SUMATRIPTAN 20 mg Spray
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Sumatriptan nasal products are used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes come with nausea and a strong reaction to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and stops the release of natural substances that cause pain, nausea, and other symptoms of migraines. Sumatriptan does not stop migraine attacks from coming or reduce the number of headaches you have.
Read the full MedlinePlus article ↗- Sumatriptan is specifically for migraine headaches — it's not a general pain reliever like ibuprofen. It's designed to stop a migraine attack once it's already started, with or wit...
- What exactly is sumatriptan for? Will it work on any headache?
- You don't need to wait until it's unbearable. Taking sumatriptan at the first sign of a migraine is generally the right move — don't wait it out. That said, it is meant for confirm...
- When should I take sumatriptan — do I have to wait until the headache is severe?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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Potassium phosphate, monobasic is a salt compound used in medicines as a pH buffer and electrolyte source. It helps stabilize the acidity level of liquid and powdered formulations.
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A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $16.891 | $101.34 / 6 spray |
| Medicaid paysCMS SDUD · 12 mo | $19.54 | $117.23 / 6 spray |
| Medicare drug plans payPart D · Q2 2026 | $23.35 | $140.12 / 6 spray |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sumatriptan 20 mg 71921-0170-61 | Florida | 1 spray | $15.996 | AB | Availability likely | save 5% |
| Sumatriptan 20 mg/.1mL 00527-1859-43 | Lannett | 1 ml | $16.891 | AB | Availability likely | — |
| Sumatriptan 20 mgthis 45802-0598-06 | Padagis | 1 spray | $16.891 | AB | Availability likely | — |
| Sumatriptan 20 mg/100uL 66993-0082-69 | Prasco | 100 uls | $16.891 | AB | Availability likely | — |
| Sumatriptan 20 mg 69097-0644-48 | Cipla | 1 spray | $16.891 | AB | Availability likely | — |
| Sumatriptan 20 mg 63629-8703-01 | Bryant | 1 spray | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45802-0598-06 You're viewing this | 6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00) | 2020-10-04 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks. • Sumatriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: • Use only if a clear diagnosis of migraine headache has been established. ( 1 ) • Not indicated for the prophylactic therapy of migraine attacks.
( 1 ) • Not indicated for the treatment of cluster headache. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended adult dose of Sumatriptan Nasal Spray for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20-mg dose may provide a greater effect than the 5-mg and 10-mg doses, but may have a greater risk of adverse reactions [see Clinical Studies (14) ] . The 5-mg and 20-mg doses are given as a single spray in 1 nostril.
The 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. If the migraine has not resolved by 2 hours after taking Sumatriptan Nasal Spray, or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24-hour period.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established. • Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. ( 2 ) • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours.
( 2 ) • Maximum dose in a 24-hour period: 40 mg. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Unit dose nasal spray devices containing 5 mg or 20 mg sumatriptan. Nasal spray: 5 mg and 20 mg ( 3 , 16 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sumatriptan Nasal Spray is contraindicated in patients with: ▪ Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1) ] ▪ Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] ▪ History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4) ] ▪ Peripheral vascular disease [see Warnings and Precautions (5.5) ] ▪ Ischemic bowel disease [see Warnings and Precautions (5.5) ] ▪ Uncontrolled hypertension [see Warnings and Precautions (5.8) ] ▪ Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions ( 7.1 , 7.3 )] ▪ Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] ▪ Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.10) ] ▪ Severe hepatic impairment [see Clinical Pharmacology (12.3) ] • History of coronary artery disease or coronary artery vasospasm ( 4 ) • Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) • Peripheral vascular disease ( 4 ) • Ischemic bowel disease ( 4 ) • Uncontrolled hypertension ( 4 ) • Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of an ergotamine-containing medication.
( 4 ) • Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. ( 4 ) • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). ( 4 ) • Severe hepatic impairment ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) • Arrhythmias: Discontinue Sumatriptan Nasal Spray if occurs. ( 5.2 ) • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
( 5.3 ) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumatriptan Nasal Spray if occurs. ( 5.4 ) • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue Sumatriptan Nasal Spray if occurs. ( 5.5 ) • Medication overuse headache: Detoxification may be necessary.
( 5.6 ) • Serotonin syndrome: Discontinue Sumatriptan Nasal Spray if occurs. ( 5.7 ) • Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ( 5.11 )
5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of Sumatriptan Nasal Spray is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Sumatriptan Nasal Spray. Some of these reactions occurred in patients without known CAD.
Sumatriptan Nasal Spray may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan Nasal Spray. If there is evidence of CAD or coronary artery vasospasm, Sumatriptan Nasal Spray is contraindicated.
For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of Sumatriptan Nasal Spray in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of Sumatriptan Nasal Spray. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Sumatriptan Nasal Spray.
5.2Arrhythmias 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-HT 1 agonists. Discontinue Sumatriptan Nasal Spray if these disturbances occur. Sumatriptan Nasal Spray is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
5.3Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw may occur after treatment with Sumatriptan Nasal Spray and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of Sumatriptan Nasal Spray is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.
5.4Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA).
Discontinue Sumatriptan Nasal Spray if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan Nasal Spray…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the prescribing information: • Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1) ] • Arrhythmias [see Warnings and Precautions (5.2) ] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] • Cerebrovascular events [see Warnings and Precautions (5.4) ] • Other vasospasm reactions [see Warnings and Precautions (5.5) ] • Medication overuse headache [see Warnings and Precautions (5.6) ] • Serotonin syndrome [see Warnings and Precautions (5.7) ] • Increase in blood pressure [see Warnings and Precautions (5.8) ] • Local irritation [see Warnings and Precautions (5.9) ] • Hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.10) ] • Seizures [see Warnings and Precautions (5.11) ] Most common adverse reactions (≥1% and >placebo) were burning sensation, disorder/discomfort of nasal cavity/sinuses, throat discomfort, nausea and/or vomiting, bad/unusual taste, and dizziness/vertigo.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1 lists adverse reactions that occurred in worldwide placebo-controlled clinical trials in 3,419 patients with migraine. Only treatment-emergent adverse reactions that occurred at a frequency of 1% or more in the group treated with sumatriptan nasal spray 20 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1. Adverse Reactions Reported by at Least 1% of Patients and at a Greater Frequency than Placebo in Controlled Migraine Clinical Trials Adverse Reaction Percent of Patients Reporting Sumatriptan Nasal Spray 5 mg (n = 496) Sumatriptan Nasal Spray 10 mg (n = 1,007) Sumatriptan Nasal Spray 20 mg (n = 1,212) Placebo (n = 704) Atypical sensations Burning sensation 0.4 0.6 1.4
0.1Ear, nose, and throat Disorder/discomfort of nasal cavity/sinuses 2.8 2.5 3.8
2.4Throat discomfort 0.8 1.8 2.4
0.9Gastrointestinal Nausea and/or vomiting 12.2 11.0 13.5
11.3Neurological Bad/unusual taste 13.5 19.3 24.5
1.7Dizziness/vertigo 1.0 1.7 1.4
0.9The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients; use of prophylactic medications; or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of sumatriptan tablets, sumatriptan nasal spray, and sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan or a combination of these factors.
Cardiovascular Hypotension, palpitations. Neurological Dystonia, tremor. Reproductive System and Breast Disorders Breast pain [ see Use in Specific Populations (8.2) ].
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Sumatriptan Nasal Spray within 24 hours of each other is contraindicated.
7.2Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by up to 7-fold. Therefore, the use of Sumatriptan Nasal Spray in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ].
7.3Other 5-HT 1 Agonists Because their vasospastic effects may be additive, coadministration of Sumatriptan Nasal Spray and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.
7.4Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data) . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data) .
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
Data Human Data: The Sumatriptan/Naratriptan/TREXIMET (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]).
The sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis.
No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]).
A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group.
Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Ani…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data) . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data) .
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
Data Human Data: The Sumatriptan/Naratriptan/TREXIMET (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]).
The sample size in this study had 80% power to detect at least a 1.73- to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis.
No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]).
A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group.
Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Animal Data: Oral administration of sumatriptan to pregnant rats during the period of organogene…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Sumatriptan Nasal Spray is not recommended for use in patients younger than 18 years of age. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack.
The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs.
These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these patients appeared to be both dose- and age-dependent, with younger patients reporting reactions more commonly than older adolescents.
Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration.
Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of sumatriptan nasal spray did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan Nasal Spray [see Warnings and Precautions (5.1) ] .
🆘 Overdosage ▾
10 OVERDOSAGE In clinical trials, the highest single doses of sumatriptan nasal spray administered without significant reactions were 40 mg to 12 volunteers and 40 mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse reactions. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of sumatriptan is approximately 2 hours [see Clinical Pharmacology (12.3) ] , and therefore monitoring of patients after overdose with Sumatriptan Nasal Spray should continue for at least 10 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
12.2Pharmacodynamics Blood Pressure Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8) ] . Peripheral (Small) Arteries In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance. Heart Rate Transient increases in blood pressure observed in some patients in clinical trials carried out during sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.
12.3Pharmacokinetics Absorption In a trial of 20 female volunteers, the mean maximum concentration following a 5- and 20-mg intranasal dose was 5 and 16 ng/mL, respectively. The mean C max following a 6-mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL). The mean C max is 18 ng/mL (range: 7 to 47 ng/mL) following oral dosing with 25 mg and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of sumatriptan.
In a trial of 24 male volunteers, the bioavailability relative to subcutaneous injection was low, approximately 17%, primarily due to presystemic metabolism and partly due to incomplete absorption. 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. Distribution Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL, is low, approximately 14% to 21%.
The effect of sumatriptan on the protein binding of other drugs has not been evaluated. The apparent volume of distribution is
2.7L/kg. Metabolism In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive.
Elimination The elimination half-life of sumatriptan 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.
Specific Populations Age: The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years). Intranasal sumatriptan has not been evaluated for age differences. Patients with Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined.
Patients with Hepatic Impairment: The effect of mild to moderate hepatic disease on the pharmacokinetics of the intranasal formulation of sumatriptan has not been evaluated. Sumatriptan bioavailability following intranasal administration is 17%, similar to that after oral administration (15%). Following oral administration, an approximately 70% increase in C max and AUC was observed in one small trial of patients with moderate liver impairment (n = 8) matched for sex, age, and weight with healthy subjects (n = 8).
Similar changes can be expected following intranasal administration. The pharmacokinetics…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan Nasal Spray is a clear, pale yellow solution supplied in boxes of 6 nasal spray devices. Each unit dose supplies 5 mg and 20 mg, respectively, of sumatriptan: • Sumatriptan Nasal Spray, USP 5 mg (NDC 45802-619-06) • Sumatriptan Nasal Spray, USP 20 mg (NDC 45802-598-06) Store between 36°F and 86°F (2°C and 30°C). Protect from light.
📋 Description ▾
11 DESCRIPTION Sumatriptan Nasal Spray, USP contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S, representing a molecular weight of 295.4. Sumatriptan is a white to pale yellow powder that is very slightly soluble in water.
Each Sumatriptan Nasal Spray contains 5 or 20 mg of sumatriptan in a 100-mcL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, benzalkonium chloride solution NF, edetate disodium dihydrate USP and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively. chemical-structure.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that Sumatriptan Nasal Spray may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed.
Apprise patients of the importance of this follow-up [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 , 5.8 )] . Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumatriptan Nasal Spray. Such reactions can be life-threatening or fatal.
In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) , Warnings and Precautions (5.10) ] . Concomitant Use with Other Triptans or Ergot Medications Inform patients that use of Sumatriptan Nasal Spray within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) , Drug Interactions ( 7.1 , 7.3 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of Sumatriptan Nasal Spray or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) , Drug Interactions (7.4) ].
Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ] . Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1) ] . Lactation Advise breastfeeding women that they may develop transient breast pain when taking Sumatriptan Nasal Spray.
Advise breastfeeding women that avoiding breastfeeding for 12 hours after treatment with Sumatriptan Nasal Spray can minimize their infant’s exposure to sumatriptan [see Use in Specific Populations (8.2) ]. Ability to Perform Complex Tasks Treatment with Sumatriptan Nasal Spray may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan Nasal Spray. Local Irritation Inform patients that they may experience local irritation of their nose and throat.
The symptoms will generally resolve in less than 2 hours. How to Use Sumatriptan Nasal Spray Provide patients instruction on the proper use of Sumatriptan Nasal Spray. Caution patients to avoid spraying the contents of the device in their eyes.