Rilutek

DRUG DESCRIPTION

RILUTEK® (riluzole) is a member of the benzothiazole class. Chemically, riluzole is 2-amino-6-(trifluoromethoxy)benzothiazole. Its molecular formula is C8H5F3N2OS and its molecular weight is 234.2. Its structural formula is as follows:

RILUTEK®
  (riluzole) Structural Formula Illustration

Riluzole is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide and methanol, freely soluble in dichloromethane, sparingly soluble in 0.1 N HCl and very slightly soluble in water and in 0.1 N NaOH. RILUTEK (riluzole) is available as a capsule-shaped, white, film-coated tablet for oral administration containing 50 mg of riluzole. Each tablet is engraved with “RPR 202” on one side.

Inactive Ingredients

Core: anhydrous dibasic calcium phosphate, USP; microcrystalline cellulose, NF; anhydrous colloidal silica, NF; magnesium stearate, NF; croscarmellose sodium, NF.

Film coating: hypromellose, USP; polyethylene glycol 6000; titanium dioxide, USP.

What are the possible side effects of riluzole (Rilutek)?

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

Stop using riluzole and call your doctor at once if you have a serious side effect such as:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • cough with yellow or green mucus; or
  • stabbing chest pain, feeling short of...

Read All Potential Side Effects and See Pictures of Rilutek »

What are the precautions when taking riluzole (Rilutek)?

Before taking riluzole, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

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.

Smoking may affect the level of this drug in your blood. Tell your doctor if you smoke or use nicotine or if you stop smoking.

Kidney and liver function decline as you grow older....

Read All Potential Precautions of Rilutek »


Rilutek Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, tiredness, nausea, vomiting, diarrhea, loss of appetite, stomach pain, or numbness/tingling around the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, chills, cough, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious signs of liver problems occur: yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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: Before taking riluzole, tell your doctor or pharmacist if you are allergic to it; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

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.

Smoking may affect the level of this drug in your blood. Tell your doctor if you smoke or use nicotine or if you stop smoking.

Kidney and liver function decline as you grow older. This medication is removed by the kidneys and liver. Therefore, the elderly may be more sensitive to the side effects of the drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Rilutek Patient Information Including Side Effects

Brand Names: Rilutek

Generic Name: riluzole (Pronunciation: RIL yoo zol)

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

What is riluzole (Rilutek)?

Riluzole works by decreasing your body's levels of glutamate, an amino acid that affects nerves that send messages from your brain to your muscles. People with amyotrophic lateral sclerosis may have very high levels of glutamate, which can damage these nerve cells.

Riluzole is used to treat amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease.

Riluzole is not a cure for ALS, but it may delay progression of the disease and prolong your life.

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

What are the possible side effects of riluzole (Rilutek)?

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

Stop using riluzole and call your doctor at once if you have a serious side effect such as:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • cough with yellow or green mucus; or
  • stabbing chest pain, feeling short of breath.

Less serious side effects may include:

  • dizziness, spinning sensation;
  • muscle stiffness;
  • weakness, drowsiness;
  • numbness or tingly feeling in or around your mouth;
  • mild nausea, diarrhea, stomach pain, constipation;
  • headache; or
  • runny nose.

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 riluzole (Rilutek)?

You should not use this medication if you are allergic to riluzole.

Before you take riluzole, tell your doctor if you have liver or kidney disease.

Riluzole can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Take riluzole on an empty stomach.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any appointments.

Avoid drinking alcohol while taking riluzole. Alcohol may increase your risk of liver damage.

Avoid products that contain caffeine. Caffeine may cause too much riluzole to build up in your body.

Smoking cigarettes may make riluzole less effective.

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