Sumatriptan Succinate 6 mg/.5mL
Sumatriptan Succinate · INJECTION · Sun Pharmaceutical Industries, Inc.
Sumatriptan Succinate is a injection containing sumatriptan succinate at 6 mg/.5mL, taken subcutaneous. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Sumatriptan Succinate
- Generic Name
- Sumatriptan Succinate
- NDC Code (Product)
47335-276- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 6 mg/.5mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA090358
- Marketing Start
- 08/20/2025
Recall History
GlaxoSmithKline, LLC.
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
GlaxoSmithKline, LLC.
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks. SUMATRIPTAN injection, for subcutaneous use 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 & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use only ( 2.1 ) Acute treatment of migraine: single dose of 4 mg or 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 ) 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, the lower dose of 4 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. 2.2 Administration Using the Sumatriptan injection Autoinjector An autoinjector device is available for use with 4-mg and 6-mg prefilled syringes. With this prefilled syringe autoinjector, the needle penetrates approximately 1/4 inch (5 to 6 mm). The injection is intended to be given subcutaneously…
Contraindications
4 CONTRAINDICATIONS Sumatriptan injection 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 or 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-hydroxytryptamine1 (5-HT1) 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…
Drug Interactions
7 DRUG INTERACTIONS 7.1 Ergot-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 injection within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of sumatriptan injection in patients receiving MAO-A inhibitors is contraindicated [ see Clinical Pharmacology ( 12.3 ) ]. 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of sumatriptan injection and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [ see Warnings and Precautions ( 5.7 ) ].
Adverse Reactions
6 ADVERSE REACTIONS 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 Alembic Pharmaceuticals, Inc. at 1-866-210- 9797 or FDA at 1-800-FDA…
Frequently Asked Questions
What is Sumatriptan Succinate used for?
Sumatriptan Succinate contains Sumatriptan Succinate. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is Sumatriptan Succinate a controlled substance?
Sumatriptan Succinate is not classified as a controlled substance by the DEA.
What is the generic name for Sumatriptan Succinate?
The generic name for Sumatriptan Succinate is Sumatriptan Succinate. There are 9 other brand versions of Sumatriptan Succinate.
What is the NDC code for Sumatriptan Succinate 6 mg/.5mL?
The NDC (National Drug Code) for Sumatriptan Succinate 6 mg/.5mL is 47335-276, listed by Sun Pharmaceutical Industries, Inc..