Generic Name: frovatriptan (FROE-va-TRIP-tan)
Brand Name: Frova
Frova 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.
Frova is a serotonin 5-HT1 receptor agonist ("triptan"). It works by narrowing the blood vessels in the brain, which helps to relieve migraines.
Do NOT use Frova if:
- you are allergic to any ingredient in Frova
- you have certain types of irregular heartbeat (eg, Wolff-Parkinson-White syndrome)
- you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
- you have uncontrolled high blood pressure
- you have a history of certain types of migraines (eg, hemiplegic, basilar)
- you have used an ergot alkaloid (eg, dihydroergotamine, ergotamine) or another "triptan" migraine medicine (eg, sumatriptan, rizatriptan) within the past 24 hours
- you are taking sibutramine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Frova:
Some medical conditions may interact with Frova. 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 have history of liver or kidney problems, seizures (eg, epilepsy), heart problems (eg, irregular heartbeat), other types of headaches (eg, cluster headaches), or shortness of breath, or if a family member has had heart disease or stroke
- if you have high blood pressure, high cholesterol, or diabetes, or if you smoke
- if you are a woman past menopause or you have had a hysterectomy
- if you are a man older than 40 years old
- if you are very overweight
Some MEDICINES MAY INTERACT with Frova. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), selective serotonin-reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), sibutramine, or tricyclic antidepressants (eg, amitriptyline) because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
- Propranolol because it may increase the risk of Frova's side effects
- Ergot alkaloids (eg, dihydroergotamine, ergotamine) or another "triptan" migraine medicine (eg, sumatriptan or rizatriptan) because they may increase the risk of Frova's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Frova 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 Frova:
Use Frova as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Frova. Talk to your pharmacist if you have questions about this information.
- Take Frova by mouth with or without food.
- Take a single dose of Frova with fluids 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 a second dose if your symptoms do not get better after your first dose without first talking with your doctor.
- Do not take more than 3 tablets in a 24-hour period or treat more than 4 headaches within 30 days without checking with your doctor.
- If you miss a dose of Frova and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do not take Frova more often than prescribed. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Frova.
Important safety information:
- Frova may cause drowsiness, dizziness, or weakness. These effects may be worse if you take it with alcohol or certain medicines. Use Frova with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Frova may cause dizziness or fainting. If dizziness occurs, sit or stand up slowly.
- Frova should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different from your usual migraine headaches, check with your doctor before using Frova.
- Overuse of Frova can cause your headache to become worse. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
- Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Frova. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; severe dizziness; sudden, severe nausea or vomiting; sudden, unusual sweating or weakness; shortness of breath; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Frova. Your risk may be greater if you take Frova with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; loss of coordination; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Tell your doctor or dentist that you take Frova before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including blood pressure and heart function tests, may be performed while you use Frova. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Frova with caution in the ELDERLY; they may be more sensitive to its effects.
- Frova is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Frova while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Frova, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Frova:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; fatigue; flushing; headache; hot or cold sensations; indigestion; numbness or tingling in the arms, legs, hands, or feet.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody diarrhea; bone or joint pain; burning or aching in the feet or toes; fever; hallucinations; heaviness or tightness in the leg muscles; irregular or rapid heartbeat; loss of coordination; mental or mood changes (eg, agitation); muscle spasms; numbness, tingling, or weakness in the legs; pain, tightness, pressure, and heaviness in the chest, throat, neck, or jaw; pain or cramps in the legs or hips; seizures; severe stomach pain or nausea; severe or persistent constipation or diarrhea; sudden, severe dizziness, fainting, headache, light-headedness, or vomiting; sudden shortness of breath; symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); very cold or blue fingers or toes; vision loss.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Frova:
Store Frova at temperatures between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Frova out of the reach of children and away from pets.
- If you have any questions about Frova, please talk with your doctor, pharmacist, or other health care provider.
- Frova 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Frova or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Frova. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Frova. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Frova.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: antimigraine agents