دواعي استعمال ريلوتك 50مجم 56 قرص

Rilutek 50 mg film-coated tablets (riluzole 50 mg, pack of 56) by Sanofi, marketed in Egypt for amyotrophic lateral sclerosis.

• To extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).European Medicines Agency
• Treatment of amyotrophic lateral sclerosis (ALS).DailyMed (U.S. National Library of Medicine)

• Very common: asthenia, nausea, abnormal liver function tests.نشرة دولية لنفس المنتج · European Medicines Agency
• Common: headache, dizziness, oral paraesthesia, somnolence, tachycardia, diarrhoea, abdominal pain, vomiting, pain.نشرة دولية لنفس المنتج · European Medicines Agency
• Uncommon: anaemia, anaphylactoid reaction, angioedema, interstitial lung disease, pancreatitis; not known: severe neutropenia, rash, hepatitis.نشرة دولية لنفس المنتج · European Medicines Agency

• Hypersensitivity to riluzole or to any excipient.نشرة دولية لنفس المنتج · European Medicines Agency
• Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.نشرة دولية لنفس المنتج · European Medicines Agency
• Pregnancy or breast-feeding.نشرة دولية لنفس المنتج · European Medicines Agency
• History of severe hypersensitivity reactions to riluzole or its components (anaphylaxis has occurred).نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)

• Risk of hepatitis: measure serum transaminases including ALT before and during therapy; discontinue if ALT rises to 5 times ULN, and rechallenge cannot be recommended.نشرة دولية لنفس المنتج · European Medicines Agency
• Neutropenia: patients should report any febrile illness; check white cell counts and discontinue riluzole if neutropenia occurs.نشرة دولية لنفس المنتج · European Medicines Agency
• Interstitial lung disease has been reported, some severe; perform chest radiography if dry cough or dyspnoea develops and discontinue immediately if findings suggest interstitial lung disease.نشرة دولية لنفس المنتج · European Medicines Agency
• May cause dizziness or vertigo; patients should not drive or operate machinery if affected.نشرة دولية لنفس المنتج · European Medicines Agency

• CYP1A2 inhibitors (e.g. caffeine, diclofenac, diazepam, fluvoxamine, theophylline, amitriptyline, quinolones)May decrease the rate of riluzole elimination (CYP1A2 is the principal enzyme in its metabolism; based on in vitro data).European Medicines Agency
• CYP1A2 inducers (e.g. cigarette smoke, charcoal-broiled food, rifampicin, omeprazole)May increase the rate of riluzole elimination.European Medicines Agency

• Contraindicated in pregnancy; clinical experience in pregnant women is lacking.نشرة دولية لنفس المنتج · European Medicines Agency
• No studies in pregnant women; animal studies showed developmental toxicity (decreased embryofetal/offspring viability, growth and functional development) at clinically relevant doses.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
• Contraindicated in breast-feeding women; it is not known whether riluzole is excreted in human milk.نشرة دولية لنفس المنتج · European Medicines Agency
• Riluzole or its metabolites have been detected in the milk of lactating rats; excretion in human milk is unknown.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)

• ALT monthly during the first 3 months, every 3 months for the rest of the first year, and periodically thereafter; more often if ALT rises.نشرة دولية لنفس المنتج · European Medicines Agency
• White blood cell count if a febrile illness is reported.نشرة دولية لنفس المنتج · European Medicines Agency

• Proposed to act by inhibiting glutamate processes; the exact mode of action is unclear.