Riluzol 50 mg Tablet

    Riluzol 50 mg

    Riluzole

    Category: Tablet

    Manufacturer: Renata Limited

    Uses of Riluzol: - Amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis Hepatic impairment (baseline transaminases >3 times the upper limit of normal).
    Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs
    The mode of action of riluzole 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.
    How to use Riluzole: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Riluzole is to be taken empty stomach. Avoid Riluzole with high-fat meals such as olive oil, nuts & seeds (Brazil nuts), dark chocolate, butter and meat. Administration: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before or 2 hr after meals. Adult Dose: Oral Amyotrophic lateral sclerosis Adult: 50 mg bid. Discontinue if ALT levels increase to 5 times the upper limit of normal (ULN). Hepatic impairment Mild or moderate (Child-Pugh A or B): Patients had increases in AUC; thus, may be at increased risk of adverse reactions Severe (Child-Pugh C): Unknown Not recommended for patients with baseline serum aminotransferases (AST/ALTs) >5x ULN or evidence of liver dysfunction (eg, elevated bilirubin)
    Decreased rate of elimination with CYP1A2 inhibitors (e.g. caffeine, ciprofloxacin, oral contraceptives). Increased rate of elimination with CYP1A2 inducers (e.g. rifampicin, omeprazole). Increased risk of hepatotoxicity with hepatotoxic drugs (e.g. allopurinol, methyldopa, sulfasalazine).
    Hepatic impairment (baseline transaminases >3 times the upper limit of normal).
    Common - Weakness - Headache - Dizziness - Nausea - Abdominal pain - Diarrhea - Decreased pulmonary function - Paresthesia (tingling or pricking sensation) - Sleepiness - Increased heart rate - Vomiting - Pain - Abnormal liver function tests >10% Oral hypoesthesia (29%) Asthenia (19%) Nausea (16%) 1-10% Decreased lung function (10%) Hypertension (5%) Abdominal pain (5%) Vomiting (4%) Arthralgia (4%) Dizziness (4%) Dry mouth (4%) Insomnia (4%) Pruritus (4%) Tachycardia (3%) Flatulence (3%) Increased cough (3%) Peripheral edema (3%) Urinary tract infection (3%) Circumoral paresthesia (2%) Somnolence (2%) Vertigo (2%) Eczema (2%)
    Pregnancy: Based on animal data, may cause fetal harmLactation: It is not known if riluzole is excreted in human milk. Riluzole 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 Riluzole is unknown.
    Precaution: Patient with history of liver diseases. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, drowsiness or vertigo, if affected, do not drive or operate machinery. Monitoring Parameters Monitor serum aminotransferase concentrations (e.g. ALT) before and during therapy; signs and symptoms of hepatic injury.
    Reported symptoms of overdose following ingestion of Riluzole 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 Riluzole overdose is available.
    Store at controlled room temperature, 20°C to 25°C, and protect from bright light.
    Neurodegenerative Disease Drugs / Neuromuscular Disorder Drugs
    Riluzole is a glutamate inhibitor used to slow disease progression and prolong survival rate in patients with amyotrophic lateral sclerosis. The exact mechanism of its action is not fully elucidated but is shown to inhibit the release of glutamate, inactivate voltage-dependent Na channels, and interfere with intracellular events following binding of transmitter at excitatory amino acid receptors.
    Pregnancy There are no studies in pregnant women, and case reports have been inadequate to inform of drug-associated risk Unknown if risk of major birth defects and miscarriage in patients with amyotrophic lateral sclerosis Animal data In studies in which riluzole was orally administered to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses Based on these results, advise women of possible risks to fetus associated with use of riluzole during pregnancy In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryo lethality Lactation Unknown if distributed in human breast milk
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