In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens Inform patients that use of sumatriptan nasal spray, USP within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated Caution patients about the risk of serotonin syndrome with the use of sumatriptan nasal spray, USP or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed Treatment with sumatriptan nasal spray, USP may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan nasal spray, USP.Inform patients that they may experience local irritation of their nose and throat. Copy the URL below and paste it into your RSS Reader application.DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth Step 4.
65 % Such reactions can be life-threatening or fatal.
Sumatriptan nasal spray, USP may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Only 3% of the dose is excreted in the urine as unchanged sumatriptan; 42% of the dose is excreted as the major metabolite, the indole acetic acid analogue of sumatriptan.
To use the nasal spray: Gently blow your nose to clear the nostrils before you use this medicine. Un soulagement de la céphalée (disparition complète ou céphalée légère) 2 heures après administration chez 43 à 54 % des patients avec la dose de 10 mg/0,1 ml et 55 à 64 % des patients avec la dose de 20 mg/0,1 ml. While holding your head level, gently breathe in through your nose and out through your mouth for 10 to 20 seconds This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. The total plasma clearance is approximately 1,200 mL/min.The pharmacokinetics of sumatriptan in patients with severe hepatic impairment has not been studied.
In 2 trials, a 5-mg dose was also evaluated. However, perform a cardiac evaluation if these patients are at high cardiac risk. TOSYMRA is a novel nasal spray formulation of sumatriptan 10 mg developed with Intravail ® technology 1,2. Remove the Sumatriptan Nasal Spray unit from the plastic pack (see Figure A).
Table 1 lists adverse reactions that occurred in worldwide placebo-controlled clinical trials in 3,419 patients with migraine.
If there is evidence of CAD or coronary artery vasospasm, sumatriptan nasal spray, USP is contraindicated.
Do not give sumatriptan nasal spray, USP to other people, even if they have the same symptoms you have.
Ask your doctor if you have any questions. Consult your pharmacist or local waste disposal company.Information last revised September 2019.