NULYTELY-FLAVORED
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NULYTELY-FLAVORED (NULYTELY-FLAVORED).
NULYTELY-FLAVORED is an osmotic laxative containing polyethylene glycol (PEG) 3350 and electrolytes. It induces diarrhea by retaining water in the colon through osmotic action, thereby cleansing the bowel.
| Metabolism | Polyethylene glycol 3350 is not metabolized; it is excreted unchanged in feces. |
| Excretion | Primarily fecal elimination as unabsorbed PEG 3350; minimal systemic absorption (<0.06%). Renal excretion of absorbed fraction is negligible. |
| Half-life | Not applicable; PEG 3350 is not significantly absorbed and does not exhibit a terminal elimination half-life in the systemic circulation. Clinical effect is due to local osmotic action in the gut. |
| Protein binding | Not applicable; PEG 3350 is not absorbed and does not bind to plasma proteins. |
| Volume of Distribution | Not applicable; PEG 3350 is not systemically distributed. Vd is essentially the gastrointestinal tract volume (approx. 0.5-1 L in adults). |
| Bioavailability | Oral: <0.06% (negligible systemic absorption due to high molecular weight and hydrophilicity). |
| Onset of Action | Oral: 1-2 hours (first bowel movement). |
| Duration of Action | Oral: Duration of bowel cleansing effect lasts approximately 4-6 hours after the last dose; complete evacuation typically occurs within 6 hours. |
Adult dose: 4 liters of reconstituted solution orally as a single dose, or 240 mL (8 oz) every 10 minutes until 4 liters are consumed, approximately 1-1.5 hours before colonoscopy.
| Dosage form | FOR SOLUTION |
| Renal impairment | No specific dose adjustment provided; use caution in patients with severe renal impairment (GFR <30 mL/min) due to potential fluid and electrolyte abnormalities. |
| Liver impairment | No specific dose adjustment provided; use caution in patients with severe hepatic impairment (Child-Pugh class C) due to potential fluid and electrolyte disturbances. |
| Pediatric use | Not approved for use in pediatric patients (safety and efficacy not established). |
| Geriatric use | No specific dose adjustment; monitor for dehydration and electrolyte imbalances, especially in elderly patients with comorbidities or concurrent medications affecting renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NULYTELY-FLAVORED (NULYTELY-FLAVORED).
| Breastfeeding | PEG is not absorbed systemically, thus expected to be excreted in breast milk in negligible amounts. M/P ratio not determined. Considered compatible with breastfeeding. |
| Teratogenic Risk | No known teratogenic risk. Polyethylene glycol (PEG) and electrolytes are not associated with fetal malformations when used as a bowel preparation agent. Safety data in pregnancy are limited; use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
Risk of serious fluid and electrolyte disturbances, including seizures and arrhythmias, especially in patients with renal impairment or those taking medications that affect electrolyte balance.
| Serious Effects |
["Gastrointestinal obstruction","Gastric retention","Bowel perforation","Toxic colitis or megacolon","Known hypersensitivity to any component"]
| Precautions | ["Fluid and electrolyte imbalances (monitor electrolytes)","Sensitivity reactions (anaphylaxis, urticaria)","Mucosal ulcerations (if retained in colon)","Risk of aspiration (in patients with impaired gag reflex)"] |
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| Monitor for electrolyte imbalances, dehydration, and acid-base disturbances in pregnant patients. Fetal heart rate monitoring may be considered in late pregnancy due to potential for maternal hypotension or electrolyte shifts. |
| Fertility Effects | No known effect on fertility. However, severe dehydration or electrolyte disturbances from use could theoretically impact ovulation or implantation. |