Frequently Asked Questions About ZOMIG Nasal Spray

patients

ZOMIG Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults.

ZOMIG Nasal Spray is not for other types of headaches.

ZOMIG Nasal Spray is not for the prevention of migraine headaches.

It is not known if ZOMIG Nasal Spray is safe and effective to treat cluster headaches.

ZOMIG Nasal Spray is not for people with moderate or severe liver problems (hepatic impairment).

It is not known if ZOMIG Nasal Spray is safe and effective in children.

ZOMIG Nasal Spray is a prescription medicine approved to treat migraine headaches in adults with or without aura. It is not known if ZOMIG Nasal Spray is safe and effective in children. Only your doctor can determine if ZOMIG Nasal Spray is right for you.

ZOMIG Nasal Spray 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 Nasal Spray, then your doctor will need to determine if you really have a migraine headache before you take another dose. ZOMIG Nasal Spray is not for the prevention of migraines or for the treatment of hemiplegic or basilar migraines (if you are not sure about this, ask your doctor). ZOMIG Nasal Spray 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).

Steps for Using the Device

Ready

  • Remove the ZOMIG Nasal Spray unit from the single-use package it comes in. Do not remove the unit until you are ready to use it. The unit contains only 1 spray
  • Blow your nose gently before use
  • Remove the protective cap

Set

  • Hold the nasal sprayer device gently with your fingers and thumb as shown
  • Block one nostril by pressing firmly on the side of your nose. Either nostril can be used
NOTE: There is only one dose in the nasal sprayer. Do not try to prime the nasal sprayer or you will lose the dose. Do not press the plunger until you have put the tip into your nostril or you will lose the dose
  • Use ZOMIG Nasal Spray exactly as your doctor tells you to use it
  • If your headache comes back after using one nasal spray or you only get some relief from your headache, you can use another nasal spray 2 hours after the previous nasal spray
  • Do not use more than a total of 10 mg of ZOMIG Nasal Spray in any 24-hour period

Spray

  • Put the tip of the sprayer device into the other nostril as far as feels comfortable and tilt your head back slightly.
NOTE: Do not press the plunger yet. Do not spray the contents of the device in your eyes
  • Breathe in slowly and gently through your nose and at the same time press the plunger firmly with your thumb
NOTE: The plunger may feel stiff and you may hear a click
  • Keep your head slightly tilted back and remove the tip from your nose
  • Breathe gently through your mouth for 5 to 10 seconds
NOTE: You may feel liquid in your nose or the back of your throat. This is normal
  • Keep out of reach of children. Store at room temperature between 68°F to 77°F (20°C to 25°C). Properly dispose of the ZOMIG Nasal Spray device after completing the full dose or as soon as it becomes outdated or is no longer needed. Do not reuse.
  • Some patients taking ZOMIG Nasal Spray 5 mg felt migraine relief in as soon as 15 minutes 11.5% vs 5.4% placebo
  • The recommended starting dose of ZOMIG Nasal Spray is 2.5 mg
  • Most patients felt maximum effect within 2-4 hours
    2.5 mg: 55.4% at 2 hours, 63.4% at 4 hours; vs 30.8% placebo
    5 mg: 69.0% at 2 hours, 74.5% at 4 hours; vs 30.8% placebo

Do not use ZOMIG Nasal Spray 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 certain medicines called 5-HT1 agonists ("triptans") such as almotriptan (AXERT®), eletriptan (RELPAX®), frovatriptan (FROVA®), naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®), sumatriptan/naproxen (TREXIMET®); medicines that contain ergotamine, or ergot medicines such as BELLERGAL-S®, CAFERGOT®, ERGOMAR®, WIGRAINE®; dihydroergotamine like D.H.E. 45® or MIGRANAL®; or methysergide (SANSERT®) in the last 24 hours. Ask your doctor or pharmacist for a list of these medicines if you are not sure
  • are taking a monoamine oxidase A inhibitor (MAO-A inhibitor) or you stopped taking a MAO-A inhibitor in the last 14 days. Ask your doctor if you are not sure if you take an MAO-A inhibitor such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®)
  • are allergic to zolmitriptan of any of the ingredients in ZOMIG Nasal Spray

Before using ZOMIG Nasal Spray, tell your doctor about all your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • 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. It is not known if ZOMIG Nasal Spray will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZOMIG Nasal Spray passes into your breast milk. You and your doctor should decide if you will use ZOMIG Nasal Spray or 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) or monoamine oxidase inhibitors (MAOIs).
  • cimetidine

ZOMIG Nasal Spray can cause serious side effects.

Call your doctor right away if you have any of the following symptoms after using ZOMIG Nasal Spray:

  • Heart attack and other heart problems. Heart problems may lead to death. Stop taking ZOMIG Nasal Spray and get emergency medical help right away if you have any of the following symptoms of a heart attack or other heart problems:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • feeling lightheaded
  • nausea or vomiting with any of the symptoms included above
  • stroke. Symptoms of stroke include face drooping, slurred speech, and unusual weakness or numbness.
  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
  • serotonin syndrome.Serotonin syndrome is a serious and life-threatening problem that can happen in people using ZOMIG Nasal Spray, especially if ZOMIG Nasal Spray is used with antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norephinephrine reuptake inhibitors (SNRIs).
  • Ask your doctor or pharmacist for a list of these medicines if you are not sure.
  • Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • nausea, vomiting, or diarrhea
  • increased blood pressure
  • allergic reactions. Symptoms of an allergic reaction include:
  • rash
  • hives
  • itching
  • swelling of the face, mouth, throat, or tongue
  • difficulty breathing

The most common side effects of ZOMIG Nasal Spray are:

  • unusual taste
  • numbness
  • dizziness
  • skin sensitivity (hyperparesthesia)

These are not all the possible side effects of ZOMIG Nasal Spray. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1‑800‑FDA‑1088.

Store ZOMIG Nasal Spray at room temperature between 68°F and 77°F (20°C-25°C).

Keep ZOMIG Nasal Spray and all medicines out of the reach of children.

Properly dispose of the ZOMIG Nasal Spray device after completing the full dose or as soon as it becomes outdated or is no longer needed.

Do not reuse.

Active ingredient: zolmitriptan
Inactive ingredients: anhydrous citric acid, dibasic sodium phosphate, and purified water

 

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 (MAO) inhibitors for depression or other conditions within the last 14 days
  • allergies to zolmitriptan or any of the ingredients in ZOMIG, ZOMIG-ZMT or 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. Seek emergency help right away if you have any of the following symptoms of a heart attack such as: severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away; shortness of breath or wheezing; or symptoms of a stroke such as: slurring of speech; or unusual weakness or numbness. Call your doctor right away if you have any of the following problems after taking ZOMIG: changes in color or sensation in your fingers and toes; sudden or severe stomach pain; cramping or pain in your legs or hips; bloody diarrhea; hives; tongue, mouth, lip or throat swelling; problems seeing. ZOMIG can cause heart attacks, increases in blood pressure, stroke, life-threatening disturbances of heart rhythm, constriction of blood vessels in the abdomen or other parts of the body, or serious allergic reactions. In extremely rare cases, patients have died from these side effects
  • 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
  • Tell your doctor if you are sensitive to phenylalanine, which can be found in the artificial sweetener aspartame. ZOMIG-ZMT contains phenylalanine
  • The safety and effectiveness of ZOMIG have not been established in patients under 18 years of age or patients over 65 years of age
  • The most common side effects reported by patients in clinical trials for ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating Tablets include tingling sensation; weakness; nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest, throat, neck, or jaw; drowsiness; and warm sensation. The most common side effects reported by patients in clinical studies for ZOMIG Nasal Spray include unusual taste; tingling sensation; skin sensitivity; dizziness; nausea; pain, pressure, and tightness sensations such as in the nose, throat, or chest; drowsiness; weakness; disorder/discomfort of the nasal cavity; and dry mouth

Approved Use for ZOMIG

ZOMIG is a prescription medicine approved to treat migraine headaches in adults with or without aura. It is not known if ZOMIG Nasal Spray is safe and effective in children. Only your doctor can determine if ZOMIG is right for you.

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 or for the treatment of hemiplegic or basilar migraines (if you are not sure about this, ask your doctor). 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).

Click here to see the full Prescribing Information for ZOMIG Nasal Spray  

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.

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.

© 2014 Impax Pharmaceuticals, a Division of Impax Laboratories, Inc. All rights reserved. 3027402 PP-ZNS-US-0002 Last updated 07/14