Can you take ibuprofen with maxalt

Contents

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for Acute Migraine Treatment

While the “triptans”—eg, sumatriptan (Imitrex), rizatriptan (Maxalt), eletriptan (Relpax)—have received more promotion and attention over the 2 decades since they first became available for general use, the non-steroidal anti-inflammatory drugs (NSAIDs) long have been a mainstay of treatment for acute migraine headache. Perhaps the best known of the NSAIDs frequently used for that purpose are ibuprofen (eg, Advil, Motrin), and naproxen sodium (eg, Aleve, Anaprox), both available in over-the-counter/non-prescription and prescription preparations—but flurbiprofen, diclofenac potassium (eg, Cataflam), and others also have been demonstrably effective in treating acute migraine headache. Indomethacin (eg, Indocin) is another NSAID widely used for the treatment of migraine and other primary headache disorders, and Cambia, a new powdered formulation of diclofenac potassium that is to be dissolved in water and taken as an oral solution, recently was found to be effective for treating moderate or severe acute migraine headache in 2 large clinical trials.

The NSAIDs typically are much less expensive than the triptans, and in the few studies that have compared a particular NSAID with a triptan, the NSAID has performed at least nearly as well. In addition, compared to other medications administered for acute migraine headache, the NSAIDs appear to possess a relatively low potential for producing medication overuse headache (often referred to as “rebound” headache). Finally, and unlike opioids/opiates (“narcotics”) or headache preparations containing a barbituate (usually butalbital; eg, Esgic, Fioricet), use of the NSAIDs for acute headache treatment does not appear to predispose to eventual “chronification” of migraine (ie, the development of daily or near-daily headache).

Virtually all of the NSAIDs may irritate the lining of the stomach or intestine, and this can be a particular problem—and even a contraindication to NSAID use—for individuals with peptic ulcer disease, gastroesophageal reflux (GERD), irritable bowel syndrome, or other gastrointestinal disorders. “Heartburn” and diarrhea are common side effects of the NSAIDs, and fluid retention also may occur (albeit infrequently with sporadic, “as needed” usage). In rare instances the NSAIDs may impair the kidneys or liver, but this is much more likely to occur in individuals who administer an NSAID on a daily or near-daily basis.

While some patients may find the NSAIDs to be consistently effective even for migraine of moderate to severe intensity, these drugs typically are more useful when taken early in the migraine attack. Co-administration of an NSAID and an oral triptan may prove more effective than administration of either drug alone, and there is currently available a compound oral medication, Treximet, that combines an NSAID (naproxen sodium) and a triptan (sumatriptan).

Treatment Hint: During an acute migraine attack the stomach may not move an orally administered NSAID along to the small intestine, where the NSAID normally would be absorbed; co-administration of a caffeinated beverage with the NSAID may overcome this problem and promote more effective intestinal absorption and a higher likelihood of a positive treatment response.

John F. Rothrock, MD

Editor-in-Chief, Headache

Director, Headache Treatment and Research Center

University of Alabama

Birmingham, AL, USA

MAXALT® Wafers

Rizatriptan benzoate

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start using MAXALT Wafers. This leaflet answers some common questions about MAXALT Wafers. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MAXALT Wafers against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What MAXALT Wafers are used for

MAXALT Wafers are used to relieve the headache pain and other symptoms of migraine attacks. MAXALT Wafers do not work for other types of headaches.

Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines.

Migraine attacks last anything from two hours to two days and they can return frequently. The severity and frequency of migraine attacks may vary.

Migraine occurs in about one out of every 10 people. It is three times more common in women than men.

Six out of ten migraine sufferers have their first attack before the age of 20.

There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are:

  • certain foods or drinks, for example, cheese and other dairy products, chocolate, citrus fruit, caffeine, alcohol (especially red wine)
  • stress, anger, worry
  • changes in routine, for example, under or over sleeping, missing a meal, change in diet
  • bright light or loud noises
  • hormonal changes in women, for example, during menstrual periods

If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. Keeping a headache diary will help you identify and monitor all of the possible migraine triggers you encounter. Once the triggers are identified, you and your doctor can modify your treatment and lifestyle appropriately.

Ask your doctor if you have any questions about why MAXALT has been prescribed for you.

How MAXALT Wafers work

During a migraine attack, blood vessels in the brain dilate, or widen, resulting in a throbbing pain. MAXALT Wafers decrease this widening, returning the blood vessels to their normal size, and therefore helps to relieve the pain. MAXALT Wafers also block the release of certain chemicals from nerve endings that cause more pain and other symptoms of migraine.

Before you take MAXALT Wafers

When you must not take it

Do not take MAXALT Wafers if you have an allergy to MAXALT or any of the ingredients listed at the end of this leaflet.

Do not take MAXALT Wafers if you have or had:

  • high blood pressure that is not being treated
  • some heart diseases, including angina, or a previous heart attack
  • a stroke or transient ischaemic attack (TIA)
  • blood vessel problems, including ischaemic bowel disease

Do not take MAXALT Wafers if you are currently taking monoamine oxidase inhibitors (MAOIs) for depression, or have taken them within the last two weeks.

MAOIs include moclobemide, phenelzine, tranylcypromine and pargyline.

Do not take MAXALT Wafers if the packaging is torn or shows signs of tampering.

Do not take MAXALT Wafers if the expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking MAXALT Wafers, talk to your doctor.

Do not give MAXALT Wafers to children under 18 years of age. The safety and effectiveness of MAXALT Wafers in children under 18 years have not been established.

Before you start to take it

Tell your doctor if:

  1. you are pregnant or intend to become pregnant
    Like most medicines, MAXALT Wafers are not recommended for use during pregnancy. If there is a need to consider MAXALT Wafers during pregnancy, your doctor will discuss with you the risks and benefits of taking them during pregnancy.
  2. you are breast-feeding or plan to breast-feed
    It is not known whether MAXALT Wafers pass into breast milk. Your doctor will discuss with you the risks and benefits of taking them while breast-feeding.
  3. you have any risks factors for heart or blood vessel disease, including:
  • high blood pressure
  • diabetes
  • smoking
  • a high cholesterol level
  • a family history of heart or blood vessel disease
  1. your headache is more severe than your ‘usual’ migraine, or it behaves differently
  2. you have a condition called phenylketonuria
    The 5mg wafer* contains 1.05mg phenylalanine (a component of aspartame) and the 10mg wafer contains 2.10mg phenylalanine.
  3. you have, or have had, any other medical conditions
  4. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any MAXALT Wafers.

Taking other medicines

Tell your doctor if you are taking any other medicines, herbal products, or dietary supplements, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should not be taken with MAXALT Wafers. These include:

  • monoamine oxidase inhibitors (MAOIs) used to treat depression, including moclobemide, tranylcypromine, phenelzine, pargyline
  • sumatriptan, another similar medicine used to treat migraine

Some medicines, herbal products, or dietary supplements, and MAXALT Wafers may interfere with each other. These include:

  • propranolol, a medicine used to treat high blood pressure
  • ergotamine, dihydroergotamine, other medicines used to treat migraine
  • methysergide, a medicine used to prevent migraine
  • St. John’s wort (Hypericum perforatum), a herbal product sold as a dietary supplement, or products containing St. John’s wort

These medicines, herbal products, or dietary supplements may be affected by MAXALT Wafers, or may affect how well it works. You may need different amounts of your medicine, you may need to take different medicines or you may need to be careful of the timing of some of these medicines.

Ask your doctor for instructions about taking MAXALT Wafers if you are also taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MAXALT Wafers.

How to take MAXALT Wafers

How much to take

Take MAXALT Wafers only when prescribed by your doctor.

The usual dose to treat a migraine is one 10 mg wafer.

If the first MAXALT Wafer does help your migraine, but it comes back later, you may take another wafer.

Take the second wafer at least 2 hours after the first. Do not take more than 30 mg (three 10 mg wafers) in a 24 hour period.

If the first MAXALT Wafer does not help your migraine, do not take another wafer for the same attack as it is unlikely to help. It is still likely, however, that you will respond to MAXALT during your next attack.

You should not take MAXALT 10mg while you are taking propranolol.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How to take it

With dry hands place the wafer on your tongue. The wafer will dissolve rapidly and be swallowed with your saliva. No water is needed for taking the wafer.

It does not matter if you take MAXALT Wafers before or after food.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too many MAXALT Wafers. Do this even if there are no signs of discomfort or poisoning.

If you take too many wafers, you may feel sleepy, dizzy, faint or have a slow heart beat.

While you are using MAXALT Wafers

Things you must do

If your headache is more severe than your ‘usual’ migraine or it behaves differently, tell your doctor.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you take MAXALT Wafers for migraines.

If you become pregnant while taking MAXALT Wafers, tell your doctor immediately.

Things you must not do

Do not give MAXALT Wafers to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how MAXALT Wafers affect you. Migraine or treatment with MAXALT Wafers may cause sleepiness or dizziness in some people. Make sure you know how you react to MAXALT Wafers before you drive a car, operate machinery, or do anything else that could be dangerous if you are sleepy or dizzy. If you drink alcohol, sleepiness or dizziness may be worse.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MAXALT Wafers.

MAXALT Wafers help most people with migraine headaches, but they may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  1. difficulty thinking or working because of:
  • sleepiness, tiredness
  • dizziness
  • inability to sleep
  • decreased mental sharpness
  • nervousness
  • agitation
  • seeing/ feeling/ hearing things that are not there
  • headache not relieved by MAXALT
  1. stomach or bowel problems
  • feeling sick (nausea), vomiting
  • stomach upset or pain
  • diarrhoea
  1. changes in your sight or taste such as:
  • blurred vision
  • dry mouth
  • thirst
  • bad taste
  • throat discomfort
  • tongue swelling
  1. skin problems
  • skin rash, itching
  • redness or flushing of the face
  • hot flushes, sweating
  1. changes in the way your body feels, such as:
  • feelings of heaviness or tightness on parts of the body
  • muscle weakness
  • muscle pain
  • tingling or numbness of the hands or feet
  • tremor, unsteadiness when walking
  • spinning sensation, also called vertigo
  • very high temperature
  • unusually increased reflexes or lack of coordination
  1. fast, slow or irregular heart beats, palpitations
  2. neck pain or facial pain

Dizziness, sleepiness and tiredness are the most common side effects of MAXALT Wafers. For the most part, these have been mild.

Abnormalities of the electrocardiogram (a test that records the electrical activity of your heart) have also been reported.

If you take MAXALT Wafers too often, you may get chronic headaches. Contact your doctor as you may have to stop taking MAXALT Wafers.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

  • fainting, coma
  • pinkish, itchy swellings on the skin, also called hives or nettlerash
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • shortness of breath, wheezing
  • pain or tightness in chest (which may be symptoms of heart attack or angina)
  • collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech (which may be symptoms of stroke)
  • severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell.
  • seizures, fits or convulsions
  • persistent purple discolouration, and/or pain in the fingers, toes, ears, nose or jaw
  • pain or spasms in the lower stomach, bloody diarrhoea and fever

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

As with other medicines in the same class as MAXALT, heart attack, angina and stroke have been reported very rarely, and generally occurred in people with risk factors for heart or blood vessel disease (including high blood pressure, diabetes, smoking, family history of heart or blood vessel disease e.g. stroke).

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using MAXALT Wafers

Storage

Keep your blister containing each individual wafer in the aluminium sachet until it is time to take it. Each wafer is packed in a blister within an outer aluminium sachet. If you take the wafer out of the blister and PVC/PVDC/Al sachet, it may not keep well.

Keep MAXALT Wafers in a cool dry place where the temperature stays below 30°C. Do not store them or any other medicine in the bathroom or near a sink.

Do not leave them in the car or on window sills. Heat and dampness can destroy some medicines.

Keep them where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the wafers, or the wafers have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

MAXALT Wafers are available in two strengths:

MAXALT Wafers 5mg* – a white to off-white round wafer with a flat or slightly irregular surface.

A pack contains 2, 3 or 6 wafers*.

MAXALT Wafers 10mg – a white to off-white round wafer with a flat or slightly irregular surface.

A pack contains 2, 3 or 6 wafers. A starter pack containing 1 MAXALT 10 mg wafer is also available.

Ingredients

Active ingredient:

  • MAXALT Wafers 5mg* – 7.265mg rizatriptan benzoate per wafer, equivalent to 5 mg rizatriptan
  • MAXALT Wafers 10mg – 14.53mg rizatriptan benzoate per wafer, equivalent to 10mg rizatriptan

Inactive ingredients:

  • gelatin
  • mannitol
  • glycine
  • aspartame
  • proprietary ingredient peppermint flavour (ARTG ID: 2890)

MAXALT Wafers do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

MAXALT Wafers are supplied in Australia by:

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A
26 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared Feb 2017

This CMI leaflet was current at the time of printing. To check if it has been updated, please visit our website, www.msd-australia.com.au, or ask your pharmacist.

Australian Register Number:
5 mg – AUST R 69077*
10 mg – AUST R 69076

* Not currently marketed in Australia.

Maxalt

How does this medication work? What will it do for me?

Rizatriptan belongs to a class of medications known as 5-hydroxytryptamine agonists (also called triptans). It is used to treat migraine headaches with or without aura (warning signs that occur prior to the onset of a migraine headache). The pain of migraine headaches is thought to be caused by dilated blood vessels inside the head. Rizatriptan relieves migraine headaches by constricting these blood vessels.

Rizatriptan is most effective if taken at the first sign of a migraine headache. It is not recommended for other types of headache or for headache prevention. Relief from the pain associated with migraine may occur as quickly as within 30 minutes, with maximum pain relief occurring about 2 hours after taking the medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

10 mg
Each pale pink, capsule-shaped compressed tablet, embossed with the code “MSD 267” on one side and “MAXALT” on the other, contains rizatriptan 10 mg (corresponding to 14.53 mg of the benzoate salt). Nonmedicinal ingredients: ferric oxide (red), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

How should I use this medication?

The recommended adult starting dose of rizatriptan is 5 mg. In some cases, a starting dose of 10 mg may be used. The dose should be taken at the first sign of migraine headache pain. If the migraine headache comes back after being relieved, another dose (5 mg to 10 mg) may be taken no sooner than 2 hours after the first dose was taken.

The maximum recommended single dose is 10 mg. No more than 20 mg of rizatriptan should be taken in any 24-hour period. If your headache pain is different from your usual migraines, do not take rizatriptan and call your doctor. Rizatriptan is not to be used for headache prevention.

It is important to take this medication exactly as prescribed by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to rizatriptan or any ingredients of this medication
  • do not have a clear diagnosis of migraine
  • have angina (chest pain), including Prinzmetal’s angina (coronary vasospasm)
  • have blood vessel disease (e.g., ischemic bowel disease, Raynaud’s syndrome)
  • have certain types of migraine headaches (including hemiplegic, ophthalmoplegic, or basilar migraine)
  • have had a heart attack
  • have had a stroke or transient ischemic attack (TIA)
  • have heart disease (e.g., atherosclerosis, heart valve disease, abnormal heart rhythms, congenital heart disease)
  • have high blood pressure that is severe or not under control
  • have severely reduced liver function
  • have taken another 5-hydroxytryptamine agonist (i.e., almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan) in the previous 24 hours
  • have taken any medications belonging to the class of medications known as MAO inhibitors (see “What other drugs could interact with this medication?” below) in the previous 2 weeks
  • have taken an ergotamine-containing or ergot-type medication (such as dihydroergotamine, ergotamine, or methysergide) in the previous 24 hours

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • hot flashes
  • nausea or vomiting
  • shortness of breath
  • changes in the way things taste
  • unusual tiredness or muscle weakness

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • muscle pain
  • pain, pressure, or tightness in the chest, neck, throat, jaw, or arms that does not go away
  • sensation of burning, warmth, heat, numbness, tightness, or tingling

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • heart attack (symptoms include pain, pressure, tightness, or heaviness in the chest, jaw, neck, or shoulder; sweating; or shortness of breath)
  • increased or decreased heart rate
  • irregular or fast heartbeat
  • seizures
  • severe allergic reaction (symptoms include swelling of the face or throat, hives, or difficulty breathing)
  • stroke (symptoms include sudden numbness or weakness, especially on one side of the body; sudden confusion or problems with speech; sudden vision problems in one or both eyes; sudden dizziness or loss of coordination; sudden severe headache, especially if it seems different from your usual headaches)
  • sudden or severe abdominal pain

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Rarely, severe allergic reactions to rizatriptan may occur. Because of the possibility of an allergic reaction, people who are allergic to any of the other medications in this class (5-hydroxytryptamine agonists, also called triptans) should not use rizatriptan.

Blood pressure: Rizatriptan may cause an increase in blood pressure. People with severe or uncontrolled high blood pressure should not take rizatriptan.

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness, which may impair your ability to operate a vehicle or engage in dangerous activities that require alertness.

Heart and blood vessel disease: This medication may cause narrowing of the blood vessels that supply the heart and brain. This can lead to chest pain (angina), heart attacks, heart rhythm problems, stroke, transient ischemic attack (TIA or “mini-stroke”), and other heart or blood vessel problems. For this reason, rizatriptan should not be used by people with heart or blood vessel disease.

If you have certain risk factors for heart disease (e.g., high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of coronary artery disease, menopause, men over 40 years of age), tell your doctor.

Kidney function: You should be closely monitored by your doctor if you are on dialysis and using this medication.

Liver function: Rizatriptan should not be used by people with severely reduced liver function. If you have moderately reduced liver function, you should be closely monitored by your doctor while taking this medication.

Medication overuse headaches: As with other pain relief medications, overuse of rizatriptan may lead to medication overuse headaches, or “rebound headaches” where the headache returns as the medication wears off. Avoid taking more of this medication than is recommended by your doctor. If you experience more frequent headaches, contact your doctor as soon as possible.

Phenylketonuria: The rapidly-dissolving wafer form of this medication contains phenylalanine.

Seizures: There have been rare reports of seizures experienced by people taking this medication. Most of these people had a previous history of epilepsy or medical conditions that increase the risk of seizures. If you have a history of epilepsy or other conditions that increase the risk for seizure, you should be closely monitored by your doctor while you are taking this medication.

Serotonin syndrome: This medication may cause a rare but potentially life-threatening condition called serotonin syndrome, especially when used with other medications that increase serotonin levels (e.g., other triptans, fluoxetine, paroxetine, venlafaxine).

If you experience symptoms such as agitation, confusion, hallucinations, fast heart rate, fever, lack of coordination, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea, get immediate medical attention.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if rizatriptan passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: The safety and effectiveness of rizatriptan have not been adequately studied in people over 65 years. Its use in this age group is not recommended.

What other drugs could interact with this medication?

There may be an interaction between rizatriptan and any of the following:

  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • bromocriptine
  • cabergoline
  • cyclobenzaprine
  • dextromethorphan
  • doxepin
  • ergotamine-containing or ergot-type medication if taken at the same time or within the previous 24 hours (e.g., dihydroergotamine or methysergide)
  • fentanyl
  • lithium
  • meperidine
  • methadone
  • metoclopramide
  • monoamine oxidase inhibitors if taken at the same time or within 14 days of taking rizatriptan (e.g., phenelzine, tranylcypromine, selegiline, moclobemide, rasagiline)
  • other 5-hydroxytryptamine agonists if taken at the same time or within the previous 24 hours (e.g., sumatriptan, naratriptan, zolmitriptan)
  • propranolol
  • St. John’s wort
  • serotonin antagonists (e.g., granisetron, ondansetron)
  • sibutramine
  • SNRI antidepressants (e.g., duloxetine, desvenlafaxine, venlafaxine)
  • SSRI antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline)
  • tapentadol
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, imipramine, nortriptyline)
  • tryptophan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Maxalt

Generic Name: rizatriptan (RYE za TRIP tan)
Brand Names: Maxalt, Maxalt-MLT

Medically reviewed by Sophia Entringer, PharmD Last updated on Jan 31, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Maxalt?

Maxalt (rizatriptan) is a headache medicine that narrows the blood vessels around the brain. Rizatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Maxalt is used to treat migraine headaches. Maxalt will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Maxalt 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 medicine only if your condition has been confirmed by a doctor as migraine headaches.

Important information

You should not use Maxalt if you have uncontrolled high blood pressure, heart problems, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Maxalt should not be taken within 24 hours before or after using certain migraine headache medicines. Consult your pharmacist to ensure you are not taking Maxalt with these medicines.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Maxalt will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a Maxalt tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 30 mg of rizatriptan in 24 hours.

Before taking this medicine

You should not use Maxalt if you are allergic to rizatriptan, or if you have:

  • severe or uncontrolled high blood pressure;

  • past or present heart problems;

  • a history of coronary artery disease, angina (chest pain), heart attack, or stroke, including “mini-stroke”;

  • • a blood vessel disorder or circulation problems that cause a lack of blood supply within the body (such as ischemic bowel disease); or

  • a headache that seems different from your usual migraine headaches.

Do not use Maxalt 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. Do not take Maxalt during or within 24 hours of treatment with a drug that acts similar to Maxalt, or an ergot-containing medication (example: methysergide, dihydroergotamine).

To make sure Maxalt is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • high blood pressure, a heart rhythm disorder;

  • a condition for which you take propranolol (Hemangeol, Inderal, InnoPran); 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).

Maxalt disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of rizatriptan 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 rizatriptan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Maxalt is not FDA-approved for use by anyone younger than 6 years old.

How should I use Maxalt?

Take Maxalt exactly as prescribed by your doctor. Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Maxalt as soon as you notice migraine symptoms.

Take the regular tablet whole with a full glass of water. Maxalt may be taken with or without food.

To take the orally disintegrating tablet (Maxalt-MLT):

  • 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 (for adults): 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 30 mg of rizatriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

After taking a tablet (for children ages 6 to 17): If your headache does not completely go away, or goes away and comes back, contact your doctor before taking any more tablets.

Call your doctor if your headache does not go away at all after taking the first Maxalt 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). Do not take migraine headache medication for longer than 10 days per month. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Maxalt can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using this medicine. If you use Maxalt long-term, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Maxalt dosing information

Usual Adult Dose for Migraine:

Use only after a clear diagnosis of migraine has been established
Initial dose: 5 mg or 10 mg orally, once
-Provided there has been a response to first dose, a second dose may be administered at least 2 hours later if migraine returns.
Maximum dose: 30 mg in a 24-hour period

-The 10 mg dose may provide greater effect, however there may be a greater risk of adverse reactions.
-This drug should not be used to treat basilar or hemiplegic migraines because these patients are at a greater risk of stroke.
-The safety of treating an average of 4 or more migraine attacks in a 30-day period has not been established; the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials.
Use: For the acute treatment of migraine with or without aura.

Usual Pediatric Dose for Migraine:

Use only after a clear diagnosis of migraine has been established
6 years or older and weight less than 40 kg:
-Initial dose: 5 mg orally once
6 years or older and weight 40 kg or greater:
-Initial dose: 10 mg orally once
Maximum: 1 dose in any 24-hour period

-This drug should not be used to treat basilar or hemiplegic migraines because these patients are at a greater risk of stroke.
-The safety of treating an average of 4 or more migraine attacks in a 30-day period has not been established; the safety and effectiveness of more than 1 dose within 24 hours has not been established.
Use: For the acute treatment of migraine with or without aura in patients 6 years or older.

What happens if I miss a dose?

Since Maxalt is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using Maxalt.

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 using Maxalt?

Do not take Maxalt within 24 hours before or after using another migraine headache medicine, including:

  • medicines like rizatriptan – almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan, and others; or

  • ergot medicine – dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Maxalt may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Maxalt side effects

Get emergency medical help if you have signs of an allergic reaction to Maxalt: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Maxalt and call your doctor at once if you have:

  • sudden and severe stomach pain and bloody diarrhea;

  • cold feeling or numbness in your feet and hands;

  • heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • high levels of serotonin in the body – agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

  • dangerously high blood pressure – severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Common Maxalt side effects may include:

  • dizziness, drowsiness, tired feeling; or

  • pain or a feeling of pressure in your throat or chest.

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 Maxalt?

Taking Maxalt 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 rizatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Maxalt 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: 11.01.

Medical Disclaimer

More about Maxalt (rizatriptan)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Español
  • 113 Reviews
  • Generic Availability
  • Drug class: antimigraine agents
  • FDA Alerts (1)

Consumer resources

  • Maxalt
  • Maxalt (Advanced Reading)

Professional resources

  • Maxalt (AHFS Monograph)
  • … +1 more

Other Formulations

  • Maxalt-MLT

Related treatment guides

  • Migraine

Generic Name: Rizatriptan Tablets (rye za TRIP tan)
Brand Name: Maxalt

Medically reviewed by Drugs.com. Last updated on Aug 22, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Uses of Maxalt:

  • It is used to treat migraine headaches.

What do I need to tell my doctor BEFORE I take Maxalt?

  • If you have an allergy to rizatriptan or any other part of Maxalt (rizatriptan tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
  • If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke or transient ischemic attack (TIA); or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
  • If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
  • If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, or zolmitriptan in the last 24 hours.
  • If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.

This is not a list of all drugs or health problems that interact with Maxalt (rizatriptan tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Maxalt (rizatriptan tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Maxalt?

  • Tell all of your health care providers that you take Maxalt (rizatriptan tablets). This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Maxalt (rizatriptan tablets) affects you.
  • High blood pressure has happened with Maxalt (rizatriptan tablets). Have your blood pressure checked as you have been told by your doctor.
  • This medicine is not meant to prevent or lower the number of migraine headaches you get.
  • If you have a headache that is not like your usual migraine headaches, talk with your doctor before you take Maxalt (rizatriptan tablets).
  • Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
  • Taking more of Maxalt (rizatriptan tablets) (a higher dose, more often) than your doctor told you to take may cause your headaches to become worse.
  • A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
  • If you are 65 or older, use Maxalt (rizatriptan tablets) with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Maxalt (rizatriptan tablets) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Maxalt) best taken?

Use Maxalt (rizatriptan tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all patients taking Maxalt (rizatriptan tablets):

  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take with or without food.
  • Take as early as you can after the attack has started.

Adults:

  • If your headache comes back after the first dose, 1 more dose may be taken 2 hours after the first one.

Children:

  • Talk with your child’s doctor about what to do if your child’s headache comes back after the dose.

What do I do if I miss a dose?

  • This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Change in eyesight.
  • Loss of eyesight. This can be long-lasting.
  • Very bad headache or if headache is not better after the first dose.
  • A burning, numbness, or tingling feeling that is not normal.
  • Constipation.
  • Diarrhea.
  • Very upset stomach or throwing up.
  • Severe stomach pain or bloody diarrhea.
  • Belly pain after meals.
  • Fever.
  • Weight loss.
  • Leg cramps.
  • Feeling of heaviness or tightness in the leg muscles.
  • Feeling cold.
  • Burning or aching pain in the feet or toes.
  • Mood changes.
  • Change in color of skin.
  • Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking Maxalt (rizatriptan tablets). 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 like stroke have rarely happened with Maxalt (rizatriptan tablets). 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.

What are some other side effects of Maxalt?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Upset stomach.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Maxalt?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Maxalt (rizatriptan tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina .
  • Arrhythmias .
  • Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure .
  • Cerebrovascular Events .
  • Other Vasospasm Reactions .
  • Medication Overuse Headache .
  • Serotonin Syndrome .
  • Increase in Blood Pressure .

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adults

Incidence in Controlled Clinical Trials

Adverse reactions to MAXALT were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of MAXALT Tablets. The most common adverse reactions during treatment with MAXALT (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These adverse reactions appeared to be dose related.

Table 1 lists the adverse reactions (incidence ≥2% and greater than placebo) after a single dose of MAXALT in adults.

Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of MAXALT Tablets or Placebo in Adults

Adverse Reactions MAXALT 5 mg
(N=977)
% of Patients MAXALT 10 mg
(N=1167)
Placebo
(N=627)
Atypical Sensations 4 5 4
Paresthesia 3 4 < 2
Pain and other Pressure Sensations 6 9 3
Chest Pain: tightness/pressure and/or heaviness < 2 3 1
Neck/throat/jaw: pain/tightness/pressure < 2 2 1
Regional Pain: tightness/pressure and/or heaviness < 1 2 0
Pain, location unspecified 3 3 < 2
Digestive 9 13 8
Dry Mouth 3 3 1
Nausea 4 6 4
Neurological 14 20 11
Dizziness 4 9 5
Headache < 2 2 < 1
Somnolence 4 8 4
Other
Asthenia/fatigue 4 7 2

The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (including propranolol), oral contraceptives, or analgesics. The incidences of adverse reactions were not affected by age or gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Other Events Observed In Association With The Administration Of MAXALT In Adults

In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. Because the reports include events observed in open studies, the role of MAXALT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used MAXALT and reported an event divided by the total number of patients exposed to MAXALT (N=3716). All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least ( > )1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

General: Infrequent was facial edema. Rare were syncope and edema/swelling.

Atypical Sensations: Frequent were warm sensations.

Cardiovascular: Frequent was palpitation. Infrequent were tachycardia, cold extremities, and bradycardia.

Digestive: Frequent were diarrhea and vomiting. Infrequent were dyspepsia, tongue edema and abdominal distention.

Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.

Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor. Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation.

Respiratory: Frequent was dyspnea. Infrequent was pharyngeal edema.

Special Senses: Infrequent were blurred vision and tinnitus. Rare was eye swelling.

Skin and Skin Appendage: Frequent was flushing. Infrequent were sweating, pruritus, rash, and urticaria. Rare was erythema, hot flashes.

The adverse reaction profile seen with MAXALT-MLT Orally Disintegrating Tablets was similar to that seen with MAXALT Tablets.

Pediatric Patients 6 To 17 Years Of Age

Incidence in Controlled Clinical Trials in Pediatric Patients

Adverse reactions to MAXALT-MLT were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (MAXALT-MLT and/or placebo) . The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received MAXALT to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.

Other Events Observed in Association with the Administration of MAXALT-MLT in Pediatric Patients

In the following section, the frequencies of less commonly reported adverse events are presented. Because the reports include events observed in open studies, the role of MAXALT-MLT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.

Event frequencies are calculated as the number of pediatric patients 6 to 17 years of age who used MAXALT-MLT and reported an event divided by the total number of patients exposed to MAXALTMLT (N=1068). All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in ( > )1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

General: Frequent was fatigue.

Ear and labyrinth disorders: Infrequent was hypoacusis.

Gastrointestinal disorders: Frequent was abdominal discomfort.

Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope.

Psychiatric disorders: Infrequent was hallucination.

Postmarketing Experience

The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of MAXALT in their causation cannot be reliably determined.

Neurological/Psychiatric: Seizure.

General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis .

Special Senses: Dysgeusia.

Read the entire FDA prescribing information for Maxalt (Rizatriptan Benzoate)

Maxalt Side Effects

Generic Name: rizatriptan

Medically reviewed by Drugs.com. Last updated on Nov 23, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about rizatriptan. Some of the dosage forms listed on this page may not apply to the brand name Maxalt.

In Summary

More frequent side effects include: asthenia, dizziness, drowsiness, fatigue, paresthesia, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to rizatriptan: oral tablet, oral tablet disintegrating

Along with its needed effects, rizatriptan (the active ingredient contained in Maxalt) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rizatriptan:

More common

  • Chest pain
  • heaviness, tightness, or pressure in the chest and/or neck
  • pounding heartbeat
  • sensation of burning, warmth, heat, numbness, tightness, or tingling
  • shortness of breath

Less common

  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • increased heartbeat
  • irregular heartbeat
  • pain, tightness, or pressure in the neck, jaw, or throat
  • slow heartbeat

Some side effects of rizatriptan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Dizziness
  • dry mouth
  • hot flashes
  • lack or loss of strength
  • nausea or vomiting
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness

Less common

  • Agitation
  • anxiety
  • blurred vision
  • chills
  • confusion
  • constipation
  • depression
  • diarrhea
  • difficulty with swallowing
  • dry eyes
  • eye irritation
  • feeling of constant movement of self or surroundings
  • gas
  • headache
  • heartburn
  • heat sensitivity
  • inability to sleep
  • increased sweating
  • increased thirst
  • irritability
  • itching of the skin
  • muscle or joint stiffness, tightness, or rigidity
  • muscle pain or spasms
  • ringing or buzzing in the ears
  • sudden, large increase in the frequency or quantity of urine
  • trembling of the hands or feet
  • unusual feeling of well-being
  • warm or cold sensations

For Healthcare Professionals

Applies to rizatriptan: oral tablet, oral tablet disintegrating

General

The most commonly reported adverse reactions include pain/pressure sensation, asthenia/fatigue, somnolence, and dizziness.

Cardiovascular

Common (1% to 10%): Palpitation, chest pain (tightness/pressure and/or heaviness), flushing

Uncommon (0.1% to 1%): Tachycardia, cold extremities, bradycardia, arrhythmia, ECG abnormalities

Rare (less than 0.1%): Syncope, edema/swelling

Frequency not reported: Acute myocardial infarction, blood pressure elevations

Postmarketing reports: Peripheral vascular ischemia

Rarely, patients with and without a history of hypertension have experienced significant blood pressure elevations including hypertensive crisis with the use of triptans including this drug. Increases of approximately 2 to 3 mmHg have been observed in healthy subjects receiving 10 mg of this drug every 2 hours for 3 doses.

Gastrointestinal

Common (1% to 10%): Dry mouth, nausea

Uncommon (0.1% to 1%): Vomiting, diarrhea, dyspepsia, tongue edema, abdominal distention, thirst

Frequency not reported: Ischemic colitis

Nervous system

Very common (10% or more): Dizziness (14%)

Common (1% to 10%): Paresthesia, headache, somnolence, tremor

Uncommon (0.1% to 1%): Vertigo, confusion/disorientation, gait abnormality, memory impairment, abnormal coordination

Frequency not reported: Serotonin syndrome

Postmarketing reports: Seizure, dysgeusia

Hypersensitivity

Postmarketing reports: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis

Other

Common (1% to 10%): Asthenia/fatigue, neck/throat/jaw pain/tightness/pressure, warm sensation

Uncommon (0.1% to 1%): Tinnitus

Rare (less than 0.1%): Hypoacusis

Dermatologic

Uncommon (0.1% to 1%): Facial edema, sweating, pruritus, rash, urticaria

Rare (less than 0.1%): Erythema

Frequency not reported: Toxic epidermal necrolysis

Musculoskeletal

Uncommon (0.1% to 1%): Muscle weakness, stiffness, myalgia, muscle cramp/spasm

Postmarketing reports: Facial pain

Ocular

Uncommon (0.1% to 1%): Blurred vision

Rare (less than 0.1%): Eye swelling

Psychiatric

Common (1% to 10%): Euphoria, insomnia

Uncommon (0.1% to 1%): Agitation, hallucination

Respiratory

Common (1% to 10%): Dyspnea

Uncommon (0.1% to 1%): Pharyngeal edema

1. Cerner Multum, Inc. “Australian Product Information.” O 0

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. “Product Information. Maxalt (rizatriptan).” Merck & Co, Inc, West Point, PA.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

rizatriptan (Maxalt, Maxalt-MLT)

What should I discuss with my healthcare provider before using rizatriptan (Maxalt, Maxalt-MLT)?

You should not use rizatriptan if you are allergic to it, or if you have:

  • severe or uncontrolled high blood pressure;
  • past or present heart problems;
  • a history of coronary artery disease, angina (chest pain), heart attack, or stroke, including “mini-stroke”;
  • 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 migraine headaches.

Do not use rizatriptan 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 rizatriptan is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • high blood pressure, a heart rhythm disorder;
  • a condition for which you take propranolol (Hemangeol, Inderal, InnoPran); 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).

Rizatriptan disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of rizatriptan 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 rizatriptan passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Rizatriptan is not approved for use by anyone younger than 6 years old.

How should I use rizatriptan (Maxalt, Maxalt-MLT)?

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take rizatriptan as soon as you notice migraine symptoms.

Take the regular tablet whole with a full glass of water.

To take the orally disintegrating tablet (Maxalt-MLT):

  • 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 (for adults): 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 30 mg of rizatriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

After taking a tablet (for children ages 6 to 17): If your headache does not completely go away, or goes away and comes back, contact your doctor before taking any more tablets.

Call your doctor if your headache does not go away at all after taking the first rizatriptan 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). Do not take migraine headache medication for longer than 10 days per month. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Rizatriptan can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using this medicine. If you use rizatriptan long-term, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

SLIDESHOW

Slideshow: 12 Surprising Headache Triggers Tips See Slideshow

Maxalt® (Rizatriptan Benzoate)

Maxalt® (rizatriptan benzoate) is a selective 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine, with or without aura, in adults and in children ages 6 to 17 who have a clear migraine diagnosis. It comes in 2 tablet forms, one that is swallowed and one that dissolves in the mouth. The tablets come in 5 mg and 10 mg dosages.

Maxalt generally works within 2 hours. It is intended to reduce acute migraine symptoms of migraine attacks that have already begun. It should not to be used as a prophylactic therapy to prevent the onset of migraine or to treat cluster headaches.

Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing on more than 10 days per month. Symptoms of overuse may need to be treated, and detoxification from migraine medications may be required.

What are the ingredients in Maxalt?

The active ingredient in Maxalt is rizatriptan benzoate.

How does Maxalt work?

Maxalt works by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) in the brainstem. It also reduces inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms. Maxalt works best if it is taken as soon as migraine symptoms appear.

What are the possible side effects of Maxalt?

Many clinical trials evaluated the safety and efficacy of Maxalt. The most common side effects experienced by those taking Maxalt include:

  • Pain or tight feeling in the chest, throat, jaw, or neck
  • Feeling weak, drowsy, or tired
  • Pressure or heavy feeling in any part of your body
  • Numbness or tingling in the fingers or toes
  • Feeling hot or cold in the extremities
  • Nausea

This is not an exhaustive list of all potential side effects of Maxalt. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Maxalt, contact your doctor or healthcare provider immediately.

Things to note about Maxalt

Maxalt comes in 2 forms, including a tablet swallowed whole and taken with liquids. The other, Maxalt -MLT Orally Disintegrating Tablets dissolve in the mouth. Before starting Maxalt talk with your doctor if you:

  • Have a history of hypersensitivity to rizatriptan benzoate
  • Have a history of coronary artery disease (CAD), angina or heart attacks
  • Have a history of high blood pressure or high cholesterol
  • Have a history of hemiplegic or basilar migraine
  • Have a history of stroke, transient ischemic attacks (TIAs), or circulatory problems
  • Have a history of peripheral vascular disease (circulation problems)
  • Have a history of ischemic bowel disease
  • Have taken a ergot-containing medication or triptan within the 24 hours prior to migraine
  • Have taken a MAO-A inhibitor within 2 weeks prior to your migraine
  • Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
  • Have severe hepatic (liver) impairment
  • Have severe renal (kidney) problems
  • Are pregnant or planning to get pregnant, as there is limited information on the use of Maxalt in pregnancy. It should be used only if the potential benefit of Maxalt therapy exceeds risk to the fetus.

Individuals with the above conditions should be monitored closely while taking Maxalt.

If there is no response to the first migraine attack treated with the Maxalt, a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.

A cardiovascular evaluation should be performed on patients who have never taken a triptan medication but who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Maxalt. For those with a cardiac history, the first dose of Maxalt should be administered in a medically supervised setting, and an electrocardiogram (ECG) should be performed immediately following the dose.

Dosing Information

Maxalt tablets are taken by mouth with water or other liquids. Adults take a 5 mg or 10 mg single dose; repeated doses can be taken separated by least two hours. The maximum adult dose in a 24-hour period is 30 mg. Children from age 6 to 17 weighing less than 88 pounds take a 5 mg single dose; those 88 pounds or more can take 10 mg. The maximum dose for children is a single dose.

A physician will determine the appropriate dose for each patient. If only partial migraine relief is attained or symptoms return quickly, a second dose may be taken 2 hours after the first (except for children).

Keep track of when you have migraine attacks and when you take Maxalt so you can monitor its effectiveness, and communicate with your doctor about how the medication is working for you.

For additional details, read the full prescribing information of Maxalt.

Generic Name: rizatriptan (RYE za TRIP tan)
Brand Name: Maxalt, Maxalt-MLT

Medically reviewed by Drugs.com on Oct 9, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Rizatriptan is a headache medicine that narrows the blood vessels around the brain. Rizatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Rizatriptan is used to treat migraine headaches. Rizatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Rizatriptan should not be used to treat a common tension headache, or a headache that causes loss of movement on one side of your body. Use rizatriptan only if your condition has been confirmed by a doctor as migraine headaches.

Rizatriptan may also be used for purposes not listed in this medication guide.

Important Information

You should not use this medicine if you have uncontrolled high blood pressure, heart problems, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not take rizatriptan within 24 hours before or after using another migraine headache medicine.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use rizatriptan if you are allergic to it, or if you have:

  • heart problems, or a stroke (including “mini-stroke”);

  • coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

  • circulation problems affecting your legs, arms, stomach, intestines, or kidneys;

  • uncontrolled high blood pressure;

  • severe liver disease; or

  • a headache that seems different from your usual migraine headaches.

Do not use rizatriptan 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.

Tell your doctor if you have ever had:

  • liver or kidney disease;

  • heart problems, chest pain;

  • shortness of breath; or

  • risk factors for coronary artery disease (such as high blood pressure, high cholesterol, diabetes, menopause, smoking, a family history of coronary artery disease, being overweight, or being older than 40 and a man).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with rizatriptan and cause a serious condition called serotonin syndrome.

Rizatriptan disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or breastfeeding.

Rizatriptan is not approved for use by anyone younger than 6 years old.

How should I use rizatriptan?

Take rizatriptan as soon as you notice headache symptoms. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Take the regular tablet whole with a full glass of water.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

After taking a tablet (for adults): If your headache does not completely go away, or goes away and comes back, take a second tablet 2 hours after the first. If your symptoms have not improved, contact your doctor before taking any more tablets.

After taking a tablet (for children ages 6 to 17): If your headache does not completely go away, or goes away and comes back, contact your doctor before taking any more tablets.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Call your doctor if your symptoms do not improve, or if you have more than 4 headaches in one month (30 days).

Rizatriptan can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using rizatriptan. If you use rizatriptan long-term, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Since rizatriptan is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using rizatriptan?

Do not take rizatriptan within 24 hours before or after using another migraine headache medicine, including:

  • almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan; or

  • ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Avoid driving or hazardous activity until you know how rizatriptan will affect you. Your reactions could be impaired.

Rizatriptan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have:

  • sudden and severe stomach pain and bloody diarrhea;

  • cold feeling or numbness in your feet and hands;

  • severe headache, blurred vision, pounding in your neck or ears;

  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • high levels of serotonin in the body–agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or

  • signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

  • dizziness, drowsiness, feeling tired; or

  • pain or a feeling of pressure in your throat or chest.

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 rizatriptan?

Tell your doctor about all your other medicines, especially:

  • propranolol;

  • an antidepressant; or

  • medicine to treat a mood disorder.

This list is not complete. Other drugs may affect rizatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Tell your doctor about all your other medicines, especially any type of antidepressant.

Other drugs may affect rizatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

More about rizatriptan

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Pricing & Coupons
  • En Español
  • 270 Reviews
  • Drug class: antimigraine agents
  • FDA Alerts (1)
  • Rizatriptan Orally Disintegrating Tablets
  • Rizatriptan Tablets
  • Rizatriptan (Advanced Reading)

Other brands: Maxalt, Maxalt-MLT

  • Rizatriptan Benzoate (AHFS Monograph)
  • … +3 more
  • Migraine

Long-Term Efficacy and Tolerability of Rizatriptan Wafers in Migraine

Discussion

As expected, rizatriptan 10-mg and 5-mg wafers were well tolerated in long-term use, with side-effect profiles comparable to, or slightly better than, the standard-care group (which mainly consisted of sumatriptan). Rizatriptan 10-mg and 5-mg wafers provided consistently high rates of pain relief without evidence of tachyphylaxis over the 6-month duration of the study. This suggests that patients and physicians can be confident that a positive clinical response to rizatriptan wafers will be maintained over time.

The typical patient randomized to rizatriptan 10-mg wafer experienced relief of moderate or severe headache at 2 hours in over 80% of attacks and was pain free at 2 hours in nearly half of attacks. On the very stringent criteria of a 24-hour sustained pain-free response, the typical patient on rizatriptan 10-mg wafer responded in nearly a third of attacks. Rizatriptan 10-mg wafer was superior to rizatriptan 5-mg wafer and to standard abortive migraine medications with regard to pain relief and pain-free status at 2 hours of dosing. The results for the rizatriptan wafer closely parallel those found for conventional rizatriptan tablets in long-term extension studies lasting for up to 1 year. In those studies, the typical patient taking rizatriptan 10 mg had pain relief at 2 hours in 90% of attacks, and was pain free at 2 hours in half of attacks.

An interesting finding in the present study was that response appeared to improve with increasing age, with patients over 40 years responding somewhat better than younger patients, regardless of treatment. Since this effect was also observed in the standard-care group, it was shown not to be a unique characteristic of rizatriptan wafers. A similar effect was observed in an acute study of rizatriptan and sumatriptan and in extension studies for the conventional tablet.

There are a number of potential limitations to the conclusions that can be drawn from this type of extension study. Due to the open-label design, patients were aware of what treatments they were receiving, and this have might biased their response (although patients were blinded to the dose of rizatriptan they received). It is also possible that only patients who responded or who did not have troublesome side effects during the preceding double-blind study would have been willing to enter an extension, possibly leading to an overestimation of efficacy and an underestimation of adverse events. This does not seem to have been the case in practice. A high percentage of both responders and nonresponders during the preceding study (approximately 90% in each group) entered the extension, and side effects in the preceding study were minor. Theoretically, differential dropout during the study could also have had an influence. However, only a small percentage of patients (2% in each group) discontinued due to adverse events, and there was no difference between groups. More patients in the rizatriptan groups (6% in each) discontinued due to lack of efficacy compared with standard care (0%), but patients in the standard-care group had the option of being switched to other medications if they were dissatisfied with treatment, so it is not possible to directly compare these discontinuation rates. The findings from the present study are based on a reasonably large sample size of 458 patients who treated 8229 attacks and probably give a reasonable indication of the results that can be expected in real-life clinical practice.

In conclusion, rizatriptan 10-mg wafer appeared to have enhanced efficacy compared with standard abortive migraine therapies for the treatment of moderate or severe migraine attacks. There was no observed penalty in terms of adverse events. Rizatriptan 5 mg was equally effective to standard care, with fewer adverse events. This study suggests that the benefit:risk ratio for rizatriptan 10 mg was superior to that of standard care and further establishes rizatriptan wafers as an important treatment option in migraine.

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *