Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: C14H21N3O2S
Molecular Formula: C14H21N3O2S•C4H6O4
CAS Number: 103628-46-2
FDA approved a REMS for sumatriptan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sumatriptan and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().
Uses for Sumatriptan
Sumatriptan Dosage and Administration
Administer orally with fluids; swallow tablet whole.148
Administer intranasally as a single spray into 1 nostril.249
Nasal solution unit contains only 1 spray; do not test before use.249
To administer, remove unit from package just before use.249 While sitting down, gently blow nose to clear nasal passages.249 Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth.249 With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle.249 Insert nozzle into open nostril about ½ inch.249 While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger.249 Remove nozzle from nostril while keeping head level for 10–20 seconds and gently inhaling through nose and exhaling through mouth; do not inhale deeply.249 Consult administration instructions provided by manufacturer before use.249
Do not administer IM or IV; IV administration may induce coronary vasospasm.1
Autoinjection device available for use with prefilled syringes (each containing a 4- or 6-mg dose) to facilitate self-administration.1 273 Needles with this device penetrate approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length.1 273
25, 50, or 100 mg as a single dose.148 274 Individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 50- or 100-mg dose; 100-mg dose may not provide substantially greater effect than 50-mg dose.148 274
If headache recurs or partial response occurs after initial dose, additional oral doses may be administered at intervals of ≥2 hours, up to a maximum oral dosage of 200 mg daily.274
If headache recurs after an initial sub-Q dose, additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.274Intranasal
5, 10, or 20 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 20-mg dose.249 Doses >20 mg provide no additional benefit.249
To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.249
If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.249Sub-Q
≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 4 mg) may be given.1 273 In patients receiving doses other than 4 or 6 mg, only the single-dose vials containing 6 mg/0.5 mL should be used to provide the desired dose.1 273
If headache recurs, a 6-mg sub-Q dose may be repeated once after ≥1 hour or additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.273
≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses may be administered using only single-dose vials; use autoinjection device only with prefilled, unit-of-use syringes containing 6 mg.1
If headache recurs, 6-mg dose may be repeated once after ≥1 hour, up to a maximum dosage of 12 mg in any 24-hour period.1
Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.273
Safety of treating an average of >4 headaches per 30-day period has not been established.148Intranasal
Maximum 40 mg daily.249
Safety of treating an average of >4 headaches per 30-day period has not been established.249Sub-Q
Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1
Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1
Contraindicated in patients with severe hepatic impairment.1 148 249 Unpredictable increases in bioavailability following oraladministration in patients with hepatic impairment.148 If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.148
Patients Receiving MAO-A Inhibitors
Concurrent or recent (within 2 weeks) use of MAO-A inhibitor and oral or intranasal sumatriptan is contraindicated;148 249 sub-Qsumatriptan is not generally recommended, but if concomitant use is clinically warranted, decrease sumatriptan sub-Q dosage and administer under careful medical supervision.1 237
Cautions for Sumatriptan
Use oral or intranasal sumatriptan only in patients in whom a clear diagnosis of migraine has been established.148 249 Use sub-Q sumatriptan only in patients in whom a clear diagnosis of migraine or cluster headache has been established.1
Exclude other potentially serious neurologic disorders before administering sumatriptan to patients not previously diagnosed with migraine or cluster headache or to those with atypical symptoms.1 61 148 236 237
Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.1 148 249
Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.1 148 249
Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy, including patients with cluster headache (predominantly males >40 years of age).1 148 249
Patients with symptoms suggestive of angina after receiving sumatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration resumed and such signs or symptoms recur, ECG evaluation recommended.1 148 249
Other Cardiovascular or Vasospastic Effects
Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported.1 148 249 Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud’s syndrome) occur following administration.1 6 8
Substantial increases in BP, including hypertensive crises, reported rarely in patients with or without history of hypertension; administer with caution in patients with controlled hypertension as transient increases in BP and peripheral vascular resistance are possible.1 148 249 (See Contraindications under Cautions.)
Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).272 273 274 275 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).272 273 274 275
Possible transient irritation in nose and throat (e.g., burning, numbness, paresthesia, discharge, pain/soreness), sometimes severe, after intranasal administration; symptoms usually resolve in <2 hours.249 Effects of extended and repeated use on nasal and/or respiratory mucosa not systematically evaluated.249
Hypersensitivity reactions (e.g., anaphylaxis/anaphylactoid reactions), possibly life-threatening or fatal, reported rarely; increased risk in patients with history of sensitivity to multiple allergens.1 148 249
Corneal opacities and corneal epithelial defects reported in dogs. No specific recommendations for monitoring.
Contraindicated in patients with severe hepatic impairment.1 148 249 Due to important role of the liver in presystemic clearance of oral sumatriptan, dosage adjustment recommended if oral therapy is deemed advisable in patients with hepatic impairment.148 (See Special Populations under Dosage and Administration.)
Common Adverse Effects
With oral therapy, pain/pressure sensations in chest/neck/throat/jaw, paresthesia, warm or cold sensation, malaise/fatigue, vertigo.148
With intranasal therapy, taste disturbances, nausea, vomiting, disorder/discomfort of nasal cavity or sinuses.249
With sub-Q therapy, injection site reaction, atypical sensations (e.g., tingling, warm/hot sensation, burning, feeling of heaviness, pressure, tightness, numbness), dizziness/vertigo, flushing, mouth/tongue discomfort, weakness, neck pain/stiffness, chest discomfort.1
Interactions for Sumatriptan
Metabolized principally by MAO-A isoenzyme in vitro.148
Pretreatment with oral sumatriptan followed by acetaminophen affected rate, but not extent of acetaminophen absorption over 8 hours187
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)
Use of nasal or oralsumatriptan within 2 weeks of MAO-A inhibitor contraindicated; although not generally recommended, if clinically warranted, sub-Q sumatriptan may be used concurrently with MAO-A inhibitors with appropriate dosage adjustment and careful monitoring1 237
Topical application of xylometazoline to nasal mucosa 15 minutes prior to intranasal sumatriptan did not affect sumatriptan pharmacokinetics249
Absorbed rapidly after oral, intranasal, or sub-Q administration, with peak plasma concentrations attained within approximately 0.5–5 hours, 0.8–1.8 hours, or 5–20 minutes, respectively.1 2 3 13 45 61 78 79 89 96 123 146 148 166 168 236 Bioavailability after sub-Q administration averages 97% of that obtained with IV administration1 44 ; bioavailability after oral or intranasal administration averages only about 15 or 17%, respectively, principally due to presystemic metabolism and in part due to incomplete absorption.2 13 14 44 45 61 89 146 148 166 168 249
Oral absorption is not appreciably affected by gastric stasis that may occur during migraine attack,3 13 45 146 but time to peak concentration is prolonged by about 30 minutes;3 13 45 96 146 148 pharmacokinetics after sub-Q injection appear to be similar during migraine attacks and pain-free periods.1
In patients with hepatic impairment, bioavailability after oral administration may be markedly increased.148 In a small study, AUC and peak plasma concentrations increased approximately 70% and time to peak plasma concentrations occurred 40 minutes earlier after oral administration compared with such values in healthy adults.148
After oral administration, onset of relief of migraine symptoms generally occurs within 1–3 hours after single doses (25–100 mg),92 148 162 178 191 with maximum pain relief attained within 3–6 hours.148 178 191
After sub-Q administration, onset of pain relief usually occurs within 10–34 minutes in patients with moderate to severe migraine headache pain, with maximum relief attained within 1–2 hours;1 8 9 13 47 56 162 176 181 onset of pain relief generally occurs within 4–7 minutes in patients with cluster headache, with headache resolution shortly thereafter.40 49 75 184
Plasma Protein Binding
Metabolized in the liver and possibly in the GI tract principally to inactive indole acetic acid metabolite and other minor metabolites;1 2 3 13 14 104 148 166 metabolized principally by MAO-A isoenzyme in vitro.1 37 48 148
After oral administration, excreted in urine (57–60%) and feces (37–40%); only 3 and 9% of dose is excreted as unchanged drug in urine and feces, respectively.14 45 148 13 45 148 166 168 After sub-Q administration, approximately 22 or 38–53% of dose is excreted in urine unchanged or as indole acetic acid metabolite, respectively;1 45 168 0.6 and 3.3% of dose is excreted in feces as unchanged drug and indole acetic acid metabolite, respectively.2 13 14 45
2–30°C; protect from light.249
2–30°C; protect from light.1
Precise mechanism of action not established;4 6 9 13 77 87 may ameliorate migraine and cluster headache through selective constriction of certain large cranial blood vessels and/or inhibition of neurogenic inflammatory processes in the CNS.1 2 3 6 7 9 10 13 47 66 73 77 88 110 119 131 177 184 186 217 236 237
Advice to Patients
Importance of immediately informing a clinician of any tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck, as well as sudden and/or severe abdominal pain, shortness of breath, wheezing, heart throbbing, facial swelling (e.g., eyelids, face, lips), rash, or hives after taking sumatriptan and of not taking sumatriptan again until evaluated by a clinician.1
Importance of providing patient a copy of manufacturer’s patient information.1 148 249 Importance of clinician providing adequate instructions, as well as the written administration instructions supplied with the autoinjection device or nasal spray, before first use.1 171 249
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1 148 249
Importance of informing patients of risk of serotonin syndrome with concurrent use of sumatriptan and an SSRI or SNRI.272 273 274 275 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.272 273 274 275
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
5 mg/0.1 mL
Imitrex Nasal Spray
20 mg/0.1 mL
Imitrex Nasal Spray
25 mg (of sumatriptan)
50 mg (of sumatriptan)
100 mg (of sumatriptan)
Injection, for sub-Q use only
4 mg/0.5 mL (of sumatriptan)
Imitrex (available in 0.5-mL [4-mg] unit-of-use syringes)
6 mg/0.5 mL (of sumatriptan)
Imitrex (available in 0.5-mL [6-mg] unit-of-use syringes and as 0.5 mL [6-mg] single-dose vials)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Imitrex 100MG Tablets (GLAXO SMITH KLINE): 9/$255.00 or 27/$754.00
Imitrex 20MG/ACT Solution (GLAXO SMITH KLINE): 6/$270.98 or 18/$790.96
Imitrex 25MG Tablets (GLAXO SMITH KLINE): 9/$272.65 or 27/$791.50
Imitrex 5MG/ACT Solution (GLAXO SMITH KLINE): 1/$55.49 or 3/$136.30
Imitrex 50MG Tablets (GLAXO SMITH KLINE): 9/$268.99 or 27/$780.99
Imitrex STATdose Refill 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$603.25
Imitrex STATdose System 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$628.59
SUMAtriptan 20MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$119.96
SUMAtriptan 5MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$125.97
SUMAtriptan Succinate 100MG Tablets (SUN PHARMACEUTICAL): 9/$205.00 or 27/$583.98
SUMAtriptan Succinate 25MG Tablets (SUN PHARMACEUTICAL): 9/$219.99 or 27/$619.95
SUMAtriptan Succinate 50MG Tablets (RANBAXY PHARMACEUTICALS): 9/$199.99 or 27/$569.97
Sumavel DosePro 6MG/0.5ML Device (ZOGENIX): 1/$106.99 or 2/$304.97
Treximet 85-500MG Tablets (GLAXO SMITH KLINE): 9/$219.98 or 27/$629.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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