- PRESCRIPTION REQUIRED
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
RIZATRIPTAN DISINTEGRATING TABLET - ORAL
COMMON BRAND NAME(S): Maxalt MLT
USES: Rizatriptan is used to treat migraines. It helps to relieve headaches, pain and other symptoms of migraines, including sensitivity to light/sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. Rizatriptan does not prevent future migraines or reduce how often you may get a headache. Rizatriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain. It may also block other pain pathways in the brain.
HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using rizatriptan and each time you get a refill. Ask your doctor or pharmacist if you have any questions. Take this medication at the first sign of a migraine. Place the tablet on your tongue, allow it to dissolve and swallow with your saliva, or use as directed by your doctor. You do not need to take it with water. It may be taken with or without food, although faster relief may occur when it is taken on an empty stomach. Do not take rizatriptan to prevent a migraine. If there is no improvement in your symptoms, do not take any more doses of this medication before talking to your doctor. Do not open the outer pouch until the dose is needed. Peel the foil back and carefully remove the tablet from the blister pack with dry hands immediately before taking your dose. Consult your pharmacist if you have any questions. Your dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. For children, the dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or take rizatriptan more often than prescribed without consulting your doctor. For adults: If your symptoms are only partly relieved, or if your headache comes back, you may take a second dose after 2 hours or as directed by your doctor. Do not take more than 30 milligrams in a 24-hour period. If you also take propranolol, do not take more than three 5-milligram doses (total 15 milligrams) of rizatriptan in a 24-hour period. For the Canadian product: according to the drug manufacturer, adults should not exceed 20 milligrams in a 24-hour period. If you also take propranolol, do not take more than two 5-milligram doses (total 10 milligrams) of rizatriptan in a 24-hour period. For children: Talk to your doctor about what to do if your symptoms are only partly relieved or your headache returns after taking one dose of rizatriptan. If you have never taken this medication before and you have risk factors for heart disease (see Precautions), you may be advised to take your first dose in your doctor's office in order to monitor for rare but serious heart problems (e.g., heart attack). Tell your doctor if your condition does not improve or if it worsens. Overuse of drugs to treat sudden migraine attacks can lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add a separate medication to help prevent the headaches.
SIDE EFFECTS: Drowsiness, dizziness, dry mouth, numbness/tingling/prickling sensations, redness (flushing), tiredness/weakness may occur. If these effects persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Chest/jaw/neck tightness can commonly occur shortly after using rizatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell this apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea. Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes. This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also How to Use section. Before taking rizatriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be taken if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have a history of: blood circulation disease (e.g., ischemic bowel disease), certain types of headaches (hemiplegic or basilar migraine), heart disease (e.g., chest pain, heart attack), uncontrolled high blood pressure (hypertension), decreased blood flow in the brain (e.g., stroke, transient ischemic attack). Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood circulation disorders (e.g., Raynaud's disease), kidney problems, liver problems. Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high blood pressure (controlled), high cholesterol, overweight, smoker, female after menopause, male over age 40. If you are at high risk for heart disease, your doctor may want to check your heart before prescribing rizatriptan. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. This medicine may contain aspartame or phenylalanine. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Side Effects section. Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be taken with the following medications because very serious interactions may occur: sibutramine, stimulants. Do not use rizatriptan within 24 hours of taking ergot-type drugs (e.g., dihydroergotamine, ergotamine, methysergide) or other triptan drugs (e.g., zolmitriptan, sumatriptan). Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) for 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: propranolol, certain types of antidepressants (e.g., SSRIs such as fluoxetine/paroxetine/sertraline, NSRIs such as venlafaxine). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, amitriptyline, risperidone, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask you pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe drowsiness/dizziness/tiredness, fainting, inability to control urine/bowel movements. Children may also experience difficulty breathing, stomach/abdominal upset.
NOTES: Take this medication only as needed when a migraine occurs, as directed by your doctor. This medication should not be taken on a regular schedule. Never increase your dose of this medication or take it more often than prescribed by your doctor. Do not share this medication with others. Certain foods/beverages or food additives (e.g., red wine, cheese, chocolate, monosodium glutamate) as well as some lifestyle patterns (e.g., irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature, between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised January 2012. Copyright(c) 2012 First Databank, Inc.