TIGLUTIK 50 mg/10mL
Riluzole · LIQUID · EDW PHARMA, INC
TIGLUTIK is a liquid containing riluzole at 50 mg/10mL, taken oral. Manufactured by EDW PHARMA, INC.
Key Facts
- Brand Name
- TIGLUTIK
- Generic Name
- Riluzole
- NDC Code (Product)
70726-0303- Manufacturer
- EDW PHARMA, INC
- Strength
- 50 mg/10mL
- Dosage Form
- LIQUID
- Route
- ORAL
- Marketing Status
- Application #
- NDA209080
- Drug Class
- Benzothiazole [EPC]
- Marketing Start
- 09/21/2018
Recall History
ITF PHARMA INC
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 50 mg (10 mL), twice daily, taken orally or via percutaneous endoscopic gastrostomy tubes (PEG-tubes), every 12 hours ( 2.1 ) Measure serum aminotransferases before and during treatment ( 2.2 , 5.1 ) Take at least 1 hour before or 2 hours after a meal ( 2.3 ) 2.1 Dosage Information The recommended dosage for TIGLUTIK is 50 mg (10 mL) taken orally or via Percutaneous Endoscopic Gastrostomy tubes (PEG-tubes) twice daily, every 12 hours. TIGLUTIK should be taken at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3) ]. 2.2 Monitoring to Assess Safety Measure serum aminotransferases before and during treatment with TIGLUTIK [see Warnings and Precautions (5.1) ]. 2.3 Important Administration Instructions Gently shake the TIGLUTIK bottle for at least 30 seconds before administration.Gently shake the TIGLUTIK bottle for at least 30 seconds before administration. TIGLUTIK can be administered by mouth or via percutaneous endoscopic gastrostomy tubes (PEG-tubes). Both silicone and polyurethane PEG tubes can be used. See the Instructions for Use for further administration details.See the Instructions for Use for further…
Contraindications
4 CONTRAINDICATIONS TIGLUTIK 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 )
Drug Interactions
7 DRUG INTERACTIONS Strong to moderate CYP1A2 inhibitors: Co-administration may increase TIGLUTIK-associated adverse reactions ( 7.1 ) Strong to moderate CYP1A2 inducers: Co-administration may result in decreased efficacy ( 7.2 ) Hepatotoxic drugs: TIGLUTIK-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 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 TIGLUTIK may increase the risk of TIGLUTIK - associated adverse reactions [see Clinical Pharmacology (12.3) ]. 7.2 Agents 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. Lo…
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 oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ITF Pharma Inc. at 1-800-664-1490 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 of Riluzole Tablets 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 riluzole-treated patients …
Frequently Asked Questions
What is TIGLUTIK used for?
TIGLUTIK contains Riluzole. It is a liquid taken oral. Consult your doctor for specific uses.
Is TIGLUTIK a controlled substance?
TIGLUTIK is not classified as a controlled substance by the DEA.
What is the generic name for TIGLUTIK?
The generic name for TIGLUTIK is Riluzole. There are 8 other brand versions of Riluzole.
What is the NDC code for TIGLUTIK 50 mg/10mL?
The NDC (National Drug Code) for TIGLUTIK 50 mg/10mL is 70726-0303, listed by EDW PHARMA, INC.