Sumatriptan

Generic

Generic for Imitrex

ID: 55111029309

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FORM

Tablet

STRENGTH

100 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION SPL UNCLASSIFIED SECTION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS

🩺What it's for

Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. Sumatriptan tablets are not indicated for the prevention of migraine attacks.

💊How to take it

Single dose of 25 mg, 50 mg, or 100 mg tablet.( 2.1 ) A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2.1 ) Maximum dose in a 24-hour period: 200 mg. ( 2.1 ) Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment.

ℹ️Common side effects

The following adverse reactions are discussed in more detail in other sections of the prescribing information: Myocardial ischemia, myocardial infarction, and Prinzmetal s angina [see Warnings and Precautions ( 5.1 )] Arrhythmias [see Warnings and Precautions ( 5.2 )] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions ( 5.3 )] Cerebrovascular events [see Warnings and Precautions ( 5.4 )] Other vasospasm reactions [see Warnings and Precautions ( 5.5 )]…

⚠️Serious risks

Myocardial ischemia/infarction and Prinzmetal s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) Arrhythmias: Discontinue sumatriptan if occurs. ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs.

📦Storage & missed dose

Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with RDY on one side and 291 on the other side. The tablets are supplied in bottles of 30, 36, 90, 100, 500 and unit of use blister pack of 9 s and 27's.

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Sumatriptan tablets are contraindicated in patients with: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal s angina [see Warnings and Precautions ( 5.1 )] Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 )] History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 )] Peripheral vascular disease [see Warnings and Precautions ( 5.5 )] Ischemic bowel disease [see Warnings and Precautions ( 5.5 )] Uncontrolled hypertension [see Warnings and Precautions ( 5.8 )] Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions ( 7.1 , 7.3 )] Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions ( 7.2 ), Clinical Pharmacology ( 12.3 )] Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 )] Severe hepatic impairment [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] History of coronary artery disease or coronary artery vasospasm ( 4 ) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication. ( 4 ) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. ( 4 ) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). ( 4 ) Severe hepatic impairment. ( 4 )

Risk Summary 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 developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data). In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data 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. 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). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]). The sample size in this study had 80% power to detect at least a 1.73-to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. No other birth defect was reported for more than 2 infants in this group. 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. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]). A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. 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. Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. 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. The highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day, or approximately 3 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis. 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. Intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 (approximately 2 times the MRHD on a mg/m2 basis) and 0.75 mg/kg/day, respectively. 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). The highest no-effect dose was 50 mg/kg/day, or approximately 2 times the MRHD on a mg/m2 basis. In offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. The highest no-effect dose for this effect was 60 mg/kg/day, or approximately 3 times the MRHD on a mg/m2 basis. Oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. The highest no-effect dose for this finding was 100 mg/kg/day, or approximately 5 times the MRHD on a mg/m2 basis.

Absorption The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of sumatriptan. This compares with a Cmax of 5 and 16 ng/mL following dosing with a 5 and 20 mg intranasal dose, respectively. The mean Cmax following a 6-mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL). The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The Cmax is similar during a migraine attack and during a migraine-free period, but the Tmax is slightly later during the attack, approximately 2.5 hours compared with 2 hours. When given as a single dose, sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the Cmax after 100 mg is approximately 25% less than expected (based on the 25 mg dose). Effect of Food: A food effect trial involving administration of sumatriptan tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the Cmax and AUC were increased by 15% and 12%, respectively, when administered in the fed state. Distribution Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated. The apparent volume of distribution is 2.7 L/kg. Metabolism In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. 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. Elimination The elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled 14C-sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, IAA, which is inactive, or the IAA glucuronide. Only 3% of the dose can be recovered as unchanged sumatriptan. Special Populations Age: The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years). Patients with Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined. Patients with Hepatic Impairment: The liver plays an important role in the presystemic clearance of orally administered sumatriptan. Accordingly, the bioavailability of sumatriptan following oral administration may be markedly increased in patients with liver disease. In one small trial of patients with moderate liver impairment (n = 8) matched for sex, age, and weight with healthy subjects (n = 8), the hepatically-impaired patients had an approximately 70% increase in AUC and Cmax and a Tmax 40 minutes earlier compared with the healthy subjects. The pharmacokinetics of sumatriptan in patients with severe hepatic impairment has not been studied. The use of sumatriptan tablets in this population is contraindicated [see Contraindications ( 4 ) and Use in Specific Populations ( 8.6 )]. Male and Female Patients: In a trial comparing females to males, no pharmacokinetic differences were observed between genders for AUC, Cmax, Tmax, and half-life. Racial Groups: The systemic clearance and Cmax of subcutaneous sumatriptan were similar in black (n = 34) and Caucasian (n = 38) healthy male subjects. Oral sumatriptan has not been evaluated for race differences. Drug Interaction Studies Monoamine Oxidase-A Inhibitors: Treatment with MAO-A inhibitors generally leads to an increase of sumatriptan plasma levels [see Contraindications ( 4) , Drug Interactions ( 7.2 )]. Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after coadministration of an MAO-A inhibitor with oral sumatriptan is greater than after coadministration of the MAO inhibitors with subcutaneous sumatriptan. In a trial of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of subcutaneous sumatriptan, resulting in a 2-fold increase in the area under the sumatriptan plasma concentration-time curve (AUC), corresponding to a 40% increase in elimination half-life. A small trial evaluating the effect of pretreatment with an MAO-A inhibitor on the bioavailability from a 25-mg oral sumatriptan tablet resulted in an approximately 7-fold increase in systemic exposure. Alcohol: Alcohol consumed 30 minutes prior to sumatriptan ingestion had no effect on the pharmacokinetics of sumatriptan.

The efficacy of sumatriptan tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range: 18 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of sumatriptan tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Trials 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or had worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, 50, and 100 mg were compared with placebo in the treatment of migraine attacks. In 1 trial, doses of 25, 50, and 100 mg were also compared with each other. In all 3 trials, the percentage of patients achieving headache response 2 and 4 hours after treatment was significantly greater among patients receiving sumatriptan tablets at all doses compared with those who received placebo. In 1 of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50-mg or 100-mg group when compared with the 25-mg dose groups. There were no statistically significant differences between the 50-mg and 100-mg dose groups in any trial. The results from the 3 controlled clinical trials are summarized in Table 2. Table 2. Percentage of Patients with Headache Response (Mild or No Headache) 2 and 4 Hours following Treatment Sumatriptan Tablets 25 mg 2 hr 4 hr Sumatriptan Tablets 50 mg 2 hr 4 hr Sumatriptan Tablets 100 mg 2 hr 4 hr Placebo 2 hr 4 hr Trial 1 52%a 67%a (n = 298) 61%a,b 78%a,b (n = 296) 62%a,b 79%a,b (n = 296) 27% 38%(n = 94) Trial 2 52%a 70%a (n = 66) 50%a 68%a (n = 62) 56%a 71%a (n = 66) 26% 38%(n = 65) Trial 3 52%a 65%a (n = 48) 54%a 72%a (n = 46) 57%a 78%a (n = 46) 17% 19%(n = 47) a P<0.05 in comparison with placebo. b P<0.05 in comparison with 25 mg. The estimated probability of achieving an initial headache response over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1. Figure 1. Estimated Probability of Achieving Initial Headache Response within 4 Hours of Treatment in Pooled Trials 1, 2, and 3a a The figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with oral sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response and/or taking rescue within 240 minutes censored to 240 minutes. For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Trial 1) and at 4 hours (Trials 1, 2, and 3) following administration of sumatriptan tablets compared with placebo. As early as 2 hours in Trials 2 and 3, or as early as 4 hours in Trial 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2. Figure 2. The Estimated Probability of Patients Taking a Second Dose of Sumatriptan Tablets or Other Medication to Treat Migraine over the 24 Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3a a Kaplan-Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose. There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with sumatriptan tablets was associated with an increase in the severity of recurrent headaches. The efficacy of sumatriptan tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.

Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that sumatriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech, and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 , 5.8 )]. Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan tablets. Such reactions can be life-threatening or fatal. 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 )]. Concomitant Use With Other Triptans or Ergot Medications Inform patients that use of sumatriptan tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications ( 4 ), Drug Interactions ( 7.1 , 7.3 )]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of sumatriptan tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions ( 5.7 ), Drug Interactions ( 7.4 )]. Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.6 )]. 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)]. Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2 )]. Ability to Perform Complex Tasks Treatment with sumatriptan tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan tablets.

PATIENTINFORMATION Sumatriptan Tablets USP (soo'' ma trip' tan) What is the most important information I should know about sumatriptan tablets? Sumatriptan tablets can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking sumatriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes, or that 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 breaking out in a cold sweat nausea or vomiting feeling lightheaded Sumatriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of heart disease What are sumatriptan tablets? Sumatriptan tablets are a prescription medicine used to treat acute migraine headaches with or without aura in adults. Sumatriptan tablets are 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. Sumatriptan tablets are not used to prevent or decrease the number of migraine headaches you have. It is not known if sumatriptan tablets are safe and effective to treat cluster headaches. It is not known if sumatriptan tablets are safe and effective in children under 18 years of age. Do not take sumatriptan tablets if you have: heart problems or a history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease) uncontrolled high blood pressure severe liver problems hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider. had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation taken any of the following medicines in the last 24 hours: almotriptan (AXERT) eletriptan (RELPAX) frovatriptan (FROVA) naratriptan (AMERGE) rizatriptan (MAXALT, MAXALT-MLT) sumatriptan and naproxen (TREXIMET) ergotamines (CAFERGOT, ERGOMAR, MIGERGOT) dihydroergotamine (D.H.E. 45, MIGRANAL) Ask your healthcare provider if you are not sure if your medicine is listed above. an allergy to sumatriptan or any of the ingredients in sumatriptan tablets. See the end of this leaflet for a complete list of ingredients in sumatriptan tablets. What should I tell my healthcare provider before taking sumatriptan tablets? Before you take sumatriptan tablets, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure . have high cholesterol . have diabetes . smoke . are overweight . have heart problems or family history of heart problems or stroke . have kidney problems . have liver problems . have had epilepsy or seizures . are not using effective birth control . are pregnant or plan to become pregnant. It is not known if sumatriptan can harm your unborn baby. are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take sumatriptan tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sumatriptan tablets and certain other medicines can affect each other, causing serious side effects. Especially tell your healthcare provider if you take antidepressant medicines called: selective serotonin reuptake inhibitors (SSRIs) serotonin norepinephrine reuptake inhibitors (SNRIs) tricyclic antidepressants (TCAs) monoamine oxidase inhibitors (MAOIs) Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take sumatriptan tablets? Certain people should take their first dose of sumatriptan tablets in their healthcare provider s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting. Take sumatriptan tablets exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider. Take sumatriptan tablets whole with water or other liquids. If you do not get any relief after your first tablet, do not take a second tablet without first talking with your healthcare provider. If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet. Do not take more than 200 mg of sumatriptan tablets in a 24-hour period. If you take too much sumatriptan tablets, call your healthcare provider or go to the nearest hospital emergency room right away. You should write down when you have headaches and when you take sumatriptan tablets so you can talk with your healthcare provider about how sumatriptan tablets are working for you. What should I avoid while taking sumatriptan tablets? Sumatriptan tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert. What are the possible side effects of sumatriptan tablets? Sumatriptan tablets may cause serious side effects. See What is the most important information I should know about sumatriptan tablets? These serious side effects include: changes in color or sensation in your fingers and toes (Raynaud s syndrome) stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody diarrhea fever problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips 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 medication overuse headaches. Some people who use too many sumatriptan tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan tablets. serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan tablets, especially if sumatriptan tablets are used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: 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 trouble walking hives (itchy bumps); swelling of your tongue, mouth, or throat. seizures. Seizures have happened in people taking sumatriptan tablets who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan tablets The most common side effects of sumatriptan tablets include: tingling or numbness in your fingers or toes warm or cold feeling feeling weak, drowsy, or tired pain, discomfort, or stiffness in your neck, throat, jaw, or chest dizziness Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sumatriptan tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store sumatriptan tablets? Store at 20 to 25 C (68 to 77 F). Light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep sumatriptan tablets and all medicines out of the reach of children. General information about the safe and effective use of sumatriptan tablets. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan tablets for a condition for which it was not prescribed. Do not give sumatriptan tablets to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about sumatriptan tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan tablets that is written for healthcare professionals. For more information, call 1-888-375-3784. What are the ingredients in sumatriptan tablets? Active ingredients: sumatriptan succinate Inactive ingredients: croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin. This Patient Information has been approved by the U.S. Food and Drug Administration. The other brands listed are trademarks of their respective owners. Rx only Manufactured by: Dr. Reddy s Laboratories Limited Bachupally 500 090 INDIA Revised: 0720 Dispense with Patient Information Sheet available at: www.drreddys.com/pi/sumatriptantabs.pdf