are pregnant or plan to become pregnant while taking Sumatriptan Nasal Spray. Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation. Lab and/or medical tests (such as blood pressure) may be done while you are using this medication. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have. 5mg; 20mg; Package. A myocardial infarction has been reported in a 14 year old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. stomach and intestinal problems (gastrointestinal and colonic ischemic events). Canada. When sumatriptan was administered by subcutaneous injection to male and female rats prior to and throughout the mating period, there was no evidence of impaired fertility at doses up to 60 mg/kg/day. For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours following administration of Sumatriptan Nasal Spray compared with placebo. of taking sumatriptan nasal spray. It is not clear whether this finding was due to an effect on males or females or both. If you have questions about side effects, call your doctor. Do not spray in your eyes. What are the new drugs for the treatment of migraines? Do not use more than 40 mg of Sumatriptan Nasal Spray in a 24 hour period. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). In all 5 trials utilizing the market formulation and recommended dosage regimen, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients receiving Sumatriptan Nasal Spray at all doses (with one exception) compared with those who received placebo. Step 5. Imitrex, Onzetra Xsail, Tosymra, Zembrace SymTouch, +2 more, prednisone, diclofenac, celecoxib, sumatriptan, metoclopramide, verapamil, Botox, indomethacin, rizatriptan, Imitrex. While sitting down, gently blow your nose to clear your nasal passages (see Figure B). Kaplan-Meier plot with patients not achieving response within 120 minutes censored to 120 minutes. It's used when. Animal Data: Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. You may also report side effects at https://www.fda.gov/medwatch. This medicine is taken on an as needed basis. Napumpujte ho antioxidantmi a vitamnmi! Do not refrigerate or freeze. Product Name (in authorisation country) MRP/DCP Authorisation number . with your doctor, nurse, pharmacist, or other health care provider. Feeling of heaviness or tightness in the leg muscles. If your headaches get worse, your healthcare provider may decide to stop your treatment with Sumatriptan Nasal Spray. Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Sumatriptan Nasal Spray within 24 hours of each other is contraindicated. The unit contains only 1 spray. Sumatriptan nasal spray is contraindicated in patients with a history of stroke or TIA. The nasal spray usually works within 15 minutes. N1R 6X3 to you and the baby. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive. Got it. The safety of treating an average of more than 4 headaches in a 30 day period has not been established. Brand names: Imitrex, Tosymra Be ready to tell or show what was . Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw may occur after treatment with Sumatriptan Nasal Spray and are usually non-cardiac in origin. The 20-mg dose may provide a greater effect than the 5-mg and 10-mg doses . The effects of an MAO inhibitor on systemic exposure after intranasal sumatriptan would be expected to be greater than the effect after subcutaneous sumatriptan but smaller than the effect after oral sumatriptan because only swallowed drug would be subject to first-pass effects. Data from a prospective exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population ( see Data). These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. If your giving sumatriptan nasal spray to your child. You could have more side effects. 20mg. ( 1) Not indicated for the prophylactic therapy of migraine attacks. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. What Are Side Effects of Tosymra? The efficacy of Sumatriptan Nasal Spray in the acute treatment of migraine headaches was demonstrated in 8, randomized, double-blind, placebo-controlled trials, of which 5 used the recommended dosing regimen and used the marketed formulation. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Each spray contains 1 dose (10mg or 20mg of sumatriptan). Place the nozzle of the spray device into the other nostril and breathe in gently as you press the plunger. Especially tell your healthcare provider if you take antidepressant medicines called: Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Serotonin syndrome is a rare but serious problem that can happen in people using Sumatriptan Nasal Spray, especially if Sumatriptan Nasal Spray is used with anti-depressant medicines called SSRIs or SNRIs. If your symptoms are only partly relieved, or if your headache comes back, you may use another dose after at least 1 or at least 2 hours (depending on your brand). Patients were instructed to treat a moderate to severe headache. Generic name: Sumatriptan Nasal Spray [ soo-ma-TRIP-tan ] Brand names: Imitrex, Tosymra Drug class: Antimigraine agents Medically reviewed by Drugs.com. This includes your doctors, nurses, pharmacists, and dentists. Tools & Info. N1R 6X3 Canada, Sumatriptan Nasal Spray The use of Sumatriptan Nasal Spray is contraindicated in patients with CAD and those with Prinzmetals variant angina. Throw away unused or expired drugs. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love If you use too much Sumatriptan Nasal Spray, call your healthcare provider or go to the nearest hospital emergency room right away. While gently taking a breath in through your nose, press the plunger firmly to release the dose of Sumatriptan Nasal Spray (see Figure E). Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in What are the ingredients in Sumatriptan Nasal Spray? This relieves the migraine attack. Impairment of Fertility: When sumatriptan (5, 50, or 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day. Oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. Keep your head upright, remove the nozzle from your nose, and gently breathe in through your nose and out through your mouth for 10 to 20 seconds. Medically reviewed by Drugs.com. Ask your doctor how long you should wait between your doses of these drugs. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. Uses Before taking Warnings Side effects Overdose Dosage FAQ Uses of Sumatriptan Nasal Spray: It is used to treat migraine headaches. Consult your doctor before breast-feeding. Ubrelvy vs Imitrex (sumatriptan): How do they compare? Sumatriptan Nasal Spray can cause serious side effects, including: Heart attack and other heart problems. Risk of Myocardial Ischemia and/or Infarction, Prinzmetals Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events: Inform patients that Sumatriptan Nasal Spray may cause serious cardiovascular side effects such as myocardial infarction or stroke. Store at room temperature. ( 1) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. This survey is being conducted by the WebMD marketing sciences department. Before you use Sumatriptan Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. Following oral administration, an approximately 70% increase in C max and AUC was observed in one small trial of patients with moderate liver impairment (n = 8) matched for sex, age and weight with healthy subjects (n = 8). Sumatriptan nasal spray is not used to prevent or decrease the number of migraine headaches you have. Oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). This product is for use in the nose only. Sumatriptan nasal spray may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynauds syndrome. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Description and Brand Names. What is the most important information I should know about Sumatriptan Nasal Spray? Read all information given to you. Sumatriptan is a white to off-white powder that is very slightly soluble in water and in saline. It is not known if Sumatriptan Nasal Spray is safe and effective in children under 18 years of age. Because their vasospastic effects may be additive, co-administration of Sumatriptan Nasal Spray and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. It may also relieve pain by affecting certain nerves in the brain.Sumatriptan does not prevent future migraines or lessen how often you get migraine attacks. Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes. Package insert / product label This product may contain inactive ingredients, which can cause allergic reactions or other problems. The 5-mg and 20-mg doses are given as a single spray in 1 nostril. Last updated on Nov 5, 2022. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Drug class: Antimigraine agents. Sumatriptan is also available in a combination product (Treximet) that also contains naproxen. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. High blood pressure has happened with sumatriptan nasal spray. Each Sumatriptan Nasal Spray contains 20 mg of sumatriptan in a 100-MicroL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP. If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). For all patients taking sumatriptan nasal spray: Use sumatriptan nasal spray as ordered by your doctor. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Canada residents can call a provincial poison control center. 6 Nasal sprays. The highest no-effect dose was 50 mg/kg/day. Keep all medications away from children and pets. You will need to talk about the benefits and risks The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Sumatriptan Nasal Spray and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition. . Be sure you know how many hours to If you have any questions about sumatriptan nasal spray, please talk Check your blood pressure regularly and tell your doctor if the results are high. Spray the medicine into the other nostril and breathe in gently at the same time. Do not remove the unit until you are ready to use. are breastfeeding or plan to breastfeed. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5HT 1 agonists. 4 CONTRAINDICATIONS Estimated Probability of Achieving Initial Headache Response within 120 Minutes a. aThe figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with intranasal sumatriptan. Discontinue Sumatriptan Nasal Spray if these disturbances occur. Sumatriptan oral tablet is used to treat migraine headaches. Generic name: sumatriptan Dosage form: Nasal Spray Company: Dr. Reddy's Laboratories, Inc. Stop taking Sumatriptan Nasal Spray and get emergency medical help right away if you have any of the following symptoms of a heart attack: Sumatriptan Nasal Spray is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. to make sure that it is safe for you to take sumatriptan nasal spray with all of your drugs and health problems. Burning or aching pain in the feet or toes. Cambridge, Ontario. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack). Human Data: The Sumatriptan/Naratriptan/Treximet (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. We comply with the HONcode standard for trustworthy health information. Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes. This document does not contain all possible drug interactions. Hives (itchy bumps); swelling of your tongue, mouth, or throat. This medicine is not meant to prevent or lower the number of migraine headaches you get. Do not test before use. Check the product package for instructions on how to store your brand, or ask your pharmacist. It can be used orally (pill), by nasal spray, or by injection (shot). Drug Interaction Studies: Monoamine Oxidase-A Inhibitors: Treatment with MAO-A inhibitors generally leads to an increase of sumatriptan plasma levels [see Contraindications (4) and Drug Interactions (7.2)] . The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group. Some of these reactions occurred in patients without known CAD. Sumatriptan nasal spray is a serotonin (5-HT 1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. Use only if a clear diagnosis of migraine headache has been established. Below, check out the tour dates, as well as a weird tour . Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists. Pregnancy: Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)] . Unusual taste or irritation/numbness/tingling of the nose or throat may occur after using the spray. advice about side effects. Canada. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Sumatriptan Nasal Spray may cause serious side effects. If there is evidence of CAD or coronary artery vasospasm, Sumatriptan Nasal Spray is contraindicated. Have your blood pressure checked as you have been told by your doctor. Concomitant use with other Triptans or Ergot Medications: Inform patients that use of Sumatriptan Nasal Spray within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) and Drug Interactions (7.1, 7.3)] . Sumatriptan Nasal Spray, 20 mg ( NDC 71921-170-61) is supplied in boxes of 6 nasal spray devices. Serotonin Syndrome: Caution patients about the risk of serotonin syndrome with the use of Sumatriptan Nasal Spray or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)]. by Novocol Pharmaceutical of Canada, Inc.. 25 Wolseley Court, Inactive ingredients: monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP. You have a higher risk for heart disease if you: Sumatriptan nasal spray is a prescription medicine used to treat acute migraine headaches with or without aura in adults. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. Migranal; Trudhesa; Descriptions. N1R 6X3 This can be long-lasting. If your headache comes back after the first dose, another dose may be used as your doctor has told you. Talk to your doctor for details. The symptoms will generally resolve in less than 2 hours. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Heart problems may lead to death. Avoiding these "triggers" may help lessen migraine attacks. There are also reports in patients where no such predisposing factors are apparent. Get free Sumatriptan coupons instantly and save up to 80%. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse. Procedure no. Do not share your drugs with others and do not take anyone else's drugs. . Do not drive, use machinery, or do anything that needs alertness until you can do it safely. What should I avoid while using Sumatriptan Nasal Spray? Sumatriptan is not indicated for the prevention of migraine attacks. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Certain conditions can increase your risk for heart problems. Published on September 1, 2022 Key takeaways: Triptan medications are go-to options for treating moderate to severe migraines after headache symptoms have started. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and blocking the release of natural substances that cause pain, nausea, and other symptoms of migraine. Consult your doctor for more details. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. If you have any of these health problems: If you have ever had any of these health problems: Chest. Brand names: Imigran, Imigran Radis. Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. There is evidence that doses above 20 mg do not provide a greater effect than 20 mg. Some people who use Sumatriptan Nasal Spray may have irritation of their throat and nose. Prompt treatment helps you . Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)] . 6 Nasal . The recommended adult dose of sumatriptan nasal spray, USP for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. Get medical help right away if these or other serious side effects occur, including: fast/irregular heartbeat, fainting, severe stomach/abdominal pain, bloody diarrhea, seizure, signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion). Tell all of your health care providers that you take sumatriptan nasal spray. There is no information regarding sumatriptan concentrations in milk from lactating women following administration of Sumatriptan Nasal Spray. The dosage is based on your medical condition and response to treatment. Sumatriptan bioavailability following intranasal administration is 17%, similar to that after oral administration (15%). Have your blood circulation the leg muscles out or trouble breathing, call 911 your healthcare provider may to. 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