Drugplain

IMITREX 4 mg/.5mL

sumatriptan · INJECTION · GlaxoSmithKline LLC

1 Recall on RecordCurrently in Shortage
Plain English

IMITREX is a injection containing sumatriptan at 4 mg/.5mL, taken subcutaneous. Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name
IMITREX
Generic Name
sumatriptan
NDC Code (Product)
0173-0739
Manufacturer
GlaxoSmithKline LLC
Strength
4 mg/.5mL
Dosage Form
INJECTION
Route
SUBCUTANEOUS
Marketing Status
Application #
NDA020080
Marketing Start
04/06/2006

Recall History

1 Recall on Record
Class II11/06/2013

GlaxoSmithKline, LLC.

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective5,407 reports
headache3,124 reports
nausea2,822 reports
migraine2,742 reports
fatigue2,114 reports
pain1,977 reports
dizziness1,684 reports
vomiting1,609 reports
dyspnoea1,347 reports
off label use1,265 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE IMITREX tablets are 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 IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks. • IMITREX is not indicated for the prevention of migraine attacks. • Safety and effectiveness of IMITREX tablets have not been established for cluster headache. IMITREX 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 & Administration

2 DOSAGE AND ADMINISTRATION • Single dose of 25-mg, 50-mg, or 100-mg tablet. ( 2.1 ) • A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. ( 2.1 ) • Maximum dose in a 24-hour period: 200 mg. ( 2.1 ) • Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. ( 2.2 ) 2.1 Dosing Information The recommended dose of IMITREX tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)] . If the migraine has not resolved by 2 hours after taking IMITREX tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period. Use after IMITREX Injection If the migraine returns following an initial treatment with IMITREX (sumatriptan) injection, additional single IMITREX tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. Th…

Contraindications

4 CONTRAINDICATIONS IMITREX Tablets are 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-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 Interac…

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 IMITREX tablets within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO‑A inhibitors increase systemic exposure by 7-fold. Therefore, the use of IMITREX tablets 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 IMITREX tablets 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 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)] • Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9)] • Seizures [see Warnings and Precautions (5.10)] Most common adverse reactions (≥2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at…

Frequently Asked Questions

What is IMITREX used for?

IMITREX contains sumatriptan. It is a injection taken subcutaneous. Consult your doctor for specific uses.

Is IMITREX a controlled substance?

IMITREX is not classified as a controlled substance by the DEA.

What is the generic name for IMITREX?

The generic name for IMITREX is sumatriptan. There are 11 other brand versions of sumatriptan.

What is the NDC code for IMITREX 4 mg/.5mL?

The NDC (National Drug Code) for IMITREX 4 mg/.5mL is 0173-0739, listed by GlaxoSmithKline LLC.

Product NDC

0173-0739

Package NDC

0173-0739-00

Other IMITREX Dosages

Other Sumatriptan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)