Rilutek 50 Mg Tablet

Riluzole is available by the brand name of Rilutek (marketed by Sanofi Aventis), among others. The exact mechanism of the drug is not known.

Riluzole (Rilutek - Sanofi) Uses:

• Amyotrophic lateral sclerosis:

  • It is used in the treatment of patients with amyotrophic lateral sclerosis (ALS).
  • Riluzole may extend survival and/or the time to tracheostomy

Riluzole (Rilutek) Dose in Adults

Riluzole (Rilutek) Dose in the treatment of Amyotrophic lateral sclerosis (ALS):

• 50 mg orally two times a day.

Riluzole (Rilutek) Dose in Children

Not applicable

Pregnancy Risk Category: 

• Negative events were observed in animal reproduction studies.

Use of iluzole while breastfeeding

• It is unknown if the drug will be excreted into breastmilk.
• Breastfeeding women should not be exposed to the drug.

Riluzole dose in Renal disease:

The manufacturer has not recommended any adjustments in the dose in patients with renal disease.

Riluzole dose in liver disease:

• Although the manufacturer has not made any adjustments to the dosage, you should still use it with caution.
• Patients with higher than five times the normal hepatic enzyme levels at baseline should avoid it.
• If hepatic dysfunction develops during treatment, the treatment must be stopped immediately.

Common Side Effects of Riluzole (Rilutek):

• Gastrointestinal:

  • Nausea

• Neuromuscular & skeletal:

  • Weakness

• Cardiovascular:

  • Hypertension
  • Peripheral Edema
  • Tachycardia

• Central Nervous System:

  • Dizziness
  • Drowsiness
  • Vertigo
  • Malaise

• Dermatologic:

  • Pruritus
  • Eczema
  • Exfoliative Dermatitis

• Gastrointestinal:

  • Abdominal Pain
  • Vomiting
  • Flatulence
  • Oral Paresthesia
  • Dental Caries
  • Oral Candidiasis
  • Stomatitis

• Genitourinary:

  • Urinary Tract Infection
  • Dysuria

• Hepatic:

  • Increased Liver Enzymes

• Neuromuscular & Skeletal:

  • Arthralgia
  • Tremor

• Respiratory:

  • Decreased Lung Function
  • Cough

Contraindications to Riluzole (Rilutek):

• Allergy reactions to riluzole and any component of this formulation
• Liver disease and serum transaminases more than 3x the ULN at baseline
• Pregnancy
• Breastfeeding

Warnings and precautions

• Depression in the CNS:

  • It can cause CNS depression, manifested as somnolence or drowsiness.
  • The drug should not be used on patients who are using heavy machinery or have mental alertness.

• Hepatic effects

  • Hepatotoxicity can occur and may prove fatal.
  • During the initial three months of therapy, liver enzymes can be deranged.
  • Patients with liver enzymes greater than 5x the normal upper limit must stop taking the medication.
  • For the first three months, it is important to monitor liver enzymes monthly and then every other month thereafter.
  • If hepatic dysfunction develops, the treatment must be stopped immediately.

• Neutropenia

  • During the first two months of therapy, there may be severe neutropenia (less than 500/mm3).
  • If a patient has a fever or any other symptoms of infection, he/she should be evaluated and monitored regularly.

• Pulmonary disorders

  • ILD (interstitial pulmonary disease) and HSP (hypersensitivity pneumonia) have been reported. 
  • If ILD is suspected, treatment should be stopped immediately.

• Hepatic impairment

  • Patients with liver disease should be cautious.