Frova (Frovatriptan) belongs to a class of medications known as 5-hydroxytryptamine agonists (also called triptans). It is used to treat migraine Headaches with or without aura (warning signs that occur prior to the onset of a migraine) in adults. The pain of migraine headaches is thought to be caused by dilated blood vessels inside the head. Frova (Frovatriptan) relieves migraine headaches by constricting these blood vessels.

Frova (Frovatriptan) is not recommended for other types of headache or for headache prevention.

Frova (Frovatriptan) may be available under multiple brand names and/or in several different forms. Any specific brand name of Frova (Frovatriptan) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Frova (Frovatriptan) may not be used for all of the conditions discussed here.

Your doctor may have suggested Frova (Frovatriptan) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Frova (Frovatriptan), speak to your doctor. Do not stop taking Frova (Frovatriptan) without consulting your doctor.

Do not give Frova (Frovatriptan) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Frova (Frovatriptan) if their doctor has not prescribed it.

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The recommended adult dose of Frova (Frovatriptan) is 2.5 mg taken by mouth with fluids for migraine headache with or without aura. If the headache goes away with the first dose but then returns, a second dose of 2.5 mg may be taken between 4 and 24 hours after the first. You should never take more than 2 tablets in a 24-hour period.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you do not have relief from the headache with the first dose of medication, it is unlikely that a second dose will help.

It is important to take Frova (Frovatriptan) exactly as prescribed by your doctor.

Store Frova (Frovatriptan) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Frova (Frovatriptan). If you are concerned about side effects, discuss the risks and benefits of Frova (Frovatriptan) with your doctor.

The following side effects have been reported by at least 1% of people taking Frova (Frovatriptan). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• decreased sensation of touch
• dizziness
• Dry Mouth
• fatigue
• feelings of (in any part of the body):
• coldness
• heat
• numbness
• tingling
• warmth
• weakness
• flushing
• headache (other than migraine)
• indigestion
• muscle aches or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased blood pressure
• skin rash, Hives, itching, or bumps on skin
• slow, fast, or pounding heartbeat
• vision changes (usually temporary)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• convulsions (seizures)
• heart attack (symptoms include pain, pressure, tightness, or heaviness in the chest, jaw, neck or shoulder, sweating, or shortness of breath)
• lower abdominal pain or severe rectal bleeding (blood in the stool or black, tarry stools)
• Anaphylaxis (severe allergic reaction) (symptoms include: swelling of the face or throat, hives, difficulty breathing)
• stroke (symptoms include: sudden numbness or weakness, especially on one side of the body; sudden confusion or problems with speech; sudden vision problems in one or both eyes; sudden dizziness or loss of coordination; sudden severe headache, especially if it seems different from your usual headaches)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Frova (Frovatriptan).

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Each round, white, film-coated tablet, debossed with "2.5" on one side and "E" on the other side, contains 2.5 mg of Frova (Frovatriptan) (base) as the succinate. Nonmedicinal ingredients: colloidal silicon dioxide NF, hydroxypropylmethylcellulose USP, lactose NF, magnesium stearate NF, microcrystalline cellulose NF, polyethylene glycol 3000 USP, sodium starch glycollate NF, triacetin USP, titanium dioxide USP, and triacetin USP.

Do not take Frova (Frovatriptan) if you:

• are allergic to Frova (Frovatriptan) or any ingredients of the medication
• do not have a clear diagnosis of migraine
• have Angina (chest pain), including Prinzmetal's angina (coronary vasospasm)
• have blood vessel disease (e.g., ischemic bowel disease, Raynaud's syndrome, Stroke, transient ischemic attacks (TIAs))
• have certain types of migraine headaches (including hemiplegic, basilar, or ophthalmoplegic migraine)
• have had a Heart Attack
• have heart disease (e.g., heart valve disease, ischemic heart disease, abnormal heart rhythms, congenital heart disease)
• have high blood pressure that is severe or not under control
• have severely reduced liver function
• have taken another 5-hydroxytryptamine agonist (i.e., Naratriptan, Rizatriptan, Zolmitriptan) in the previous 24 hours
• have taken ergotamine-containing or ergot-type medications (such as Dihydroergotamine, ergotamine, or methysergide) in the previous 24 hours

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There may be an interaction between Frova (Frovatriptan) and any of the following:

• amphetamines (e.g., Dextroamphetamine, lisdexamphetamine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, olanzepine, Quetiapine, Risperidone)
• Bromocriptine
• Buspirone
• Cabergoline
• Cyclobenzaprine
• Dextromethorphan
• ergot-containing medications (e.g., dihydroergotamine, ergotamine, or methysergide), if taken at the same time or within the previous 24 hours
• Linezolid
• lithium
• Metoclopramide
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Maprotiline, Moclobemide, Selegiline, Tranylcypromine)
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• other 5-hydroxytryptamine agonists (e.g., rizatriptan, naratriptan, zolmitriptan) if taken at the same time or within the previous 24 hours
• Propranolol
• St. John's wort
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, venlafaxine)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Paroxetine, Fluoxetine, Sertraline, Fluvoxamine)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Tapentadol
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Imipramine)
• Tryptophan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Frova (Frovatriptan). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Frova (Frovatriptan).

Allergy: People allergic to other medications in this class (5-hydroxytryptamine agonists such as rizatriptan and naratriptan) can also have an allergic reaction to Frova (Frovatriptan). If you are allergic to any of these medications, you should not take Frova (Frovatriptan) unless advised to do so by your doctor.

Blood pressure: Frova (Frovatriptan) may cause an increase in blood pressure. If you have high blood pressure, discuss with your doctor how Frova (Frovatriptan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Frova (Frovatriptan), and whether any special monitoring is needed. People with severe or uncontrolled high blood pressure should not take Frova (Frovatriptan).

Drowsiness/reduced alertness: Frova (Frovatriptan) may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how Frova (Frovatriptan) affects you.

Heart disease and stroke: Frova (Frovatriptan) may cause narrowing of the blood vessels that supply the heart. This can lead to chest pain, heart attacks, Arrhythmias (irregular heartbeat), and other heart problems. There have also been reports of bleeding in the brain and stroke with Frova (Frovatriptan). For this reason, Frova (Frovatriptan) should not be used by people with heart or blood vessel disease. If you have certain risk factors for heart disease (e.g., high blood pressure, High Cholesterol, smoking, Obesity, Diabetes, family history of Coronary Artery Disease, Menopause, men over 40 years of age), tell your doctor.

Medication overuse headaches: As with other medications used to treat headache pain, taking Frova (Frovatriptan) too frequently may cause headaches to recur as the medication wears off. If you find that headaches return frequently, you may be taking too much of Frova (Frovatriptan). This situation should be discussed with your doctor.

Seizures: If you have seizures or a history of seizure disorder, discuss with your doctor how Frova (Frovatriptan) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Frova (Frovatriptan), and whether any special monitoring is needed.

Serotonin syndrome: Frova (Frovatriptan) may cause a rare but potentially life-threatening condition called serotonin syndrome, especially when used with other medications that increase serotonin levels (e.g., Sumatriptan, rizatriptan, certain antidepressants, St. John's wort, sibutramine, Venlafaxine). If you experience symptoms such as agitation, confusion, hallucinations, fast heart rate, Fever, lack of coordination, increased body temperature, overactive reflexes, nausea, vomiting, and Diarrhea, get immediate medical attention.

Pregnancy: Frova (Frovatriptan) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Frova (Frovatriptan), contact your doctor immediately.

Breast-feeding: It is not known if Frova (Frovatriptan) passes into breast milk. If you are a breast-feeding mother and are taking Frova (Frovatriptan), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Frova (Frovatriptan) have not been established for children less than 18 years of age.

Seniors: There is limited experience with the use of Frova (Frovatriptan) by people over 65 years of age. The use of Frova (Frovatriptan) by seniors is not recommended.

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