Usual Adult Dose for Lambert-Eaton Myasthenic Syndrome

• Initial dose: 15 mg to 30 mg orally once a day in divided doses (3 to 4 times daily)
• Maximum single dose: 20 mg
• Maximum daily dose: 80 mg/day

• Dose may be increased by 5 mg daily every 3 or 4 days.
• If a dose is missed, patients should not take double or extra doses.

Usual Pediatric Dose for Lambert-Eaton Myasthenic Syndrome

6 years to less than 17 years weighing less than 45 kg:

• Initial dose: 7.5 mg to 15 mg orally once a day in divided doses (2 to 3 times daily)
• Maximum single dose: 15 mg
• Maximum daily dose: 50 mg

• Dose may be increased daily in 2.5 mg to 5 mg increments, divided in up to 5 doses daily.
• Dosage should be increased based on clinical response and tolerability.
• A suspension can be prepared when patients require a dosage in less than 5 mg increments.

• Initial dose: 15 mg to 30 mg daily in divided doses (2 to 3 times daily)
• Maximum single dose: 30 m
• Maximum daily dose: 100 mg

• Dose may be increased daily in 5 mg to 10 mg increments, divided in up to 5 doses daily.
• Dosage should be increased based on clinical response and tolerability.

Renal Dose Adjustments

Adults:
Mild (CrCl 60 to less than 90 mL/min), moderate (CrCl 30 to less than 60 mL/min), or severe (CrCl 15 to less than 30 mL/min) renal impairment: The recommended starting dose is 15 mg orally once a day in 3 divided doses
End-stage (CrCl less than 15 mL/min) renal disease: Data not available

Pediatric patients weighing less than 45 kg:
Renal impairment: 7.5 mg orally once a day in divided doses
End-stage (CrCl less than 15 mL/min) renal disease: Data not available

Pediatric patients weighing 45 kg or more:
Renal impairment (creatinine clearance 15 to 90 mL/min): 15 mg orally once a day in divided doses
End-stage (CrCl less than 15 mL/min) renal disease: Data not available

Liver Dose Adjustments

Adults patients with any degree of hepatic impairment: 15 mg orally once a day in 3 divided doses

Pediatric patients weighing less than 45 kg with any degree of hepatic impairment: 7.5 mg orally once a day in divided doses

Pediatric patients weighing 45 kg or more with any degree of hepatic impairment: 15 mg orally once a day in divided doses

Dose Adjustments

Known N-acetyltransferase 2 (NAT2) Poor Metabolizers:
Adults:

• Initial dose is 15 mg orally once a day in 3 divided doses

• Weighing less than 45 kg: 7.5 mg orally once a day in divided doses
• Weighing 45 kg or more: 15 mg orally once a day in divided doses

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• History of seizures

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken with or without food.
• The tablets may be divided in half at the score, if needed.
• Do not take a double dose to make up for a missed dose.
• Refer patients and/or caregivers to the Instructions for Use if they require a dosage in less than 5 mg increments, have difficulty swallowing tablets, or require feeding tubes.
• The prepared 1 mg/mL suspension should be prepared daily and refrigerated between doses.

• Store tablets at 20C to 25C with excursions permitted from 15C to 30C (59F to 86F).
• The suspension can be stored under refrigeration for up to 24 hours, discard any unused portion after 24 hours.

• Read the patient information leaflet before taking this drug.
• Seek medical help immediately if you experience hypersensitivity or seizures.

Frequently asked questions

• What is the difference between Ruzurgi and Firdapse?
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