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Tiglutik Generic Name & Formulations
Legal Class
Rx
General Description
Riluzole 50mg/10mL (5mg/mL); oral susp.
Pharmacological Class
Benzothiazole.
How Supplied
Oral susp (300mL)—2 (w. supplies)
Manufacturer
Generic Availability
NO
Tiglutik Indications
Indications
Amyotrophic lateral sclerosis (ALS).
Tiglutik Dosage and Administration
Adult
Take ≥1hr before or 2hrs after a meal. 50mg (10mL) orally or via PEG-tubes every 12hrs.
Children
Not established.
Tiglutik Contraindications
Not Applicable
Tiglutik Boxed Warnings
Not Applicable
Tiglutik Warnings/Precautions
Warnings/Precautions
Monitor for hepatic injury monthly for the first 3 months, and periodically thereafter. Measure serum aminotransferases before and during treatment. If ALT >5×ULN: not recommended. Discontinue if liver dysfunction evident (eg, elevated bilirubin). Risk of neutropenia: monitor for febrile illness. Discontinue immediately if interstitial lung disease develops. Japanese patients (higher drug concentration/adverse reactions). Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
Tiglutik Pharmacokinetics
See Literature
Tiglutik Interactions
Interactions
May be potentiated by strong or moderate CYP1A2 inhibitors (eg, ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton). May be antagonized by CYP1A2 inducers. Increased risk of hepatotoxicity with concomitant other hepatotoxic agents (eg, allopurinol, methyldopa, sulfasalazine).
Tiglutik Adverse Reactions
Adverse Reactions
Oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, abdominal pain; elevated ALTs, severe neutropenia, interstitial lung disease, hypersensitivity pneumonitis.
Tiglutik Clinical Trials
See Literature
Tiglutik Note
Not Applicable
Tiglutik Patient Counseling
See Literature
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