How To Use Video Figure 1 (Frontal view of hives (itchy bumps); swelling of your tongue, mouth, or throat, seizures even in people who have never had seizures before. When the used Syringe Cartridges are inserted correctly, the Cartridge Pack is a disposable, protective case to help you avoid needle sticks. Seizures have been reported following administration of IMITREX. Serotonin syndrome may occur with IMITREX injection, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see DRUG INTERACTIONS]. Find a comfortable, well-lit place and put everything you need where you can reach it (autoinjector, alcohol or sterile swabs). Defects in the corneal epithelium were noted in a 60-week study. It helps to relieve pain and other symptoms of migraines / headaches including sensitivity to light or sound, nausea, and vomiting. Zembrace SymTouch is a prescription medicine used to treat acute migraine headaches with or without aura in adults 18 years of age and older who have been diagnosed with migraine. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving IMITREX injection. (4) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). tingling or numbness in your fingers or toes, warm, hot, burning feeling to your face (flushing). Because these effects may be additive, use of ergotamine-containing or ergot-type . The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. There may be new information. Therefore, the use of IMITREX injection in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY]. Ask your healthcare provider if you should take your first dose in a medical setting. Other data suggest that treatment with IMITREX injection is not associated with an increase in early recurrence of headache and has little effect on the incidence of later-occurring headaches (i.e., those occurring after 2, but before 18 or 24 hours). Check with your physician for additional information about side effects. Sumatriptan Injection USP Autoinjector System includes 2 Autoinjectors, each with an associated single-dose prefilled syringe which contains 6 mg of sumatriptan and 3.5 mg of sodium chloride in 0.5 mL of solution Professionals Also Viewed View Full Comparison #949873 164 Auromedics Pharmaceuticals #55150017301 Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Seizures have happened in people taking IMITREX who have never had seizures before. Take the Pen out of the Carrying Case (see, Put the Pen in the open Cartridge Pack. It is not known if IMITREX can harm your unborn baby. Do not recycle your used sharps disposal container. Imitrex Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. properly labeled to warn of hazardous waste inside the container. (4) Myocardial ischemia/infarction and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine. Do notremove the white needle shield from the autoinjector until you are ready to inject. If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider. Imitrex (sumatriptan) STATdose: Migraine: The typical dose is 4 mg or 6 mg injected under the skin once for the treatment of a migraine attack. The use of IMITREX injection in this population is contraindicated [see CONTRAINDICATIONS]. changes in color or sensation in your fingers and toes (Raynauds syndrome), problems with blood circulation to your legs and feet (peripheral, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in 1 or both legs or feet. Sumatriptan was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays. IMITREX injection may cause coronary artery vasospasm (Prinzmetals angina), even in patients without a history of CAD. 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. 2016;9:131-137. discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw or stomach, shortness of breath with or without chest discomfort, narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease). IMITREX injection is contraindicated in patients with: Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. MAO-A inhibitors increase systemic exposure by 2-fold. After a single 6-mg subcutaneous dose, 22% 4% was excreted in the urine as unchanged sumatriptan and 38% 7% as the IAA metabolite. Read the Patient Information leaflet carefully before using the sumatriptan succinate injection. Watch the Instructions for Use video to learn how to use Zembrace SymTouch. For more information, ask your provider. IMITREX may cause serious side effects. Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal IMITREX are not presently available. Some people who use too many IMITREX injections may have worse headaches (medication overuse headache). Talk with your healthcare provider about your chance of having seizures while you take IMITREX. Corneal opacities were seen at the lowest dose tested, 2 mg/kg/day, and were present after 1 month of treatment. Upsher-Smith Laboratories, LLC is not responsible for content or policies on linked sites. RxList does not provide medical advice, diagnosis or treatment. An autoinjector device (IMITREX STATdose Pen) is available for use with 4-mg and 6-mg prefilled syringe cartridges. Protect from light. D.H.E. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. The injection is intended to be given subcutaneously, and intramuscular or intravascular delivery must be avoided. For more information, call 1-888-825-5249. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. 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). Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Following a 6-mg subcutaneous injection into the deltoid area of the arm, the systemic clearance of sumatriptan was 1,194 149 mL/min and the terminal half-life was 115 19 minutes. (4) Severe hepatic impairment. What is the most important information I should know about IMITREX? It may harm them. Then close the lid. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of IMITREX injection in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of IMITREX injection. With this device, the needle penetrates approximately 1/4 inch (5 to 6 mm). How to store Sumatriptan 6. We recognize our responsibility and see it as an opportunity to improve lives and to make a lasting social impact. IMITREX injection is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. The frequency of all adverse reactions in these patients appeared to be both dose-and age-dependent, with younger patients reporting reactions more commonly than older pediatric patients. 7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs - Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use. In as little as 10 minutes, you may get migraine pain relief (17% of patients for sumatriptan 3 mg vs. 5% for placebo). One study showed that 60% of people experienced pain relief within 2 hours of use (vs. 21% for placebo). What you need to know before you use Sumatriptan 3. After removal of the needle shield, the open end of the pre-filled pen is to be placed on the injection site (for example on the upper arm or thigh), straight up at a right angle (90). Medicare, Medicaid, and other federal and state healthcare program patients are not eligible. Checkthe appearance of sumatriptan succinate injection, through the inspection window. Such reactions can be life-threatening or fatal. Exceptions include reports of paresthesia (5% IMITREX injection, 0% placebo), nausea and vomiting (4% IMITREX injection, 0% placebo), and bronchospasm (1% IMITREX injection, 0% placebo). Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. Discontinue IMITREX injection if a cerebrovascular event occurs. A myocardial infarction has been reported in a 14-year-old male following the use of oral IMITREX; clinical signs occurred within 1 day of drug administration. ED is often a symptom of another health problem or health-related factor. The inspection window will be blue, confirming the injection is complete. medication overuse headaches. Tell your provider if you have any side effect that bothers you or does not go away. Apprise patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS]. The Pen will only work when the Safety Catch is released. Imitrex Injection can pass into breast milk and may harm a nursing baby. Do not change your dose without first talking with your healthcare provider. Imitrex is available as a generic drug. Proportion of Patients with Cluster Headache Relief by Time in Studies 4 and 5. 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). Administration Using the IMITREX STATdose Pen . Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. home General information about the safe and effective use of IMITREX. Do not reuse or recycle a Syringe Cartridge. There is no need to replace the white needle shield. 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 IMITREX injection. Table 3. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. 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. 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. Click to view complete program terms and conditions. Excursions permitted between 59F and 86F. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional injections of IMITREX. 45: A 10-ml container is $12,295, which is $1,229 per unit. Sumatriptan is used to treat migraines when you feel one coming on. The Tmax or amount absorbed was not significantly altered by either the site or technique of injection. 4-mg and 6-mg single-dose prefilled syringe cartridges for use with the IMITREX STATdose Pen. Use of this website is governed by our Terms of Use and Privacy Policy. 2003-document.write(new Date().getFullYear()); Sun Pharmaceutical Industries, Inc. All Rights Reserved. imitrex injection (sumatriptan succinate injection) drug. Do not inject into areas where the skin is tender, bruised, red, or hard. Identify the application area with an adequate fatty tissue layer on top part of the thigh or back of the arm. 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. The highest no-effect dose for this effect was 60 mg/kg/day. If there is evidence of CAD or coronary artery vasospasm, IMITREX injection is contraindicated. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. (IM-i-trex) Sumatriptan Succinate Injection Kit contains 1 autoinjector pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case Professionals Also Viewed View Full Comparison #949873 167 Auromedics Pharmaceuticals #55150017301 Sumatriptan Succinate 6 mg / 0.5 mL Injection Single-Dose Vial 0.5 mL #771878 49 Mylan Pharmaceuticals #00378563159 If the lid will not close, push the Pen down until you feel it click. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among patients receiving 6 mg of IMITREX injection compared with those who received placebo (see Table 4). Know the medicines you take. Slide it down smoothly (see, The Cartridge Pack will click into place when the 2 buttons show through the holes in the Carrying Case (see. 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