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Riluzole (Riluzole)

Trade Name : Riluzole

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 50 mg/1

RILUZOLE Benzothiazole [EPC],Benzothiazoles [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Riluzole (Riluzole) which is also known as Riluzole and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 50 mg/1 per ml. Read more

Riluzole (Riluzole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
  • Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS) ()
  • The recommended dosage for riluzole tablets is 50 mg taken orally twice daily. Riluzole tablets should be taken at least 1 hour before or 2 hours after a meal .
  • Measure serum aminotransferases before and during treatment with riluzole tablets .
  • 2n- 5.1
  • Riluzole Tablets, USP are available containing 50 mg of riluzole, USP.
  • Tablets: 50 mg ()
  • Riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) n
  • Patients with a history of severe hypersensitivity reactions to riluzole tablets or to any of its components ()
  • No data
  • The following adverse reactions are described below and elsewhere in the labeling:
  • 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 ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or n
  • No data
  • No data
  • u2022
  • 8.1
  • Reported symptoms of overdose following ingestion of riluzole ranging from 1.5 grams 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.
  • Riluzole tablets, USP are 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 234.20. The chemical structure is:
  • Riluzole, USP is a white to slightly yellow powder or crystalline 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.
  • No data
  • No data
  • The efficacy of riluzole tablets was demonstrated in two studies (Study 1 and 2) that evaluated riluzole tablets 50 mg twice daily in patients with amyotrophic lateral sclerosis (ALS). Both studies included patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity greater than or equal to 60% of normal.
  • Study 1 was a randomized, double-blind, placebo-controlled clinical study that enrolled 155 patients with ALS. Patients were randomized to receive riluzole 50 mg twice daily (n = 77) or placebo (n = 78) and were followed for at least 13 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.
  • The time to tracheostomy or death was longer for patients receiving riluzole compared to placebo. There was an early increase in survival in patients receiving riluzole compared to placebo. Figure 1 displays the survival curves for time to death or tracheostomy. The vertical axis represents the proportion of individuals alive without tracheostomy at various times following treatment initiation (horizontal axis). Although these survival curves were not statistically significantly different when evaluated by the analysis specified in the study protocol (Logrank test p = 0.12), the difference was found to be significant by another appropriate analysis (Wilcoxon test p = 0.05). As seen in Figure 1, the study showed an early increase in survival in patients given riluzole. Among the patients in whom the endpoint of tracheostomy or death was reached during the study, the difference in median survival between the riluzole 50 mg twice daily and placebo groups was approximately 90 days.
  • Study 2 was a randomized, double-blind, placebo-controlled clinical study that enrolled 959 patients with ALS. Patients were randomized to riluzole 50 mg twice daily (n = 236) or placebo (n = 242) and were followed for at least 12 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.
  • The time to tracheostomy or death was longer for patients receiving riluzole compared to placebo. Figure 2 displays the survival curves for time to death or tracheostomy for patients randomized to either riluzole 100 mg per day or placebo. Although these survival curves were not statistically significantly different when evaluated by the analysis specified in the study protocol (Logrank test p = 0.076), the difference was found to be significant by another appropriate analysis (Wilcoxon test p = 0.05). Not displayed in Figure 2 are the results of riluzole 50 mg per day (one-half of the recommended daily dose), which could not be statistically distinguished from placebo, or the results of riluzole 200 mg per day (two times the recommended daily dose), which were not distinguishable from the 100 mg per day results. Among the patients in whom the endpoint of tracheostomy or death was reached during the study, the difference in median survival between riluzole and placebo was approximately 60 days.
  • Although riluzole improved survival in both studies, measures of muscle strength and neurological function did not show a benefit.
  • u00a0
  • Riluzole Tablets, USP are available containing 50 mg of riluzole, USP.
  • The 50 mg tablets are white, film-coated, capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-4145-91bottles of 60 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from bright light.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Advise patients to inform their healthcare provider if they experience:
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 034, IndiaCode No.: MH/DRUGS/25/NKD/89
  • 75059091
  • Revised: 5/2016MX:RILU:R2
  • NDC 0378-4145-91
  • Riluzolen- Tablets, USPn- 50 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a060 Tablets
  • Each film-coated tablet contains:Riluzole, USP 50 mg
  • Usual Dosage:
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Protect from bright light.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4145D1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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Clinical Trials Supply

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