*The recommended starting dose is 2.5 mg.2
Important Safety Information
- ZOMIG is contraindicated in patients with
- History of coronary artery disease (CAD)
or coronary artery vasospasm - Symptomatic Wolff-Parkinson-White syndrome
or other cardiac accessory conduction pathway
disorders - History of stroke, transient ischemic attack,
or hemiplegic or basilar migraine - Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent (within 24 hours) use of another
5-HT1 agonist (eg, another triptan), or an
ergotamine-containing medication - Monoamine oxidase (MAO)-A inhibitor
used in past 2 weeks - Known hypersensitivity to ZOMIG, ZOMIG-ZMT,
or ZOMIG Nasal Spray. Anaphylaxis,
anaphylactoid, and hypersensitivity reactions
including angioedema have occurred in patients
receiving zolmitriptan
- History of coronary artery disease (CAD)
- Myocardial ischemia, myocardial infarction and
Prinzmetal’s Angina: Perform cardiac evaluation
in patients with multiple risk factors and, if
satisfactory, administer first dose of ZOMIG in
a medically supervised setting - Arrhythmias: Discontinue ZOMIG if these occur
- Sensations of tightness, pain and pressure in the
chest, throat, neck, and jaw commonly occur after
treatment with 5-HT1 agonists like ZOMIG and are
usually non-cardiac in origin: Perform a cardiac
evaluation if these patients are at cardiac risk - Cerebrovascular events, some fatal; non-coronary
Gastrointestinal Ischemic Reactions and
Peripheral Vasospastic Reactions; and increases
in blood pressure (which have been very rarely
associated with serious clinical events) have been
reported with ZOMIG. Discontinue use of ZOMIG
if any of these events occur - Overuse of acute migraine drugs may lead to
exacerbation headache (medication overuse
headache). Detoxification of patients, including
withdrawal of the overused drugs, and treatment of
withdrawal symptoms may be necessary - Serotonin syndrome may occur with triptans,
including ZOMIG, particularly during
co-administration with selective serotonin reuptake
inhibitors (SSRIs), serotonin norepinephrine
reuptake inhibitors (SNRIs), tricyclic
antidepressants (TCAs), and MAO inhibitors.
Discontinue ZOMIG if serotonin syndrome is
suspected - The most common adverse reactions in adults
(≥5% and > placebo; in any dosage strength) in
clinical trials for ZOMIG Nasal Spray were: unusual
taste, paresthesia, hyperesthesia, and dizziness - The most common adverse reaction in pediatrics
(age 12 to 17 years; ≥5% and > placebo; in either
the 2.5 or 5 mg ZOMIG dose groups) in clinical
trials for ZOMIG Nasal Spray was unusual taste
Indication
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D
receptor agonist (triptan) indicated for the acute
treatment of migraine with or without aura in adults
and pediatric patients 12 years and older.
Limitations of Use:
Use ZOMIG only after a clear diagnosis of migraine
has been established. If a patient has no response
to ZOMIG treatment for the first migraine attack,
reconsider the diagnosis of migraine before ZOMIG
is administered to treat any subsequent attacks.
ZOMIG is not indicated for the prevention of
migraine attacks. Safety and effectiveness of
ZOMIG have not been established for cluster
headache. ZOMIG Nasal Spray is not
recommended in patients with moderate to severe
hepatic impairment.
Click here to see the full Prescribing Information
for ZOMIG Nasal Spray.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
To report SUSPECTED ADVERSE REACTIONS
contact Impax Laboratories, Inc. at
1-877-994-6729.
References: 1. Data on file, REF-MED-ZNS-US-0002,
Impax Laboratories, Inc. 2. ZOMIG Nasal Spray
[package insert]. Hayward, CA: Impax Specialty
Pharma, a division of Impax Laboratories, Inc.; 2016.

ZOMIG is a registered trademark of the AstraZeneca
group of companies.
© 2017 Impax Specialty Pharma, a division of Impax
Laboratories, Inc. All rights reserved.
PP-ADW-ZNS-US-0031 05/2017