Rizatriptan Benzoate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat migraine headaches. It will not prevent migraine headaches or reduce the number you may have. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious heart problems, stroke, increased blood pressure, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine within 1 to 14 days of taking certain other medicines may cause life-threatening side effects. It is very important to tell your provider ALL of the medicines that you have taken in the past 2 weeks. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antimigraine

Generic and brand names: rizatriptan benzoate, oral; Maxalt; Maxalt-MLT

What is this medicine used for?

This medicine is taken by mouth to relieve the pain of acute migraine headaches in adults. It will not prevent migraine headaches or reduce the number you may have. This medicine is not intended to treat other types of headaches.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A heart attack, irregular heartbeat, or other heart disease
• A stroke or transient ischemic attack (TIA)
• Angina pectoris (chest pain)
• Cluster headaches
• Hemiplegic or basilar migraine headaches
• High blood pressure
• Liver, kidney, or bowel disease
• Peripheral vascular disease or Raynaud syndrome (problems with blood circulation)
• Phenylketonuria (PKU). The tablets that melt on your tongue contain aspartame, a source of phenylalanine.

Talk with your healthcare provider if you have any risk factors for heart disease such as diabetes, high cholesterol, smoking, being overweight, or a family history of heart disease or stroke. Women who have had a hysterectomy or are past menopause and men over the age of 40 are also at risk for heart disease.

Taking this medicine within 1 to 14 days of taking certain other medicines may cause life-threatening side effects. These medicines include some antidepressants, antibiotics, antifungal medicines, antiviral medicines, medicines to treat migraines, pain medicines, some cough medicines, St. John’s wort, and others. It is very important to tell your provider ALL of the medicines that you have taken in the past 2 weeks.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Take 1 dose with water when you start getting a migraine. If approved by your healthcare provider, you may take a second dose at least 2 hours after the first dose if the migraine returns. If the first dose is not effective, DO NOT take a second dose unless your healthcare provider approves. Do not take more or take it more often than prescribed. If you are not sure of the directions for taking this medicine, ask your healthcare provider or pharmacist to explain.

Check with your healthcare provider before using this medicine in children under age 6.

Do not take more than 30 mg in a 24-hour period.

This medicine is available in two forms: tablets that you can swallow and tablets that melt on your tongue. The tablets that melt on your tongue come in an aluminum pouch with a blister pack inside that holds a tablet. Do not open the blister pack until you are ready to take the tablet. With dry hands, peel open the blister pack and place the tablet on your tongue. No water is necessary.

If you are also taking propranolol (Inderal), do not take more than 5 mg of this medicine (rizatriptan) at one time, up to a maximum of 3 doses (15 mg total) of this medicine in 24 hours.

Do not take other migraine medicines within 24 hours of a dose of this medicine. Overuse of migraine headache medicine can make your headaches worse.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe headache, blurred vision, confusion, trouble concentrating, chest pain, numbness, seizures, stiff neck, tiredness, lack of coordination, shortness of breath, dizziness, fainting, loss of bowel and bladder control, irregular or slow heartbeat, vomiting.

What should I watch out for?

This medicine may cause serious heart problems, stroke, or increased blood pressure. If you develop tightness or pain in your chest, jaw, or neck, contact your healthcare provider right away.

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination or trouble walking
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature
• Nausea and vomiting
• Stiff muscles
• Diarrhea

You should not use this medicine for more than 10 days per month. Taking too much of this medicine, or taking it too often, can cause overuse or rebound headaches. Tell your healthcare provider if you need to use the medicine more often, if the medicine is not working as well, if you have headaches more often, or if your headaches get worse. If you have more than 4 migraine attacks a month, ask your healthcare provider what to do.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Do not smoke while using this medicine. Smoking may increase your risk of side effects.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; chest pain or tightness in your chest; trouble breathing; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Jaw or neck tightness; chest pain; irregular or fast heartbeat; hallucinations; sudden or severe stomach pain; bloody or severe diarrhea; pale or blue-colored hands or feet; numbness or tingling in hands or feet; severe nausea or vomiting; unexplained fever; unusual sweating; unusual muscle stiffness; severe nervousness; vision changes.

Other: Nausea; vomiting; diarrhea; dizziness; drowsiness; depression; tiredness; ringing in the ears; nervousness; tremor; mild flushing or tingling sensation; muscle or joint pain; sore throat; dry mouth; constipation; weight gain; ankle swelling; sweating; eye pain; weakness; confusion.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antidepressants such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), levomilnacipran (Fetzima), sertraline (Zoloft), and venlafaxine (Effexor)
• Ergot medicines such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine (Do not take these within 24 hours of a dose of this medicine.)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Metoclopramide (Metozolv, Reglan)
• Natural remedies such as kava, SAMe, St. John's wort, and tryptophan
• Nausea medicines such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), and palonosetron (Aloxi)
• Nefazodone
• Other migraine medicines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), sumatriptan/naproxen (Treximet), and zolmitriptan (Zomig) (Do not take these within 24 hours of a dose of this medicine.)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sibutramine (Meridia)
• Stimulants such as benzphetamine (Regimex), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Tramadol (ConZip, Ultram)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.