Patient Case Study: A Rare Neurological Disease Diagnostic Journey
Imitrex Tablets
Imitrex Tablets Generic Name & Formulations General DescriptionSumatriptan (as succinate) 25mg, 50mg, 100mg.
Pharmacological ClassSelective 5-HT1B/1D receptor agonist.
How SuppliedSTATdose kit (2 prefilled cartridges + 1 Pen)—1; Refills (2 prefilled cartridges)—1; Single-dose vials (6mg/0.5mL)—5; Tabs—9; Nasal spray (single dose)—6
How SuppliedImitrex Tablets
25mg – white, triangular-shaped, film-coated tablets debossed with "I" on one side and "25" on the other in blister packs of 9 tablets.
50mg – white, triangular-shaped, film-coated tablets debossed with "IMITREX 50" on one side and a chevron shape (^) on the other in blister packs of 9 tablets.
100mg – 100 mg, are pink, triangular-shaped, film-coated tablets debossed with "IMITREX 100" on one side and a chevron shape (^) on the other in blister packs of 9 tablets.
Imitrex Tablets – Store between 2°C and 30°C (36°F and 86°F).
Mechanism of ActionThe vascular 5-HT1 receptor subtype to which sumatriptan binds selectively, and through which it presumably exerts its antimigrainous effect, is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of the isolated dura mater of humans. In these tissues, sumatriptan activates this receptor to cause vasoconstriction, an action in humans correlating with the relief of migraine and cluster headache.
Imitrex Tablets Indications IndicationsAcute treatment of migraine.
Limitations of UseConfirm diagnosis of migraine or cluster headache. Do not use for the prevention of migraine or cluster headache attacks.
Imitrex Tablets Dosage and Administration Adult≥18yrs: 25–100mg once, swallow whole with fluids as soon as possible after migraine onset; may repeat dose at intervals of at least 2hrs, max 200mg/day; or single-dose tablets up to 100mg/day if injection has been used. Hepatic dysfunction: max 50mg/dose. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Children<18yrs: not recommended.
Imitrex Tablets Contraindications ContraindicationsIschemic coronary artery disease (eg, angina pectoris, silent ischemia, history of MI). Coronary artery vasospasm (eg, Prinzmetal's variant angina). Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac conduction pathway disorders. Uncontrolled hypertension. History of stroke or transient ischemic attack (TIA). History of basilar or hemiplegic migraine. Peripheral vascular disease. Ischemic bowel disease. Severe hepatic impairment. Within 24 hours of ergot-type drugs (eg, methysergide, dihydroergotamine), or other 5-HT1 agonists. During or within 2 weeks after discontinuing MAO-A inhibitors (MAOI type A).
Imitrex Tablets Boxed WarningsNot Applicable
Imitrex Tablets Warnings/Precautions Warnings/PrecautionsConfirm diagnosis. Avoid excessive use. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary artery disease (eg, postmenopausal women, hypercholesterolemia, men over age 40, hypertension, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Peripheral vascular or colonic ischemia following other 5-HT1 agonists. Hepatic or renal dysfunction. Seizure risk. Latex allergy (Inj). Instruct patient on use of autoinjector. Elderly: not recommended. Pregnancy. Nursing mothers (avoid nursing for 12 hours after treatment).
Warnings/PrecautionsMyocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina
Imitrex is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD). Rare reports of serious cardiac adverse reactions, including acute myocardial infarction, have occurred within a few hours following administration.
Prior to treatment, perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Do not administer if there is evidence of CAD or coronary artery vasospasm (see Contraindications). For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first Imitrex dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration and consider periodic cardiovascular evaluation in intermittent long-term users of Imitrex Injection.
Arrhythmias
Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue Imitrex if these disturbances occur.
Imitrex is contraindicated in patients with Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
Chest, Throat, Neck and Jaw Pain/Tightness/Pressure
Perform a cardiac evaluation if patients who are at high cardiac risk experience sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw after treatment with Imitrex.
Imitrex is contraindicated in patients with CAD or Prinzmetal's variant angina.
Cerebrovascular Events
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities.
Exclude other potentially serious neurological conditions before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine.
Discontinue Imitrex if a cerebrovascular event occurs. Imitrex is contraindicated in patients with a history of stroke or transient ischemic attack.
Other Vasospasm Reactions
May cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome.
Rule out a vasospastic reaction before receiving additional doses of Imitrex in patients who experience symptoms or signs suggestive of a non-coronary vasospastic reaction following the use of any 5-HT1 agonist.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. A causal relationship between visual disorders and the use of 5-HT1 agonists has not been clearly established.
Medication Overuse Headache
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).
Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks.
May be necessary to detoxify patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache).
Serotonin Syndrome
May occur when Imitrex is coadministered with SSRIs, SNRIs, TCAs, and MAO inhibitors.
The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication.
Discontinue if serotonin syndrome is suspected.
Increase in Blood Pressure
Significant elevations in blood pressure, including hypertensive crisis with acute impairment of organ systems, have been reported in patients treated with 5-HT1 agonists including patients without a history of hypertension.
Monitor blood pressure. Imitrex is contraindicated in patients with uncontrolled hypertension.
Anaphylactic/Anaphylactoid Reactions
Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred which may be life-threatening or fatal.
Imitrex is contraindicated in patients with a history of hypersensitivity reaction to Imitrex.
Seizures
Pregnancy ConsiderationsRisk Summary
Clinical Considerations
Nursing Mother ConsiderationsRisk Summary
There are no data on the effects of sumatriptan on the breastfed infant, or the effects of sumatriptan on milk production.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Imitrex and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition.
Clinical Considerations
Pediatric ConsiderationsSafety and effectiveness in pediatric patients have not been established. Imitrex is not recommended for use in patients younger than 18 years of age.
Geriatric ConsiderationsClinical trials of Imitrex did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, use caution with dose selection for an elderly patient, usually starting at the low end of the dosing range.
Perform cardiovascular evaluation for geriatric patients who have other cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Imitrex.
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 bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption.
Effect of Food: A food effect trial involving administration of Imitrex 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.
DistributionProtein 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.
EliminationThe elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled 14Csumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces.
Imitrex Tablets Interactions InteractionsErgotamines, other 5-HT1 agonists, MAOIs: see Contraindications. Serotonin syndrome with SSRIs (eg, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) or SNRIs (eg, duloxetine, venlafaxine).
Imitrex Tablets Adverse Reactions Adverse ReactionsTingling, warm/hot sensation, flushing; chest/neck/sinus/jaw discomfort; dizziness/vertigo, muscle pain/weakness, numbness, fatigue, drowsiness, anxiety, sweating, local reactions, seizures, colonic ischemia, drug overuse headache (discontinue if occurs), hypersensitivity reactions; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss. Nasal spray: also dysgeusia, local irritation.
Imitrex Tablets Clinical Trials Clinical TrialsImitrex Tablets was evaluated for the acute treatment of migraine headaches in 3 randomized, double-blind, placebo-controlled trials. Patients were instructed to treat a moderate to severe headache. Patients were allowed to take a second dose of Imitrex tablets or other medication 4 to 24 hours after the initial treatment for recurrent headache.
Headache response was defined as a reduction in headache severity from moderate to severe pain to mild or no pain and was assessed up to 2 hours after dosing. Maintenance of response was assessed for up to 24 hours post-dose.
In all 5 trials, a greater percentage of patients treated with Imitrex 25mg, 50mg, and 100mg achieved headache response (no or mild pain) at 2 and 4 hours post-dose compared with placebo.
Trial 1
Imitrex 25mg: 52%a at 2hrs and 67%a at 4hrs
Imitrex 50mg: 61%a,b at 2hrs and 78%a,b at 4hrs
Imitrex 100mg: 62%a,b at 2hrs and 79%a,b at 4hrs
Placebo: 27% at 2hrs and 38% at 4hrs
Trial 2
Imitrex 25mg: 52%a at 2hrs and 70%a at 4hrs
Imitrex 50mg: 50%a at 2hrs and 68%a at 4hrs
Imitrex 100mg: 56%a at 2hrs and 71%a at 4hrs
Placebo: 26% at 2hrs and 38% at 4hrs
Trial 3
Imitrex 25mg: 52%a at 2hrs and 65%a at 4hrs
Imitrex 50mg: 54%a at 2hrs and 72%a at 4hrs
Imitrex 100mg: 57%a at 2hrs and 78%a at 4hrs
Placebo: 17% at 2hrs and 19% at 4hrs
aP <.05 in comparison with placebo; bP <.05 in comparison with 25mg
Patients treated with Imitrex nasal spray had a lower incidence of photophobia, phonophobia, nausea and vomiting associated with migraine attacks.
Register pregnant patients exposed to sumatriptan by calling (800) 336-2176.
Imitrex Tablets Patient Counseling Patient CounselingRisk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospastic Reactions, and Cerebrovascular Events
Inform patients that Imitrex Injection may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms; serious cardiovascular reactions may occur without warning symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions.
Hypersensitivity Reactions
Concomitant Use with Other Triptans or Ergot Medications
Serotonin Syndrome
Inform patients about the risk of serotonin syndrome with the use of Imitrex Injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors.
Medication Overuse Headache
Inform patients that use of drugs to treat acute migraines 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).
Pregnancy
Lactation
Ability to Perform Complex Tasks
Imitrex (Sumatriptan (Injection))
You should not use sumatriptan if you are allergic to it, or if you have ever had:
Do not use sumatriptan if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, serious infections, or prevention of nausea and vomiting. These medicines may interact with sumatriptan and cause a serious condition called serotonin syndrome.
Tell your doctor if you have ever had:
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breastfeed within 12 hours after using sumatriptan. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
Sumatriptan is not approved for use by anyone younger than 18 years old.
Imitrex Nasal Spray
Imitrex Nasal Spray Generic Name & Formulations General DescriptionSumatriptan 5mg, 20mg; per spray.
Pharmacological ClassSelective 5-HT1B/1D receptor agonist.
How SuppliedSTATdose kit (2 prefilled cartridges + 1 Pen)—1; Refills (2 prefilled cartridges)—1; Single-dose vials (6mg/0.5mL)—5; Tabs—9; Nasal spray (single dose)—6
How SuppliedImitrex Nasal Spray 5mg and 20mg are each supplied in boxes of 6 nasal spray devices.
StorageImitrex Nasal Spray – Store between 2° and 30°C (36° and 86°F). Protect from light.
Mechanism of Action
The vascular 5-HT1 receptor subtype to which sumatriptan binds selectively, and through which it presumably exerts its antimigrainous effect, is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of the isolated dura mater of humans. In these tissues, sumatriptan activates this receptor to cause vasoconstriction, an action in humans correlating with the relief of migraine and cluster headache.
Imitrex Nasal Spray Indications IndicationsAcute treatment of migraine.
Limitations of UseConfirm diagnosis of migraine or cluster headache. Do not use for the prevention of migraine or cluster headache attacks.
Imitrex Nasal Spray Dosage and Administration Adult≥18yrs: 5mg, 10mg, or 20mg once. Reevaluate if no response. May repeat once after 2hrs; max 40mg/day. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Children<18yrs: not recommended.
Imitrex Nasal Spray Contraindications ContraindicationsIschemic coronary artery disease (eg, angina pectoris, silent ischemia, history of MI). Coronary artery vasospasm (eg, Prinzmetal's variant angina). Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac conduction pathway disorders. Uncontrolled hypertension. History of stroke or transient ischemic attack (TIA). History of basilar or hemiplegic migraine. Peripheral vascular disease. Ischemic bowel disease. Severe hepatic impairment. Within 24 hours of ergot-type drugs (eg, methysergide, dihydroergotamine), or other 5-HT1 agonists. During or within 2 weeks after discontinuing MAO-A inhibitors (MAOI type A).
Imitrex Nasal Spray Boxed WarningsNot Applicable
Imitrex Nasal Spray Warnings/Precautions Warnings/PrecautionsConfirm diagnosis. Avoid excessive use. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary artery disease (eg, postmenopausal women, hypercholesterolemia, men over age 40, hypertension, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Peripheral vascular or colonic ischemia following other 5-HT1 agonists. Hepatic or renal dysfunction. Seizure risk. Latex allergy (Inj). Instruct patient on use of autoinjector. Elderly: not recommended. Pregnancy. Nursing mothers (avoid nursing for 12 hours after treatment).
Warnings/PrecautionsMyocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina
Imitrex is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD). Rare reports of serious cardiac adverse reactions, including acute myocardial infarction, have occurred within a few hours following administration.
Prior to treatment, perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Do not administer if there is evidence of CAD or coronary artery vasospasm (see Contraindications). For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first Imitrex dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration and consider periodic cardiovascular evaluation in intermittent long-term users of Imitrex Injection.
Arrhythmias
Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue Imitrex if these disturbances occur.
Imitrex is contraindicated in patients with Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
Chest, Throat, Neck and Jaw Pain/Tightness/Pressure
Perform a cardiac evaluation if patients who are at high cardiac risk experience sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw after treatment with Imitrex.
Imitrex is contraindicated in patients with CAD or Prinzmetal's variant angina.
Cerebrovascular Events
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities.
Exclude other potentially serious neurological conditions before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine.
Discontinue Imitrex if a cerebrovascular event occurs. Imitrex is contraindicated in patients with a history of stroke or transient ischemic attack.
Other Vasospasm Reactions
May cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome.
Rule out a vasospastic reaction before receiving additional doses of Imitrex in patients who experience symptoms or signs suggestive of a non-coronary vasospastic reaction following the use of any 5-HT1 agonist.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. A causal relationship between visual disorders and the use of 5-HT1 agonists has not been clearly established.
Medication Overuse Headache
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).
Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks.
May be necessary to detoxify patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache).
Serotonin Syndrome
May occur when Imitrex is coadministered with SSRIs, SNRIs, TCAs, and MAO inhibitors.
The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication.
Discontinue if serotonin syndrome is suspected.
Increase in Blood Pressure
Significant elevations in blood pressure, including hypertensive crisis with acute impairment of organ systems, have been reported in patients treated with 5-HT1 agonists including patients without a history of hypertension.
Monitor blood pressure. Imitrex is contraindicated in patients with uncontrolled hypertension.
Anaphylactic/Anaphylactoid Reactions
Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred which may be life-threatening or fatal.
Imitrex is contraindicated in patients with a history of hypersensitivity reaction to Imitrex.
Seizures
Pregnancy ConsiderationsRisk Summary
Clinical Considerations
Nursing Mother ConsiderationsRisk Summary
There are no data on the effects of sumatriptan on the breastfed infant, or the effects of sumatriptan on milk production.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Imitrex and any potential adverse effects on the breastfed infant from sumatriptan or from the underlying maternal condition.
Clinical Considerations
Pediatric ConsiderationsSafety and effectiveness in pediatric patients have not been established. Imitrex is not recommended for use in patients younger than 18 years of age.
Geriatric ConsiderationsClinical trials of Imitrex did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. In general, use caution with dose selection for an elderly patient, usually starting at the low end of the dosing range.
Perform cardiovascular evaluation for geriatric patients who have other cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Imitrex.
Clinical and pharmacokinetic data indicate that administration of two 5-mg doses, 1 dose in each nostril, is equivalent to administration of a single 10-mg dose in 1 nostril.
DistributionProtein 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.
EliminationThe elimination half-life of sumatriptan administered as a nasal spray is approximately 2 hours, similar to the half-life seen after subcutaneous injection. Only 3% of the dose is excreted in the urine as unchanged sumatriptan; 42% of the dose is excreted as the major metabolite, the indole acetic acid analogue of sumatriptan. The total plasma clearance is approximately 1,200 mL/min.
Imitrex Nasal Spray Interactions InteractionsErgotamines, other 5-HT1 agonists, MAOIs: see Contraindications. Serotonin syndrome with SSRIs (eg, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) or SNRIs (eg, duloxetine, venlafaxine).
Imitrex Nasal Spray Adverse Reactions Adverse ReactionsTingling, warm/hot sensation, flushing; chest/neck/sinus/jaw discomfort; dizziness/vertigo, muscle pain/weakness, numbness, fatigue, drowsiness, anxiety, sweating, local reactions, seizures, colonic ischemia, drug overuse headache (discontinue if occurs), hypersensitivity reactions; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss. Nasal spray: also dysgeusia, local irritation.
Imitrex Nasal Spray Clinical Trials Clinical TrialsImitrex nasal spray was evaluated for the acute treatment of migraine headaches in 8 randomized, double-blind, placebo-controlled trials, of which 5 used the recommended dosing regimen and used the marketed formulation. Patients were instructed to treat a moderate to severe headache. Patients were allowed to take a second dose of Imitrex nasal spray or other medication 2 to 24 hours after the initial treatment for recurrent headache.
Headache response was defined as a reduction in headache severity from moderate to severe pain to mild or no pain and was assessed up to 2 hours after dosing. Maintenance of response was assessed for up to 24 hours post-dose.
In all 5 trials, a greater percentage of patients treated with Imitrex 5mg, 10mg, and 20mg achieved headache response (no or mild pain) at 2 hours post-dose compared with placebo.
Trial 1: 49% for 5mg (P <.05 in comparison with placebo); 46% for 10mg (P <.05 in comparison with placebo); 64% for 20mg (P <.05 in comparison with placebo, 5mg, and 10mg); vs 25% for placebo
Trial 2: Not applicable for 5mg; 44% for 10mg (P <.05 in comparison with placebo); 55% for 20mg (P <.05 in comparison with placebo, 10mg); vs 25% for placebo
Trial 3: Not applicable for 5mg; 54% for 10mg (P <.05 in comparison with placebo); 63% for 20mg (P <.05 in comparison with placebo); vs 35% for placebo
Trial 4: Not applicable for 5mg; 43% for 10mg; 62% for 20mg (P <.05 in comparison with placebo, 10mg); vs 29% for placebo
Trial 5: 45% for 5mg (P <.05 in comparison with placebo); 53% for 10mg (P <.05 in comparison with placebo); 60% for 20mg (P <.05 in comparison with placebo, 5mg); vs 36% for placebo
Patients treated with Imitrex nasal spray had a lower incidence of photophobia, phonophobia, nausea and vomiting associated with migraine attacks.
Register pregnant patients exposed to sumatriptan by calling (800) 336-2176.
Imitrex Nasal Spray Patient Counseling Patient CounselingRisk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospastic Reactions, and Cerebrovascular Events
Inform patients that Imitrex Injection may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms; serious cardiovascular reactions may occur without warning symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions.
Hypersensitivity Reactions
Concomitant Use with Other Triptans or Ergot Medications
Serotonin Syndrome
Inform patients about the risk of serotonin syndrome with the use of Imitrex Injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors.
Medication Overuse Headache
Inform patients that use of drugs to treat acute migraines 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).
Pregnancy
Lactation
Ability to Perform Complex Tasks
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