Tiglutik 50 mg/10 mL oral suspension

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Medication name

Generic name:
Riluzole - oral

Pronunciation
(RIL-ue-zole)

Brand name(s)
Rilutek , Tiglutik

Uses

This medication is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). Riluzole helps to slow down the worsening of this disease and prolong survival. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness. Riluzole is thought to work by protecting the nerves in the brain and spinal cord from too much of a natural substance called glutamate that may be part of the cause of nerve damage.

How to use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking riluzole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually every 12 hours on an empty stomach at least 1 hour before or 2 hours after a meal.

If you are using the liquid form of this medication, gently shake the bottle for at least 30 seconds before use. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or take this drug more often or for longer than prescribed because your risk of side effects will increase.

Tell your doctor if your condition gets worse.

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 last or get worse, 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 right away if you have any serious side effects, such as:

  • signs of infection (such as sore throat that doesn't go away, fever, chills, cough)

Get medical help right away if you have any very serious side effects, such as:

  • nausea/vomiting that doesn't stop
  • yellowing eyes/skin
  • severe stomach/abdominal pain
  • dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as:

  • 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 or at www.fda.gov/medwatch.

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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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.

Liquid products may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

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.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • other drugs that may cause liver problems (such as allopurinol, methyldopa, sulfasalazine)
  • drugs affecting liver enzymes that remove riluzole from your body (such as amitriptyline, caffeine, omeprazole, rifampin, tacrine, quinolone antibiotics such as ciprofloxacin)
Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom.

If you are using the liquid form of this medication, store the bottle upright. Keep bottle tightly closed between each use. Do not freeze. Use/discard within 15 days after opening. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.