SUMAtriptan (Lexi-Drugs)

Pronunciation

(soo ma TRIP tan)

Brand Names: US

Imitrex; Imitrex STATdose Refill; Imitrex STATdose System; Onzetra Xsail; Sumavel DosePro; Zembrace SymTouch

Brand Names: Canada

ACT SUMAtriptan; APO-SUMAtriptan; DOM-SUMAtriptan; Imitrex; Imitrex DF; MYLAN-SUMAtriptan; PHL-SUMAtriptan [DSC]; PMS-SUMAtriptan; RATIO-SUMAtriptan; RIVA-SUMAtriptan [DSC]; SANDOZ SUMAtriptan; SUMAtriptan DF; TARO-SUMAtriptan; TEVA-SUMAtriptan; TEVA-SUMAtriptan DF

Dosing: Adult

Note: Limit use to <10 days per month to avoid medication overuse headache (CHS [Worthington 2013]). Triptans should not be used within 24 hours of the use of an ergotamine preparation or a different triptan.

Cluster headache, acute: Note: As monotherapy or in combination with 100% oxygen. Some experts recommend initial treatment with only 100% oxygen if available (May 2019).

SubQ (preferred route): Initial: 6 mg once; a lower dose of 3 mg may be effective in select patients (Gregor 2005). If initial dose was effective but headache recurs, may repeat a dose (usually same as first dose) after ≥1 hour; some experts recommend waiting ≥2 hours before repeating a dose (May 2019). Maximum dose: 6 mg per dose; 12 mg in 24 hours.

Intranasal (alternative route) (off-label): Solution: Initial: 20 mg once in single nostril contralateral to side of headache (May 2019; van Vliet 2003). If initial dose was effective but headache recurs, may repeat the dose after ≥2 hours. Maximum dose: 40 mg in 24 hours.

Note: When treating acute cluster headache, following initiation of medication(s) for prevention of cluster headaches, patients with ≥2 headaches per day may temporarily receive >2 doses of sumatriptan per day (either SubQ or intranasal at usual dose and interval) until prophylaxis becomes effective, according to some experts (May 2019).

Migraine, moderate to severe, acute: Note: As monotherapy or in combination with an NSAID (eg, naproxen). Administer at first sign of headache. When attack is complicated by vomiting or severe nausea, use of a non-oral preparation is recommended as oral agents may be ineffective (CHS [Worthington 2013]; Derry 2012).

Oral: Initial: Usual: 50 to 100 mg once (CHS [Worthington 2013]; Derry 2012). If initial dose was partially effective or headache recurs, may repeat a dose (usually same as first dose) after ≥2 hours. Maximum dose: 100 mg per dose; 200 mg per 24 hours.

Intranasal:

Solution: Initial: Usual: 20 mg once in a single nostril. If initial dose was partially effective or headache recurs, may repeat the dose once after ≥2 hours. Maximum dose: 40 mg per 24 hours.

Powder, breath-activated: Initial: 22 mg once; using product-specific device, give as one 11 mg capsule insufflated in each nostril. If initial dose was partially effective or headache recurs, may repeat the dose once after ≥2 hours. Maximum dose: 44 mg per 24 hours. Refer to product-specific administration instructions.

SubQ: Initial: Usual: 6 mg once. If initial dose was partially effective or headache recurs, may repeat a dose (usually same as first dose) after ≥1 hour. If 6 mg was not tolerated, subsequent doses of 1 to 5 mg may provide sufficient relief with better tolerability. Maximum dose: 6 mg per dose; 12 mg in 24 hours.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, dosage adjustment not expected due to extensive metabolism to inactive agents.

Dosing: Hepatic Impairment: Adult

Mild to moderate hepatic impairment:

Oral: Bioavailability of oral sumatriptan is increased with liver disease. If treatment is needed, do not exceed single doses of 50 mg.

Intranasal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, because the solution and powder do not undergo first-pass metabolism, levels would not be expected to be altered.

Subcutaneous: No dosage adjustment necessary.

Severe hepatic impairment: Oral, intranasal, and subcutaneous (Alsuma, Imitrex, and Zembrace injection) formulations are contraindicated in severe hepatic impairment. Sumavel is not recommended in severe hepatic impairment.

Dosing: Pediatric

Migraine: Note: Results of clinical studies are mixed with regards to efficacy, particularly with oral and SubQ sumatriptan doses; a 2004 practice parameter concluded that sumatriptan nasal spray was effective for the acute treatment of migraines in adolescent patients (AAN [Lewis 2004]).

Intranasal:

Children 5 to 12 years: Limited data available: 5 mg, 10 mg, or 20 mg administered in one nostril as a single dose as soon as possible after the onset of migraine; dose should be selected on an individual basis. A double-blind, placebo controlled study of 129 patients (mean age: 12.4 years; range: 8 to 17 years) used a weight-based dosing regimen: Body weight: 20 to 39 kg: 10 mg/dose; body weight ≥40 kg: 20 mg/dose; however, relatively few children <12 years old were included in the study (Ahonen 2004). A small, randomized, double-blind, placebo-controlled study of 14 children (range: 6 to 9 years; median: 8.2 years) used intranasal doses of 20 mg/dose (Ueberall 1999). A small, retrospective review of 10 children (range: 5 to 12 years; mean: 9.9 years), used intranasal doses of 5 mg (n=2) or 20 mg (n=8) (Hershey 2001).

Children ≥12 years and Adolescents ≤17 years: Limited data available: 5 mg, 10 mg, or 20 mg administered in one nostril as a single dose as soon as possible after the onset of migraine; dose should be selected on an individual basis (AAN [Lewis 2004]; Rothner 2000; Winner 2000; Winner 2006)

Adolescents ≥18 years: Initial single dose:

Powder: (Onzetra Xsail): 22 mg (11 mg nosepiece in each nostril). If headache has not resolved within 2 hours or returns, the dose may be repeated once ≥2 hours after the first dose (maximum: 44 mg [4 nosepieces] per 24 hours or 22 mg [2 nosepieces] and one dose of another sumatriptan product [separated by ≥2 hours] per 24 hours). The safety of treating an average of >4 headaches in a 30-day period has not been established.

Solution: 5 mg, 10 mg, or 20 mg administered in one nostril as soon as possible after the onset of migraine; dose should be selected on an individual basis. A 10 mg dose may be achieved by administering as 5 mg in each nostril. If headache has not resolved within 2 hours or returns, the dose may be repeated once after 2 hours, not to exceed a total daily dose of 40 mg. In clinical trials, a greater number of patients responded to initial doses of 20 mg versus 5 or 10 mg. The safety of treating an average of >4 headaches in a 30-day period has not been established.

Oral:

Adolescents ≤17 years: Limited data available; efficacy results variable; efficacy of oral sumatriptan was not established in five controlled trials in adolescent patients; frequency of adverse events was dose-related and age-dependent (ie, younger patients reported more adverse events)

Adolescents ≥18 years: Initial single dose: 25 mg, 50 mg, or 100 mg. If a satisfactory response has not been obtained at 2 hours, a second dose may be administered. Results from clinical trials show that initial doses of 50 mg and 100 mg are more effective than doses of 25 mg, and that 100 mg doses do not provide a greater effect than 50 mg and may have increased incidence of side effects. Maximum daily dose (cumulative 24 hours): 200 mg total dose/24 hours. The safety of treating an average of >4 headaches in a 30-day period have not been established.

SubQ:

Children ≥6 years and Adolescents ≤17 years: 3 to 6 mg single dose. An open-labeled prospective trial of 17 children 6 to 16 years with juvenile migraine used SubQ doses of 6 mg in 15 patients weighing 30 to 70 kg, and 3 mg/dose in two children weighing 22 kg and 30 kg (MacDonald 1994). Another open-label prospective trial in 50 consecutive children (ages 6 to 18 years) with severe migraine used SubQ doses of 0.06 mg/kg/dose. Relief was reported as good/excellent in 84% of the patients; 16% reported fair to poor relief; additional studies are needed (Linder 1996).

Adolescents ≥18 years:

Imitrex, Sumavel: Initial: 6 mg; if side effects are dose limiting, use lower doses: Imitrex: 1 to 5 mg or Sumavel: 4 mg. May repeat if needed ≥1 hour after initial dose; maximum dose: 6 mg/dose; cumulative maximum 24-hour dose: 12 mg total dose (two 6 mg injections). Controlled clinical trials have failed to document a benefit with administration of a second 6 mg dose in nonresponders.

Zembrace: Initial: 3 mg; after 1 hour may repeat dose if needed up to 4 injections separated by at least 1 hour; may also administer following the dose of another sumatriptan product if separated by at least 1 hour; cumulative maximum 24-hour dose: 12 mg total dose

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, dosage adjustment not expected due to extensive metabolism to inactive agents.

Dosing: Hepatic Impairment: Pediatric

Adolescents ≥18 years:

Mild to moderate hepatic impairment:

Intranasal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, because the intranasally administered drug does not undergo first-pass metabolism, serum concentrations would not be expected to be altered.

Oral: Bioavailability of oral sumatriptan is increased with liver disease. If treatment is needed, do not exceed single doses of 50 mg.

SubQ: No dosage adjustment necessary; has been studied and pharmacokinetics were not altered in patients with hepatic impairment compared to healthy patients.

Severe hepatic impairment: Oral, nasal, and SubQ (Imitrex and Zembrace injection) formulations are contraindicated with severe hepatic impairment. Sumavel is not recommended in severe hepatic impairment.

Use: Labeled Indications

Cluster headache, acute: SubQ (excluding Zembrace): Acute treatment of cluster headache episodes in adults as monotherapy or in combination with 100% oxygen (May 2019)

Migraine, moderate to severe, acute: Intranasal, Oral, SubQ: Acute treatment of migraine with or without aura in adults

Administration: Oral

Administer as soon as symptoms appear.

Administration: Subcutaneous

Administer as soon as symptoms appear.

Not for IM or IV use. Needle penetrates 1/4 inch of skin; use in areas of the body with adequate skin and subcutaneous thickness (lateral thigh or upper arm). In patients receiving doses other than 4 or 6 mg, use the 6 mg single-dose vial instead of the autoinjector device.

Needleless administration (Sumavel DosePro): Administer to the abdomen (>2 inches from the navel) or thigh; not for IM or IV administration. Do not administer to other areas of the body (eg, arm). Device is for single use only, discard after use; do not use if the tip of the device is tilted or broken.

Administration: Intranasal

Administer as soon as symptoms appear.

Powder: For intranasal administration with the Xsail device only. Remove the clear device cap from the reusable delivery device; remove one 11 mg disposable nosepiece from the foil pouch and click into the device body. Prior to administration, pierce the capsule inside the nosepiece by pressing and releasing the white piercing button one time on the device body. Insert the nosepiece into one nostril so there is a tight seal; rotate the device to place the mouthpiece in the mouth. Blowing forcefully through the mouthpiece for 2 to 3 seconds will deliver the powder into the nasal cavity; vibration may occur. Do not press white button while blowing into mouthpiece. Once administered into the first nostril, remove and discard nosepiece; repeat same process using a second 11 mg nosepiece into the other nostril to administer the remainder of the 22 mg dose.

Solution: Each nasal spray unit is preloaded with 1 dose; do not test the spray unit before use; remove unit from plastic pack when ready to use; while sitting down, gently blow nose to clear nasal passages; keep head upright and close one nostril gently with index finger; hold container with other hand, with thumb supporting bottom and index and middle fingers on either side of nozzle; insert nozzle into nostril about 1/2 inch; close mouth; take a breath through nose while releasing spray into nostril by pressing firmly on blue plunger; remove nozzle from nostril; keep head level for 10 to 20 seconds and gently breathe in through nose and out through mouth; do not breathe deeply.

Administration: Pediatric

Administer as soon as symptoms appear.

Intranasal:

Powder (Onzetra Xsail): For intranasal administration with the Xsail device only. Remove the clear device cap from the reusable delivery device; remove one 11 mg disposable nosepiece from the foil pouch and click into the device body. Prior to administration, pierce the capsule inside the nosepiece by pressing and releasing the white piercing button one time on the device body. Insert the nosepiece into one nostril so there is a tight seal; rotate the device to place the mouthpiece in the mouth. Blowing forcefully through the mouthpiece for 2 to 3 seconds will deliver the powder into the nasal cavity; vibration may occur. Do not press white button while blowing into mouthpiece. Once administered into the first nostril, remove and discard nosepiece; repeat same process using a second 11 mg nosepiece into the other nostril to administer the remainder of the 22 mg dose.

Solution: Each nasal spray unit is preloaded with 1 dose; do not test the spray unit before use; remove unit from plastic pack when ready to use; while sitting down, gently blow nose to clear nasal passages; keep head upright and close one nostril gently with index finger; hold container with other hand, with thumb supporting bottom and index and middle fingers on either side of nozzle; insert nozzle into nostril about 1/2 inch; close mouth; take a breath through nose while releasing spray into nostril by pressing firmly on blue plunger; remove nozzle from nostril; keep head level for 10 to 20 seconds and gently breathe in through nose and out through mouth; do not breathe deeply.

Oral: Administer with water or other fluids; swallow tablet whole; do not split tablet

SubQ: Administer SubQ only; do not administer IM; do not administer IV (may cause coronary vasospasm). Needle penetrates 1/4 inch of skin; use in areas of the body with adequate skin and subcutaneous thickness (lateral thigh or upper arm). Do not use the auto-injector device for doses that are not 4 to 6 mg; vials should be used.

Needleless administration (Sumavel DosePro): Do not administer IM; do not administer IV (may cause coronary vasospasm). Administer SubQ to the abdomen (>2 inches from the navel) or thigh; do not administer to other areas of the body (eg, arm). Device is for single use only; discard after use; do not use if the tip of the device is tilted or broken; Note: A loud burst of air will be heard and a sensation in the skin will be felt at the time a dose is delivered with this device.

Storage/Stability

Alsuma: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not refrigerate. Protect from light.

Imitrex injectable, tablet, intranasal: Store at 2°C to 30°C (36°F to 86°F). Protect from light.

Onzetra Xsail: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not refrigerate or freeze. Use nosepiece immediately after removing from pouch (Onzetra Xsail).

Sumavel DosePro, Zembrace: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not freeze (Sumavel DosePro). Protect from light.

Extemporaneously Prepared

A 5 mg/mL oral liquid preparation made from tablets and one of three different vehicles (Ora-Sweet®, Ora-Sweet® SF, or Syrpalta® syrups).Note: Ora-Plus® Suspending Vehicle is used with Ora-Sweet® or Ora-Sweet® SF to facilitate dispersion of the tablets (Ora-Plus® is not necessary if Syrpalta® is the vehicle). Crush nine 100 mg tablets in a mortar and reduce to a fine powder. Add 40 mL of Ora-Plus® in 5 mL increments and mix thoroughly between each addition; rinse mortar and pestle 5 times with 10 mL of Ora-Plus®, pouring into bottle each time, and add quantity of appropriate syrup (Ora-Sweet® or Ora-Sweet® SF) sufficient to make 180 mL. Store in amber glass bottles in the dark; label “shake well”, “refrigerate”, and “protect from light”. Stable for 21 days refrigerated.

Fish DN, Beall HD, Goodwin SD, et al, “Stability of Sumatriptan Succinate in Extemporaneously Prepared Oral Liquids,” Am J Health Syst Pharm, 1997, 54(14):1619-22.[PubMed 9248606]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flushing, feeling of warmth, loss of strength and energy, fatigue, bad taste, burning, rhinitis, pharyngitis, rhinorrhea, or injection site irritation. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of a heart attack (angina; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting), abnormal heartbeat, tachycardia, seizures, blindness, severe headache, severe dizziness, passing out, vision changes, burning or numbness feeling, blue/gray skin discoloration, constipation, diarrhea, severe nausea, vomiting, severe abdominal pain, bloody diarrhea, weight loss, leg cramps, sensation of cold, feeling of heaviness in legs, burning or aching of feet, hearing impairment, or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity (eg, angioedema, anaphylaxis) to sumatriptan or any component of the formulation; ischemic heart disease or signs or symptoms of ischemic heart disease (coronary artery vasospasm, Prinzmetal angina, angina pectoris, MI, silent myocardial ischemia); history of cerebrovascular syndromes (including strokes, transient ischemic attacks), history of hemiplegic or basilar migraine; peripheral vascular disease (including ischemic bowel disease); uncontrolled hypertension; use within 24 hours of ergotamine derivatives; use within 24 hours of another 5-HT1 agonist; concurrent administration or within 2 weeks of discontinuing an MAO type A inhibitors; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; severe hepatic impairment (excluding Sumavel)

Canadian labeling: Additional contraindications (not in the US labeling): Valvular heart disease; significant underlying cardiovascular disease (eg, atherosclerotic disease, congenital heart disease); ophthalmoplegic migraine

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/anaphylactoid reactions: Anaphylactic, anaphylactoid, and hypersensitivity reactions (including angioedema) have been reported; may be life threatening or fatal.

• Cardiac events: Coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia/fibrillation, cardiac arrest, and death have been reported with 5-HT1agonist administration (some occurring within a few hours of administration). Discontinue sumatriptan if these events occur. Patients who experience sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetal angina before receiving additional doses; if dosing is resumed and similar symptoms recur, monitor with ECG.

• Cerebrovascular events: Cerebral/subarachnoid hemorrhage and stroke (may be fatal) have been reported with 5-HT1 agonist administration. Discontinue sumatriptan if a cerebrovascular event occurs.

• CNS depression: May cause CNS depression, such as dizziness, weakness, or drowsiness, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Elevated blood pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. Use is contraindicated in patients with uncontrolled hypertension.

• Ocular effects: Transient and permanent blindness and significant partial vision loss have been reported (rare) with use of 5-HT1 agonist.

• Serotonin syndrome: Serotonin syndrome may occur with 5-HT1 agonists, particularly when used concomitantly with other serotonergic drugs; symptoms (eg, diarrhea, hyperreflexia, hyperthermia, incoordination, mental status changes, nausea, tachycardia, vomiting) typically occur minutes to hours after initiation/dose increase of a serotonergic drug. Discontinue use if serotonin syndrome is suspected.

• Vasospasm-related events: Peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud syndrome have been reported with 5-HT1 agonists.

Disease-related concerns:

• Coronary artery disease: Perform a cardiovascular evaluation in 5-HT1 agonists-naive patients who have risk factors for CAD (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, menopause, male >40 years of age) prior to initiation of therapy. Patients with suspected CAD should have cardiovascular evaluation to rule out CAD before considering use; if cardiovascular evaluation is “satisfactory,” first dose should be given in the health care provider’s office (consider ECG monitoring). Periodic evaluation of cardiovascular status should be done in these patients during intermittent long-term use.

• Hepatic impairment: Use oral formulations of sumatriptan with caution (and with dosage limitations) in patients with mild to moderate hepatic impairment where treatment is necessary and advisable. Presystemic clearance of orally administered sumatriptan is reduced in hepatic impairment, leading to increased plasma concentrations; dosage reduction of the oral product is recommended. Non-oral routes of administration (intranasal, subcutaneous) do not undergo similar hepatic first-pass metabolism and are not expected to result in significantly altered pharmacokinetics in patients with hepatic impairment. Use of the oral, intranasal, Alsuma, Imitrex, and Zembrace injectable is contraindicated in severe hepatic impairment; Sumavel is not recommended in severe hepatic impairment.

• Seizure disorders: Use with caution in patients with history of seizure disorder or in patients with a lowered seizure threshold; seizures have been reported after sumatriptan administration in patients with or without a history of seizures.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution; perform a cardiovascular evaluation prior to initiation of therapy in elderly patients with cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) and periodically during intermittent long-term use.

Dosage form specific issues:

• Latex:The packaging (needle cover of prefilled syringe) may contain dry natural rubber, which is a derivative of latex.

Other warnings/precautions:

• Appropriate use: Only indicated for the acute treatment of migraine or cluster headache (depending on product); not indicated for migraine or cluster headache prophylaxis, or for the treatment of hemiplegic or basilar migraine. Acute migraine agents (eg, 5-HT1 agonists, opioids, ergotamine, or a combination of the agents) used for 10 or more days per month may lead to worsening of headaches (medication overuse headache); withdrawal treatment may be necessary in the setting of overuse. If a patient does not respond to the first dose, the diagnosis of migraine or cluster headache should be reconsidered; rule out underlying neurologic disease in patients with atypical headache and in patients with no prior history of migraine or cluster headache.

Geriatric Considerations

Use is not recommended in the elderly given the risk of cardiovascular adverse effects. However, given the lack of safer alternatives for the treatment of migraine, it is appropriate to undertake shared decision making with regard to risks versus benefits and an appropriate monitoring plan. Care should be taken when sumatriptan is used in an older adult patient receiving other medications which can increase serotonin, as this can increase the risk of serotonin syndrome. Safety and efficacy in this population (≥65 years) have not been established. Pharmacokinetic disposition in healthy elderly patients is, however, similar to that in young adults (Fowler 1991).

Warnings: Additional Pediatric Considerations

Serious adverse effects, such as MI, stroke, visual loss, and death, have been reported in pediatric patients after sumatriptan use by the oral, intranasal, and/or SubQ routes; frequency of such adverse effects cannot currently be determined, monitor patients closely.

Pregnancy Risk Factor

C

Pregnancy Considerations

In a study using full-term, healthy human placentas, limited amounts of sumatriptan were found to cross the placenta (Schenker 1995).

Pregnancy outcome information for sumatriptan is available from a pregnancy registry sponsored by GlaxoSmithKline. As of September 2012, data were available for 617 pregnancies (626 infants/fetuses) exposed to sumatriptan (including 7 pregnancies also exposed to naratriptan). Following sumatriptan exposure, the risk of major birth defects following first trimester exposure was 4.2% and no consistent pattern of birth defects was observed. The pregnancy registry was closed to enrollment in January 2012 (Ephross 2014).

An analysis of data collected between 1995 and 2008 using the Swedish Medical Birth Register reported pregnancy outcomes following 5-HT1B/1D agonist exposure. An increased risk of major congenital malformations was not observed following sumatriptan exposure (2,229 exposed during the first trimester) (Källén 2011). An increased risk of major congenital malformations was also not observed using data collected from a Norwegian pregnancy registry study. This study included 415 women who used sumatriptan during the first trimester of pregnancy between 2004 and 2007 (Nezvalová-Henriksen 2013).

If treatment for cluster headaches is needed during pregnancy, sumatriptan may be used (Jürgens 2009). Other agents are preferred for the initial treatment of migraine in pregnancy (Da Silva 2012; MacGregor 2014; Williams 2012); however, sumatriptan may be considered if first-line agents fail (MacGregor 2014).

Breast-Feeding Considerations

Sumatriptan is present in breast milk.

The authors of a study calculated the mean relative infant dose (RID) of sumatriptan to be 3.5% when compared to a weight-adjusted maternal dose of 6 mg.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of sumatriptan was calculated using a mean milk concentration of 87.2 mcg/L (range: 61.9 to 112.5 mcg/L). This milk concentration was obtained following maternal administration of sumatriptan 6 mg SubQ as a single dose to 5 women (mean duration of lactation 22.2 weeks), and milk concentrations were measured over 8 hours. The median half-life in breast milk was 2.2 hours and the maximum milk concentrations occurred between 1.7 and 3.5 hours after the maternal dose (Wojnar-Horton 1996).

Following oral, subcutaneous, or intranasal administration, the manufacturers recommend withholding breastfeeding for 12 hours after the maternal dose. However, according to other sources, if treatment is needed, breastfeeding does not need to be discontinued (Jürgens 2009; MacGregor 2014).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Injection:

>10%:

Central nervous system: Tingling sensation (14%), dizziness (≤12%), vertigo (≤12%), feeling hot (≤11%)

Local: Injection site reaction (59%), warm sensation at injection site (≤11%)

1% to 10%:

Cardiovascular: Flushing (7%), chest discomfort (5%), chest tightness (3%), local discomfort (jaw or throat: 2% to 3%), chest pressure (2%)

Central nervous system: Burning sensation (7%), feeling of heaviness (7%), sensation of pressure (7%), numbness (5%), paresthesia (5%), sensation of tightness (5%), drowsiness (≤3%), sedated state (≤3%), headache (2%), strange feeling (2%), tight feeling in the head (2%)

Dermatologic: Diaphoresis (2%)

Gastrointestinal: Nausea and vomiting (4%)

Neuromuscular & skeletal: Neck pain (≤5%), neck stiffness (≤5%), weakness (5%), myalgia (2%)

Respiratory: Nasal discomfort (nasal cavity: ≤2%), sinus discomfort (≤2%), bronchospasm (1%)

Nasal:

>10%:

Gastrointestinal: Dysgeusia (≤25%), unusual taste (≤25%), nausea (≤14%), vomiting (≤14%)

Respiratory: Nasal discomfort (≤11%)

1% to 10%:

Central nervous system: Localized numbness (≤5%), nasal cavity pain (≤5%), paresthesia (≤5%), dizziness (≤2%), vertigo (≤2%), localized burning (1%)

Local: Local irritation (≤5%)

Respiratory: Rhinorrhea (≤5%), sore nose (≤5%), nasal signs and symptoms (≤4%), sinus discomfort (≤4%), rhinitis (2%)

Tablet:

1% to 10%:

Cardiovascular: Hot and cold flashes (3%), chest pain (≤2%), chest pressure (≤2%), chest tightness (≤2%)

Central nervous system: Pain (≤8%), sensation of pressure (≤8%), paresthesia (3% to 5%), fatigue (≤3%), feeling of heaviness (≤3%), malaise (≤3%), sensation of tightness (≤3%), heaviness of chest (≤2%), vertigo (2%)

Gastrointestinal: Sore throat (≤3%)

Local: Local pain (2%)

Neuromuscular & skeletal: Jaw pain (≤3%), jaw pressure (≤3%), jaw tightness (≤3%), neck pain (≤3%)

Respiratory: Pharyngeal edema (≤3%)

Route unspecified:

Frequency not defined:

Cardiovascular: Ischemia, Raynaud syndrome

Hematologic & oncologic: Splenic infarction

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, blindness, cerebral hemorrhage, cerebrovascular accident, dystonia, heaviness in neck (includes jaw or throat), hypersensitivity reaction, hypotension, myocardial infarction, neck pressure, neck tightness, nonimmune anaphylaxis, seizure, subarachnoid hemorrhage, tremor, vision loss (partial)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Risk X: Avoid combination

Droxidopa: Serotonin 5-HT1D Receptor Agonists may enhance the hypertensive effect of Droxidopa. Risk C: Monitor therapy

Ergot Derivatives: Serotonin 5-HT1D Receptor Agonists may enhance the vasoconstricting effect of Ergot Derivatives. Ergot Derivatives may enhance the vasoconstricting effect of Serotonin 5-HT1D Receptor Agonists. Exceptions: Nicergoline. Risk X: Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk X: Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Risk C: Monitor therapy

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May decrease the metabolism of Serotonin 5-HT1D Receptor Agonists. Management: If MAO inhibitor therapy is required, naratriptan, eletriptan or frovatriptan may be a suitable 5-HT1D agonist to employ. Risk X: Avoid combination

Opioid Agonists: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Serotonin 5-HT1D Receptor Agonists: May enhance the adverse/toxic effect of SUMAtriptan. Risk X: Avoid combination

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid.Risk C: Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy

Monitoring Parameters

Headache severity, blood pressure, signs/symptoms suggestive of angina; perform a cardiovascular evaluation prior to initiation of therapy in 5-HT1agonist-naive patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD); monitor ECG with first dose in patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation and consider periodic cardiovascular evaluation in such patients during intermittent long-term use.

Advanced Practitioners Physical Assessment/Monitoring

Assess headache severity. Monitor blood pressure. Perform a cardiovascular evaluation prior to initiation in patients with multiple cardiovascular risk factors. Obtain an ECG with the first dose in patients with multiple cardiovascular risk factors, but negative cardiovascular evaluation. Consider periodic cardiovascular evaluation in these patients. Assess for signs and symptoms of angina.

Nursing Physical Assessment/Monitoring

Monitor blood pressure. Monitor for signs and symptoms of angina. Instruct patient on proper administration technique for subcutaneous administration.

Product Availability

Tosymra nasal spray: FDA approved January 2019; anticipated availability is currently unknown. Information pertaining to this product within the monograph is pending revision. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Exhaler Powder, Nasal, as succinate [strength expressed as base]:

Onzetra Xsail: 11 mg per nosepiece (2 ea)

Solution, Nasal:

Imitrex: 5 mg/actuation (1 ea); 20 mg/actuation (1 ea)

Generic: 5 mg/actuation (1 ea); 20 mg/actuation (1 ea)

Solution, Subcutaneous, as succinate [strength expressed as base]:

Generic: 6 mg/0.5 mL (0.5 mL)

Solution, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Imitrex: 6 mg/0.5 mL (0.5 mL)

Generic: 6 mg/0.5 mL (0.5 mL)

Solution Auto-injector, Subcutaneous, as succinate [strength expressed as base]:

Zembrace SymTouch: 3 mg/0.5 mL (0.5 mL)

Generic: 4 mg/0.5 mL (0.5 mL); 6 mg/0.5 mL (0.5 mL)

Solution Auto-injector, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Imitrex STATdose System: 4 mg/0.5 mL (0.5 mL); 6 mg/0.5 mL (0.5 mL)

Solution Cartridge, Subcutaneous, as succinate [strength expressed as base]:

Generic: 4 mg/0.5 mL (0.5 mL)

Solution Cartridge, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Imitrex STATdose Refill: 4 mg/0.5 mL (0.5 mL); 6 mg/0.5 mL (0.5 mL)

Solution Jet-injector, Subcutaneous, as succinate [strength expressed as base]:

Sumavel DosePro: 4 mg/0.5 mL (0.5 mL [DSC]); 6 mg/0.5 mL (0.5 mL)

Solution Prefilled Syringe, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Generic: 6 mg/0.5 mL (0.5 mL)

Tablet, Oral, as succinate [strength expressed as base]:

Imitrex: 25 mg, 50 mg, 100 mg

Generic: 25 mg, 50 mg, 100 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Nasal:

Imitrex: 5 mg/actuation (0.1ml, 0.5ml, 1ea); 20 mg/actuation (0.1ml, 0.5ml, 1ea)

Solution, Subcutaneous, as succinate [strength expressed as base]:

Imitrex: 6 mg/0.5 mL (0.5ml, 1ea)

Generic: 6 mg/0.5 mL (0.5ml)

Tablet, Oral, as succinate [strength expressed as base]:

Imitrex DF: 50 mg, 100 mg

Generic: 25 mg, 50 mg, 100 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • N02CC01
Generic Available (US)

May be product dependent

Pricing: US

Exhaler Powder (Onzetra Xsail Nasal)

11MG/NOSEPC (per each): $59.40

Solution (Imitrex Nasal)

5 mg/ACT (per each): $97.83

20 mg/ACT (per each): $97.83

Solution (Imitrex Subcutaneous)

6 mg/0.5 mL (per 0.5 mL): $228.53

Solution (SUMAtriptan Nasal)

5 mg/ACT (per each): $49.26 – $81.33

20 mg/ACT (per each): $49.26 – $81.33

Solution (SUMAtriptan Succinate Subcutaneous)

6 mg/0.5 mL (per 0.5 mL): $28.80 – $90.84

Solution Auto-injector (Imitrex STATdose System Subcutaneous)

4 mg/0.5 mL (per 0.5 mL): $244.98

6 mg/0.5 mL (per 0.5 mL): $244.98

Solution Auto-injector (SUMAtriptan Succinate Subcutaneous)

4 mg/0.5 mL (per 0.5 mL): $107.36 – $187.03

6 mg/0.5 mL (per 0.5 mL): $92.20 – $187.03

Solution Auto-injector (Zembrace SymTouch Subcutaneous)

3 mg/0.5 mL (per 0.5 mL): $207.37

Solution Cartridge (Imitrex STATdose Refill Subcutaneous)

4 mg/0.5 mL (per 0.5 mL): $232.02

6 mg/0.5 mL (per 0.5 mL): $232.02

Solution Prefilled Syringe (SUMAtriptan Succinate Subcutaneous)

6 mg/0.5 mL (per 0.5 mL): $42.00 – $42.00

Tablets (Imitrex Oral)

25 mg (per each): $35.96

50 mg (per each): $78.38

100 mg (per each): $78.38

Tablets (SUMAtriptan Succinate Oral)

25 mg (per each): $27.05 – $28.25

50 mg (per each): $25.14

100 mg (per each): $25.14

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Selective agonist for serotonin (5-HT1B and 5-HT1D receptors) on intracranial blood vessels and sensory nerves of the trigeminal system; causes vasoconstriction and reduces neurogenic inflammation associated with antidromic neuronal transmission correlating with relief of migraine

Pharmacodynamics/Kinetics

Onset of action: Oral: ~30 minutes; Intranasal: Solution: ~15 to 30 minutes; SubQ: ~10 minutes; Peak effect: Oral: 2 to 4 hours

Distribution: Vd (central): SubQ: 50 L; Vd (apparent): Oral, Intranasal powder and solution: 2.7 L/kg

Protein binding: 14% to 21%

Metabolism: Hepatic to an indole acetic acid metabolite (inactive) which then undergoes ester glucuronide conjugation; may be metabolized by monoamine oxidase (MAO); extensive first-pass metabolism following oral administration

Bioavailability: Intranasal: Solution 17%, Powder 19% (compared to SubQ); Oral: 15%; SubQ: 97% ± 16%; Note: Sumavel DosePro is bioequivalent to sumatriptan SubQ injection via needle when administered into the thigh or abdomen

Half-life elimination: Distribution: 15 minutes; Terminal: 2 hours; range: 1 to 4 hours

Time to peak, serum: Oral: 2 to 2.5 hours; Intranasal: Powder: ~45 minutes; SubQ: 12 minutes (range: 4 to 20 minutes)

Excretion:

Intranasal: Urine (42% of total dose as indole acetic acid metabolite; 3% of total dose as unchanged drug)

Oral: Urine (~60% of total dose, mostly as indole acetic acid metabolite; 3% of total dose as unchanged drug); feces (~40%)

SubQ: Urine (38% of total dose as indole acetic acid metabolite; 22% of total dose as unchanged drug)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Bioavailability following oral administration may be markedly increased in patients with hepatic disease.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Bad taste, dysphagia, hyposalivation (tablet), mouth/tongue discomfort (injection).

Effects on Bleeding

No information available to require special precautions

Index Terms

Sumatriptan Succinate

FDA Approval Date
December 28, 1992
References

Alsuma (sumatriptan) [prescribing information]. New York, NY: Pfizer; April 2014.

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. doi: 10.1002/cpt.377.[PubMed 27060684]

Da Silva AN, Tepper SJ. Acute treatment of migraines. CNS Drugs. 2012;26(10):823-839. doi: 10.2165/11635440-000000000-00000.[PubMed 22823482]

Derry CJ, Derry S, Moore RA. Sumatriptan (oral route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev. 2012;(2):CD008615. doi: 10.1002/14651858.CD008615.pub2.[PubMed 22336849]

Ephross SA, Sinclair SM. Final results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry. Headache. 2014;54(7):1158-1172. doi: 10.1111/head.12375.[PubMed 24805878]

FDA Safety Alert: MedWatch. FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm504588.htm. Accessed June 14, 2016.

Fowler PA, Lacey LF, Thomas M, Keene ON, Tanner RJ, Baber NS. The clinical pharmacology, pharmacokinetics and metabolism of sumatriptan. Eur Neurol. 1991;31(5):291-294.[PubMed 1653135]

Gregor N, Schlesiger C, Akova-Oztürk E, Kraemer C, Husstedt IW, Evers S. Treatment of cluster headache attacks with less than 6 mg subcutaneous sumatriptan. Headache. 2005;45(8):1069-1072.[PubMed 16109122]

Imitrex injection (sumatriptan) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; July 2018.

Imitrex (sumatriptan) nasal spray [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; December 2017.

Imitrex tablets (sumatriptan) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; November 2013.

Imitrex (sumatriptan) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline; April 2018.

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126. doi: 10.1056/NEJM200007133430208.[PubMed 10891521]

Jürgens TP, Schaefer C, May A. Treatment of cluster headache in pregnancy and lactation. Cephalalgia. 2009;29(4):391-400. doi: 10.1111/j.1468-2982.2008.01764.x.[PubMed 19170693]

Källén B, Nilsson E, Otterblad Olausson P. Delivery outcome after maternal use of drugs for migraine: a register study in Sweden. Drug Saf. 2011;34(8):691-703. doi: 10.2165/11590370-000000000-00000.[PubMed 21751829]

MacGregor EA. Migraine in pregnancy and lactation. Neurol Sci. 2014;35(suppl 1):61-64. doi: 10.1007/s10072-014-1744-2.[PubMed 24867839]

MacDonald JT. Treatment of juvenile migraine with subcutaneous sumatriptan. Headache. 1994;34(10):581-582.[PubMed 7843952]

May A. Cluster headache: Treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed January 8, 2019.

Nezvalová-Henriksen K, Spigset O, Nordeng H, et al. Triptan safety during pregnancy: a Norwegian population registry study. Eur J Epidemiol. 2013;28(9):759-769. doi: 10.1007/s10654-013-9831-x.[PubMed 23884894]

Onzetra Xsail (sumatriptan nasal powder) [prescribing information]. Aliso Viejo, CA: Avanir Pharmaceuticals; January 2016.

Schenker S, Yang Y, Perez A, Henderson GI, Lee MP. Sumatriptan (Imitrex) transport by the human placenta. Proc Soc Exp Biol Med. 1995;210(3):213-220.[PubMed 8539258]

Scott AK. Sumatriptan clinical pharmacokinetics. Clin Pharmacokinet. 1994;27(5):337-344. doi: 10.2165/00003088-199427050-00002.[PubMed 7851052]

Sumavel DosePro (sumatriptan) [prescribing information]. San Diego, CA: Zoginex Inc; October 2014

van Vliet JA, Bahra A, Martin V, et al. Intranasal sumatriptan in cluster headache: randomized placebo-controlled double-blind study. Neurology. 2003;60(4):630-633.[PubMed 12601104]

Williams SH, Kehr HA. An update in the treatment of neurologic disorders during pregnancy–focus on migraines and seizures. J Pharm Pract. 2012;25(3):341-351. doi: 10.1177/0897190012442068.[PubMed 22550159]

Wojnar-Horton RE, Hackett LP, Yapp P, Dusci LJ, Paech M, Ilett KF. Distribution and excretion of sumatriptan in human milk. Br J Clin Pharmacol. 1996;41(3):217-221[PubMed 8866921]

Worthington I, Pringsheim T, Gawel MJ, et al; Canadian Headache Society Acute Migraine Treatment Guideline Development Group. Canadian Headache Society guideline: acute drug therapy for migraine headache. Can J Neurol Sci. 2013;40(5)(suppl 3):S1-S80.[PubMed 23968886]

Zembrace SymTouch (sumatriptan succinate) [prescribing information]. San Diego, CA: Dr. Reddy’s; March 2017.

Brand Names: International

Adracon (PE); Amigren (UA); Apigrane (JO, QA); Cetatrex (ID); Cinie (LV); Fermig (MX); Imigran (AE, AT, AU, BB, BG, BH, BM, BR, BS, BZ, CH, CL, CY, CZ, DE, DK, EC, EE, EG, ES, FI, GB, GR, GY, HK, HN, HR, HU, IE, IS, IT, JM, JO, KR, KW, LB, LK, LT, MT, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SI, SK, SR, TH, TR, TT, TW, UY, VE, VN, ZW); Imigran aerozol do nosa (PL); Imigran FDT (SG); Imigran nasal (CR, DO, GT, HN, NI, PA, SV, UY); Imigran Nasal (ES); Imigran Nasal Spray (AE, AU, GB, HR, IE, IS, NZ, QA, SA); Imigran nasal spray (KW); Imigran Nesespray (NO); Imigran Neusspray (NL); Imigran Radis (GB); Imigran S Nasal Spray (AU); Imigrane (FR); Imigrane Nasal Spray (FR); Imiject (FR); Imitrex (BE, IL, LU); Imitrex nasal spray (IL); Imitrex Nasal Spray (LU); Micranil (AR); Migane (ET); Migragesin (CO); Migraval (VE); Na Chuan (CN); Nograine (MX); Nomigra (BD); Rontadol (AR); Rosemig (CZ); Siagran (TH); Sitran (CO); Somatran (CL); Stopmigren (UA); Sumagraine (EG); Sumagran (AU); Sumalux (BD); Sumamigren (UA); Sumatab (AU); Sumatan (BD); Sumatran (IE, SG); Sumatridex (IL); Sumavel DosePro (DE, DK); Sumavel Pro (LB); Sumax (BR); Sumax Uso Nasal (BR); Sumig (PH); Sumigran (EG); Sumitran (MY, SG); Sumitrex (IN, MX); Sutagran (VN); Tebegran (MX)

Sumatriptan (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(soo ma TRIP tan)

Brand Names: US

Imitrex; Imitrex STATdose Refill; Imitrex STATdose System; Onzetra Xsail; Sumavel DosePro; Zembrace SymTouch

Brand Names: Canada

Imitrex DF; Imitrex Injection; Imitrex Nasal Spray; Sumatriptan DF

What is this drug used for?
  • It is used to treat migraine headaches.
  • It is used to treat cluster headaches.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to sumatriptan succinate or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
  • If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke or transient ischemic attack (TIA); or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
  • If you have liver disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking another drug that has the same drug in it.
  • If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan in the last 24 hours.
  • If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • This drug is not meant to prevent or lower the number of migraine headaches you get. Talk with your doctor.
  • If you have a headache that is not like your usual migraine headaches, talk with your doctor before you take this drug.
  • Taking more of this drug (a higher dose, more often) than your doctor told you to take may cause your headaches to become worse.
  • Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
  • Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this drug. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
  • Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with this drug. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
  • Children:
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
  • Injection:
  • If you have a latex allergy, talk with your doctor. Some products have latex.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your 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:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Seizures.
  • Loss of eyesight. This can be long-lasting.
  • Very bad headache or if headache is not better after the first dose.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
  • Constipation.
  • Diarrhea.
  • Very upset stomach or throwing up.
  • Severe stomach pain or bloody diarrhea.
  • Belly pain after meals.
  • Fever.
  • Weight loss.
  • Cramps and pain in legs or hips.
  • Feeling of heaviness or tightness in the leg muscles.
  • Feeling cold.
  • Burning or aching pain in the feet or toes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All products:
  • Dizziness.
  • Flushing.
  • Feeling of warmth.
  • Feeling tired or weak.
  • Feeling sleepy.
  • Upset stomach or throwing up.
  • Nose spray:
  • Change in taste.
  • Burning.
  • Nose and throat irritation.
  • Nose powder:
  • Change in taste.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Injection:
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • If your headache comes back after the first dose, another dose may be used as your doctor has told you. Be sure you know how many hours to space each dose. This includes if other forms of this drug were used for the first dose.
  • Tablets:
  • Take with or without food.
  • Swallow whole. Do not chew, break, or crush.
  • Take with liquids as early as you can after the attack has started.
  • Injection:
  • The shot is given under the skin as early as it can be after the attack has started.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Be sure you know where to give the shot. If you are not sure where to give the shot, talk with the doctor.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Nose spray:
  • Do not take this drug by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
  • Use this drug as early as you can after the attack has started.
  • Sit down before use.
  • Blow your nose before use.
  • Nose powder:
  • For the nose only.
  • Use this drug as early as you can after the attack has started.
  • Use nosepiece right after taking it out of the foil pouch.
  • Only use the device that comes with this drug. Do not use any other devices.
What do I do if I miss a dose?
  • This drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature. Do not refrigerate or freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Injection:
  • If you were given a storage case, store in the case you were given.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Sumatriptan (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(soo ma TRIP tan)

Brand Names: US

Imitrex; Imitrex STATdose Refill; Imitrex STATdose System; Onzetra Xsail; Sumavel DosePro; Zembrace SymTouch

Brand Names: Canada

Imitrex DF; Imitrex Injection; Imitrex Nasal Spray; Sumatriptan DF

What is this drug used for?
  • It is used to treat migraine headaches.
  • This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
  • If your child has ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke; or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
  • If your child has liver disease.
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If your child is taking another drug that has the same drug in it.
  • If your child has taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan in the last 24 hours.
  • If your child has taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your child’s doctor.
  • This drug is not meant to prevent or lower the number of migraine headaches your child gets. Talk with the doctor.
  • If your child has a headache that is not like the usual migraine headaches, talk with the doctor before you give this drug.
  • Giving more of this drug (a higher dose, more often) than the doctor told you to give may cause your child’s headaches to become worse.
  • Use care if your child has risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, other family members with early heart disease). Talk with the doctor.
  • Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this drug. Call the doctor right away if your child has chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; breaking out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
  • Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with this drug. Call your child’s doctor right away if your child has weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Injection:
  • If your child has a latex allergy, talk with the doctor. Some products have latex.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Seizures.
  • Loss of eyesight. This can be long-lasting.
  • Very bad headache or if headache is not better after the first dose.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
  • Constipation.
  • Diarrhea.
  • Very upset stomach or throwing up.
  • Severe stomach pain or bloody diarrhea.
  • Belly pain after meals.
  • Fever.
  • Weight loss.
  • Cramps and pain in legs or hips.
  • Feeling of heaviness or tightness in the leg muscles.
  • Feeling cold.
  • Burning or aching pain in the feet or toes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Dizziness.
  • Flushing.
  • Feeling of warmth.
  • Feeling tired or weak.
  • Feeling sleepy.
  • Upset stomach or throwing up.
  • Nose spray:
  • Change in taste.
  • Burning.
  • Nose and throat irritation.
  • Nose powder:
  • Change in taste.
  • Nose and throat irritation.
  • Runny nose.
  • Stuffy nose.
  • Injection:
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • If your child’s headache comes back after the first dose, another dose may be used as your child’s doctor has told you. Be sure you know how many hours to space each dose. This includes if other forms of this drug were used for the first dose.
  • Tablets:
  • Give this drug with or without food.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Give this drug with liquids as early as you can after the attack has started.
  • Injection:
  • The shot is given under the skin as early as it can be after the attack has started.
  • If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
  • Be sure you know where to give the shot. If you are not sure where to give the shot, talk with the doctor.
  • Wash hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • Nose spray:
  • Do not give this drug by mouth. Use in your child’s nose only. Keep out of your child’s mouth and eyes (may burn).
  • Give as early as you can after the attack has started.
  • Have your child sit down before use.
  • Have your child blow nose before use.
  • Nose powder:
  • For the nose only.
  • Give as early as you can after the attack has started.
  • Use nosepiece right after taking it out of the foil pouch.
  • Only use the device that comes with this drug. Do not use any other devices.
What do I do if my child misses a dose?
  • This drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature. Do not refrigerate or freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Injection:
  • If you were given a storage case, store in the case you were given.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.