Extals50 mg

Extals 50 mg is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs

The mode of action of Extals 50 mg is unknown. Its pharmacological properties include the following, some of which may be related to its effect: An inhibitory effect on glutamate release (activation of glutamate reuptake), Inactivation of voltage-dependent sodium channels,  Ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors.

The recommended dosage for Extals 50 mg is 50 mg taken orally twice daily. Extals 50 mg should be taken at least 1 hour before or 2 hours after a meal. Measure serum aminotransferases before and during treatment with Extals 50 mg

The recommended dosage for Extals 50 mg is 50 mg taken orally twice daily. Extals 50 mg should be taken at least 1 hour before or 2 hours after a meal. Measure serum aminotransferases before and during treatment with Extals 50 mg

Strong to moderate CYP1A2 inhibitors: Coadministration may increase Extals 50 mg-associated adverse reactionsStrong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy Hepatotoxic drugs: Extals 50 mg-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity

Extals 50 mg is contraindicated in patients with a history of severe hypersensitivity reactions to Extals 50 mg or to any of its components (anaphylaxis has occurred)

The following adverse reactions are described below and elsewhere in the labeling: Hepatic Injury, Neutropenia, Interstitial lung disease

Pregnancy: Based on animal data, may cause fetal harmLactation: It is not known if Extals 50 mg is excreted in human milk. Extals 50 mg or its metabolites have been detected in milk of lactating rat. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from Extals 50 mg is unknown.

Hepatic Injury: Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking Extals 50 mg. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with Extals 50 mg.In clinical studies, the incidence of elevations in hepatic transaminases was greater in Extals 50 mgtreated patients than placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in Extals 50 mg-treated patients. Maximum increases in ALT occurred within 3 months after starting Extals 50 mg. About 50% and 8% of Extals 50 mgtreated patients in pooled Studies 1 and 2, had at least one elevated ALT level above ULN and above 3 times ULN, respectively Monitor patients for signs and symptoms of hepatic injury, every month for the first 3 months of treatment, and periodically thereafter. The use of Extals 50 mg is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue Extals 50 mg if there is evidence of liver dysfunction (e.g., elevated bilirubin).Neutropenia: Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of Extals 50 mg treatment have been reported. Advise patients to report febrile illnesses.Interstitial Lung Disease: Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking Extals 50 mg. Discontinue Extals 50 mg immediately if interstitial lung disease develops.

Reported symptoms of overdose following ingestion of Extals 50 mg ranging from 1.5 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 Extals 50 mg overdose is available.

Store at controlled room temperature, 20°C to 25°C, and protect from bright light.

Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs

The mode of action of Extals 50 mg is unknown. Its pharmacological properties include the following, some of which may be related to its effect: An inhibitory effect on glutamate release (activation of glutamate reuptake), Inactivation of voltage-dependent sodium channels,  Ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors.

Pregnancy: Based on animal data, may cause fetal harmLactation: It is not known if Extals 50 mg is excreted in human milk. Extals 50 mg or its metabolites have been detected in milk of lactating rat. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from Extals 50 mg is unknown.