FDA approved a REMS for sumatriptan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sumatriptan and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
SUMATRIPTAN (soo ma TRIP tan) is used to treat migraines with or without aura. An aura is a strange feeling or visual disturbance that warns you of an attack. It is not used to prevent migraines.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin. Follow the directions on the prescription label. Only use this medicine at the first symptoms of a migraine. It is not for everyday use. If you are using an autoinjector, read the instruction leaflet carefully. A single injection is given just under the skin. Before you make an injection, clean and examine your skin. Do not inject at a place where the skin is damaged or infected. If your symptoms return you can use a second injection. If there is no improvement at all in your symptoms after the first injection, call your doctor or health care professional. Wait at least 1 hour between doses and do not use more than 6 mg as a single dose. Do not use more than 12 mg total in any 24 hour period. Do not use your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply; this medicine is not for regular use.
What may interact with this medicine?
Do not take this medicine with any of the following medicines:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Only use this medicine for a migraine headache. Use it if you get warning symptoms or at the start of a migraine attack. This medicine is not for regular use to prevent migraine headaches.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness, dizziness and flushing. Avoid alcoholic drinks.
Smoking cigarettes may increase the risk of heart-related side effects from using sumatriptan.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
tingling, pain, or numbness in the face, hands or feet
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
diarrhea
feeling warm, flushing, or redness of the face
muscle cramps, pain
nausea, vomiting
pain at site where injected
stomach upset
unusually weak or tired
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 2 and 30 degrees C (36 and 86 degrees F). Protect from light. Throw away any unused medicine after the expiration date.
Make sure you receive a puncture-resistant container to dispose of the needles and syringes once you have finished with them. Do not reuse these items. Return the container to your health care professional for proper disposal. Keep the autoinjector device.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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