TM Owner Upsher-Smith
Tosymra 10mg Nasal Spray
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Indications & Clinical Uses
- Tosymra (sumatriptan) 10 mg nasal spray is a selective serotonin (5-HT1) receptor agonist ('triptan') used for the acute treatment of migraine, with or without aura, in adults.
- It is not approved to prevent migraine attacks and is not used for cluster headache.
- Tosymra was originally launched by Upsher-Smith Laboratories; more recently fetched DailyMed labelling for this product lists Tonix Medicines, Inc. as the labeler, reflecting a change in marketing rights for this brand.
- Tosymra is self-administered by the patient into one nostril at the start of a migraine attack, without needing to prime the device or coordinate a deep inhalation, making it useful for people whose migraine includes nausea or vomiting that limits oral tablets.
Side Effects
- Tosymra has no boxed warning.
- Local nasal and throat effects are very common, reported in roughly half of patients, including an unusual taste, nasal discomfort, throat irritation and burning sensation.
- Other common effects include dizziness, a feeling of tingling or warmth, chest tightness or pressure, and neck or jaw discomfort.
- Serious but rare risks include heart attack, dangerous heart rhythm disturbances, and stroke or other reduced blood flow to the bowel or limbs, because sumatriptan narrows blood vessels; seek urgent care for chest pain, severe dizziness, sudden weakness or slurred speech after a dose.
- Serotonin syndrome, a rare but serious reaction, can occur, especially when combined with certain antidepressants - watch for agitation, rapid heartbeat, muscle twitching or high fever.
Precautions & Warnings
- Tosymra is contraindicated in people with coronary artery disease or its risk equivalents, a history of stroke or transient ischaemic attack, uncontrolled high blood pressure, severe liver impairment, and peripheral vascular disease, because of its vessel-narrowing effect.
- It should not be used within 24 hours of another triptan or an ergotamine-type medicine.
- Using it on 10 or more days a month can itself cause medication-overuse headache, so frequency is limited and reviewed with a healthcare provider.
- Tosymra has not been shown safe and effective for hemiplegic or basilar migraine.
- It should be used with caution in pregnancy and discussed with a healthcare provider beforehand; safety in breastfeeding has not been fully established.
- It has not been shown effective in children.
Avoid Interactions
- Do not use Tosymra within 24 hours of another triptan (such as sumatriptan tablets, rizatriptan or zolmitriptan) or an ergot-type medicine (such as ergotamine or dihydroergotamine), because combining vessel-narrowing drugs raises the risk of prolonged vasoconstriction.
- Avoid it within 2 weeks of taking a monoamine oxidase (MAO-A) inhibitor, which raises sumatriptan levels.
- Combining Tosymra with SSRIs, SNRIs, tricyclic antidepressants or MAO inhibitors increases the risk of serotonin syndrome - watch for agitation, tremor or fever.
- Tell your healthcare provider about every prescription and over-the-counter medicine, herbal remedy and supplement you take, especially antidepressants and other migraine medicines, before using Tosymra.
References
Frequently Asked Questions
Tosymra (sumatriptan) 10 mg nasal spray treats a migraine attack that has already started, in adults, with or without aura. It's a triptan, not a preventive medicine, and is not used for cluster headache.
Tosymra is sprayed into one nostril as soon as a migraine starts; no priming or deep breath is needed. If the migraine returns after some relief, a second dose can be taken at least 1 hour later, up to 2 doses (40 mg) in 24 hours.
Tosymra commonly causes an unusual taste, nasal or throat irritation, dizziness and tingling or chest tightness. Rare but serious risks include heart attack and stroke, since it narrows blood vessels. Seek urgent care for chest pain, sudden weakness or slurred speech.
Do not use Tosymra within 24 hours of another triptan or an ergot medicine. Avoid it within 2 weeks of an MAO inhibitor. Combining Tosymra with antidepressants such as SSRIs or SNRIs raises the risk of serotonin syndrome - tell your doctor about all your medicines.
Using Tosymra on 10 or more days a month can itself cause medication-overuse headache. If you need it that often, talk to your healthcare provider about migraine prevention options, since Tosymra treats individual attacks rather than reducing how often they occur.
Tosymra is contraindicated if you have coronary artery disease, a past stroke or TIA, uncontrolled high blood pressure, or severe liver disease, because it narrows blood vessels. It also has not been shown safe and effective in children, and caution is needed in pregnancy.
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