Ruzurgi Dosage

Generic name: Amifampridine 10mg
Dosage form: tablet
Drug class: Cholinergic muscle stimulants

Medically reviewed by Drugs.com. Last updated on Sep 27, 2023.

Recommended Dosage

The recommended oral dosage for pediatric patients 6 to less than 17 years of age is dependent on body weight and is included in Table 1. Dosage should be increased based on clinical response and tolerability.

If a dose is missed, patients should not take double or extra doses.

Table 1: Recommended Dosage for Pediatric Patients 6 to Less Than 17 Years of Age
*see Dosage and Administration (2.2) for method to achieve these doses
Age and Body Weight	Initial Dosage	Titration Regimen	Maximum Single Dose	Maximum Total Daily Maintenance Dosage
Pediatric patients 6 to less than 17 years of age weighing 45 kg or more	15 mg to 30 mg daily, in divided doses (2 to 3 times per day)	Increase daily in 5 mg to 10 mg increments, divided in up to 5 doses per day	30 mg	100 mg
Pediatric patients 6 to less than 17 years of age weighing less than 45 kg	7.5 mg* to 15 mg daily, in divided doses (2 to 3 times per day)	Increase daily in 2.5 mg* to 5 mg increments, divided in up to 5 doses per day	15 mg	50 mg

Administration Instructions

RUZURGI can be taken without regard to food.

Preparation of 1 mg/mL Suspension

When patients require a dosage in less than 5 mg increments, have difficulty swallowing tablets, or require feeding tubes, a 1 mg/mL suspension can be prepared (e.g., by placing three 10 mg tablets in a 30 mL container, adding 30 mL of sterile water, and shaking well for 30 seconds).

Crushing the tablets prior to making the suspension is not necessary. After preparation of the suspension, an oral syringe can be used to draw up and administer the correct dose by mouth or by feeding tube. Refrigerate the suspension between doses and shake well before drawing up each dose. The suspension can be stored under refrigeration for up to 24 hours. Discard any unused portion of the suspension after 24 hours.

Patients with Renal Impairment

The recommended starting dosage of RUZURGI in pediatric patients weighing 45 kg or more with renal impairment (creatinine clearance 15 to 90 mL/min) is 15 mg daily taken orally in divided doses. The recommended starting dosage for pediatric patients weighing less than 45 kg with renal impairment is 7.5 mg daily taken orally in divided doses [see Dosage and Administration (2.1) and Use in Specific Populations (8.6)]. No dosage recommendations for RUZURGI can be made for patients with end-stage renal disease.

Patients with Hepatic Impairment

The recommended starting dosage of RUZURGI in pediatric patients weighing 45 kg or more with any degree of hepatic impairment is 15 mg daily taken orally in divided doses. The recommended starting dosage for pediatric patients weighing less than 45 kg with any degree of hepatic impairment is 7.5 mg daily taken orally in divided doses [see Dosage and Administration (2.1) and Use in Specific Populations (8.7)].

Known N-acetyltransferase 2 (NAT2) Poor Metabolizers

The recommended starting dosage of RUZURGI in pediatric patients weighing 45 kg or more who are known N-acetyltransferase 2 (NAT2) poor metabolizers is 15 mg daily taken orally in divided doses. The recommended starting dosage in pediatric patients weighing less than 45 kg who are known NAT2 poor metabolizers is 7.5 mg daily taken orally in divided doses [see Dosage and Administration (2.1), Use in Specific Populations (8.8), and Clinical Pharmacology (12.5)].