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treatment & management

Drug Profiles:
FROVA
® (frovatriptan succinate tablets)

elan

CAUTION: Federal law prohibits dispensing without prescription.

What is Frova®?
Frova (frovatriptan) is an abortive medication used for the treatment of Migraine attacks in adults. It is one of the Triptan group of drugs which also includes Imitrex (sumatriptan), Amerge (naratriptan), Maxalt (rizatriptan), Zomig (zolmitriptan), and Axert (almotriptan).

   
Description
Frovatriptan (froe-va-TRIP-tan) is used to treat Migraine attacks. Many people find that their Migraine symptoms go away completely after they take frovatriptan. Other people find that their symptoms are reduced, and that they are able to go back to their normal activities even though their Migraines are not completely gone. Frovatriptan often relieves many symptoms that occur together with the pain of a Migraine, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Frovatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than Migraine. This medicine is usually used for people whose Migraines are not relieved by acetaminophen, aspirin, or other pain relievers.

Frovatriptan may cause 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 good that it can do.

Frovatriptan is available only with your doctor's prescription.

Before Using This Medicine
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 frovatriptan, the following should be considered:

Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to frovatriptan. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-
Frovatriptan has not been studied in pregnant women. However, in some animal studies, frovatriptan caused harmful effects to the fetus. These unwanted effects usually occurred when frovatriptan was given in amounts that were large enough to cause harmful effects in the mother.

Breast-feeding-
It is not known whether frovatriptan passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children-
Studies on this medicine have been done only in patients 18 years of age and older, and there is no specific information comparing use of frovatriptan in children with use in other age groups.

Older adults-
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of frovatriptan in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines-
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.

Do not take frovatriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) within the last 14 days. The combination could cause seizures, nausea, vomiting, sweating, flushing, and dizziness.

Do not take frovatriptan if you:

  • have taken an ergot-based medication within the last 24 hours--ergot-based medicines include methysergide (Sansert), ergotamine (Ergostat, Ergomar, others) dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), and ergotamine combination products (Bellergal-S, Cafergot, Ercaf, Wigraine, Cafatine, Cafatine-PB, Cafetrate)
  • have taken another serotonin receptor agonist within the last 24 hours - these include frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), and zolmitriptan (Zomig, Zomig-ZMT); or
  • have taken ketoconazole (Nizoral), itraconazole (Sporanox), ritonavir (Norvir), or erythromycin (E-Mycin, others) in the last 7 days.

Taking a serotonin receptor agonist with any of the medicines listed above may be dangerous.

Before taking frovatriptan, tell your doctor if you are taking a selective serotonin reuptake inhibitor (SSRI) such as citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). You may not be able to take frovatriptan, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed.

Drugs other than those listed here may also interact with frovatriptan. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Other medical problems-
The presence of other medical problems may affect the use of frovatriptan. Make sure you tell your doctor if you have any other medical problems, especially:

  • Uncontrolled high blood pressure—Use of frovatriptan may cause this condition to become worse.
  • Coronary artery disease
  • Heart attack (recent)
    Heart disease or Risk factors for coronary artery disease such as high cholesterol, family history, diabetes, obesity, women after menopause and men over 40 years of age—Use of frovatriptan may cause problems in patients with these risk factors.
  • Blood vessel disease, especially in the intestines and fingers—Use of frovatriptan may cause these conditions to become worse.
  • Bleeding in the brain or Stroke (or history of)—Use of frovatriptan may increase the chance of having a stroke

Proper Use of This Medicine
Do not use frovatriptan for an episode that is different from your usual Migraines

To relieve your Migraine as soon as possible, use frovatriptan as soon as the pain begins. Even if you get warning signals of a coming Migraine (an aura), you should wait until the pain starts before using frovatriptan. Using frovatriptan during the aura probably will not prevent the pain from occurring. However, even if you do not use frovatriptan until your Migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your Migraine.

If you feel much better after a dose of frovatriptan, but your Migraine comes back or gets worse after 2 or more hours, you may use one additional dose of frovatriptan

Your doctor may direct you to take another medicine to help prevent Migraines. It is important that you follow your doctor's directions, even if your Migraines continue to occur. Migraine-preventing medicines may take several weeks to start working. Even after they do start working, your Migraines may not go away completely. However, your Migraines should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of frovatriptan or pain relievers that you need. If you do not notice any improvement after several weeks of Migraine-preventing treatment, check with your doctor.

Dosing-
The dose of frovatriptan 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 frovatriptan. If your dose is different, do not change it unless your doctor tells you to do so.

  • Adults—Take one tablet (2.5 mg (milligrams) anytime after the start of your migraine headache. You may take a second tablet if your headache comes back after relief from the 1st dose. You should wait at least 2 hours between doses. Do not take more than 3 tablets in a 24 hour period. 
  • Children—Use and dose must be determined by your doctor.

Storage-
To store this medicine:

  • Keep out of the reach of children since overdose is especially dangerous in children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine
Drinking alcoholic beverages can make Migraines worse or cause new Migraines to occur. People who suffer from severe Migraines should probably avoid alcoholic beverages, especially during an attack.

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 if you are dizzy or are not alert.

Side Effects of This Medicine
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: Chest pain

Other side effects may occur that usually do not need medical attention. Some of these effects, such as nausea, vomiting, drowsiness, dizziness, and general feeling of illness or tiredness, often occur during or after a Migraine, even when frovatriptan has not been used. Most of the side effects caused by frovatriptan go away within a short time (less than 2 hours). However, check with your doctor if these side effects continue or are bothersome.

  • More common: dizziness 
  • Less common: Acid or sour stomach, belching, heartburn, indigestion, stomach discomfort, upset or pain; dry mouth; fatigue, such as unusual tiredness or weakness; flushing, such as feeling of warmth, redness of the face, neck, arms and occasionally upper chest; headache; hot or cold sensation; nausea; skeletal pain, such as pain in bones; tingling, burning, or prickly sensations; sleepiness or unusual drowsiness. 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

 
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Information offered at this Web site by either a lay person or a health professional should not be interpreted as giving a diagnosis or a treatment recommendation. These can only be provided by a physician who has had an opportunity to interact with a patient in person and at length, with access to the patient's previous records and appropriate follow-up.