Adult Dosing

Amyotrophic lateral sclerosis

• 50 mg PO bid taken atleast 1 hr before or 2 hrs after meals

Pediatric Dosing

• Safety and effectiveness in pediatric patients below the age of 12 years have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Amyotrophic lateral sclerosis (ALS) to extend survival and/or time to tracheostomy

• Hypersensitivity to any of the ingredients of the component

• N/A

Renal Dose Adjustment

• Renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustments not defined
• Multiple elevated LFTs/bilirubin: Avoid use

See Supplemental Patient Information

• Prescribe with extreme caution in patients with current evidence or history of abnormal liver function indicated by significant elevations of liver enzymes. Baseline elevations of LFTs (especially elevated bilirubin) should preclude use of riluzole
• Severe neutropenia may occur, especially within the first 2 months of riluzole therapy
• Cases of interstitial lung disease have been reported in patients treated with riluzole. If symptoms such as dry cough and/or dyspnea occur, chest radiography should be performed. If findings are suggestive of interstitial lung disease or hypersensitivity pneumonitis, discontinue therapy immediately
• Riluzole can cause elevations in LFTs, especially ALT and bilirubin. Discontinue therapy if ALT levels are 5 x ULN or if clinical jaundice develops
• Monitor ALT at baseline, then qmo for 3 months, then q3mo for 3 times, then periodically
• Monitor LFTs qwk if ALT > 5 times ULN

Cautions: Use cautiously in

• Renal impairment (refer dose adjustment section)
• Hepatic impairment (refer dose adjustment section)
• Hypertension
• Hx of neutropenia
• Hepatotoxic agent use
• Pregnancy (safety unknown)
• Lactation (safety unknown)
• Female patients (decreased metabolism)
• Japanese patients (decreased metabolism)
• Geriatric population

Supplemental Patient Information

• Riluzole may cause dizziness, vertigo, or somnolence. Do not drive or operate machinery until sufficient experience on Riluzole has been gained to gauge whether or not it affects mental and/or motor performance adversely

Rilutek interacts with :

Smoking

Pregnancy Category:C

Breastfeeding: Safety unknown; is excreted in breastmilk of lactating rats. Due to the potential for possible serious adverse reactions in nursing infants, use during breastfeeding is not recommended.

• CNS: Dizziness, asthenia, headache, vertigo, somnolence, depression, hypertonia
• NEURO: Circumoral paresthesia
• RESP: Pneumonia, decreased lung function, increased cough, sinusitis, rhinitis, interstitial lung disease, pneumonitis (hypersensitivity)
• HEMA: Neutropenia
• DERM: Erythema multiforme
• CV: Hypertension, tachycardia, peripheral edema, palpitation, postural hypertension
• GI: Nausea, vomiting, abdominal pain, dry mouth, oral monoliasis, anorexia, diarrhea, dyspepsia, flatulence, elevated liver transaminases, hepatotoxicity
• MUSC: Arthralgia, back pain
• GU: UTI, dysuria
• METABOLIC: Weight loss
• MISC: Anaphylactic reactions

• Neuroprotective. Exact mechanism of action unknown. Exerts an inhibitory effect on glutamate release and causes inactivation of voltage-dependent sodium channels. Also, interferes with intracellular events that follow transmitter binding at excitatory amino acid receptors.
• Well absorbed after oral administration, approximately 90%
• Absolute Oral Bioavailability: 60%
• Metabolized by liver; CYP450: 1A2 substrate
• Renally excreted: 90% (2% unchanged); minimal in feces (5%)
• Half life: 12 hrs (after multiple doses)

US Trade Name(s)

• Rilutek

US Availability

riluzole (generic)

• TABS: 50 mg

Rilutek

• TABS: 50 mg

Canadian Trade Name(s)

• Rilutek

Canadian Availability

Rilutek

• TABS: 50 mg

UK Trade Name(s)

• Rilutek

UK Availability

Rilutek

• TABS: 50 mg

Australian Trade Name(s)

• Rilutek

Australian Availability

Rilutek

• TABS: 50 mg

[Outline]

Neurologic

Glutamate Antagonists

Pricing data from www.DrugStore.com in U.S.A.

• Rilutek 50 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
  60 mg = $1112.01
  180 mg = $3282.99

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Rilutek 50 MG Oral Tablet

Pill Image:

[
See full size image]

Ingredient(s): Riluzole

Imprint: RPR;202

Color(s): White

Shape: Oval

Size (mm): 10.00

Score: 1

Inactive Ingredient(s): anhydrous dibasic calcium phosphate / microcrystalline cellulose / anhydrous colloidal silica / magnesium stearate / croscarmellose sodium / hypromellose / polyethylene glycol 6000 / titanium dioxide

Drug Label Author:
sanofi-aventis U.S. LLC

DEA Schedule:
Non-Scheduled