Frova

• Anti-migraine Agents
• Vasoconstrictor Agents
• Anti-inflammatory Agents
• ATC:N02CC07

• Frova
• Miguard

• No information avaliable

C₁₄H₁₇N₃O

http://www.rxlist.com/cgi/generic3/frova.htm

Frova FDA

No information avaliable

243.304 g/mol

No information avaliable

Soluble

Solid

No information avaliable

Tablet

For the acute treatment of migraine attacks with or without aura in adults.

Frovatriptan is a second generation triptan 5-HT receptor agonist that binds with high affinity for 5-HT_1B and 5-HT_1D receptors. Frovatriptan has no significant effects on GABA_A mediated channel activity and has no significant affinity for benzodiazepine binding sites. Frovatriptan 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. Frovatriptan eases the pain associated with migraine by narrowing these blood vessels. Frovatriptan has one of the highest affinities for the 5-HT_1B of the second-generation triptan agonists.

Frovatriptan is rapidly absorbed from the duodenum, but has low oral bioavailability.

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.

FROVA^TM (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.

Humans and other mammals