Tiglutik
(riluzole)riluzole 5 MG/ML Oral Suspension [Tiglutik]
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Tiglutik FAQs
Are there studies on riluzole use during pregnancy?No studies on riluzole in pregnant women are available. Case reports have been insufficient to determine the associated risk. The background risk for major birth defects and miscarriage in ALS patients and the general population is also unknown.
What do animal studies indicate about riluzole's effects during pregnancy?Oral administration of riluzole to pregnant animals resulted in decreased fetal growth, increased embryofetal mortality, and maternal toxicity at higher doses. These findings suggest potential developmental toxicity.
Is there data on riluzole presence in breast milk and its effects on breastfeeding?No data exists on riluzole presence in human milk or its effects on breastfed infants. However, riluzole or its metabolites have been detected in the milk of lactating rats. Consideration should be given to breastfeeding benefits and potential adverse effects on the infant.
What are the effects of riluzole on fertility in rats?In rats, oral administration of riluzole led to decreased fertility indices and increased embryolethality.
Is riluzole safe and effective for pediatric use?Safety and effectiveness for pediatric patients have not been established for riluzole.
How does riluzole perform in elderly patients?In clinical studies, no significant differences in safety or effectiveness were observed between elderly and younger patients. However, some older individuals might exhibit increased sensitivity.
What considerations should be made for patients with hepatic impairment when using TIGLUTIK?Patients with mild or moderate hepatic impairment might face increased risk of adverse reactions due to elevated riluzole exposure. TIGLUTIK is not recommended for certain patients with liver abnormalities.
How does riluzole impact Japanese patients?Japanese patients might have higher riluzole concentrations, potentially leading to a greater risk of adverse reactions.
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