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|Rizatriptan Orally Disintegrating Tablets

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Rizatriptan Orally Disintegrating Tablets

Generic Name: Rizatriptan Orally Disintegrating Tablets (rye-za-TRIP-tan)
Brand Name: Maxalt-MLT

Rizatriptan Orally Disintegrating Tablets is used for:

Treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots) in adults. It should not be used to prevent migraines or cluster headaches.

Rizatriptan Orally Disintegrating Tablets is a selective serotonin receptor agonist. It works by narrowing dilated blood vessels in the brain, relieving migraine headaches.

Do NOT use Rizatriptan Orally Disintegrating Tablets if:

you are allergic to any ingredient in Rizatriptan Orally Disintegrating Tablets
you are taking ergot alkaloids (eg, ergotamine) or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days
you have taken another serotonin receptor agonist (eg, sumatriptan) within the last 24 hours
you have a history of chest pain, blood flow or heart conditions, ischemic heart disease, irregular heartbeat, stroke, or uncontrolled high blood pressure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rizatriptan Orally Disintegrating Tablets:

Some medical conditions may interact with Rizatriptan Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you are obese, postmenopausal, or smoke cigarettes
if you have basilar artery or hemiplegic migraines, or cluster headaches
if you have diabetes, kidney or liver problems, seizures, high cholesterol, high blood pressure, phenylketonuria (PKU), or a family history of coronary artery disease

Some MEDICINES MAY INTERACT with Rizatriptan Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the effectiveness of Rizatriptan Orally Disintegrating Tablets may be decreased
Beta-blockers (eg, propranolol), ergot alkaloids (eg, ergotamine), or MAO inhibitors (eg, phenelzine) because the actions and side effects of Rizatriptan Orally Disintegrating Tablets may be increased
Dexfenfluramine, ergot alkaloids (eg, ergotamine), or sibutramine because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rizatriptan Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rizatriptan Orally Disintegrating Tablets:

Use Rizatriptan Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Rizatriptan Orally Disintegrating Tablets comes with a patient information leaflet. Read it carefully. Ask your doctor or pharmacist any questions you may have about Rizatriptan Orally Disintegrating Tablets.
It is not necessary to take Rizatriptan Orally Disintegrating Tablets with liquid.
These tablets are packaged in a blister with an outer aluminum pouch. Do not remove the blister from the outer pouch until you are ready to take Rizatriptan Orally Disintegrating Tablets. Peel the blister pack open with dry hands and place the tablet on your tongue. The tablet will dissolve and it can be swallowed with saliva.
Take a single dose of Rizatriptan Orally Disintegrating Tablets as soon as migraine symptoms appear. A second dose may be taken if there is only a partial response or symptoms of the migraine return. However, do not take it sooner than 2 hours following the first dose. Do not take more than 30 milligrams (mg) in a 24-hour period.
Do not take additional doses if you do not get a response from the first dose.

Ask your health care provider any questions you may have about how to use Rizatriptan Orally Disintegrating Tablets.

Important safety information:

Rizatriptan Orally Disintegrating Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rizatriptan Orally Disintegrating Tablets. Using Rizatriptan Orally Disintegrating Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Rizatriptan Orally Disintegrating Tablets is not intended to prevent or reduce the number of migraine attacks that you experience.
If you have a headache that is different than your usual migraine attacks, check with your doctor before using Rizatriptan Orally Disintegrating Tablets.
Phenylketonuria patients - Rizatriptan Orally Disintegrating Tablets contains phenylalanine.
Diabetes patients - Rizatriptan Orally Disintegrating Tablets may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Rizatriptan Orally Disintegrating Tablets is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Rizatriptan Orally Disintegrating Tablets during pregnancy. It is unknown if Rizatriptan Orally Disintegrating Tablets is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to your baby.

Possible side effects of Rizatriptan Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; fatigue; nausea; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; changes in vision; chest pain, heaviness, or pressure; cold, tingling, or numb hands or feet; fainting or unsteadiness; fast or irregular heartbeat; pain or tightness in jaw or neck; stomach pain; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include slow, fast, or irregular heartbeat; unusual dizziness or drowsiness; vomiting.

Proper storage of Rizatriptan Orally Disintegrating Tablets:

Store Rizatriptan Orally Disintegrating Tablets at room temperature, between 59 to 86 degrees F (15 to 30 degrees C). Store away from heat, light, and moisture. Keep Rizatriptan Orally Disintegrating Tablets in the blister with the outer aluminum pouch until ready to use. Keep Rizatriptan Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Rizatriptan Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
Rizatriptan Orally Disintegrating Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rizatriptan Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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