Maxalt-MLT

What is Maxalt-MLT used for?

Maxalt-MLT is a prescription medicine that is used to treat migraine headaches.

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.

Before taking Maxalt-MLT, tell your doctor:

• If you are allergic to Maxalt-MLT; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: High blood pressure or some types of migraine headaches like hemiplegic or basilar migraine.
• If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke or transient ischemic attack (TIA); or a heartbeat that is not normal like Wolff-Parkinson-White syndrome.
• If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, or zolmitriptan in the last 24 hours.
• If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Maxalt-MLT with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Maxalt-MLT?

• Tell all of your health care providers that you take Maxalt-MLT. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Maxalt-MLT affects you.
• High blood pressure has happened with Maxalt-MLT. Have your blood pressure checked as you have been told by your doctor.
• This medicine is not meant to prevent or lower the number of migraine headaches you get.
• If you have a headache that is not like your usual migraine headaches, talk with your doctor before you take Maxalt-MLT.
• Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
• Taking more of Maxalt-MLT (a higher dose, more often) than your doctor told you to take may cause your headaches to become worse.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
• If you are 65 or older, use Maxalt-MLT with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Maxalt-MLT best taken?

Use Maxalt-MLT as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all patients taking Maxalt-MLT:

• Take with or without food.
• Take as early as you can after the attack has started.
• Be sure your hands are dry before you touch Maxalt-MLT.
• Some brands of Maxalt-MLT come in a blister pack. If Maxalt-MLT comes in a blister pack, take out the tablet right before use. Peel back the foil on the blister. Do not push the tablet through the foil. Doing so may cause the tablet to break.
• Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.

Adults:

• If your headache comes back after the first dose, 1 more dose may be taken 2 hours after the first one.

Children:

• Talk with your child’s doctor about what to do if your child’s headache comes back after the dose.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of Maxalt-MLT that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Change in eyesight.
• Loss of eyesight. This can be long-lasting.
• Very bad headache or if headache is not better after the first dose.
• A burning, numbness, or tingling feeling that is not normal.
• Diarrhea or constipation.
• Very upset stomach or throwing up.
• Severe stomach pain or bloody diarrhea.
• Belly pain after meals.
• Fever.
• Weight loss.
• Leg cramps.
• Feeling of heaviness or tightness in the leg muscles.
• Feeling cold.
• Burning or aching pain in the feet or toes.
• Mood changes.
• Change in color of skin.
• Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking Maxalt-MLT. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
• Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with Maxalt-MLT. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight.

What are some other side effects of Maxalt-MLT?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Maxalt-MLT?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 10 MG TABLET POUCH CARTON

• Maxalt®
  (rizatriptan benzoate)
  10 mg
  TABLETS
• NDC 78206-142-01
• Each tablet contains 14.53 mg of rizatriptan benzoate,
  equivalent to 10 mg rizatriptan.
• 18 Tablets
• USUAL DOSAGE:
  See accompanying circular.
• Rx only
• Manuf. by:
  Zhejiang Huahai Pharmaceutical Co., Ltd.
  Xunqiao, Linhai, Zhejiang 317024, China
  Dist. by: Organon LLC, a subsidiary of
  ORGANON & Co.,
  Jersey City, NJ 07302, USA
  Rizatriptan benzoate (active ingred.) Made in Ireland.
  Formulated in China.

SRC: NLM .