Sumatriptan

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For subcutaneous use only.
• ( 2.1 ) Acute treatment of migraine: Single dose of 1 mg to 6 mg.
• ( 2.1 ) Acute treatment of cluster headache: Single dose of 6 mg.
• ( 2.1 ) Maximum dose in a 24-hour period: 12 mg, Separate doses by at least 1 hour.
• ( 2.1 ) Patients receiving doses other than 4 or 6 mg: Use the 6 mg single-dose vial.
• ( 2.3 )
• 2.1 Dosing Information The maximum single recommended adult dose of sumatriptan injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously.
• For the treatment of migraine, if side effects are dose limiting, lower doses (1 to 5 mg) may be used [see Clinical Studies ( 14.1 )] .
• For the treatment of cluster headache, the efficacy of lower doses has not been established.
• The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6 mg injections separated by at least 1 hour.
• A second 6 mg dose should only be considered if some response to a first injection was observed.
• 2.3 Administration of Doses of Sumatriptan Other than 4 or 6 mg In patients receiving doses other than 4 or 6 mg, use the 6 mg single-dose vial.
• Visually inspect the vial for particulate matter and discoloration before administration.
• Do not use if particulates and discolorations are noted.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Safety and effectiveness in pediatric patients have not been established.
• Sumatriptan Injection 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 pediatric 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 pediatric patients.
• 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 enrolled a total of 701 pediatric migraineurs.
• These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in pediatric patients.
• 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 pediatric patients.
• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical trials of Sumatriptan Injection 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 Injection [ see Warnings and Precautions ( 5.1 ) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are described below and elsewhere in the labeling:
• 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 )] Hypersensitivity reactions [see Contraindications ( 4 ), Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc at 1-877‑845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical 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.
• Migraine Headache:
• Table 1 lists adverse reactions that occurred in 2 U.S. placebo-controlled clinical trials in patients with migraines (Studies 2 and 3) following either a single 6-mg dose of Sumatriptan Injection or placebo.
• Only reactions that occurred at a frequency of 2% or more in groups treated with Sumatriptan Injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
• Table 1.
• Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3) Adverse Reactions Sumatriptan Injection 6 mg Subcutaneous (n = 547) % Placebo (n = 370) % Atypical sensations 42 9 Tingling 14 3 Warm/hot sensation 11 4 Burning sensation 7 <1 Feeling of heaviness 7 1 Pressure sensation 7 2 Feeling of tightness 5 <1 Numbness 5 2 Feeling strange 2 <1 Tight feeling in head 2 <1 Cardiovascular Flushing 7 2 Chest discomfort 5 1 Tightness in chest 3 <1 Pressure in chest 2 <1 Ear, nose, and throat Throat discomfort 3 <1 Discomfort:
• nasal cavity/sinuses 2 <1 Injection site reaction Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding. 59 24 Miscellaneous Jaw discomfort 2 0 Musculoskeletal Weakness 5 <1 Neck pain/stiffness 5 <1 Myalgia 2 <1 Neurological Dizziness/vertigo 12 4 Drowsiness/sedation 3 2 Headache 2 <1 Skin Sweating 2 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
• There were insufficient data to assess the impact of race on the incidence of adverse reactions.
• Cluster Headache :
• In the controlled clinical trials assessing the efficacy of Sumatriptan Injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of Sumatriptan Injection in patients with migraine.
• Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials.
• Exceptions include reports of paresthesia (5% Sumatriptan Injection, 0% placebo), nausea and vomiting (4% Sumatriptan Injection, 0% placebo), and bronchospasm (1% Sumatriptan Injection, 0% placebo).
• 6.2 Postmarketing 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.
• Cardiovascular: Hypotension, palpitations.
• Neurological: Dystonia, tremor.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that Sumatriptan Injection 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 )] .
• Hypersensitivity Reactions Inform patients that anaphylactic reactions have occurred in patients receiving Sumatriptan Injection.
• Such reactions can be life threatening or fatal.
• In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications ( 4 ), Warnings and Precautions ( 5.9 )] .
• Concomitant Use with Other Triptans or Ergot Medications Inform patients that use of Sumatriptan Injection 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 Injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions ( 5.7 ), Drug Interactions ( 7.4 )] .
• Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.6 )] .
• Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations ( 8.1 )] .
• Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2 )] .
• Ability to Perform Complex Tasks Treatment with Sumatriptan Injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan Injection.
• How to Use Sumatriptan Injection Instruct patients to read the Instructions for Use before starting therapy.
• Provide patients instruction on the proper use of Sumatriptan Injection if they are able to self-administer Sumatriptan Injection in medically unsupervised situations.
• Inform patients that the injection is intended to be given subcutaneously and intramuscular or intravascular delivery should be avoided.
• Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
• Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.
• Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by:
• Hikma Pharmaceuticals USA Inc.
• Berkley Heights, NJ 07922 Revised: January 2023 PIN311-WES/5

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 6 mg single-dose vial. Each 0.5 mL injection contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan. Injection:
• 6 mg single-dose vial ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
• Single-Dose Vial :
• Sumatriptan Injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials (NDC 0143-9638-05).
• Sumatriptan Injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 25 vials (NDC 0143-9638-25).
• Store between 2° and 30°C (36° and 86°F).
• Protect from light.

Quoted from the official label, section “How Supplied”.

What is in it

• Sumatriptan Injection, USP contains sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
• The empirical formula is C 14 H 21 N 3 O 2 S
• C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Sumatriptan Injection, USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of Sumatriptan Injection, USP 12-mg/mL solution contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range is approximately 4.2 to 5.3. The osmolality is 291 mOsmol. chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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