- AstraZeneca enters agreement with Grünenthal to divest rights to migraine treatment Zomig
- NOTES TO EDITORS
- Zomig (zolmitriptan) for Migraines: Side Effects, Dosage, Generic
- What are the uses of zolmitriptan?
- What are the side effects of zolmitriptan?
- What is the dosage for zolmitriptan?
- Which drugs or supplements interact with zolmitriptan?
- Is zolmitriptan safe to take if I'm pregnant or breastfeeding?
- What preparations of zolmitriptan are available?
- How should I keep zolmitriptan stored?
- Zomig (zolmitriptan)
- How does Zomig work?
- Things to know about Zomig
- Dosing information
- Zolmitriptan is a Triptan Used for Migraine Relief
- Buy Affordable Zolmitriptan (generic Zomig®) for Migraines | Cove
- What will it do for me?
- How does it help?
- How do I get zolmitriptan?
- How should I take it?
- What should I be cautious of?
- Can I take zolmitriptan with other migraine medications?
- What happens if I can’t take it right away?
- Where should I keep my zolmitriptan?
- What other triptans are available?
- Zomig: Uses, Side Effects & Dosage Guide – Drugs.com
- What is Zomig?
- Important information
- Before taking this medicine
- How should I take Zomig?
- Zomig dosing information
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking Zomig?
- What other drugs will affect Zomig?
- Further information
- ZOMIG® (zolmitriptan) Nasal Spray
AstraZeneca enters agreement with Grünenthal to divest rights to migraine treatment Zomig
7 June 2017
AstraZeneca today announced that it has entered an agreement with Grünenthal for the global rights to Zomig (zolmitriptan) outside Japan. Zomig is indicated for the acute treatment of migraines and cluster headaches, an area of medicine outside AstraZeneca’s strategic focus.
Grünenthal will pay AstraZeneca $200 million upon completion. AstraZeneca will also receive up to an additional $102 million in future milestone payments.
Grünenthal will acquire the rights to Zomig in all markets outside Japan, including the US, where the rights were previously licensed to Impax Pharmaceuticals (Impax). Impax will continue to market Zomig in the US.
AstraZeneca will continue to manufacture and supply the medicine to Grünenthal during a transition period.
Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca said: “Grünenthal is an established partner with expertise in the treatment of pain. It is well placed to ensure patients continue to benefit from Zomig, and toextend the commercial potential of the medicine through its dedicated salesforce.”
Gabriel Baertschi, CEO of Grünenthal said: “Migraine is a very debilitating disease with more than 75 million people worldwide suffering from attacks that can lead to sensitivity to light or sound, to nausea or even vomiting.
The acquisition of the well-established Zomig products complements our existing pain portfolio. Migraine has been one of the very few main pain indications we haven’t yet been able to offer a solution for. This is an important step to reach our ambition to become a €2 billion company by 2022.
It will also support our efforts to bring four to five innovative products to market in the same timeframe.”
In 2016, revenues from Zomig outside Japan were $96 million, including Product Sales and Externalisation Revenue.
The transaction is expected to complete in the second quarter of 2017, subject to customary closing conditions and regulatory clearances.
The net consideration from the agreement will be reported as Other Operating Income in the Company’s financial statements. The agreement does not impact the Company’s financial guidance for 2017.
NOTES TO EDITORS
Zomig (zolmitriptan) is indicated for the acute treatment of migraine, and for the acute treatment of cluster headache in the EU. Zomig is available in three formulations: An oral tablet, orally dispersible tablet and nasal spray.
The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a €2 billion company.
We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.
Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America and the US.
Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. €1.4 bn. More information: www.grunenthal.
com. Follow us on LinkedIn: @GrunenthalGroup
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory.
The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.
com and follow us on @AstraZeneca.
Zomig (zolmitriptan) for Migraines: Side Effects, Dosage, Generic
Zolmitriptan is a drug for treating migraine headaches. Migraine headaches are believed to result from dilation of the blood vessels in the brain. Zolmitriptan causes constriction of the blood vessels and thereby relieves the pain of a migraine headache.
While zolmitriptan is very effective in relieving migraine headaches, it does not prevent or reduce the number of headaches if taken prophylactically. Its mechanism of action and effectiveness are similar to those of sumatriptan (Imitrex).
Zolmitriptan was approved by the FDA in November of 1997.
What are the uses of zolmitriptan?
Zolmitriptan is used for the treatment of migraines.
What are the side effects of zolmitriptan?
Side effects are generally transient. Some common side effects include:
Rarely, allergic reactions (even shock) have been reported though usually in individuals who are highly allergic to many substances.
What is the dosage for zolmitriptan?
Dosing: The initial dose is 2.5 mg or less. The dose can be repeated after 2 hours if symptoms persist. The maximum dose is 10 mg per day. Doses less than 2.5 mg can be achieved by splitting the 2.5 mg tablet. Zolmitriptan may be taken with or without food.
12 Surprising Headache Triggers Tips See Slideshow
Which drugs or supplements interact with zolmitriptan?
Monoamine oxidase inhibitors, for example, isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and procarbazine (Matulane)) may exaggerate the effects of zolmitriptan.
Zolmitriptan directly stimulates serotonin receptors on nerves.
Serotonin reuptake inhibitors (SSRIs) that are used for treating depression, for example, fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft), enhance the effects of serotonin by preventing its uptake by nerves.
Therefore, the combination of zolmitriptan and an SSRI may lead to exaggerated effects of serotonin, and has been reported to cause weakness, increased reflexes, and loss of coordination.
Ergots, dihydroergotamine (DHE) and ergotamine tartrate (Cafergot) that often are used to treat migraine headaches, can cause blood vessels to go into spasm. It is possible that the combination of ergots and zolmitriptan will result in exaggerated spasm of the vessels. Therefore, it is not recommended that zolmitriptan and ergots be used within 24 hours of each other.
Cimetidine (Tagamet) may double the concentration of zolmitriptan in the blood by interfering with its elimination. Potentially, this may lead to zolmitriptan toxicity.
Is zolmitriptan safe to take if I'm pregnant or breastfeeding?
Safe use in pregnancy has not been established.
Safe use in nursing mothers has not been established.
What preparations of zolmitriptan are available?
Tablet: 2.5 and 5 mg. Tablet (orally disintegrating): 2.5 and 5 mg.
How should I keep zolmitriptan stored?
Zolmitriptan should be stored at room temperature, away from heat and light. It should be kept the reach of children.
Symptoms & Signs FAQs & Doctor's Views Medications FDA Drug Labels on RxList.com Health News Health Features Who suffers more frequently from migraine headaches? See Answer
Medically Reviewed on 8/20/2019
FDA Prescribing Information
Zomig® is a serotonin (5HT1B/1D) receptor agonist that is used in the treatment of acute migraines in adults. The active ingredient in Zomig is zolmitriptan, a selective serotonin receptor agonist. It is classified as a triptan, which is believed to reduce the pain of migraine by relieving swelling by narrowing blood vessels.
As a selective serotonin receptor agonist, Zomig also stops pain signals being sent to the brain and blocks the release of certain chemicals in the body that cause the symptoms of migraine, including head pain, nausea, and sensitivity to light and sound.
Zomig is indicated for migraines with or without aura, the visual or sensory symptoms some people with migraines experience before the head pain.1,2
Zomig was first approved to treat migraines in 1997 in a tablet formulation. It is now also available in an orally dissolving tablet (Zomig ZMT) and as a nasal spray. The tablets and orally dissolving tablets are available in generic forms under the name zolmitriptan.1,3
How does Zomig work?
The zolmitriptan in Zomig binds to certain serotonin receptors. Researchers believe that Zomig works by binding to these receptors in neurons (nerve cells) and on blood vessels in the brain, causing the blood vessels to constrict and inhibiting chemicals that would increase inflammation.
Zomig also reduces substances that trigger head pain and which may be involved in other common symptoms of migraine, such as nausea, sensitivity to light, and sensitivity to sound. Zomig works best when it is taken at the first sign of a migraine.
It does not prevent a migraine or reduce the number of migraine attacks you have.1-3
all medications, Zomig may cause unintended side effects.
The most common side effects experienced by people taking Zomig tablets are pain, tightness or pressure in the neck, throat, or jaw; dizziness, tingling, weakness or lack of energy, sleepiness, feelings of warmth or cold, nausea, heaviness sensation, and dry mouth. The most common side effects experienced by people taking Zomig nasal spray are an unusual taste, tingling, dizziness, and sensitivity of the skin, especially the skin around the nose.1,4
Rarely, Zomig may cause serious side effects, including heart attack, increased blood pressure, stroke, life-threatening disturbances of the heart rhythm, constriction of blood flow to the abdomen or other parts of the body, or serious allergic reactions. If you experience serious side effects with Zomig, you should seek immediate medical attention.
Signs of serious side effects include:
- Severe pain, tightness, pressure or heaviness in the chest, throat, neck or jaw that does not go away
- Slurring of speech
- Sudden weakness or numbness
- Changes in color to the fingers or toes ( paleness or a bluish tint)
- Allergic reactions, such as hives, swelling of the eyes, face, lips, or throat or difficulty breathing.1,3
Before using Zomig, talk to your doctor about all your medical conditions, particularly if you have:
- High blood pressure
- High cholesterol
- Liver disease
- Personal or family history of heart disease or stroke
- History of circulation problems, varicose veins, blood clots, Raynaud’s disease, or ischemic bowel disease
- Pregnancy or planning to become pregnant
- Breastfeeding or planning to breastfeed
- Past menopause 1,3
Things to know about Zomig
People with any of the following health conditions should not use Zomig or its generic zolmitriptan:
- History of heart disease or coronary artery vasospasm
- Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (“mini stroke), or hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled high blood pressure (hypertension)
- Hypersentivity to zolmitriptan1
In addition, people taking certain medications should not use Zomig, including:
- Recent use (within 24 hours) of another selective serotonin receptor agonist or another triptan
- Recent use of an ergotamine-containing medication
- Use of a monoamine oxidase A (MAO-A) inhibitor within the last 2 weeks1
Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take, as some of these may interact with Zomig.1,2
The tablet comes in dosage of 2.5 mg and 5mg. A dosage of 1.25 mg can be achieved by breaking the 2.5 mg tablet in half along the centerline; however, the dissolving tablets should not be broken or split.
The tablet should be taken at the first sign of a migraine. If migraine symptoms improve but return or worsen after 2 hours, a second dose may be taken.
However, the maximum amount anyone should take in a 24-hour period is 10 mg.1,2
The nasal spray administers single doses of 2.5 mg or 5 mg of zolmitriptan. The recommended starting dose is 2.5 mg, and the maximum single dose is 5 mg. A second dose of the nasal spray may be used if symptoms return after two hours, but the maximum dose anyone should take in a 24-hour period is 10 mg.4
Zolmitriptan is a Triptan Used for Migraine Relief
Zomig (zolmitriptan) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of migraines in adults. The tablet is available in a form that can be swallowed, as well as an oral (by mouth) disintegrating form.
Zomig ZMT (zolmitriptan nasal spray) is FDA approved for the treatment of migraines in adults and children age 12 and older.
Zolmitriptan is one of the triptan medications, a category of prescription migraine treatments used to alleviate acute migraine attacks.
Zolmitriptan works by the same mechanism of the other triptans. It interacts with the blood vessels in the brain and it inhibits pain.
According to the manufacturer, zolmitriptan preferentially binds to serotonin 5 HT1D and 5 HT1B receptors. This causes vasoconstriction (narrowing of the blood vessels) in the brain. Migraines are associated with vasodilation (widening of the blood vessels), so alleviating this effect is believed to play a role in reducing the symptoms of an acute migraine attack.
Zolmitriptan may also reduce inflammation and stimulation of the sensory nerves, particularly the trigeminal nerve, which mediates migraine pain.
Because this medication is available as a tablet, an orally disintegrating tablet, and a nasal spray, you have several options to think about when considering your preferred route of administration. The orally disintegrating tablet and the nasal spray may be easier for you than the tablet if you experience nausea with your migraines or if you have trouble swallowing.
other triptans, zolmitriptan is a powerful medication. Be sure to use it as recommended and not to exceed the maximum recommended daily dose.
Zolmitriptan tablets are available in 2.5 mg or 5 mg strengths. The 2.5 mg tablets are scored so they can be cut in half, which allows you to take 1.25 mg. (You might be given instructions to take 1.25 mg, 2.5 mg, or 5 mg for an acute migraine episode.)
If a migraine does not resolve or if it returns after improvement, a second dose of zolmitriptan may be repeated two hours after the first dose.
The maximum daily dose of zolmitriptan is 10 mg within a 24-hour period.
Exception: If you have moderate to severe liver impairment, it is recommended that you only take a 1.25 mg dose of zolmitriptan. Your maximum daily dose should be 5 mg of zolmitriptan, as opposed to 10 mg.
Orally disintegrating tablets are available in 2.5 mg and 5 mg strengths. These tablets dissolve on your tongue and cannot be cut, therefore it cannot be taken as a 1.25 mg dose. The recommended dose is the same as that of the regular tablet otherwise.
The zolmitriptan nasal spray comes in a 2.5 mg strength and a 5 mg strength. It is taken as a single spray of 2.5 mg or 5 mg in one nostril. If the migraine persists or returns within two hours of the first dose, a second dose may be repeated once.
The maximum daily dose should not exceed 10 mg.
A pediatrician will recommend the right dose of zolmitriptan nasal spray for your child his or her size and weight, medical history, and other medications.
Another form, the Adhesive Dermally-Applied Microarray (ADAM) zolmitriptan, is currently being developed. This form of delivery is still in the investigational phase, and preliminary results are promising.
Zomig can produce the same side effects as other triptans. Common side effects typically last for approximately an hour and include:
- Warm or cold sensation
The zolmitriptan spray may cause an unpleasant taste in your mouth.
Serious side effects include:
- Chest pain or tightness
- Shortness of breath
- Neck, throat, or jaw tightness, pressure, or dizziness
Seek medical attention immediately if you experience any of these.
Zolmitriptan and other triptans have been linked to several serious conditions, such as a heart attack, potentially life-threatening heart arrhythmias (irregular heartbeat), and increased blood pressure.
Zolmitriptan interacts with the Tagamet (cimetidine), a medication used for heartburn. If you are taking both medications, your doctor or pharmacist will recommend a maximum single dose of zolmitriptan of 2.5mg and a maximum daily dose of 5 mg.
It is not safe to use zolmitriptan within 24 hours of another triptan or ergotamine medication.
When zolmitriptan is used along with antidepressants, including serotonin reuptake inhibitors and monoamine oxidase-A inhibitors, it can increase the risk of serotonin syndrome, a rare but serious condition.
Zolmitriptan is not safe for you if you have any of the following conditions:
Experts suggest caution in taking a triptan if you have risk factors for coronary heart disease, obesity, a history of smoking or diabetes, or a family history of heart disease.
The zolmitriptan oral disintegrating tablets (Zomig ZMT) contain a substance called phenylalanine, a component of aspartame. Ingesting phenylalanine can be harmful if you have phenylketonuria. Take note, the regular zolmitriptan tablets (Zomig) do not contain phenylalanine.
There are a number of powerful prescription migraine medications, and zolmitriptan and other triptans are considered very effective and safe if you don't have contraindications. Still, it is a good idea to try over-the-counter remedies first before using stronger medications such as triptans.
Be sure to keep track of how many times you are using zolmitriptan. If you are taking more than four doses per month, talk to your doctor about strategies to prevent your migraines and possibly revisiting your treatment plan.
Buy Affordable Zolmitriptan (generic Zomig®) for Migraines | Cove
Zolmitriptan (brand names: Zomig® and Zomig ZMT®) is a triptan medication that aims to ease all of the acute symptoms of a migraine headache, including pain, dizziness, nausea, and light and/or sound sensitivity.
What will it do for me?
Zolmitriptan helps stop an oncoming migraine attack in its tracks by reducing that awful headache pain, as well as any nausea, dizziness, or sensitivity to light and sound you might also be experiencing.
How does it help?
Research shows that blood vessels in the brain over-expand during a migraine headache, so zolmitriptan tablets try to get them back to their usual size. If you want to get scientific, zolmitriptan combats migraine symptoms by…
- narrowing the expanded blood vessels (“vasoconstriction,” if you want to get extra scientific)
- decreasing any inflammation in the nerves
- turning down the volume on those loud pain signals
How do I get zolmitriptan?
Zolmitriptan is a prescription medication so you’ll need to talk to your doctor before you can get it. Get started today with a Cove doctor consultation.
How should I take it?
Right away, at the very first sign of a migraine headache. You can take zolmitriptan with water and with or without food.
What should I be cautious of?
If any of the below looks familiar, definitely talk to your doctor before taking zolmitriptan. With any prescription medication, drug interactions and side effects can be unpleasant. Here are some risk factors to consider:
- You’re on other medications.
- You’ve had angina, heart attack, chest pain, or other heart problems.
- You’ve had a stroke or TIA.
- You’ve had a stroke- migraine (hemiplegic migraine).
- You’ve been told you’ve had a brainstem migraine (basilar migraine).
- You have poor circulation.
- You have uncontrolled high blood pressure.
- You have certain heart arrhythmias ( irregular rhythms).
- You have severe liver disease
- You’re taking other acute prescription migraine medication.
Can I take zolmitriptan with other migraine medications?
If you’re already taking a different triptan, don’t add zolmitriptan. If you’re using other types of pain relievers, or a daily preventative medication, adding zolmitriptan shouldn’t cause you any problems. That said, you still may want to consult with your doctor if you’re not sure if zolmitriptan will interact with another medication you’re taking.
What happens if I can’t take it right away?
If you feel a migraine headache starting, take it as quickly as you can. The sooner you take it, the sooner it’ll start reducing your headache pain.
Where should I keep my zolmitriptan?
Keep it in a dry place at a cool room temperature.
Many people who use zolmitriptan do not experience serious side effects. Some people experience dizziness, warmth, tingling, and non-heart related chest discomfort. If you’re experiencing any of these symptoms, you should discontinue use and contact your health care professional.
What other triptans are available?
There are currently six other triptan drugs prescribed in the United States in addition to zolmitriptan: almotriptan (generic Axert®), eletriptan (generic Relpax®), frovatriptan (generic Frova®), naratriptan (generic Amerge®), rizatriptan (generic Maxalt®), and sumatriptan (generic Imitrex®).
In addition to zolmitriptan (available as a 5mg tablet), Cove also currently offers oral eletriptan, naratriptan, rizatriptan, and sumatriptan.
The information provided in this article is not a substitute for professional medical advice, diagnosis, or treatment. You should not rely upon the content provided in this article for specific medical advice. If you have any questions or concerns, please talk to your doctor.
Eletriptan, naratriptan, and zolmitriptan are oral medications indicated for the acute treatment of migraine with or without aura in adults and is not used to prevent migraines. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
Tell your doctor if you are breast-feeding.
Call your doctor right away if you have allergic reactions skin rash, itching or hives, swelling of the face, lips, or tongue, chest pain or chest tightness, signs and symptoms of a dangerous change in heartbeat or heart rhythm chest pain; dizziness; fast, irregular heartbeat; palpitations; feeling faint or lightheaded; falls; breathing problems.
Call your doctor right away if you have signs and symptoms of a stroke changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination.
Call your doctor right away if you have signs and symptoms of serotonin syndrome irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting. You can read more about eletriptan’s side effects, warnings, and precautions here.
Full prescribing information for eletriptan is available here. You can read more about naratriptan’s side effects, warnings, and precautions here. Full prescribing information for naratriptan is available here. You can read more about zolmitriptan’s side effects, warnings, and precautions here. Full prescribing information for zolmitriptan is available here. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch: https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.
Sumatriptan and rizatriptan are oral medications indicated for the acute treatment of migraine with or without aura in adults and not for the prophylactic therapy of migraine attacks or for the treatment of cluster headache. Tell your doctor if you are pregnant or plan on getting pregnant.
You will need to talk about the benefits and risks of using either of these drugs while you are pregnant. Tell your doctor if you are breast-feeding.
Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out. Very bad and sometimes deadly brain blood vessel problems stroke have rarely happened with this drug.
Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight. You can read more about sumatriptan’s side effects, warnings, and precautions here. Full prescribing information for sumatriptan is available here.
You can read more about rizatriptan side effects, warnings, and precautions here. Full prescribing information for rizatriptan is available here. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch: https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.
Photo by Gian Cescon on Unsplash.
Zomig: Uses, Side Effects & Dosage Guide – Drugs.com
Generic Name: zolmitriptan (oral) (ZOLE mi TRIP tan)
Brand Names:Zomig, Zomig-ZMT
Medically reviewed by Drugs.com. Last updated on Oct 24, 2019.
What is Zomig?
Zomig (zolmitriptan) is a headache medicine that narrows blood vessels around the brain. Zolmitriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.
Zomig is used to treat migraine headaches in adults.
Zomig will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.
Zomig should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.
You should not use Zomig if you have uncontrolled high blood pressure, heart problems, certain heart rhythm disorders, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.
Do not use Zomig if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Do not take Zomig within 24 hours before or after using another migraine headache medicine, including zolmitriptan nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex, Treximet), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).
Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).
Zomig will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.
After taking a Zomig tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 10 mg of zolmitriptan in 24 hours.
Before taking this medicine
You should not use Zomig if you are allergic to zolmitriptan, or if you have:
- coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
- a history of heart disease, heart attack, or stroke, including “mini-stroke”;
- Wolff-Parkinson-White syndrome;
- severe or uncontrolled high blood pressure;
- a blood vessel disorder or circulation problems that cause a lack of blood supply within the body; or
- a headache that seems different from your usual migraines.
Do not use Zomig if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure Zomig is safe for you, tell your doctor if you have:
- heart disease, high blood pressure, or a heart rhythm disorder;
- epilepsy or seizures;
- liver or kidney disease;
- a condition for which you take cimetidine (Tagamet); or
- coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).
Zomig disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of zolmitriptan if you have phenylketonuria (PKU).
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether zolmitriptan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Zomig is not approved for use by anyone younger than 18 years old.
How should I take Zomig?
Take Zomig exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Use Zomig as soon as you notice migraine symptoms.
Take the regular tablet whole with a full glass of water.
To take the orally disintegrating tablet (Zomig-ZMT):
- Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
- Use dry hands to remove the tablet and place it in your mouth.
- Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.
After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first. Do not take more than 10 mg of zolmitriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.
Call your doctor if your headache does not go away at all after taking the first Zomig tablet.
Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse.
Contact your doctor if you have more than four headaches in one month (30 days). Tell your doctor if this medicine seems to stop working as well in treating your migraine attacks.
Zomig can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using this medicine. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Store at room temperature away from moisture, heat, and light.
Zomig dosing information
Usual Adult Dose for Migraine:
Oral:-Initial dose: 1.25 or 2.5 mg orally once (may break the scored 2.5 mg tablet in half to obtain 1.25 mg dose); may repeat in 2 hours if migraine has not resolved or returns after a transient improvement-Maintenance Dose: Adjust dose individual responseMaximum single dose: 5 mgMaximum daily dose: 10 mg in a 24-hour period Orally Disintegrating Tablets:-Initial dose: 2.
5 mg orally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement-Maintenance Dose: Adjust dose individual responseMaximum single dose: 5 mgMaximum daily dose: 10 mg in a 24-hour period Nasal Spray:-Initial dose: 2.
5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement-Maintenance Dose: Adjust dose individual responseMaximum single dose: 5 mgMaximum daily dose: 10 mg in a 24-hour period Comments:-This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.-Do not break the oral disintegrating tablet, they are not scored.-In trials, the majority of patients had headache response following a 2.5 mg or 5 mg dose compared with a 1 mg dose; little added benefit was observed with the 5 mg dose compared to the 2.5 mg dose, but adverse events were more frequent.-The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Use: For the acute treatment of migraine with or without aura.
Usual Pediatric Dose for Migraine:
Age 12 years and older: Nasal Spray:-Initial dose: 2.
5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement-Maintenance Dose: Adjust dose individual responseMaximum single dose: 5 mgMaximum daily dose: 10 mg in a 24-hour period Comments:-This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response to this drug for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.-The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Use: For the acute treatment of migraine with or without aura.
What happens if I miss a dose?
Since Zomig is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using Zomig .
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Zomig?
Do not take Zomig within 24 hours before or after using another migraine headache medicine, including:
- zolmitriptan nasal spray, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or sumatriptan; or
- ergot medicine – dihydroergotamine, ergotamine, ergonovine, methylergonovine.
Zomig may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Get emergency medical help if you have signs of an allergic reaction to Zomig: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Zomig and call your doctor at once if you have:
- feeling of tightness in your jaw, neck, throat, or chest;
- fast or pounding heartbeats, dizziness;
- sudden and severe stomach pain and bloody diarrhea;
- heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
- high levels of serotonin in the body – agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Common Zomig side effects may include:
- pain or tightness in your throat or chest;
- dry mouth, upset stomach;
- pressure or heavy feeling anywhere in your body;
- drowsiness, feeling tired; or
- flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Zomig?
Using Zomig while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:
- medicine to treat depression;
- medicine to treat a psychiatric disorder;
- a narcotic (opioid) medication; or
- medicine to prevent nausea and vomiting.
This list is not complete. Other drugs may interact with zolmitriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines the reach of children, never share your medicines with others, and use Zomig only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2020 Cerner Multum, Inc. Version: 9.01.
ZOMIG® (zolmitriptan) Nasal Spray
WHENEVER A MIGRAINE STRIKES… *Most adult patients (69%) said their headache pain was reduced from moderate or severe to mild or no pain with ZOMIG Nasal Spray 5 mg at 2 hours (primary measurement of the study). The recommended starting dose is 2.5 mg.
†In a clinical study, some adult patients (12%) who used a single spray of ZOMIG Nasal Spray 5 mg felt relief in as soon as 15 minutes.1 References: 1. Data on file, Impax Laboratories, LLC. 2. ZOMIG Nasal Spray [package insert].
- 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-Ainhibitor 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 Nasal Spray, 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. Talk to your doctor about the best way to feed your baby while using ZOMIG Nasal Spray.
- 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 Nasal Spray 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 Nasal Spray may have a reaction called serotonin syndrome which can be life-threatening. In particular this reaction may occur when ZOMIG Nasal Spray 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 Nasal Spray
- The safety and effectiveness of ZOMIG Nasal Spray 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 (12 to 17 years of age) 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 Nasal Spray
ZOMIG Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age). 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 Nasal Spray is right for you.
Limitations of Use:
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.
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).
The maximum daily dose should not exceed 10 mg in any 24-hour period.