RUZURGI Tablet Ref.[11071] Active ingredients: Amifampridine

2.1 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

2.2 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.

2.3 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.

2.4 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)].

2.5 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)].

In case reports, events reported after intake of RUZURGI at doses of 300 mg per day or greater (more than three times the maximum recommended daily dosage) include vomiting, nystagmus, seizures and status epilepticus, rhabdomyolysis, chest pain, diaphoresis, palpitations, paroxysmal supraventricular tachycardia, transient QTc prolongation, aspiration with acute respiratory failure, and cardiac arrest.

Patients with suspected overdose with RUZURGI should be monitored for signs or symptoms of exaggerated RUZURGI adverse reactions or effects, and appropriate symptomatic treatment instituted immediately.

Prior to Dispensing: Store tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). Keep container tightly closed with desiccant canister inside after opening. Protect from moisture and light.

After Dispensing: Store tablets at 20°C to 25°C (68°F to 77°F) for up to 3 months; excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].