Descriptions Drug information provided by: Micromedex Sumatriptan is used to treat acute migraine headaches in adults. It is not used to prevent migraine headaches and is not used for cluster headaches. Sumatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans. Many people find that their headaches go away completely after they take sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound. Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers. Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can have. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: • Tablet Before Using Drug information provided by: Micromedex In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan in the pediatric population. Safety and efficacy have not been established. Geriatric Use of sumatriptan is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems. Pregnancy Information about this sumatriptan-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. • Almotriptan • Bromocriptine • Dihydroergotamine • Eletriptan • Ergoloid Mesylates • Ergonovine • Ergotamine • Frovatriptan • Furazolidone • Iproniazid • Isocarboxazid • Linezolid • Methylene Blue • Methylergonovine • Methysergide • Moclobemide • Naratriptan • Phenelzine • Procarbazine • Rasagiline • Rizatriptan • Selegiline • Tranylcypromine • Zolmitriptan Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Amitriptyline • Citalopram • Desvenlafaxine • Dexfenfluramine • Duloxetine • Escitalopram • Fentanyl • Fluoxetine • Fluvoxamine • Levomilnacipran • Lorcaserin • Milnacipran • Mirtazapine • Paroxetine • Reboxetine • Sertraline • Sibutramine • St John’s Wort • Tapentadol • Tramadol • Trazodone • Venlafaxine • Vilazodone • Vortioxetine Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Angina (chest pain) or • Basilar migraine (migraine with vision and hearing problems) or • Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or • Heart attack, history of or • Heart or blood vessel problems or • Hemiplegic migraine (migraine with some paralysis) or • Hypertension (high blood pressure), uncontrolled or • Ischemic bowel disease (bowels have low blood supply) or • Liver disease, severe or • Peripheral vascular disease (clogged arteries)—Should not be used in patients with these conditions. • Bleeding problems or • Blurred vision or • CNS disorders or • Kidney disease or • Liver disease or • Seizures or epilepsy, history of or • Stomach or intestinal bleeding—Use with caution. May make these conditions worse. • Coronary artery disease, history of or • Diabetes or • Hypercholesterolemia (high cholesterol in the blood) or • Hypertension (high blood pressure), controlled or • Obesity or • Raynaud’s syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions. Proper Use Drug information provided by: Micromedex Do not use this medicine for a headache that is different from your usual migraines. Talk to your doctor about what to do for regular headaches. To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work. Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine. If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours before taking another dose. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not take more than 200 mg in 24 hours. You may take the tablet with or without food. Using this medicine for 10 or more days per month may make your headache worse (medication overuse headache). If your headache becomes worse, call your doctor. It is also important that you write down when you have migraine headaches and when you take this medicine. This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. • For oral dosage form (tablets): For migraine headaches: Adults—25, 50, or 100 milligrams (mg) as a single dose. If you get some relief, or if the migraine comes back after being relieved, another dose may be taken 2 hours after the last dose. Do not take more than 200 mg in any 24-hour period. Children—Use and dose must be determined by your doctor. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Precautions Drug information provided by: Micromedex It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. You should not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 2 weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan/naproxen, zolmitriptan, Amerge®, Axert™, Frova®, Maxalt®, Relpax®, Treximet®, or Zomig®) or an ergotamine medicine (e.g., dihydroergotamine, methysergide, Cafergot®, D.H.E. 45®, Ergomar®, Migergot®, or Migranal®) within the past 24 hours. Check with your doctor if you have used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often. This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, he or she may want you to take your first dose in the doctor’s office or clinic. This medicine may increase your risk of having a heart attack, angina, or stroke. This is more likely to occur if you have diabetes, high blood pressure, or high cholesterol, or if you already have a heart disease or a family history of heart disease, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, shortness of breath, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech. Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome. This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor). Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache. Some people feel dizzy or drowsy during or after a migraine, or using sumatriptan to relieve a migraine. As long as you are feeling dizzy or drowsy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Side Effects Drug information provided by: Micromedex Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Less common • Abdominal or stomach pain • anxiety • blurred vision • changes in patterns and rhythms of speech • chest pain or tightness • chills • confusion • dizziness • fast, slow, irregular, pounding, or racing heartbeat or pulse • headache • muscle cramps and stiffness • neck, throat, or jaw pain • nightmares • shivering • sweating • swelling of the fingers, hands, feet, or lower legs • tightness in the chest • trouble breathing Rare • blindness • chest pain or discomfort • chest tightness or heaviness • flushing or redness of the skin, especially on the face and neck • increased blinking or spasms of the eyelid • itching, pain, redness, or swelling • lightheadedness, dizziness, or fainting • nerve pain • severe numbness, especially on one side of the face or body • severe or continuing stomach pain • trouble with breathing, speaking, or swallowing • twitching • unusual bleeding or bruising • vomiting of blood or material that looks like coffee grounds • weakness of the arms and legs Incidence not known • Agitation • back, leg, or stomach pains • bleeding gums • changes in vision • flushing or redness of the skin • hives • itching • muscle twitching • pinpoint red spots on the skin • poor coordination • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue • restlessness • skin rash • unexplained bleeding or bruising • unusually warm skin • weakness in the arm or leg on one side of the body, sudden and severe Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings • change in color vision • change in hearing • difficulty with concentrating • drowsiness • heartburn • increased sensitivity of the eyes to sunlight • itching skin • joint pain • muscle aching or cramping • muscle stiffness or tightness • swollen joints • trouble with sleeping Rare • aggressiveness • belching • change in taste • feeling halos around lights • increased sensitivity to pain • loss of appetite • numbness, pain, tingling, or weakness • stomach discomfort or upset • tingling in the hands and feet • tunnel vision • weakness Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.