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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include a
ll the information needed to use
IMITREX safely and effectively. S
ee full prescribing information for
IMITREX.
IMITREX (sumatriptan) Nasal Spray
Initial U.S. Approval: 1992
----------------------------INDICATIONS AND USAGE ---------------------
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 th
erapy of migraine attacks. (1)
•
Not indicated for the treatment of cluster headache. (1)
----------------------- DOSAGE AND ADMINISTRATION ----------------
•
Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. (2)
•
A second dose should only be considered if some response to the first
dose was observed. Separate doses by at least 2 hours. (2)
•
Maximum dose in a 24-hour period: 40 mg. (2)
--------------------- DOSAGE FORMS AND STRENGTHS --------------
Nasal spray: 5 mg and 20 mg (3, 16)
-------------------------------
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-HT
1
agonist (e.g., another
triptan) or of an ergotamin
e-containing medication. (4)
•
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor. (4)
•
Hypersensitivity to IMITREX (angioe
dema and anaphylaxis seen). (4)
•
Severe hepatic impairment (4)
----------------------- WARNINGS AND PRECAUTIONS ----------------
•
Myocardial ischemia/infarction and Pr
inzmetal’s angina: Perform cardiac
evaluation in patients with multiple ca
rdiovascular risk factors. (5.1)
•
Arrhythmias: Discontinue IMITREX if occurs. (5.2)
•
Chest/throat/neck/jaw pain, tightness, pr
essure, or heaviness: Generally
not associated with myocardial ischemia; evaluate for coronary artery
disease in patients at high risk. (5.3)
•
Cerebral hemorrhage, subarachnoid he
morrhage, and stroke: Discontinue
IMITREX if occurs. (5.4)
•
Gastrointestinal ischemic reactions
and peripheral vasospastic reactions:
Discontinue IMITREX if occurs. (5.5)
•
Medication overuse headache: Detoxi
fication may be necessary. (5.6)
•
Serotonin syndrome:
Discontinue IMITREX if occurs. (5.7)
•
Seizures: Use with caution in patients
with epilepsy or a lowered seizure
threshold. (5.11)
------------------------------ ADVERSE REACTIONS -----------------------
Most common adverse reactions (
≥
1% and >placebo) were burning sensation,
disorder/discomfort of nasal cavity/sinus
es, throat discomfort, nausea and/or
vomiting, bad/unusual taste, a
nd dizziness/vertigo. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact
GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or
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