Maxalt

What is Maxalt?

Maxalt is a prescription medicine that belongs to a class of medicines called Triptans. Maxalt is available as a traditional tablet (Maxalt) and as an orally disintegrating tablet (Maxalt-MLT).

Maxalt and Maxalt-MLT are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.

Maxalt is not to be used to prevent migraine attacks.

Maxalt is not for the treatment of hemiplegic or basilar migraines.

It is not known if Maxalt is safe and effective for the treatment of cluster headaches.

It is not known if taking more than 1 dose of Maxalt in 24 hours is safe and effective in children 6 to 17 years of age.

It is not known if Maxalt is safe and effective in children under 6 years of age.

Description

MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.

Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:

Its empirical formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.

MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in a strength of 10 mg (corresponding to 14.53 mg of the benzoate salt). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.

Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.

Mechanism of Action

Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. MAXALT presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

Who should not take Maxalt?

Do not take Maxalt if you:

• have or have had heart problems
• have or have had a stroke or a transient ischemic attack (TIA)
• have or have had blood vessel problems including ischemic bowel disease
• have uncontrolled high blood pressure
• have taken other Triptan medicines in the last 24 hours
• have taken ergot-containing medicines in the last 24 hours
• have hemiplegic or basilar migraines
• take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks
• are allergic to rizatriptan benzoate or any of the ingredients in Maxalt. See the end of this guide for a complete list of Ingredients in Maxalt.

Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.

What should I tell my healthcare provider before taking Maxalt?

Before you take Maxalt, tell your doctor if you:

• have or have had heart problems, high blood pressure, chest pain, or shortness of breath
• have any risk factors for heart problems or blood vessel problems such as:
  • high blood pressure
  • high cholesterol
  • smoking
  • obesity
  • diabetes
  • family history of heart problems
  • you are post menopausal
  • you are a male over 40
• have phenylketonuria (PKU). Maxalt-MLT orally disintegrating tablets contain phenylalanine.
• have kidney or liver problems
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if Maxalt will harm your unborn baby. If you become pregnant while taking Maxalt, talk to your healthcare provider.
• are breastfeeding or plan to breastfeed. It is not known if Maxalt passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Maxalt.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Maxalt and other medicines may affect each other causing side effects. Maxalt may affect the way other medicines work, and other medicines may affect how Maxalt works.

Especially tell your doctor if you take:

• propranolol containing medicines such as Inderal, Inderal LA, or Innopran XL
• medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Maxalt?

• Take Maxalt exactly as your doctor tells you to take it.
• Your doctor will tell you how much Maxalt to take and when to take it.
• To take Maxalt-MLT:
  • Leave Maxalt-MLT orally disintegrating tablets in the package it comes in until you are ready to take it. When you are ready to take it:
    • Remove the blister from the foil pouch. Do not push the Maxalt-MLT orally disintegrating tablet through the blister.
    • Peel open the blister pack with dry hands and place the Maxalt-MLT orally disintegrating tablet on your tongue. The tablet will dissolve and be swallowed with your saliva. No liquid is needed to take the orally disintegrating tablet.
• If your headache comes back after your first Maxalt dose:
  • For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of Maxalt in a 24-hour period (for example, do not take more than 3 10-mg tablets in a 24-hour period).
  • For children 6 to 17 years of age: It is not known if taking more than 1 dose of Maxalt in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back.
• If you take too much Maxalt, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Maxalt?

Maxalt may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.

What are the possible side effects of Maxalt?

Maxalt may cause serious side effects. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of Maxalt including:

• Heart attack. Symptoms of a heart attack may include:
  • chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
• Stroke. Symptoms of a stroke may include the following sudden symptoms:
  • numbness or weakness in your face, arm or leg, especially on one side of your body
  • confusion, problems speaking or understanding
  • problems seeing in 1 or both of your eyes
  • problems walking, dizziness, loss of balance or coordination
  • severe headache with no known cause
• Blood vessel problems. Symptoms of blood vessel problems may include:
  • stomach pain
  • bloody diarrhea
  • vision problems
  • coldness and numbness of hands and feet
• Serotonin syndrome. A condition called serotonin syndrome can happen when Triptan medicines such as Maxalt are taken with certain other medicines. Symptoms of serotonin syndrome may include:
  • agitation
  • hallucinations
  • coma
  • fast heartbeat
  • fast changes in your blood pressure
  • increased body temperature
  • muscle spasm
  • loss of coordination
  • nausea, vomiting or diarrhea
• Increased blood pressure.

The most common side effects of Maxalt in adults include:

• feeling sleepy or tired
• pain or pressure in your chest or throat
• dizziness

Tell your doctor if you have any side effect that bothers you or that does not go away.

If you take Maxalt too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking Maxalt.

These are not all the possible side effects of Maxalt. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General Information about the safe and effective use of Maxalt.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Maxalt for a condition for which it was not prescribed. Do not give Maxalt to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information guide summarizes the most important information about Maxalt. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about Maxalt that is written for health professionals.

For more information, go to www.Maxalt.com.

How should I store Maxalt?

• Store Maxalt at room temperature between 59°F to 86°F (15°C to 30°C).
• Safely throw away medicine that is out of date or no longer needed.

Keep Maxalt and all medicines out of the reach of children.

What are the ingredients in Maxalt?

Active ingredient: rizatriptan benzoate.

Inactive ingredients:

Tablets: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.

Orally disintegrating tablets: gelatin, mannitol, glycine, aspartame, and peppermint flavor.

Phenylketonurics:

Orally disintegrating tablets contain aspartame, a source of phenylalanine.

Maxalt-MLT orally disintegrating tablets 5-mg contain 1.1 mg of phenylalanine. Maxalt-MLT orally disintegrating tablets 10-mg contain 2.1 mg of phenylalanine.

Label

PRINCIPAL DISPLAY PANEL – 10 MG TABLET POUCH CARTON

PRINCIPAL DISPLAY PANEL – 10 MG TABLET CASE CARTON

• Maxalt-MLT®
  (rizatriptan benzoate)
  ORALLY DISINTEGRATING TABLETS
  10 mg
• NDC 78206-143-01
• Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan.
• Phenylketonurics: contains phenylalanine (a component of aspartame)
  2.10 mg per 10-mg orally disintegrating tablet.
• 6 Carrying Cases, Each Containing
  3 Orally Disintegrating Tablets
• USUAL DOSAGE: See accompanying circular.
  Rx only
• Manuf. by: Catalent UK Swindon, Zydis Ltd.
  Swindon, Wiltshire, SN5 8RU, UK
• Dist. by: Organon LLC, a subsidiary of
  ORGANON & Co.,
  Jersey City, NJ 07302, USA
• Rizatriptan benzoate (active ingred.) Made in Ireland. Formulated in UK.

SRC: NLM .