Riluzole 50 mg Tablet, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Benzothiazole class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Riluzole is used to treat amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Riluzole is in a class of medications called benzothiazoles. It works by changing the activity of certain natural substances in the body that affect nerves and muscles.
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- Why do I have to take it on an empty stomach? Can I take it with a light snack?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.284 | $17.03 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.6904 | $41.42 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.9007 | $54.04 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Riluzole 50 mgthis 67877-0286-60 | Ascend | 60 tablets | $0.284 | AB | Availability likely | — |
| Riluzole 50 mg 69076-0200-60 | Florida | 60 tablets | $0.284 | AB | Availability likely | — |
| Riluzole 50 mg 42291-0775-60 | AvKARE | 60 tablets | — | AB | FDA listed | — |
| Riluzole 50 mg 62756-0538-18 | Sun | 1000 tablets | — | — | FDA listed | — |
| riluzole 50 mg 68462-0381-10 | Glenmark | 1000 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 67877-0286-05 | 500 TABLET in 1 BOTTLE (67877-286-05) | — | — | 2016-03-31 | Active |
| 67877-0286-10 | 1000 TABLET in 1 BOTTLE (67877-286-10) | — | — | 2016-03-31 | Active |
| 67877-0286-14 | 10 BLISTER PACK in 1 CARTON (67877-286-14) / 14 TABLET in 1 BLISTER PACK | — | — | 2016-03-31 | Active |
| 67877-0286-60 You're viewing this | 60 TABLET in 1 BOTTLE (67877-286-60) | $0.2838 / ea | $17.03 | 2016-03-31 | Active |
| 67877-0286-90 | 90 TABLET in 1 BOTTLE (67877-286-90) | — | — | 2016-03-31 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 67877-0286-60?
What is the difference between NDC 67877-0286-60 and NDC 67877-0286-90?
What NDC number is used to bill for this package of Riluzole 50 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION The recommended dosage for riluzole is 50 mg taken orally twice daily. Riluzole should be taken at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology ( 12.3 )] . Measure serum aminotransferases before and during treatment with riluzole [ see Warnings and Precautions (5.1 )]. · Recommended dosage: 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal ( 2 ) · Measure serum aminotransferases before and during treatment ( 2 , 5.1 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Riluzole Tablets, USP 50 mg is available as a white to off-white coloured, capsule-shaped film coated tablet, debossed with “RIL” on one side and “50” on other side. Tablets: 50 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [ see Adverse Reactions (6.1) ] . Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS · Hepatic injury: Use of riluzole is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue riluzole if there is evidence of liver dysfunction ( 5.1 ) · Neutropenia: Advise patients to report any febrile illness ( 5.2 ) · Interstitial lung disease: Discontinue riluzole if interstitial lung disease develops ( 5.3 ) • Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue riluzole ( 5.4 )
5.1Hepatic Injury Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole. In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole-treated patients than placebo-treated patients.
The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in riluzole-treated patients. Maximum increases in ALT occurred within 3 months after starting riluzole. About 50% and 8% of riluzole -treated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively [ see Clinical Studies (14) ].
Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of riluzole is not recommended if patients develop hepatic transaminase levels greater than 5 times the ULN. Discontinue riluzole if there is evidence of liver dysfunction (e.g., elevated bilirubin).
5.2Neutropenia Cases of severe neutropenia (absolute neutrophil count less than 500 per mm 3 ) within the first 2 months of riluzole treatment have been reported. Advise patients to report febrile illnesses.
5.3Interstitial Lung Disease Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking riluzole. Discontinue riluzole immediately if interstitial lung disease develops.
5.4Pancreatitis Acute pancreatitis, including fatal and non-fatal necrotizing pancreatitis, has been observed in patients treated with riluzole in the postmarketing setting. Pancreatitis has occurred weeks to several years after initiation of riluzole. Patients and caregivers should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation.
If pancreatitis is suspected, promptly discontinue riluzole and initiate appropriate management. If an alternative cause is identified, reinitiation of riluzole may be considered.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: · Hepatic Injury [see Warnings and Precautions ( 5.1 )] · Neutropenia [see Warnings and Precautions ( 5.2 )] · Interstitial lung disease [see Warnings and Precautions ( 5.3 )] • Pancreatitis [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Controlled Clinical Trials In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received riluzole 50 mg twice daily [ see Clinical Studies (14) ] . The most common adverse reactions in the riluzole group (in at least 5% of patients and more frequently than in the placebo group) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain.
The most common adverse reactions leading to discontinuation in the riluzole group were nausea, abdominal pain, constipation, and elevated ALT. There was no difference in rates of adverse reactions leading to discontinuation in females and males. However, the incidence of dizziness was higher in females (11%) than in males (4%).
The adverse reaction profile was similar in older and younger patients. There were insufficient data to determine if there were differences in the adverse reaction profile in different races. Table 1 lists adverse reactions that occurred in at least 2% of riluzole-treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.
Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials (Studies 1 and 2) in Patients with ALS Riluzole 50 mg twice daily (N=313) Placebo (N=320) Asthenia 19% 12% Nausea 16% 11% Decreased lung function 10% 9% Hypertension 5% 4% Abdominal pain 5% 4% Vomiting 4% 2% Arthralgia 4% 3% Dizziness 4% 3% Dry mouth 4% 3% Insomnia 4% 3% Pruritus 4% 3% Tachycardia 3% 1% Flatulence 3% 2% Increased cough 3% 2% Peripheral edema 3% 2% Urinary Tract Infection 3% 2% Circumoral paresthesia 2% 0% Somnolence 2% 1% Vertigo 2% 1% Eczema 2% 1%
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of riluzole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. · Acute hepatitis and icteric toxic hepatitis [ see Warnings and Precautions (5.1) ] · Renal tubular impairment • Pancreatitis [see Warnings and Precautions ( 5.4 )]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS · Strong to moderate CYP1A2 inhibitors: Coadministration may increase riluzole -associated adverse reactions ( 7.1 ) · Strong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy ( 7.2 ) · Hepatotoxic drugs: Riluzole -treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity ( 7.3 )
7.1Agents that may Increase Riluzole Blood Concentrations CYP1A2 inhibitors Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inhibitors was not evaluated in a clinical trial; however, in vitro findings suggest an increase in riluzole exposure is likely. The concomitant use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton) with riluzole may increase the risk of riluzole-associated adverse reactions [ see Clinical Pharmacology (12.3) ] .
7.2Agents that may Decrease Riluzole Plasma Concentrations CYP1A2 inducers Co-administration of riluzole (a CYP1A substrate) with CYP1A2 inducers was not evaluated in a clinical trial; however, in vitro findings suggest a decrease in riluzole exposure is likely. Lower exposures may result in decreased efficacy [ see Clinical Pharmacology (12.3)] .
7.3Hepatotoxic Drugs Clinical trials in ALS patients excluded patients on concomitant medications which were potentially hepatotoxic (e.g., allopurinol, methyldopa, sulfasalazine). Riluzole-treated patients who take other hepatotoxic drugs may be at an increased risk for hepatotoxicity [ see Warnings and Precautions (5.1) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS · Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )
8.1Pregnancy Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data] . Based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. Data Animal Data Oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose.
The mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (RHDD, 100 mg) on a mg/m 2 basis. When riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. The no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the RHDD on a mg/m 2 basis.
Maternal toxicity was observed at the highest dose tested in rat and rabbit. When riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. The mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the RHDD on a mg/m 2 basis.
8.2Lactation Risk Summary It is not known if riluzole is excreted in human milk. Riluzole or its metabolites have been detected in milk of lactating rats. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown.
8.3Females and Males of Reproductive Potential In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [ see Nonclinical Toxicology (13.1)].
8.4Pediatric Use Safety and effectiveness of riluzole in pediatric patients have not been established.
8.5Geriatric Use In clinical studies of riluzole, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
8.6Hepatic Impairment Patients with mild [Child-Pugh's (CP) score A] or moderate (CP score B) hepatic impairment had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. The impact of severe hepatic impairment on riluzole exposure is unknown.
Use of riluzole is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [ Clinical Pharmacology (12.3) ] .
8.7Japanese Patients Japanese patients are more likely to have higher riluzole concentrations. Consequently, the risk of adverse reactions may be greater in Japanese patients [ see Clinical Pharmaco…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data] . Based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. Data Animal Data Oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose.
The mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (RHDD, 100 mg) on a mg/m 2 basis. When riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. The no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the RHDD on a mg/m 2 basis.
Maternal toxicity was observed at the highest dose tested in rat and rabbit. When riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. The mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the RHDD on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of riluzole in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical studies of riluzole, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE Reported symptoms of overdose following ingestion of riluzole ranging from 1.5 to 3 grams (30 to 60 times the recommended dose) included acute toxic encephalopathy, coma, drowsiness, memory loss, and methemoglobinemia. No specific antidote for the treatment of riluzole overdose is available. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.
12.2Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans.
12.3Pharmacokinetics Table 2 displays the pharmacokinetic parameters of riluzole. Table 2. Pharmacokinetic Parameters of Riluzole A bsorption Bioavailability (oral) Approximately 60% Dose Proportionality Linear over a dose range of 25 mg to 100 mg every 12 hours (1/2 to 2 times the recommended dosage) Food effect AUC ↓ 20% and Cmax ↓ 45% (high fat meal) D i stribution Plasma Protein Binding 96% (Mainly to albumin and lipoproteins) E li m i n ation Elimination half-life • 12 hours (CV=35%) • The high interindividual variability in the clearance of riluzole is potentially attributable to variability of CYP1A2.
The clinical implications are not known. Accumulation Approximately 2-fold M etabolism Fraction metabolized (% dose) At least 88% Primary metabolic pathway(s) [ i n vitro ] • Oxidation: CYP1A2 • Direct and sequential glucoronidation: UGT-HP4 Active Metabolites Some metabolites appear pharmacologically active in vitro, but the clinical implications are not known. Excretion Primary elimination pathways (% dose) • Feces: 5% • Urine: 90% (2% unchanged riluzole) Specific Populations Hepatic Impairment Compared with healthy volunteers, the AUC of riluzole was approximately 1.7-fold greater in patients with mild chronic hepatic impairment (CP score A) and approximately 3-fold greater in patients with moderate chronic hepatic impairment (CP score B).
The pharmacokinetics of riluzole have not been studied in patients with severe hepatic impairment (CP score C) [see Use in Specific Populations (8.6)] . Race The clearance of riluzole was 50% lower in male Japanese subjects than in Caucasian subjects, after normalizing for body weight [ see Use in Specific Populations (8.7) ] . Gender The mean AUC of riluzole was approximately 45% higher in female patients than male patients.
Smokers The clearance of riluzole in tobacco smokers was 20% greater than in nonsmokers. Geriatric Patients and Patients with Moderate to Severe Renal Impairment Age 65 years or older, and moderate to severe renal impairment do not have a meaningful effect on the pharmacokinetics of riluzole. The pharmacokinetics of riluzole in patients undergoing hemodialysis are unknown.
Drug Interaction Studies Drugs Highly Bound To Plasma Proteins Riluzole and warfarin are highly bound to plasma proteins. In vitro, riluzole did not show any displacement of warfarin from plasma proteins. Riluzole binding to plasma proteins was unaffected by warfarin, digoxin, imipramine and quinine at high therapeutic concentrations in vitro.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Riluzole Tablets, USP are white to off-white coloured, capsule-shaped film coated tablets, debossed with “RIL” on one side and “50” on other side. Riluzole Tablets, USP are supplied in the following presentations: Bottles of 60 tablets NDC 67877-286-60 Bottles of 90 tablets NDC 67877-286-90 Bottles of 500 tablets NDC 67877-286-05 Bottles of 1000 tablets NDC 67877-286-10 Blister pack of 140 (10 x 14) Tablets NDC 67877-286-14 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] and protect from bright light.
Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Riluzole is a member of the benzothiazole class. The chemical designation for riluzole is 2-amino-6-(trifluoromethoxy)benzothiazole. Its molecular formula is C 8 H 5 F 3 N 2 OS, and its molecular weight is 234.2.
The chemical structure is: Riluzole is a white to slightly yellow powder that is freely soluble in acetonitrile, in alcohol, in methylene chloride, very slightly soluble in hexane and water. Riluzole Tablets, USP is available as a white to off-white coloured, capsule shaped film coated tablet, debossed with “RIL” on one side and “50” on other side. Each film-coated tablet for oral use contains 50 mg of riluzole and the following inactive ingredients: Core: dibasic calcium phosphate dihydrate, USP; croscarmellose sodium, USP/NF; hypromellose, USP; microcrystalline cellulose, USP/NF; magnesium stearate, USP/NF; colloidal silicon dioxide, USP/NF.
Film coating: Opadry Y-1-7000H White (hypromellose, USP; titanium dioxide, USP; polyethylene glycol 400, NF) riluzole-st
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to inform their healthcare provider if they experience: Hepatic Injury Advise patients that riluzole can cause liver injury, which can be fatal. Inform patients of the clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) and to contact a healthcare provider promptly if these signs or symptoms occur [see Warnings and Precautions ( 5.1 )]. Neutropenia Advise patients that riluzole can cause neutropenia, and to report to their healthcare provider if they have a fever [see Warnings and Precautions ( 5.2 )].
Interstitial Lung Disease Advise patients that riluzole can cause interstitial lung disease, and to report to their healthcare provider if they have respiratory symptoms (e.g., dry cough and difficult or labored breathing) [see Warnings and Precautions ( 5.3 )]. Pancreatitis Advise patients that riluzole can cause pancreatitis and to report to their healthcare provider if they have abdominal pain, nausea, vomiting, and/or anorexia [see Warnings and Precautions ( 5.4 )]. Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA.
Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Revised: April 2026 PT 1789-05