Frova - General Information:

Frova (Frova®) is a triptan drug developed by Vernalis for the treatment of migraine headaches, in particular those associated with menstruation. The product is licensed to Endo Pharmaceuticals in North America and Menarini in Europe.[1] Frova causes vasoconstriction of arteries and veins that supply blood to the head. It is available as 2.5 mg tablets.
Frova has mean terminal elimination half-life of approximately 26 hours, which is substantially longer than other triptans.
Frova is available only by prescription in the United States, where a secondary New Drug Approval (sNDA) was filed in July 2006[2] and which is currently pending.[3] The FDA anticipates completing its review of this application on or before the current PDUFA (Prescription Drug User Fee Act) review date of August 19, 2007. If the sNDA is approved, Frova® will be the only medication indicated in the U.S. for the short-term prevention of menstrual migraine (MM).

Pharmacology:

Frova is a second generation triptan 5-HT receptor agonist that binds with high affinity for 5-HT1B and 5-HT1D receptors. Frova has no significant effects on GABAA mediated channel activity and has no significant affinity for benzodiazepine binding sites. Frova is believed to act on extracerebral, intracranial arteries and to inhibit excessive dilation of these vessels in migraine. Research has shown that migraine can be caused by the swelling of blood vessels around the brain. Frova eases the pain associated with migraine by narrowing these blood vessels. Frova has one of the highest affinities for the 5-HT1B of the second-generation triptan agonists.

Frova for patients

FROVATM (frovatriptan succinate) Tablets

Read this information before you start taking FROVA (FRO-va). Also, read the information each time you renew your prescription, in case anything has changed. This leaflet does not contain all of the information about FROVA. For further information or advice ask your doctor or pharmacist. You and your doctor should discuss FROVA before you start taking the medicine and at regular checkups.

What is FROVA?

FROVA is a prescription medicine used to treat migraine attacks in adults. It is in the class of drugs called selective serotonin receptor agonists. FROVA should only be taken for a migraine headache. Do not use FROVA to treat headaches that might be caused by other conditions. Tell your doctor about your symptoms. Your doctor will decide if you have migraine headaches and if FROVA is for you. There is more information about migraine at the end of this leaflet.

Who should not take FROVA?

Do not take FROVA if you:

* have uncontrolled high blood pressure

* have heart disease or a history of heart disease

* have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor)

* have had a stroke

* have circulation (blood flow) problems

* have taken a similar drug (a serotonin receptor agonist) in the last 24 hours. These include sumatriptan (IMITREX® ), naratriptan (AMERGE® ) zolmitriptan (ZOMIG® ), rizatriptan (MAXALT® ), or almotriptan (AXERTTM)

* have taken ergotamine type medicines in the last 24 hours. These include BELLERGAL®, CAFERGOT®, ERGOMAR®, WIGRAINE®, DHE 45®, or SANSERT®

* have any allergic reaction to the tablet

What should you tell your doctor before and during treatment with FROVA?

To help your doctor decide if FROVA is right for you, tell your doctor if you:

* are pregnant, or planning to become pregnant

* are breast-feeding or plan to breast-feed
* have any history of chest pain, shortness of breath, or palpitations
* have any risk factors for heart disease, including

- high blood pressure
- diabetes
- high cholesterol
- overweight
- smoking
- a family history of heart disease
- past menopause
- male over 40 years old
- are taking any other medicine, including prescription and nonprescription medicines, and herbal supplements

* have any past or present medical problems
* have previous allergies to any medicine Tell your doctor if you take
* propranolol
* selective serotonin reuptake inhibitors (SSRIs) such as Prozac® (fluoxetine), Luvox® (fluvoxamine), Paxil® (paroxetine), and Zoloft® (sertraline) These medicines may affect how FROVA works, or FROVA may affect how these medicines work.

How should you take FROVA?

* Take one FROVA tablet anytime after the start of your migraine headache.

* If your headache comes back after your first dose, you may take a second tablet after two (2) hours. Do not take more than three (3) FROVA tablets in a 24-hour period.

* If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

What are the common side effects of FROVA?

The most common side effects associated with use of FROVA are:
* dizziness
* fatigue (tiredness)
* headache (other than a migraine headache)
* paresthesia (feeling of tingling)
* dry mouth
* flushing (hot flashes)
* feeling hot or cold
* chest pain
* dyspepsia (indigestion)
* skeletal pain (pain in joints or bones)

Tell your doctor about any symptoms that you develop while taking FROVA. If you feel dizziness or fatigue, take extra care or avoid driving and operating machinery.

In very rare cases, patients taking this class of medicines experience serious heart problems, stroke, or increased blood pressure. If you develop pain, tightness, heaviness, or pressure in your chest, throat, neck, or jaw, contact your doctor right away. Also contact your doctor right away if you develop a rash or itching after taking FROVA. You may be allergic to this medicine.

What is a migraine and how does it differ from other headaches?

Migraine is an intense, throbbing headache that often affects one side of the head. It often includes nausea, vomiting, and sensitivity to light and sound. The pain and symptoms from a migraine headache may be worse than the pain and symptoms of a common headache. Migraine headaches usually last for hours or longer.

Some people have problems with vision (an aura) before they get a migraine headache. These include flashing lights, wavy lines, and dark spots.

Only your doctor can determine that your headache is a migraine headache, so it is important that you discuss all of your symptoms with your doctor.

Manufactured under license from Vernalis Limited., FROVA is a trademark of Vernalis Development Limited.
© 2002 Elan Pharmaceuticals, Inc.

Frova Interactions

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Due to a theoretical risk of a pharmacodynamic interaction, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and FROVA within 24 hours of each other should be avoided (see CONTRAINDICATIONS).

Concomitant use of other 5-HT1B/1D agonists within 24 hours of FROVA treatment is not recommended.

Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) have been reported, rarely, to cause weakness, hyperreflexia, and incoordination when coadministered with 5-HT1 agonists. If concomitant treatment with frovatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised.

Drug/Laboratory Test Interactions

FROVA is not known to interfere with commonly employed clinical laboratory tests.

Frova Contraindications

FROVA should not be given to patients with ischemic heart disease (e.g. angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetalís variant angina or other significant underlying cardiovascular disease.

FROVA should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks.

FROVA should not be given to patients with peripheral vascular disease including (but is not limited to) ischemic bowel disease.

FROVA should not be given to patients with uncontrolled hypertension . FROVA should not be administered to patients with hemiplegic or basilar migraine.

FROVA should not be used within 24 hours of treatment with another 5-HT1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide.

FROVA is contraindicated in patients who are hypersensitive to frovatriptan or any of the inactive ingredients in the tablets.

Additional information about Frova

Frova Indication: For the acute treatment of migraine attacks with or without aura in adults.
Mechanism Of Action: Three distinct pharmacological actions have been implicated in the antimigraine effect of the triptans: (1) stimulation of presynaptic 5-HT1D receptors, which serves to inhibit both dural vasodilation and inflammation; (2) direct inhibition of trigeminal nuclei cell excitability via 5-HT1B/1D receptor agonism in the brainstem and (3) vasoconstriction of meningeal, dural, cerebral or pial vessels as a result of vascular 5-HT1B receptor agonism.
Drug Interactions: Citalopram Increased risk of CNS adverse effects
Escitalopram Increased risk of CNS adverse effects
Fluoxetine Increased risk of CNS adverse effects
Fluvoxamine Increased risk of CNS adverse effects
Nefazodone Increased risk of CNS adverse effects
Paroxetine Increased risk of CNS adverse effects
Sertraline Increased risk of CNS adverse effects
Sibutramine Increased risk of CNS adverse effects
Venlafaxine Increased risk of CNS adverse effects
Dihydroergotamine Possible severe and prolonged vasoconstriction
Dihydroergotoxine Possible severe and prolonged vasoconstriction
Ergonovine Possible severe and prolonged vasoconstriction
Ergotamine Possible severe and prolonged vasoconstriction
Methylergonovine Possible severe and prolonged vasoconstriction
Methysergide Possible severe and prolonged vasoconstriction
Food Interactions: Take without regard to meals.
Food does not affect amount of absorption but delays maximal levels by about 1 hour.
Generic Name: Frovatriptan
Synonyms: Frovatriptan succinate
Drug Category: Anti-migraine Agents; Vasoconstrictor Agents; Anti-inflammatory Agents
Drug Type: Small Molecule; Approved; Investigational
Other Brand Names containing Frovatriptan: Miguard; Frova;
Absorption: Frovatriptan is rapidly absorbed from the duodenum, but has low oral bioavailability.
Toxicity (Overdose): There is no direct experience of any patient taking an overdose of Frovatriptan. The maximum single dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the clinical dose) and the maximum single dose given to healthy male subjects was 100 mg (40 times the clinical dose) without significant adverse events.
Protein Binding: Binding to serum proteins is low (approximately 15%). Reversible binding to blood cells at equilibrium is approximately 60%.
Biotransformation: In vitro, cytochrome P450 1A2 appears to be the principal enzyme involved in the metabolism of frovatriptan to several metabolites including hydroxylated frovatriptan, N-acetyl desmethyl frovatriptan, hydroxylated N-acetyl desmethyl frovatriptan and desmethyl frovatriptan, and several other minor metabolites. Desmethyl frovatriptan has lower affinity for 5-HT1B/1D receptors compared to the parent compound. The N-acetyl desmethyl metabolite has no significant affinity for 5-HT receptors. The activity of the other metabolites is unknown.
Half Life: 26 hours
Dosage Forms of Frova: Tablet Oral
Chemical IUPAC Name: (6R)-6-methylamino-6,7,8,9-tetrahydro-5H-carbazole-3-carboxamide
Chemical Formula: C14H17N3O
Frovatriptan on Wikipedia: http://en.wikipedia.org/wiki/Frovatriptan
Organisms Affected: Humans and other mammals

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