You Have the Right to Be Pain-Free

More pediatric patients (12–17 years of age) taking ZOMIG Nasal Spray 5 mg* had no headache pain at 2 hours vs placebo (30% vs 17%).

Almost twice as many patients experienced no headache pain

Pediatric patients (ages 12-17) using ZOMIG Nasal Spray 5 mg were 2x as likely to experience migraine relief vs placebo at 2 hours (30% vs 17%).

Most patients did not need additional medication

Nearly 80% of pediatric using ZOMIG Nasal Spray DID NOT use additional medication for 24 hours compared to 68% for placebo.

In addition to migraine pain, ZOMIG Nasal Spray may improve other migraine symptoms

In a clinical trial (“Study 2”), more patients showed absence of sensitivity to light or bright lights (56% vs 44%, P<0.05) and sensitivity to loud noise (58% vs 48%, P<0.05) with ZOMIG Nasal Spray 5 mg vs placebo 2 hours following treatment. No significant reduction in the occurrence of nausea was seen.

Side effects are similar to those of adults

The most common side effects for pediatric patients taking ZOMIG Nasal Spray:

  • unusual taste
  • nasal discomfort
  • dizziness
  • mouth/throat pain
  • nausea

*The recommended starting dose of ZOMIG Nasal Spray is 2.5 mg.

 

IMPORTANT SAFETY INFORMATION

Do not use ZOMIG if you have:

  • heart problems, a history of heart problems, or problems with the electrical system of your heart
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider
  • narrowing of blood vessels to your legs, arms, or stomach (peripheral vascular disease)
  • uncontrolled high blood pressure
  • used other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications
  • used monoamine oxidase A inhibitors (MAO-A inhibitors) or you stopped taking a MAO-A inhibitor in the last 14 days
  • allergies to zolmitriptan or any of the ingredients in ZOMIG Nasal Spray

If you are not sure about any of the above, ask your doctor.

  • Before taking ZOMIG, tell your doctor about all your medical conditions, including if you have high blood pressure, high cholesterol, diabetes, if you smoke, are overweight, are a female who has gone through menopause, have heart disease or a family history of heart disease or stroke, have liver problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines used to treat mood disorders including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors or cimetidine (reduces stomach acid production)
  • ZOMIG can cause serious side effects such as heart attacks (symptoms include severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away), increases in blood pressure, stroke (symptoms include slurring of speech; or unusual weakness or numbness), life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body (symptoms include changes in color or sensation in your fingers and toes), or serious allergic reactions (symptoms include hives; tongue, mouth, lip or throat swelling; problems breathing). In extremely rare cases, patients have died from these side effects. If you experience any of the above side effects, seek emergency help or contact your doctor right away
  • ZOMIG Nasal Spray can cause dizziness, weakness, or drowsiness. If you have any of these symptoms do not drive a car, use machinery, or do anything that needs you to be alert
  • Some people who take ZOMIG may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when ZOMIG is used together with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (confusion, seeing things that are not there (hallucinations), agitation, coma), fast heartbeat, changes in blood pressure, feeling faint, fever, sweating, muscle spasm, trouble walking, nausea, vomiting, and/or diarrhea. Call your doctor immediately if you have any of these symptoms after taking ZOMIG
  • The safety and effectiveness of ZOMIG have not been established in patients under 12 years of age or patients over 65 years of age
  • The most common side effects reported by adult patients in clinical studies for ZOMIG Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, warm sensation, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth
  • The most common side effects in pediatrics (age 12 to 17 years) in clinical trials for ZOMIG Nasal Spray were unusual taste, nasal discomfort, dizziness, mouth/throat pain, and nausea
  • These are not all of the possible side effects of ZOMIG Nasal Spray. For more information, ask your doctor

Approved Use for ZOMIG

ZOMIG is a prescription medicine approved to treat migraine headaches with or without aura in adults and pediatric patients (age 12 to 17 years). It is not known if ZOMIG Nasal Spray is safe and effective in children under 12 years of age. Only your doctor can determine if ZOMIG is right for you.

Limitations of Use:

ZOMIG should only be used where a clear diagnosis of migraine has been established. For a given migraine attack, if you do not respond to the first dose of ZOMIG, then your doctor will need to determine if you really have a migraine headache before you take another dose. ZOMIG is not for the prevention of migraines. ZOMIG is not for other types of headaches, including cluster headache. ZOMIG Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment).

It is not known if taking more than 1 dose of ZOMIG Nasal Spray in 24 hours is safe and effective in pediatric patients 12 to 17 years of age.

Click here to see the full Prescribing Information for ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating Tablets  

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-877-994-6729.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professionals. You should not use this information for diagnosing a health problem or disease. In order for you to make intelligent healthcare decisions, you should always consult with a physician or other healthcare provider for your, or your loved one’s, personal medical needs. All quotes included in this Web site represent the individual experience of some doctors, some patients, and their caregivers. Individual responses to treatment may vary.

This site is intended for residents of the United States only. Any products discussed herein may have different product labeling in different countries.

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ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.

© 2016 Impax Laboratories, Inc. All rights reserved. PP-ZNS-US-0028 3274901 09/2016