Maxalt

Rizatriptan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• tiredness
• upset stomach
• vomiting
• diarrhea
• muscle pain or cramps
• tremors
• flushing (feeling of warmth)
• dry mouth

Some side effects can be serious. If you experience any of these, call your doctor immediately or get emergency medical treatment:

• tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw
• rapid, pounding, or irregular heartbeat
• shortness of breath
• breaking out in a cold sweat
• lightheadedness
• slow or difficult speech
• weakness or numbness of an arm or leg
• sudden or severe stomach pain
• bloody diarrhea
• paleness or blue color of the fingers and toes
• pain, burning, or tingling in the hands or feet
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, lips, eyes, hands, feet, ankles, or lower legs
• rash
• itching
• changes in vision

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Maxalt and Maxalt XLT are brand names for the generic drug rizatriptan, used to relieve pain caused by migraine attacks.

Maxalt belongs to a group of drugs known as 5-hydroxytryptamine agonists, more commonly known as triptans.

Triptans work by increasing the brain's sensitivity to serotonin, a neurotransmitter that causes blood vessels to contract. This relieves pressure in the brain that causes migraines.

Manufactured by Merck & Co., Maxalt was approved by the Food and Drug Administration (FDA) in 1998.

Maxalt Warnings

Don't take Maxalt if you:

• Are allergic to rizatriptan or any other ingredients in the drug
• Have migraines caused by a disorder in your brain stem
• Have migraines that cause weakness on one side of your body
• Have high blood pressure that is not under control
• Have ischemic heart disease or other significant cardiovascular disease
• Have coronary artery vasospasm (including Prinzmetal's angina)
• Have a history of stroke or transient ischemic attack (TIA)

Talk to your doctor before taking Maxalt if you:

• Have peripheral vascular disease (PVD) or poor circulation to the brain
• Have poor circulation in your bowels
• Are on dialysis
• Have liver problems

Pregnancy and Maxalt

The effects of Maxalt on a pregnant woman's unborn child have not been studied.

If you're pregnant, you and your doctor should determine whether the possible benefits of taking Maxalt are worth the potential risks to your baby's health.

Scientists aren't sure how taking Maxalt might affect a nursing baby, so talk to your doctor before taking the drug if you're breastfeeding.

It's always a good idea to talk to your doctor about all of your medications if you're pregnant, planning a pregnancy, or breastfeeding.

Maxalt is a prescription medication used to treat migraine headaches once they have started. Maxalt belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

This medication comes as a tablet and as an orally disintegrating tablet. Take Maxalt at the first sign of a migraine headache.

Common side effects of Maxalt include tiredness, dizziness and nausea.

Do not take Maxalt if you:

• have or have had heart problems
• have or have had a stroke or a transient ischemic attack (TIA)
• have or have had blood vessel problems including ischemic bowel disease
• have uncontrolled high blood pressure
• have taken other triptan medicines in the last 24 hours
• have taken ergot-containing medicines in the last 24 hours
• have hemiplegic or basilar migraines
• take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks
• are allergic to Maxalt benzoate or any of the ingredients in it.

Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.

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.

Do not take rizatriptan 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.

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

Absorption

Bioavailability

Completely absorbed from GI tract, 1 2 but absolute bioavailability (as conventional tablet) is 45%,1 indicating first-pass metabolism.1 2 Bioavailability is similar for orally disintegrating tablets.1

Peak plasma concentrations attained within 1–1.5 hours when administered as conventional tablets; peak concentrations are delayed by up to 0.7 hour when administered as orally disintegrating tablets.1

AUC and peak plasma concentration are approximately 30 and 11% higher, respectively, in females than in males.1

Exposure in pediatric patients 6–17 years of age receiving a single dose at recommended dosage levels is similar to that in adults receiving a single 10-mg dose.1

Food

Food does not substantially affect bioavailability but may delay time to peak concentration by 1 hour.1

Distribution

Extent

Crosses placenta and is distributed into milk in animals; no studies in pregnant or nursing women.1

Plasma Protein Binding

14%.1

Elimination

Metabolism

Metabolized principally via oxidative deamination by MAO-A to an inactive indole acetic acid metabolite.1 Other minor metabolites, including an N-monodesmethyl derivative with similar activity to the parent compound, have been identified.1

Elimination Route

Excreted principally in urine (14% of dose as unchanged drug, 51% as indole acetic acid metabolite).1 19

Half-life

Approximately 2–3 hours.1

Special Populations

In patients with moderate hepatic impairment, plasma rizatriptan concentrations are approximately 30% higher than in healthy individuals.1

In hemodialysis patients, AUC is approximately 44% greater than in patients with normal renal function.1 AUC in patients with CLcr of 10–60 mL/minute per 1.73 m2 is similar to that in healthy individuals.1

Pharmacokinetic profile in healthy geriatric individuals is similar to that in younger adults.1

• Binds with high affinity to 5-HT1B and 5-HT1D receptors.1 2 3 21

• Structurally and pharmacologically related to other selective 5-HT1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, zolmitriptan).1 2 21

• Precise mechanism of action not established;1 2 3 may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.1 2 21

• Risk of serious cardiovascular or cerebrovascular events (e.g., MI, stroke) or other vasospastic reactions.1 Importance of seeking medical care if symptoms of such reactions (e.g., shortness of breath, weakness, slurring of speech, sudden or severe abdominal pain, difficulty in seeing, or tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw) occur and of not taking rizatriptan again until evaluated by clinician.1

• Importance of taking rizatriptan exactly as prescribed.1

• Importance of providing patient a copy of manufacturer’s patient information.1

• Risk of dizziness, somnolence, and fatigue; importance of exercising caution when driving or operating machinery.1

• For patients taking orally disintegrating tablets, importance of not removing the blister from the outer pouch until just before administering dose; importance of opening blister pack with dry hands and of placing tablet on tongue to dissolve and be swallowed with saliva.1

• Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1

• Importance of informing patients of risk of serotonin syndrome, particularly with concurrent use of rizatriptan and an SSRI or SNRI.1 20 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.1 20

• Overuse of drugs indicated for the management of acute migraine attacks may exacerbate headaches; importance of recording headache frequency and drug use to monitor effectiveness of treatment.1 31

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad headache or if headache is not better after the first dose.
• Change in eyesight.
• Loss of eyesight. This can be long-lasting.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Very upset stomach or throwing up.
• Very bad belly pain or bloody loose stools.
• 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.
• Shortness of breath.
• Mood changes.
• Change in color of skin.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or 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; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• 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. 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 this medicine. Call your doctor right away if you have a change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina

Maxalt should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Maxalt. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT1 agonists, including Maxalt may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD.

Triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) should have a cardiovascular evaluation prior to receiving Maxalt. If there is evidence of CAD or coronary artery vasospasm, Maxalt should not be administered [see Contraindications (4)]. For patients who have a negative cardiovascular evaluation, consideration should be given to administration of the first Maxalt dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following Maxalt administration. Periodic cardiovascular evaluation should be considered in intermittent long-term users of Maxalt who have cardiovascular risk factors.

Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue Maxalt if these disturbances occur.

Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure

As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck and jaw commonly occur after treatment with Maxalt and are usually non-cardiac in origin. However, if a cardiac origin is suspected, patients should be evaluated. Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT1 agonists.

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). Discontinue Maxalt if a cerebrovascular event occurs.

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. Maxalt should not be administered to patients with a history of stroke or transient ischemic attack [see Contraindications (4)].

Other Vasospasm Reactions

5-HT1 agonists, including Maxalt, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, the suspected vasospasm reaction should be ruled out before receiving additional Maxalt doses.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Serotonin Syndrome

Serotonin syndrome may occur with triptans, including Maxalt particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.5)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms can occur within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Maxalt treatment should be discontinued if serotonin syndrome is suspected [see Drug Interactions (7.4) and Patient Counseling Information (17)].

Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients with and without a history of hypertension receiving 5-HT1 agonists, including Maxalt. In healthy young adult male and female patients who received maximal doses of Maxalt (10 mg every 2 hours for 3 doses), slight increases in blood pressure (approximately 2-3 mmHg) were observed. Maxalt is contraindicated in patients with uncontrolled hypertension [see Contraindications (4)].

No. 3732 Maxalt Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other:

NDC 0006-0266-18, carton of 18 tablets.

No. 3733 Maxalt Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded Maxalt on one side and MRK 267 on the other:

NDC 0006-0267-18, carton of 18 tablets.

No. 3800 Maxalt-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3800-18, 6 × unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

No. 3801 Maxalt-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows:

NDC 0006-3801-18, 6 × unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

Storage

Store Maxalt Tablets at room temperature, 59-86°F (15-30°C).

Store Maxalt-MLT Orally Disintegrating Tablets at room temperature, 59-86°F (15-30°C).

See FDA-Approved Patient Labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events

Inform patients that Maxalt may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the use of Maxalt or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].

Pregnancy

Inform patients that Maxalt should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

Ability to Perform Complex Tasks

Since migraines or treatment with Maxalt may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of Maxalt.

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].

Handling of Orally Disintegrating Tablets Packages

Instruct patients not to remove the blister from the outer aluminum pouch until ready to use the orally disintegrating tablet inside [see Dosage and Administration (2.3)].

Patients with Phenylketonuria

Inform phenylketonuric patients that Maxalt-MLT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 1.1 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 2.1 mg phenylalanine [see Use in Specific Populations (8.6)].

Maxalt Tablets and Maxalt-MLT Orally Disintegrating Tablets are distributed by:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0462-t-tol-1503r012

Patient Information
Maxalt® (max-awlt) and Maxalt-MLT®
rizatriptan benzoate
Tablets and Orally Disintegrating Tablets

Read this Patient Information before you start taking Maxalt® and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Unless otherwise stated, the information in this Patient Information leaflet applies to both Maxalt Tablets and to Maxalt-MLT® Orally Disintegrating Tablets.

What is Maxalt?

Maxalt is a prescription medicine that belongs to a class of medicines called Triptans. Maxalt is available as a traditional tablet (Maxalt) and as an orally disintegrating tablet (Maxalt-MLT).

Maxalt and Maxalt-MLT are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.

Maxalt is not to be used to prevent migraine attacks.

Maxalt is not for the treatment of hemiplegic or basilar migraines.

It is not known if Maxalt is safe and effective for the treatment of cluster headaches.

It is not known if taking more than 1 dose of Maxalt in 24 hours is safe and effective in children 6 to 17 years of age.

It is not known if Maxalt is safe and effective in children under 6 years of age.

Who should not take Maxalt?

Do not take Maxalt if you:

• have or have had heart problems
• have or have had a stroke or a transient ischemic attack (TIA)
• have or have had blood vessel problems including ischemic bowel disease
• have uncontrolled high blood pressure
• have taken other Triptan medicines in the last 24 hours
• have taken ergot-containing medicines in the last 24 hours
• have hemiplegic or basilar migraines
• take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks
• are allergic to rizatriptan benzoate or any of the ingredients in Maxalt. See the end of this leaflet for a complete list of ingredients in Maxalt.

Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.

What should I tell my doctor before taking Maxalt?

Before you take Maxalt, tell your doctor if you:

• have or have had heart problems, high blood pressure, chest pain, or shortness of breath
• have any risk factors for heart problems or blood vessel problems such as:
  • high blood pressure
  • high cholesterol
  • smoking
  • obesity
  • diabetes
  • family history of heart problems
  • you are post menopausal
  • you are a male over 40
• have phenylketonuria (PKU). Maxalt-MLT orally disintegrating tablets contain phenylalanine.
• have kidney or liver problems
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if Maxalt will harm your unborn baby. If you become pregnant while taking Maxalt, talk to your healthcare provider about registering with the pregnancy registry at the Merck National Service Center. You can enroll in this registry by calling 1-800-986-8999. The purpose of this registry is to collect information about the safety of Maxalt in pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if Maxalt passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Maxalt.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Maxalt and other medicines may affect each other causing side effects. Maxalt may affect the way other medicines work, and other medicines may affect how Maxalt works.

Especially tell your doctor if you take:

• propranolol containing medicines such as Inderal®, Inderal® LA, or Innopran® XL
• medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Maxalt?

• Take Maxalt exactly as your doctor tells you to take it.
• Your doctor will tell you how much Maxalt to take and when to take it.
• To take Maxalt-MLT:
  • Leave Maxalt-MLT orally disintegrating tablets in the package it comes in until you are ready to take it. When you are ready to take it:
    • Remove the blister from the foil pouch. Do not push the Maxalt-MLT orally disintegrating tablet through the blister.
    • Peel open the blister pack with dry hands and place the Maxalt-MLT orally disintegrating tablet on your tongue. The tablet will dissolve and be swallowed with your saliva. No liquid is needed to take the orally disintegrating tablet.
• If your headache comes back after your first Maxalt dose:
  • For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of Maxalt in a 24-hour period (for example, do not take more than 3 10-mg tablets in a 24-hour period).
  • For children 6 to 17 years of age: It is not known if taking more than 1 dose of Maxalt in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back.
• If you take too much Maxalt, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Maxalt?

Maxalt may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of Maxalt?

Maxalt may cause serious side effects. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of Maxalt including:

• heart attack. Symptoms of a heart attack may include:
  • chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
• stroke. Symptoms of a stroke may include the following sudden symptoms:
  • numbness or weakness in your face, arm or leg, especially on one side of your body
  • confusion, problems speaking or understanding
  • problems seeing in 1 or both of your eyes
  • problems walking, dizziness, loss of balance or coordination
  • severe headache with no known cause
• blood vessel problems. Symptoms of blood vessel problems may include:
  • stomach pain
  • bloody diarrhea
  • vision problems
  • coldness and numbness of hands and feet
• serotonin syndrome. A condition called serotonin syndrome can happen when Triptan medicines such as Maxalt are taken with certain other medicines. Symptoms of serotonin syndrome may include:
  • agitation
  • hallucinations
  • coma
  • fast heartbeat
  • fast changes in your blood pressure
  • increased body temperature
  • muscle spasm
  • loss of coordination
  • nausea, vomiting or diarrhea
• increased blood pressure.

The most common side effects of Maxalt in adults include:

• feeling sleepy or tired
• pain or pressure in your chest or throat
• dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

If you take Maxalt too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking Maxalt.

These are not all the possible side effects of Maxalt. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Maxalt?

• Store Maxalt at room temperature between 59°F to 86°F (15°C to 30°C).
• Safely throw away medicine that is out of date or no longer needed.

Keep Maxalt and all medicines out of the reach of children.

General Information about the safe and effective use of Maxalt.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Maxalt for a condition for which it was not prescribed. Do not give Maxalt to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Maxalt. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about Maxalt that is written for health professionals.

For more information, go to www.Maxalt.com or call 1-800-986-8999.

What are the ingredients in Maxalt?

Active ingredient in Maxalt and Maxalt-MLT orally disintegrating tablets:

rizatriptan benzoate.

Inactive ingredients in Maxalt: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.

Inactive ingredients in Maxalt-MLT orally disintegrating tablets: gelatin, mannitol, glycine, aspartame, and peppermint flavor.

Maxalt-MLT orally disintegrating tablets contain aspartame, a source of phenylalanine.

Phenylketonurics:

Maxalt-MLT orally disintegrating tablets 5-mg contain 1.1 mg of phenylalanine. Maxalt-MLT orally disintegrating tablets 10-mg contain 2.1 mg of phenylalanine.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Maxalt Tablets and Maxalt-MLT Orally Disintegrating Tablets are distributed by:
Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The brands listed are the trademarks of their respective owners.

Copyright © 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 03/2015

usppi-mk0462-t-tol-1503r012

Maxalt-MLT®
(rizatriptan benzoate)
ORALLY DISINTEGRATING TABLETS

5 mg

NDC 0006-3800-18

Each tablet contains 7.265 mg of rizatriptan benzoate, equivalent to 5 mg rizatriptan.

Phenylketonurics: contains phenylalanine (a component of aspartame)
1.05 mg per 5-mg orally disintegrating tablet.

6 Carrying Cases, Each Containing
3 Orally Disintegrating Tablets

USUAL DOSAGE: See accompanying circular.

Rx only

Manuf. by: Catalent UK Swindon, Zydis Ltd.
Swindon, Wiltshire, SN5 8RU, UK

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

Rizatriptan benzoate (active ingred.) Made in Ireland.
Formulated in UK.

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.

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.

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.

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

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.

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:

• 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

• 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:

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

• 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

Applies to rizatriptan: oral tablet, oral tablet disintegrating

General

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

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[Ref]

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.[Ref]

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[Ref]

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[Ref]

Hypersensitivity

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

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[Ref]

Dermatologic

Uncommon (0.1% to 1%): Facial edema, sweating, pruritus, rash, urticaria
Rare (less than 0.1%): Erythema
Frequency not reported: Toxic epidermal necrolysis[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle weakness, stiffness, myalgia, muscle cramp/spasm
Postmarketing reports: Facial pain[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision
Rare (less than 0.1%): Eye swelling[Ref]

Psychiatric

Common (1% to 10%): Euphoria, insomnia
Uncommon (0.1% to 1%): Agitation, hallucination[Ref]

Respiratory

Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Pharyngeal edema[Ref]

Some side effects of Maxalt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.