Ruzurgi Dosage
Generic name: Amifampridine 10mg
Dosage form: tablet
Drug class: Cholinergic muscle stimulants
Medically reviewed by Drugs.com. Last updated on Sep 27, 2024.
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.
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*see Dosage and Administration (2.2) for method to achieve these doses |
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| 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. 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.
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.
Frequently asked questions
- What is the difference between Ruzurgi and Firdapse?
- What is Firdapse (amifampridine) used to treat?
More about Ruzurgi (amifampridine)
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- During pregnancy
- FDA approval history
- Drug class: cholinergic muscle stimulants
- Breastfeeding
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Further information
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