Drug Class: Miscellaneous central nervous system agents
Usual Adult Dose for Amyotrophic Lateral Sclerosis
Initial dose: 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) orally once daily for three weeks
Maintenance dose: 1 packet (3 g sodium phenylbutyrate and 1 g taurursodiol) orally twice daily
Comment: Maintenance dose should be initiated after first 3 weeks of initial dose.
Use: Amyotrophic lateral sclerosis
Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate to severe renal impairment: Avoid use
Liver Dose Adjustments
Mild liver impairment: No adjustment recommended
Moderate to severe liver impairment: Avoid use
Dose Adjustments
No data available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Empty the contents of one packet in a cup containing 8 ounces of room temperature water and stir vigorously.
- This drug can be taken orally or administered via feeding tube, within 1 hour of preparation.
- Administer this drug before a snack or meal.
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Protect from moisture.
- The reconstituted suspension may be stored for up to 1 hour at room temperature.
General:
- Carcinogenic potential of this drug has not been studied.
- This combination reported negative invitro and invivo mutagenesis assays.
Patient advice:
- Patients should read the FDA-approved patient labeling (Patient Information).
- Inform patients about the risks and benefits with the use of this drug if they have preexisting medical conditions such as enterohepatic circulation, pancreatic, or intestinal disorders.
- Notify health care provider if patients have new or worsening diarrhea.
- Inform patients about the sodium content of this combination (two packets contain 928 mg sodium; 46% of WHO daily recommended amount) and advise them to limit their sodium intake if they are sensitive to sodium (e.g., those with congestive heart failure, severe renal insufficiency, or other conditions associated with sodium retention).
- Aluminum-based antacids may hamper absorption of this drug, and therefore should not be taken during the treatment with this drug combination.
- Patients should notify their health care provider if they become pregnant or intend to become pregnant during the therapy.
- Patients should notify their health care provider if they intend to breastfeed or are breastfeeding an infant.
