Riluzole is the generic equivalent of the brand-name drug Riluzole. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Riluzole through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
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) ] 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…
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) 7.1 Agents that may Increase Riluzole Blood Concentrations CYP1A2 inhibitors Coadministration of riluzole (a CYP1A substrate) with CYP1A2 inhibitor…
Dosage & Administration
2 DOSAGE AND 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 )
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise patients to inform their healthcare provider if they experience: Yellowing of the whites of the eyes [ see Warnings and Precautions (5.1) ] Fever [ see Warnings and Precautions (5.2) ] Respiratory symptoms—for example, dry cough and difficult or labored breathing [ see Warnings and Precautions (5.3)] Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. PJPI0248C ISS. 05/2020
Source: FDA. For professional use only. Not a substitute for prescribing information.
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