Maxalt

DRUG 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:

MAXALT
  (rizatriptan benzoate) Structural Formula Illustration

Its empirical formula is C15H19N5C7H6O2, 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 25C.

MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). 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.

What are the possible side effects of rizatriptan (Maxalt, Maxalt-MLT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or...

Read All Potential Side Effects and See Pictures of Maxalt

What are the precautions when taking rizatriptan benzoate (Maxalt)?

See also How to Use section.

Before taking rizatriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have a history of: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar...

Read All Potential Precautions of Maxalt


Maxalt Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, numbness/tingling/prickling sensations, redness (flushing), tiredness/weakness may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Chest/jaw/neck tightness can commonly occur shortly after using rizatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell this apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., sumatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section.

Before taking rizatriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan migraine drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have a history of: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood circulation disorders (e.g., Raynaud's disease), kidney problems, liver problems.

Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high blood pressure (controlled), high cholesterol, overweight, smoker, female after menopause, male over age 40.

If you are at high risk for heart disease, your doctor may want to check your heart before prescribing rizatriptan.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Maxalt Patient Information Including Side Effects

Brand Names: Maxalt, Maxalt-MLT

Generic Name: rizatriptan (Pronunciation: RYE za TRIP tan)

  • What is rizatriptan (Maxalt)?
  • What are the possible side effects of rizatriptan (Maxalt)?
  • What is the most important information I should know about rizatriptan (Maxalt)?
  • What should I discuss with my healthcare provider before using rizatriptan (Maxalt)?
  • How should I use rizatriptan (Maxalt)?
  • What happens if I miss a dose (Maxalt)?
  • What happens if I overdose (Maxalt)?
  • What should I avoid while using rizatriptan (Maxalt)?
  • What other drugs will affect rizatriptan (Maxalt)?
  • Where can I get more information?

What is rizatriptan (Maxalt)?

Rizatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Rizatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Rizatriptan is used to treat migraine headaches.

Rizatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Rizatriptan should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Rizatriptan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of rizatriptan (Maxalt)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) - agitation, high fever, sweating, fast or pounding heartbeats, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting.

Less serious side effects may include:

  • dry mouth, mild nausea;
  • feeling of pain or tightness in your jaw, neck, or throat;
  • pressure or heavy feeling in any part of your body;
  • dizziness, drowsiness, weakness; or
  • mild tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rizatriptan (Maxalt)?

You should not take this medication if you are allergic to rizatriptan, or if you have a history of heart disease, angina (chest pain), blood circulation problems, ischemic bowel disease, uncontrolled high blood pressure, or history of a heart attack or stroke.

Do not use rizatriptan within 24 hours before or after using another migraine headache medicine, including almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use rizatriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days.

Before taking rizatriptan, tell your doctor if you have liver disease, kidney disease (or if you are on dialysis), high blood pressure, a heart rhythm disorder, coronary artery disease, or risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Before taking rizatriptan, tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Rizatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a rizatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 30 mg of rizatriptan in 24 hours.

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