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Riluzole

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Overview

What is Riluzole?

RILUZOLE is a member of the benzothiazole class. Chemically, riluzole is 2-amino-6-(trifluoromethoxy)benzothiazole. Its molecular formula is CHFNOS, and its molecular weight is 234.2. The chemical structure is:

RILUZOLE is a white to slightly yellow powder that is very soluble in dimethylformamide, dimethylsulfoxide and methanol; freely soluble in dichloromethane; sparingly soluble in 0.1 N HCl; and very slightly soluble in water and in 0.1 N NaOH.

Each film-coated tablet for oral use contains 50 mg of riluzole and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.



What does Riluzole look like?



What are the available doses of Riluzole?

Tablets: 50 mg ()

What should I talk to my health care provider before I take Riluzole?

How should I use Riluzole?

RILUZOLE is indicated for the treatment of amyotrophic lateral sclerosis (ALS)

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)].


What interacts with Riluzole?

Sorry No Records found


What are the warnings of Riluzole?

Sorry No Records found


What are the precautions of Riluzole?

Sorry No Records found


What are the side effects of Riluzole?

Sorry No records found


What should I look out for while using Riluzole?

RILUZOLE is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred)


What might happen if I take too much Riluzole?

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


How should I store and handle Riluzole?

Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].RILUZOLE 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUZOLE is supplied in bottles of 60 tablets, NDC 64980-191-06.Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.RILUZOLE 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUZOLE is supplied in bottles of 60 tablets, NDC 64980-191-06.Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.

Non-Clinical Toxicology
RILUZOLE is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred)

Caution should be exercised when propranolol hydrochloride extended-release capsules are administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).

Alcohol

Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking RILUZOLE tablets. 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

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 transaminases levels greater than 5 times the ULN. Discontinue RILUZOLE if there is evidence of liver dysfunction (e.g., elevated bilirubin).

The following adverse reactions are described below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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