sumatriptan 6 mg/.5mL
sumatriptan · INJECTION, SOLUTION · ONESOURCE SPECIALTY PHARMA LIMITED
sumatriptan is a injection, solution containing sumatriptan at 6 mg/.5mL, taken subcutaneous. Manufactured by ONESOURCE SPECIALTY PHARMA LIMITED.
Key Facts
- Brand Name
- sumatriptan
- Generic Name
- sumatriptan
- NDC Code (Product)
83270-151- Manufacturer
- ONESOURCE SPECIALTY PHARMA LIMITED
- Strength
- 6 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA090314
- Marketing Start
- 02/02/2026
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.
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.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Sun Pharmaceutical Industries, Inc.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan Injection, USP 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 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 attacks or cluster headache attacks. Sumatriptan injection, USP is a serotonin (5-HT 1B/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 1 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, USP 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 mg 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 4mg or 6 mg, use the 6-mg single-dose vial; Visually inspect the vial for particulate matter and discoloration b…
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-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 D…
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, coadministration 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 coadministration 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 Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Frequently Asked Questions
What is sumatriptan used for?
sumatriptan contains sumatriptan. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is sumatriptan a controlled substance?
sumatriptan is not classified as a controlled substance by the DEA.
What is the generic name for sumatriptan?
The generic name for sumatriptan is sumatriptan. There are 11 other brand versions of sumatriptan.
What is the NDC code for sumatriptan 6 mg/.5mL?
The NDC (National Drug Code) for sumatriptan 6 mg/.5mL is 83270-151, listed by ONESOURCE SPECIALTY PHARMA LIMITED.