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riluzole

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Overview

What is Rilutek?

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

RILUTEK 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 Rilutek look like?



What are the available doses of Rilutek?

Tablets: 50 mg ()

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

How should I use Rilutek?

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

The recommended dosage for RILUTEK is 50 mg taken orally twice daily. RILUTEK should be taken at least 1 hour before or 2 hours after a meal .

Measure serum aminotransferases before and during treatment with RILUTEK .


What interacts with Rilutek?

Sorry No Records found


What are the warnings of Rilutek?

Sorry No Records found


What are the precautions of Rilutek?

Sorry No Records found


What are the side effects of Rilutek?

Sorry No records found


What should I look out for while using Rilutek?

RILUTEK 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 Rilutek?

Reported symptoms of overdose following ingestion of RILUTEK 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 RILUTEK 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.


How should I store and handle Rilutek?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. RILUTEK 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 70515-700-60.Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), and protect from bright light.RILUTEK 50 mg tablets are white, capsule-shaped, film-coated, and engraved with “RPR 202” on one side. RILUTEK is supplied in bottles of 60 tablets, NDC 70515-700-60.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
RILUTEK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) .

Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking RILUTEK. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with RILUTEK.

In clinical studies, the incidence of elevations in hepatic transaminases was greater in RILUTEK-treated patients than placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in RILUTEK-treated patients. Maximum increases in ALT occurred within 3 months after starting RILUTEK. About 50% and 8% of RILUTEK-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 RILUTEK is not recommended if patients develop hepatic transaminase levels greater than 5 times the ULN. Discontinue RILUTEK 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

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Tips

Tips

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Interactions

Interactions

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