Maxalt 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.

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.

Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), venlafaxine (Effexor), or vilazodone (Viibryd).

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.

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.

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

Comments:
-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

Comments:
-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.

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.

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.

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.

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.

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.