"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 "...
Sumavel DosePro Consumer
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
SUMATRIPTAN SUCCINATE - SUBCUTANEOUS INJECTION
COMMON BRAND NAME(S): Alsuma, Imitrex, Sumavel DosePro
USES: Sumatriptan is used to treat migraines and cluster headaches. It helps to relieve pain and other symptoms of migraines/headaches including sensitivity to light or sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. It does not prevent future migraines/headaches or reduce how often you may get a headache.
Sumatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.
HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using sumatriptan and each time you get a refill. Ask your doctor or pharmacist if you have any questions.
This medication can be injected by using a syringe/needle, an auto-injector, or a needle-free device (depending on the brand prescribed). Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist. Make sure you understand the correct technique for injection and how to properly dispose of needles, syringes, auto-injectors, needle-free devices, and unused medication.
Inject the medication just below the skin as soon as the symptoms of your migraine/headache appear. Before injecting each dose with a syringe and needle or an auto-injector, clean the injection site with rubbing alcohol. If using a needle-free device, your skin should be clean and dry before injecting. This medication should never be injected directly into a vein (IV) or into a muscle (IM). Also, never inject this medication through clothing.
If there is no improvement in your symptoms, do not take any more doses of this medication before talking to your doctor. If your symptoms are only partly relieved, or if your headache comes back, you may use a second injection after one hour or as directed by your doctor. Do not use more than 2 injections (12 milligrams) in a 24-hour period. Do not reuse the syringe or the needle-free device. If you are using an auto-injector device, it may be re-used.
If your symptoms are only partly relieved or your headache returns, 2 hours after the injection you may switch to sumatriptan taken by mouth instead of using a second injection. After the initial injection you may take sumatriptan by mouth every 2 hours if needed to a maximum of 100 milligrams of tablets in a 24-hour period.
If you have never taken this medication before and you have risk factors for heart disease (see Precautions), you may need to be monitored for rare but serious side effects (e.g., chest pain) when you take the first dose. Your doctor may ask you to take the first dose in the office.
Your dosage is based on your medical condition and response to therapy. Tell your doctor if your condition does not improve or worsens.
Overuse of drugs to treat sudden migraine attacks can lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add a separate medication to help prevent the headaches.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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