Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Look in the transparent medicine window on the pen. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among patients receiving 6 mg of Sumatriptan Injection compared with those who received placebo (see Table 4). Do not take Sumatriptan Injection if you have: tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, Especially tell your healthcare provider if. Sumatriptan Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Prefilled Syringe and/or Autoinjector Pen: Each pack contains a Patient Information and Instructions for Use leaflet. Pushing to the stop point unlocks the button, As long as the pen is firmly pressed against the skin, the safety lock is de- activated; the pen could fire unintentionally if the blue button is pressed by acciden, 0 Keep pushing the pen against your skin then firmly press down the blue button on the top of the pen until it will not go further, 15. Read the Patient Information leaflet carefully before using the sumatriptan succinate injection. 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. It is not known whether SUMAtriptan Succinate Syringe Succinate Syringe will harm an unborn baby. 7. Keep Sumatriptan and all medicines out of the reach of children. RxNorm, Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Pushing to the stop point unlocks the button. You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine or cluster headache attack. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20mg) in 1,248 pediatric migraineurs aged 12 to 17years who treated a single attack. Sumatriptan Injection also relieved photophobia, phonophobia (sound sensitivity), nausea, and vomiting associated with migraine attacks. In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance. Brands listed are trademarks of their respective owners. Patients with little or no clinical disability. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. How to unload the Pen after taking your medicine Do not take more than 12 mg in a 24 hour period. The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals. With the Pen still pressed firmly against the skin, push the Blue Button (see Figure G). Sumatriptan Injection contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Without pressing the blue button, push the pen firmly against your skin until you feel the stop point (see FigureF). Each 0.5 mL injection contains 5.6 mg or 8.4 mg of sumatriptan succinate See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Using too much sumatriptan may increase the chance of side effects. 7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs - Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. For such patients, consider periodic cardiovascular evaluation in intermittent longterm users of Sumatriptan Injection. If you take the pen off before, not all of the medicine will be injected. Before you use the Sumatriptan Injection Kit 4 UNI | 4.95 per 1UNI. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The pharmacokinetics of subcutaneously administered sumatriptan in patients with severe hepatic impairment has not been studied. 66993-084-79, Defects in the corneal epithelium were noted in a 60-week study. If you use too much Sumatriptan Injection, call your healthcare provider or go to the nearest hospital emergency room right away. 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. Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)]. Each 0.5 mL of Sumatriptan Injection 12-mg/mL solution contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Brand names: Imitrex, Imitrex Statdose, SUMAtriptan Succinate Syringe, Sumavel DosePro, Zembrace SymTouch Headache relief was defined as a reduction in headache severity to mild or no pain. The generic is considered to be as safe and effective as . What is the most important information I should know about Sumatriptan Injection? Call your doctor for medical advice about side effects. . Protect from light. The highest no-effect dose for this effect was 60 mg/kg/day. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. What is the most important information I should know about Sumatriptan? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The maximum cumulative dose that may be given in 24hours is 12mg, two 6mg injections separated by at least 1 hour. Transient increases in blood pressure observed in some patients in clinical trials carried out during sumatriptans development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate. Files, Presentations The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) which may cause allergic reactions in latex-sensitive patients. Pharmacological properties 6. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have. Look inside the cap, check that the gray needle cover is inside (see Figure E).Do not use the pen if the gray needle cover is not inside the cap. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. In Study 1, 6 different doses of Sumatriptan Injection (n = 30 each group) were compared with placebo (n = 62), in a single-attack, parallel-group design, the dose-response relationship was found to be as shown in Table 2. a Relief is defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication. Approximately 82% and 65% of patients treated with Sumatriptan Injection 6 mg had headache relief and were pain free within 2 hours, respectively. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4), Warnings and Precautions (5.9)]. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or opthalmoplegic migraine. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). With this device, the needle penetrates approximately 1/4 inch (5 to 6mm). Patients with Hepatic Impairment: The effect of mild to moderate hepatic disease on the pharmacokinetics of subcutaneously administered sumatriptan has been evaluated. Certain people should take their first dose of Sumatriptan Injection in their healthcare providers office or in another medical setting. Proportion of Patients with Pain Relief and Relief of Migraine Symptoms after 1, and 2 Hours of Treatment in Studies 2 and 3, Figure 1. Sumatriptan Injection is contraindicated in patients with: The use of Sumatriptan Injection is contraindicated in patients with ischemic or vasospastic CAD. Side effects Interactions Dosage FAQ What is sumatriptan injection? For adults, the usual dose is a single injection given just below the skin. The pH range of both solutions is approximately 4.2 to 5.3. Do not use a vial if the medicine looks cloudy, has changed colors, or has particles in it. You may report side effects to FDA at 1-800-FDA-1088. 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. Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000ng/mL is low, approximately 14% to 21%. An estimate of the cumulative probability of a patient with a cluster headache obtaining relief after being treated with either Sumatriptan Injection or placebo is presented in Figure 1. Before taking Sumatriptan, 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 over-the-counter medicines, vitamins, and herbal supplements. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. 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. Ask your doctor or pharmacist if you have questions. The grey and blue Carrying Case is used for storing the unloaded autoinjector Pen and the Cartridge Pack when they are not being used. Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Your reactions could be impaired. (current), sumatriptan 6 MG (as sumatriptan succinate) per 0.5 ML Cartridge, sumatriptan 4 MG (as sumatriptan succinate) per 0.5 ML Cartridge. Manufactured by: This Patient Information has been approved by the U.S. Food and Drug Administration. Sumatriptan Injection is contraindicated in patients with uncontrolled hypertension. Labels, All Index If it is difficult to see what is in the window, hold the pen upto the light and check. Sumatriptan can cause serious side effects, including: Heart attack and other heart problems. Time to Relief of Cluster Headache from Time of Injectiona. Sumatriptan is excreted in human milk following subcutaneous administration (see Data). Pharmaceutical particulars 7. The use of Sumatriptan Injection is contraindicated in patients with CAD and those with Prinzmetals variant angina. SUMAtriptan Succinate Syringe (injection). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. If you are a consumer or patient please visit For those adults with moderate-to-severe migraine attacks that cannot tolerate triptans or who have found them ineffective, Ubrelvy is beneficial for treating migraines compared to no treatment. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine and cluster headaches through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release. If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan. Some people who use too many Sumatriptan Injections may have worse headaches (medication overuse headache). Sumatriptan is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. Using too much sumatriptan may increase the chance of side effects. Proportion of Patients with Migraine Relief and Incidence of Adverse Reactions by Time and by Dose of Sumatriptan in Study 1, Table 3. 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)]. Patients with little or no clinical disabilityb. Instruct patients on storage and disposal of the pen [see How Supplied/Storage and Handling (16)]. Drug class: Antimigraine agents. Put your used syringe cartridge pack in an FDA-cleared sharps disposal container right away after use (see Figure Q). 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 pediatric migraineurs. The efficacy of Sumatriptan Injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials (Studies 4 and 5). If there is liquid, consult your doctor or pharmacist. Heart problems may lead to death. Headache relief, as defined by a reduction in pain from severe or moderately severe to mild or no headache, was achieved in 70% of the patients within 1 hour of a single 6 mg subcutaneous dose of Sumatriptan Injection. Table 4. This is not a complete list of side effects and others may occur. The Tmax or amount absorbed was not significantly altered by either the site or technique of injection. Do not reuse or recycle a Syringe Cartridge. We comply with the HONcode standard for trustworthy health information. It belongs to the group of medicines called triptans. For more information about safe sharps disposal, and for speci c information about sharps disposal in the state that you live in, go to the FDAs website at: http://www.fda.gov/safesharpsdisposal. Sumatriptan may cause serious side effects. There were no significant differences in the pharmacokinetics of subcutaneously administered sumatriptan in moderately hepatically impaired subjects compared with healthy controls. In the controlled clinical trials assessing the efficacy of Sumatriptan Injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in patients with migraine. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.. Sumatriptan is used to treat migraines and cluster headaches in adults. The use of Sumatriptan Injection in this population is contraindicated [see Contraindications (4)]. If you use a breast pump during this time, throw out any milk you collect. Defects in the corneal epithelium were noted in a 60 week study. Provide patients instruction on the proper use of Sumatriptan Injection if they are able to self-administer Sumatriptan Injection in medicaly unsupervised situations. C4H6O4, representing a molecular weight of 413.5. Similar efficacy was seen when patients self-administered Sumatriptan Injection using the sumatriptan autoinjector. The highest dose to mice and rats was approximately 130 and 260 times the single maximum recommended human dose (MRHD) of 6 mg administered subcutaneously on a mg/m2 basis. If needed, you may cover the injection site with a bandage. 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. The NDC Packaged Code 66993-084-79 is assigned to a package of 2 syringe in 1 carton / .5 ml in 1 syringe of Sumatriptan, a human prescription drug labeled by Prasco Laboratories. The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in pediatric patients. 19.79. risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or being older than 40 and a man). PubMed, What are the possible side effects of Sumatriptan Injection? Sumatriptan Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. What should I avoid while taking Sumatriptan Injection? Proportion of Patients with Pain Relief and Relief of Migraine Symptoms after 1 and 2 Hours of Treatment in Studies 2 and 3. b A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally. 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 . 1.Read all of the instructions carefully before using this pen. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). The blue plunger will move down the window, completely fill it, and stop moving when the injection is done (see Figure H). Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Events, See How to Dispose of your used Syringe Cartridge Pack below. Sumatriptan can pass into breast milk. Ask your healthcare provider if you are not sure if your medicine is listed above. Overuse of migraine headache medicine can make headaches worse. This device is called an Autoinjector pen. Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available. Inactive ingredients: sodium chloride, water for injection. For the treatment of cluster headache, the efficacy of lower doses has not been established. After an injection: If your headache does not completely go away, call your doctor before using a second injection. Date of revision of the text Earlier examinations for these toxicities were not conducted and no-effect doses were not established; however, the relative plasma exposure at the lowest dose tested was approximately 3 times the human exposure after a 6-mg subcutaneous dose. Data from a prospective pregnancy 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). In controlled clinical trials enrolling more than 1,000 patients during migraine attacks who were experiencing moderate or severe pain and 1 or more of the symptoms enumerated in Table 3, onset of relief began as early as 10 minutes following a 6-mg Sumatriptan Injection. To reorder additional Patient information sheets contact Dr. Reddys Customer Service at 1-866-733-3952. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Sumatriptan Injection. Sumatriptan can cause dizziness, weakness, or drowsiness. Such reactions can be life-threatening or fatal. It is not clear whether this finding was due to an effect on males or females or both. (8.1). Pharmaceutical form 4. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Heart problems may lead to death. Figure 1. IMITREX (sumatriptan succinate) Injection is a selective 5-hydroxytryptamine1receptor subtype agonist. 3.Clean the skin area to be injected with alcohol or a new sterile swab (see Figure A). Written by Cerner Multum. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. However, use this medicine only as directed by your doctor. The safety of treating an average of more than 4 headaches in a 30 day period has not been established. This Patient Information has been approved by the U.S. Food and Drug Administration. Time to Relief of Cluster Headache from Time of Injection. 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. Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving sumatriptan. Sumatriptan succinate, USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Risk of Myocardial Ischemia and/or Infarction, Prinzmetals Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events. Biochemical Data Summary. If your headache goes away and then comes back, use a second injection if it has been at least 1 hour since your first injection. Call your doctor if your symptoms do not improve after using SUMAtriptan Succinate Syringe Succinate Syringe. The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection. Keep the Sumatriptan Autoinjector System out of the reach of children. Do not take it at the warning stage, before your migraine starts. 14. See full prescribing information for Sumatriptan. Inform patients that Sumatriptan Injection may cause serious cardiovascular side effects such as myocardial infarction or stroke. Know the medicines you take. You have a higher risk for heart disease if you: medication overuse headaches. General information about the safe and effective use of Sumatriptan. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: Such reactions can be life-threatening or fatal. There are also reports in patients where no such predisposing factors are apparent. Get Label RSS Feed, 12.Carefully take the pen off your skin (see Figure J). Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8)]. Sumatriptan Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation taken any of the following medicines in the last 24 hours: ergotamines (CAFERGOT, ERGOMAR, MIGERGOT). Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5HT1 agonists. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0.75 mg/kg/day, respectively. Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. 66993-084-98, To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or, Table 1. Do not use more than 2 injections in 24 hours. Common side effects of SUMAtriptan Succinate Syringe may include: numbness, tingling, warmth, redness, or burning sensation; pressure or heavy feeling in any part of your body; dizziness, drowsiness, feeling weak or tired; pain or redness where the medicine was injected. Angioedema and anaphylaxis, have occurred in patients receiving sumatriptan 24hours is 12mg, two injections! Sumatriptan and all medicines out of the medicine looks cloudy, has changed colors, or has particles in.... And set up your own personal medication records 4 headaches in a 60 week study of the reach children... Vision loss have been identified during postapproval use of sumatriptan Injection lookup drug information, identify,! 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