Description
Frovatriptan is used to treat acute migraine headaches in adults. Frovatriptan 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 frovatriptan. 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. Frovatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.
Frovatriptan is not an ordinary pain reliever. It should not be used to 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.
Frovatriptan 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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 frovatriptan in the pediatric population. 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 frovatriptan in the elderly.
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
- Avitriptan
- Bromocriptine
- Dihydroergotamine
- Eletriptan
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Metergoline
- Methylergonovine
- Methysergide
- Naratriptan
- Pergolide
- Rizatriptan
- 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
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Benzhydrocodone
- Benzphetamine
- Buprenorphine
- Butorphanol
- Citalopram
- Clomipramine
- Codeine
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Dextromethorphan
- Dibenzepin
- Dihydrocodeine
- Dolasetron
- Doxepin
- Duloxetine
- Escitalopram
- Fenfluramine
- Fentanyl
- Fluoxetine
- Fluvoxamine
- Furazolidone
- Gepirone
- Granisetron
- Hydrocodone
- Hydromorphone
- Hydroxyamphetamine
- Imipramine
- Iproniazid
- Isocarboxazid
- Lasmiditan
- Levomilnacipran
- Levorphanol
- Linezolid
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
- Arrhythmia (heart rhythm problem) or
- Basilar migraine (migraine with vision and hearing problems), history of or
- Heart attack, history of or
- Heart or blood vessel disease or
- Hemiplegic migraine (migraine with some paralysis), history of 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), 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
- Hypertension (high blood pressure) or
- Obesity or
- Raynaud's syndrome—Use with caution. May be at increased risk for certain side effects.
- Heart rhythm problems (eg, ventricular fibrillation, ventricular tachycardia)—Use with caution. May make these conditions worse.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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 frovatriptan may increase the chance of side effects.
Do not use frovatriptan for a headache that is different from your usual migraines. Instead, check with your doctor.
To relieve your migraine as soon as possible, use frovatriptan 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 frovatriptan.
Ask your doctor ahead of time about any other medicine you might take if frovatriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by frovatriptan are sometimes caused by conditions that need other treatment.
If you feel much better after a dose of frovatriptan, but your headache comes back or gets worse after a while, you may use one additional dose of frovatriptan 2 hours after the first dose. Do not use more than 3 doses in any 24-hour period.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
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 oral dosage form (tablets):
- For migraine headaches:
- Adults—1 tablet once a day. If the migraine comes back after being relieved, another dose may be taken if at least 2 hours have passed since the first dose. Do not take more than 3 tablets in any 24-hour period.
- Children—Use is not recommended.
- For migraine headaches:
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 your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Do not take this medicine if you have used other triptan or ergot-type migraine medicines within the past 24 hours. Some examples of triptan medicines are almotriptan (Axert®), eletriptan (Relpax®), naratriptan (Amerge®), sumatriptan (Imitrex®, Treximet®), or zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, Wigraine®), or methysergide (Sansert®).
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Check with your doctor if you have used frovatriptan and 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, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, shortness of breath, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech.
Check with your doctor right away if you have chest discomfort, jaw or neck tightness after taking this medicine. Also, tell your doctor if you have sudden or severe abdominal or 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 are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Using frovatriptan 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. Frovatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This includes medicines to treat depression, such as amitriptyline (Elavil®), citalopram (Celexa®), duloxetine (Cymbalta®), escitalopram (Lexapro®), fluoxetine (Prozac®, Sarafem®, Symbyax®), fluvoxamine (Luvox®), olanzapine (Zyprexa®), paroxetine (Paxil®), sertraline (Zoloft®), or venlafaxine (Effexor®). Check with your doctor right away if you 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 drowsy or dizzy during or after a migraine, or after taking frovatriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
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:
Less common
- Changes in vision
- chest pain
- fast, irregular, pounding, or racing heartbeat or pulse
- increased sweating
Incidence not known
- Abdominal or stomach pain
- agitation
- bloody diarrhea
- cold fingers or toes
- confusion
- cough
- diarrhea
- difficulty swallowing
- dizziness
- fainting
- fever
- headache, sudden, severe, and continuing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness or tingling of the fingers or toes
- overactive reflexes
- pain spreading to the left shoulder
- paleness or cold feeling in the fingertips and toes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- skin rash, hives, or itching skin
- talking or acting with excitement you cannot control
- tightness in the chest, throat, neck, and jaw
- tingling or pain in the fingers or toes when exposed to cold
- trembling or shaking
- twitching
- unusual tiredness or weakness
- weakness in the legs
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:
Less common
- Acid or sour stomach
- belching
- bone pain
- continuing ringing or buzzing or other unexplained noise in the ears
- dry mouth
- feeling of warmth
- hearing loss
- heartburn
- hot or cold sensation
- indigestion
- pain or tenderness around the eyes and cheekbones
- redness of the face, neck, arms, and occasionally upper chest
- stomach discomfort or upset
- stuffy or runny nose
- trouble sleeping
Incidence not known
- Seizures
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.
DRG-20063959
