Rilukem Tablets / Film-coated
Riluzole
50mg
Alkem Laboratories Limited
| Pack size | 56's (14's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | INDIA |
| Agent | AL MANARAH MEDICINE STORE L.L.C. |
| Retail Price | 104.50 AED |
Indications
Rilukem Tablets / Film-coated is used for:
Amyotrophic lateral sclerosis
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)
Child Dose
Renal Dose
Administration
Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before or 2 hr after meals.
Contra Indications
Hepatic impairment (baseline transaminases >3 times the upper limit of normal).
Precautions
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.
Pregnancy-Lactation
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
Interactions
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).
Adverse Effects
Side effects of Riluzole :
>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%)
Mechanism of Action
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.
Note
Rilukem 50mg Tablets / Film-coated manufactured by Alkem Laboratories Limited. Its generic name is Riluzole. Rilukem is availble in United Arab Emirates.
Farmaco UAE drug index information on Rilukem Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.