Sumatriptan 6 MG / 0.5 ML — Generic For Imitrex — Auto Injection Syringe — 2 Syringes Per Box — Dr. Reddy

These highlights do not include all the information needed to use SUMATRIPTAN INJECTION safely and effectively.

See full prescribing information for SUMATRIPTAN INJECTION.

SUMATRIPTAN injection, for subcutaneous use

Initial U.S. Approval: 1992

Indications And Usage

Sumatriptan injection is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for:

Acute treatment of migraine with or without aura in adults (1)

Acute treatment of cluster headache in adults (1)

Limitations of Use:

Use only if a clear diagnosis of migraine or cluster headache has been established. (1)

Not indicated for the prophylactic therapy of migraine or cluster headache attacks (1)

Dosage And Administration

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)

Dosage Forms And Strengths

Injection: 6 mg single-dose prefilled syringe assembled in an autoinjector (3)

Contraindications

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-HT1 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 injection (angioedema and anaphylaxis seen) (4)

Severe hepatic impairment (4)

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 injection 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 injection if occurs. (5.4)
• Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan injection if occurs. (5.5)
• Medication overuse headache: Detoxification may be necessary. (5.6)
• Serotonin syndrome: Discontinue sumatriptan injection if occurs. (5.7)
• Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.10)

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1)
• Arrhythmias: Discontinue sumatriptan injection 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 injection if occurs. (5.4)
• Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan injection if occurs. (5.5)
• Medication overuse headache: Detoxification may be necessary. (5.6)
• Serotonin syndrome: Discontinue sumatriptan injection if occurs. (5.7)
• Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.10)

Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1)

Arrhythmias: Discontinue sumatriptan injection 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 injection if occurs. (5.4)

Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan injection if occurs. (5.5)

Medication overuse headache: Detoxification may be necessary. (5.6)

Serotonin syndrome: Discontinue sumatriptan injection if occurs. (5.7)

Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.10)

Adverse Reactions

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 Dr.Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Use In Specific Populations

Pregnancy: Based on animal data, may cause fetal harm (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 1/2026