>> You should give an injection as soon as the symptoms of your migraine start, but it may be given at any time during an attack. you should know that this medication may make you drowsy or dizzy. You could have more side effects. Discuss the risks and benefits with your doctor. Dosage Form and Strengths: Tablets - 10 mg/60 mg and 85 mg/500 mg Using too much sumatriptan may increase the chance of side effects. The Pen will only work when you slide the grey part of the barrel down to the blue part. This medication can be injected by using a syringe/needle, an auto-injector, or a needle-free device (depending on the brand prescribed). The clinical significance of this binding is unknown. (1) For subcutaneous use only . IMITREX and PAXIL are registered trademarks of GlaxoSmithKline. IMITREX Injection is used to relieve your migraine or cluster headache. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. However, if you are using a one-time use auto-injector, discard the auto-injector after use. The Pen is now ready to use. Also, never inject this medication through clothing. endobj http://www.upandaway.org. This medicine comes with a patient information leaflet. Volunteers (N=47) have received single subcutaneous doses of up to 16mg without serious adverse events. See PATIENT INFORMATION at the end of this labeling for the text of the separate leaflet provided for patients. Clean the skin around this area. The dose of this medicine will be different for different patients. Keep the IMITREX STATdose System out of the reach of children. IMITREX Injection is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Embryolethality: When given intravenously to pregnant rabbits daily throughout the period of organogenesis, sumatriptan caused embryolethality at doses at or close to those producing maternal toxicity. Learn all preparation and usage instructions in the product package. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. If the headache comes back after being relieved, one more dose may be injected after 1 hour. The mechanism of the embryolethality is not known. However, because sumatriptan may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following sumatriptan should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of sumatriptan and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. /CreationDate (D:20230323184040-04'00') >> Defects in the corneal epithelium were noted in a 60-week study. Sumatriptan is not an ordinary pain reliever. Do not chew, break, or crush. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Urogenital: Rare were dysuria, frequency, dysmenorrhea, and renal calculus. Infrequent were mental confusion, euphoria, agitation, relaxation, chills, sensation of lightness, tremor, shivering, disturbances of taste, prickling sensations, paresthesia, stinging sensations, facial pain, photophobia, and lacrimation. You may need to pull hard on the Pen, but this is normal. Read and follow the instructions carefully. Last updated on Jan 3, 2023. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome, following sumatriptan should be evaluated for atherosclerosis or predisposition to vasospasm (see WARNINGS: Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events and WARNINGS: Other Vasospasm-Related Events). Prescription only Reviewed by: Yen Nguyen, PharmD Allison Barnes, PharmD Last reviewed on: February 1, 2022 What is sumatriptan (Imitrex) injection? doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. This drug passes into breast milk in small amounts. Accordingly, interest has focused on events beginning within 1hour of the administration of IMITREX. All rights reserved. Otherwise, call a poison control center right away. tell your doctor and pharmacist if you are allergic to sumatriptan, any other medications, or any of the ingredients in sumatriptan tablets. If this happens to you, tell your healthcare provider before taking any more IMITREX Injection. He/she may also direct you to take your first dose of this medication in the office/clinic to monitor for serious side effects (such as chest pain). Push the Blue Button. Do not take off the tamper-evident seals (see Figure 12). The amount of medicine that you take depends on the strength of the medicine. If you take sumatriptan more often or for longer than the recommended period of time, your headaches may get worse or may occur more frequently. A p p r o v a l : 1 9 9 2) Ask your pharmacist for a list of the ingredients. Keep this container away from children and pets. Non-Site Specific: Angioneurotic edema, cyanosis, death (see WARNINGS), temporal arteritis. If you also take any ergotamine medication (such as dihydroergotamine) or other "triptan" drugs (such as zolmitriptan, rizatriptan), you will need to separate your sumatriptan dose from your dose of these other medications to lessen the chance of serious side effects. You will be shown how to use the injection. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Imitrex will only treat a headache. This survey is being conducted by the WebMD marketing sciences department. Each 0.5mL of IMITREX Injection 12mg/mL solution contains 6mg of sumatriptan (base) as the succinate salt and 3.5mg of sodium chloride, USP in Water for Injection, USP. Adults25, 50, or 100 milligrams (mg) as a single dose. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Avoid driving and doing other tasks or actions that call for you to be. Have you had, or do you have, any disease of the liver or kidney? Rare was skin tenderness. If your dose is different, do not change it unless your doctor tells you to do so. Read the Patient Information leaflet carefully before using the sumatriptan succinate injection. There is no evidence that establishes that sumatriptan is a human teratogen; however, there are no adequate and well-controlled studies in pregnant women. If you are taking another drug that has the same drug in it. You may use a single dose vial, prefilled syringe, or a prefilled autoinjector. >> In a study in rats dosed daily with subcutaneous sumatriptan prior to and throughout pregnancy, there was no evidence of teratogenicity. BIN PCN Group Member ID. For all patients taking this medicine (sumatriptan tablets): Use this medicine (sumatriptan tablets) as ordered by your doctor. The osmolality of both injections is 291mOsmol. Do not touch the needle. Rare were peptic ulcer, retching, flatulence/eructation, and gallstones. health information, we will treat all of that information as protected health Turn the Pen to the left (counterclockwise) about half a turn until it is released from the Syringe Cartridge (see Figure 8). Protect from light. Ask your healthcare provider if you have a question about where to inject. fZ 4+(5\xj@@`nbO%{maT vl yo 3. If the headache comes back after being relieved, one more dose may be injected after 1 hour. Consult your doctor for more details. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Tell all of your health care providers that you take this medicine (sumatriptan tablets). However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing. /Length 15 0 R How it works Sumatriptan may be used to relieve symptoms of a migraine. IMITREX Injection should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. Store at room temperature. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. AHFS Patient Medication Information. Since the injection is intended to be given subcutaneously, intramuscular or intravascular delivery should be avoided. You may opt-out of email communications at any time by clicking on Gastrointestinal: Abdominal distention, colitis, constipation, dental pain, dyspeptic symptoms, feelings of gastrointestinal pressure, gastric symptoms, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, melena, nausea and/or vomiting, oral itching and irritation, pancreatitis, salivary gland swelling, and swallowing disorders. The no-effect dose for this finding was approximately 8 times the maximum recommended single human dose of 6mg on a mg/m2 basis. Six of these 8patients had ECG changes consistent with transient ischemia, but without accompanying clinical symptoms or signs. Do not throw away your IMITREX STATdose Pen. The Kaplan-Meier (product limit) Survivorship Plot (Figure1) provides an estimate of the cumulative probability of a patient with a cluster headache obtaining relief after being treated with either sumatriptan or placebo. include protected health information. In 1 well-controlled study where placebo (n=62) was compared with 6 different doses of IMITREX Injection (n=30 each group) in a single-attack, parallel-group design, the dose response relationship was found to be as shown in Table 1. aRelief is defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication. Sumatriptan Succinate blocks a chemical that transmits pain signals to the brain. Adverse events observed in these clinical trials were similar in nature to those reported in clinical trials in adults. 356.639999 0] This content does not have an Arabic version. Sumatriptan does not prevent migraine attacks . 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