Description
Rizatriptan is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches and is not used for cluster headaches. Rizatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.
Many people find that their headaches go away completely after they take rizatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Rizatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.
Rizatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.
Rizatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can do.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet, Disintegrating
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rizatriptan tablets in children younger than 6 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of rizatriptan oral film in children younger than 12 years of age and weighs less than 40 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rizatriptan in the elderly. However, elderly patients are more likely to have diabetes, high blood pressure, and age-related heart problems, which may require caution and an adjustment in the dose for patients receiving rizatriptan.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Almotriptan
- Bromocriptine
- Dihydroergotamine
- Eletriptan
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Frovatriptan
- Isocarboxazid
- Linezolid
- Lisuride
- Metergoline
- Methylene Blue
- Methylergonovine
- Methysergide
- Naratriptan
- Nicergoline
- Phenelzine
- Procarbazine
- Propranolol
- Sumatriptan
- Tranylcypromine
- Zolmitriptan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Amitriptyline
- Amphetamine
- Benzhydrocodone
- Benzphetamine
- Buprenorphine
- Butorphanol
- Citalopram
- Codeine
- Desvenlafaxine
- Dextroamphetamine
- Dextromethorphan
- Dihydrocodeine
- Dolasetron
- Duloxetine
- Escitalopram
- Fenfluramine
- Fentanyl
- Fluoxetine
- Fluvoxamine
- Gepirone
- Granisetron
- Hydrocodone
- Hydromorphone
- Hydroxyamphetamine
- Lasmiditan
- Levomilnacipran
- Levorphanol
- Lisdexamfetamine
- Lithium
- Lorcaserin
- Meperidine
- Metaxalone
- Methadone
- Methamphetamine
- Milnacipran
- Mirtazapine
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (chest pain) or
- Basilar migraine (migraine with vision and hearing problems) or
- Heart attack, history of or
- Heart or blood vessel problems or
- Hemiplegic migraine (migraine with some paralysis) or
- Hypertension (high blood pressure), uncontrolled or
- Ischemic bowel disease (bowels have low blood supply) or
- Peripheral vascular disease (clogged arteries) or
- Stroke, history of or
- Transient ischemic attack (TIA), or history of or
- Wolff-Parkinson-White Syndrome (heart rhythm problem)—Should not be used in patients with these conditions.
- Coronary artery disease, family history of or
- Diabetes or
- Hypercholesterolemia (high cholesterol in the blood) or
- Hypertension (high blood pressure) or
- Obesity or
- Raynaud's syndrome—Use with caution. May be at increased risk for certain side effects.
- Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Using too much rizatriptan may increase the chance of side effects.
Do not use this medicine for a headache that is not a migraine headache. Talk to your doctor about what to do for regular headaches.
This medicine usually comes with patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using rizatriptan.
Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.
Ask your doctor ahead of time about any other medicine you may take if rizatriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by rizatriptan are sometimes caused by conditions that need other treatment.
If you feel much better after a dose of rizatriptan, but your headache comes back or gets worse after a while, adults may use one additional dose of rizatriptan 2 hours after the first dose. Do not use more than 2 doses in any 24-hour period. Do not use this medicine for more than 10 days in any 30-day period, unless your doctor tells you to.
Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
Keep the orally disintegrating tablet in the blister pack inside the outer foil pouch until you are ready to take the medicine. Make sure your hands are dry and peel open the blister to remove the tablet. Place the tablet on your tongue and let it dissolve. You do not need to drink water to swallow the dissolved tablet.
To use the film:
- Do not open the aluminum pouch that contains the film until you are ready to take it.
- Fold the pouch on the dotted line and tear it open.
- Place the film on your tongue. It will dissolve in about 2 minutes and can be swallowed with saliva. No need to drink any liquid.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For migraine headaches:
- For oral dosage form (film):
- Adults—10 milligrams (mg) placed on the tongue as needed. If extra doses are needed, separate them by at least 2 hours. The maximum dose is usually not more than 30 mg per day.
- Children 12 years of age and older weighing 40 kilograms (kg) or more—10 mg placed on the tongue as needed.
- Children younger than 12 years of age or weighing less than 40 kg—Use and dose must be determined by your doctor.
- For oral dosage forms (orally disintegrating tablets and tablets):
- Adults—At first, 5 or 10 milligrams (mg) as a single dose. If the migraine comes back after being relieved, another dose may be taken 2 hours after the last dose. Do not take more than 30 mg in any 24-hour period.
- Children 6 years of age and older and weighing 40 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 mg per day. Do not take more than one dose in any 24-hour period.
- Children 6 years of age and older and weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 mg per day. Do not take more than one dose in any 24-hour period.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (film):
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.
Do not use this medicine if you or your child have used other triptan or ergot-type migraine medicines within the past 24 hours. Some examples of triptan medicines are almotriptan (Axert™), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), sumatriptan (Imitrex®, Treximet®), and zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, or Wigraine®), and methysergide (Sansert®). Do not take this medicine within 2 weeks after taking an MAO inhibitor, such as Eldepryl®, Marplan®, Nardil®, or Parnate®. Do not use this medicine if you are using propranolol (Inderal®, Inderal® LA, InnoPran XL®).
Check with your doctor if you or your child used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often.
This medicine may increase your risk of having abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, high cholesterol, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty with speaking, double vision, headaches, inability to move the arms, legs, or facial muscles, uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, trouble breathing, slow speech, or sweating.
Check with your doctor right away if you or your child have chest discomfort, jaw or neck tightness after taking this medicine. Also, tell your doctor if you have sudden or severe stomach pain or bloody diarrhea after using this medicine.
Check with your doctor right away if you have blurred vision, difficulty with reading, or any other change in vision while you or your child are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.
Using rizatriptan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record the headache frequency and drug use.
Make sure your doctor knows about all the other medicines you are using. Rizatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This includes medicines to treat depression, including citalopram (Celexa®), duloxetine (Cymbalta®), escitalopram (Lexapro®), fluoxetine (Prozac®, Sarafem®, or Symbyax®), fluvoxamine (Luvox®), olanzapine (Zyprexa®), paroxetine (Paxil®), sertraline (Zoloft®), or venlafaxine (Effexor®). Check with your doctor right away if you or your child have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.
Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.
Some people feel dizzy or drowsy during or after a migraine, or after taking rizatriptan to relieve a migraine. As long as you are feeling dizzy or drowsy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
This medicine may increase your blood pressure. Talk to your doctor if you have any concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Chest pain
- heaviness, tightness, or pressure in the chest and/or neck
- pounding heartbeat
- sensation of burning, warmth, heat, numbness, tightness, or tingling
- trouble breathing
Less common
- 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
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- difficulty swallowing
- dizziness
- hives, itching, skin rash
- joint or muscle pain
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- seizures
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
Some side effects 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:
More common
- Dry mouth
- hot flashes
- lack or loss of strength
- nausea or vomiting
- sleepiness or unusual drowsiness
Less common
- Agitation
- anxiety
- blurred vision
- confusion
- constipation
- depression
- 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
- 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
Incidence not known
- Change in taste
- loss of taste
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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