand Name

    1. Axert

    Descriptions

    Almotriptan is used to treat severe migraine headaches in adults and teenagers. It is not used to prevent migraine headaches and is not used for cluster headaches. Almotriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

    Almotriptan is not an ordinary pain reliever. It will not help with any kind of pain other than migraine headaches. This medicine is given to people when their headaches are not helped by acetaminophen (Tylenol®), aspirin, or other pain relievers.

    This medicine is available only with your doctor’s prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using Almotriptan (Oral Route)

    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

    Appropriate studies have not been performed on the relationship of age to the effects of almotriptan in children younger than 12 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of almotriptan in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving almotriptan.

    Pregnancy

    Breastfeeding

    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.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    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
    • Eletriptan
    • 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.

    • Amitriptyline
    • Amoxapine
    • Amphetamine
    • Bromocriptine
    • Brompheniramine
    • Buspirone
    • Carbamazepine
    • Chlorpheniramine
    • Citalopram
    • Clomipramine
    • Clovoxamine
    • Cocaine
    • Cyclobenzaprine
    • Desipramine
    • Desvenlafaxine
    • Dextroamphetamine
    • Dextromethorphan
    • Doxepin
    • Duloxetine
    • Escitalopram
    • Femoxetine
    • Fentanyl
    • Fluoxetine
    • Fluvoxamine
    • Hydroxytryptophan
    • Imipramine
    • Isocarboxazid
    • Levomilnacipran
    • Lithium
    • Lorcaserin
    • Meperidine
    • Methadone
    • Methylene Blue
    • Milnacipran
    • Mirtazapine
    • Nefazodone
    • Nortriptyline
    • Paroxetine
    • Pentazocine
    • Propoxyphene
    • Reboxetine
    • Sertraline
    • Sibutramine
    • St John’s Wort
    • Tapentadol
    • Trazodone
    • Tryptophan
    • Venlafaxine
    • Vilazodone
    • Vortioxetine
    • 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

    Other Interactions

    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, history of or
    • Basilar migraine (migraine with vision and hearing problems) or
    • Heart attack, history of or
    • Hemiplegic migraine (migraine with some paralysis) or
    • Hypertension (high blood pressure), uncontrolled or
    • Ischemic bowel disease (bowels have low blood supply) or
    • Peripheral vascular disease (clogged arteries) or
    • Stroke, history of or
    • Transient ischemic attack (TIA), or history of – Should not be used in patients with these conditions.
    • Coronary artery disease, history of or
    • Diabetes or
    • Hypercholesterolemia (high cholesterol in the blood) or
    • Hypertension (high blood pressure) or
    • Obesity or
    • Raynaud syndrome – Use with caution. May cause side effects to become worse.
    • Kidney disease or
    • Liver disease – Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use of Almotriptan (Oral Route)

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Do not use this medicine for a headache that is not a migraine headache. Talk to your doctor about what to do for regular headaches.

    This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

    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 and teenagers 12 years of age and older – 6.25 or 12.5 milligrams (mg) as a single dose. Your doctor may tell you to take another dose if the migraine comes back. However, the maximum dose for a single day (24 hours) is 25 mg.
        • Children younger than 12 years of age – 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.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Precautions

    It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

    Check with your doctor if you used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often.

    You should not take this medicine if you have used other triptan or ergot-type migraine medicines within the past 24 hours. Some examples of triptan medicines are frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®), sumatriptan (Imitrex®, Treximet®), and zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®) and ergotamine (Bellergal®, Cafergot®, Ergomar®, or Wigraine®).

    This medicine may increase your risk of having a heart attack, angina, or stroke. This is more likely to occur if you or a family member already have heart disease, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort; an irregular heartbeat; nausea or vomiting; pain or discomfort in the shoulders, arms, jaw, back, or neck; shortness of breath; or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion; difficulty with speaking; double vision; headaches; an inability to move the arms, legs, or facial muscles; an inability to speak; or slow speech.

    Make sure your doctor knows about all the other medicines you are using. Almotriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This includes medicines to treat depression, such as citalopram (Celexa®), duloxetine (Cymbalta®), escitalopram (Lexapro®), fluoxetine (Prozac®, Sarafem®, or Symbyax®), fluvoxamine (Luvox®), olanzapine (Zyprexa®), paroxetine (Paxil®), sertraline (Zoloft®), or venlafaxine (Effexor®). Check with your doctor right away if you have agitation; confusion; diarrhea; excitement while talking that is not normal; fever; overactive reflexes; poor coordination; restlessness; shivering; sweating; trembling or shaking that you cannot control; or twitching. These could be symptoms of serotonin syndrome.

    Check with your doctor right away if you have blurred vision, difficulty with reading, or any other change in vision while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

    Almotriptan may cause drowsiness, dizziness, or trouble with your vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert and able to see well.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

    Side Effects of Almotriptan (Oral Route)

    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:

    Less common

    1. Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    2. chest pain
    3. discharge from the eye
    4. eye irritation
    5. fast, irregular, pounding, or racing heartbeat or pulse
    6. itching, redness, or swelling of the skin
    7. neck pain or rigid neck
    8. redness of inner lining of the eyelid
    9. skin rash
    10. shortness of breath
    11. tightness in the throat

    Rare

    1. Abdominal or stomach cramping or pain
    2. black, tarry stools
    3. blood in the stools
    4. bringing back up of food
    5. chest pain, severe
    6. cool, pale skin
    7. diarrhea
    8. difficulty with swallowing
    9. earache
    10. fainting
    11. fever
    12. heartburn, repeated
    13. increased sweating
    14. loss of appetite
    15. loss of vision
    16. rapid breathing
    17. tightness in the chest
    18. weight loss

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    1. Burning, numbness, prickly, or tingling feeling
    2. dizziness
    3. dry mouth
    4. headache
    5. nausea
    6. sleepiness

    Less common

    1. Aching, fullness, or tension in the sinuses
    2. anxious feeling
    3. back pain
    4. belching
    5. change in sense of taste
    6. chills
    7. cough producing mucus
    8. decreased sensitivity to touch
    9. feeling of constant movement of self or surroundings
    10. feeling of spinning
    11. feeling of warmth or heat
    12. flushing or redness of the skin
    13. increased sense of hearing
    14. indigestion
    15. lack or loss of strength
    16. muscle aches
    17. muscle weakness
    18. nosebleed
    19. painful menstrual period
    20. quivering or trembling
    21. restlessness
    22. runny or stuffy nose
    23. sore throat
    24. trouble with sleeping
    25. vomiting

    Rare

    1. Abnormal increase in reflexes
    2. abnormally increased feeling of mental and physical well-being
    3. buzzing or ringing in the ears
    4. change in dreams or nightmares
    5. change in sense of smell
    6. change in sense of touch
    7. clumsiness or unsteadiness
    8. continuous, uncontrolled, back-and-forth or rolling eye movements
    9. cough
    10. difficulty in concentrating
    11. double vision
    12. drooling
    13. dry eyes
    14. dry throat
    15. feeling of pins and needles
    16. hoarseness
    17. increased sensitivity to sunlight
    18. increased thirst
    19. loss of voice
    20. mental depression
    21. muscle stiffness
    22. nervousness
    23. pain, redness, swelling, or warmth in the joints
    24. sneezing
    25. 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.