Movilax

Approved Indications:

• Bowel Cleansing Prior to Colonoscopy or Barium Enema X-ray:
  Indicated for colonic lavage to prepare the bowel before procedures requiring a clean colon (e.g., colonoscopy, sigmoidoscopy, or radiological exams).
• Constipation with Severe Fecal Impaction (Short-term Use):
  Occasionally used for treatment-resistant constipation or when rapid bowel evacuation is medically necessary.

Clinically Accepted Off-label Uses:

• Bowel Cleansing Before GI Surgery:
  Used prior to gastrointestinal surgeries, especially colorectal procedures, to minimize the risk of infection or contamination.
• Pediatric Bowel Preparation (Under Medical Supervision):
  Sometimes used in pediatric cases for bowel cleanout in severe constipation or Hirschsprung’s disease under physician guidance.

Adults:

• Standard Colonoscopy Prep (e.g., 4 L solution):
  Dissolve the powder in water to make 4 liters of solution. Administer 240 mL (8 oz) every 10–15 minutes until complete (usually over 3–4 hours), or until rectal effluent is clear.
• Split-Dose Regimen:
• First 2 liters in the evening before the procedure
• Remaining 2 liters 4–6 hours prior to procedure

Pediatrics (off-label):

• 6 months to <18 years (under supervision):
  Dose adjusted by weight. Common regimen:
• 25–40 mL/kg/hour (max 4 L) administered over 4–6 hours orally or via nasogastric tube

Elderly:

• Same as adults. Monitor for dehydration, electrolyte imbalance, or volume overload in frail individuals.

Special Populations:

• Renal Impairment:
  Use with caution; monitor fluid and electrolyte status closely.
• Hepatic Impairment:
  Generally safe due to minimal systemic absorption, but monitor if advanced liver disease with fluid overload risk.

Administration Route:

• Oral or via nasogastric tube
• Solution must be freshly prepared and consumed within 48 hours if refrigerated.

Polyethylene Glycol 3350 + Electrolytes functions as a non-absorbable osmotic agent. PEG 3350 holds water in the colon by creating an osmotic gradient, leading to increased stool water content and volume, resulting in softening and rapid colonic evacuation. The added electrolytes (sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) maintain isosmolarity, preventing significant fluid or electrolyte shifts. This combination ensures effective cleansing of the bowel without significant systemic absorption or dehydration, preserving electrolyte balance during high-volume lavage.

• Absorption:
  Polyethylene glycol and electrolytes are minimally absorbed from the GI tract.
• Distribution:
  Local effect in the colon; no significant systemic distribution.
• Metabolism:
  PEG 3350 is not metabolized by gut flora or hepatic enzymes. Electrolytes may undergo passive absorption but are generally excreted unchanged.
• Excretion:
  Majority excreted unchanged in the feces.
• Onset of Action:
  Initial bowel movement usually occurs within 1 to 2 hours of starting the solution. Complete evacuation typically achieved in 4 to 6 hours.
• Half-life / Bioavailability:
  Not systemically relevant.

• Pregnancy:
  No formal FDA pregnancy category. Available data suggest low risk during pregnancy, especially since PEG and electrolytes are not systemically absorbed in significant amounts.
• Lactation:
  Considered safe during breastfeeding. Systemic exposure is minimal; no detectable levels expected in breast milk.
• Recommendation:
  May be used under medical supervision during pregnancy or lactation, especially when bowel cleansing is necessary.

• Primary Class: Osmotic Bowel Evacuant
• Subclass: PEG-based Colonic Lavage Solution with Electrolytes

• Known hypersensitivity to polyethylene glycol or any electrolyte components
• Gastrointestinal obstruction or ileus
• Bowel perforation or suspected perforation
• Toxic megacolon or toxic colitis
• Gastric retention
• Severe dehydration or known electrolyte abnormalities

• Electrolyte Imbalance Risk:
  Though isosmotic, large volumes may still disturb fluid balance in vulnerable patients (e.g., elderly, renal impairment, heart failure).
• Seizure Risk:
  Rare cases of seizures associated with hyponatremia have been reported, especially in predisposed individuals.
• Cardiac Patients:
  Monitor for fluid overload in patients with CHF or arrhythmias.
• Dehydration Risk:
  Ensure adequate hydration before, during, and after administration.
• Nausea/Vomiting:
  Can occur if consumed too quickly; slow down intake if symptoms develop.
• Do Not Add Flavoring Agents Containing Sorbitol or Sugar Alcohols as these may alter osmolarity and cause additional GI effects.

Common (≥1%):

• Gastrointestinal:
• Nausea
• Abdominal bloating
• Cramping
• Flatulence
• Vomiting
• Others:
• Thirst
• Hunger
• Mild chills

Less Common:

• Diarrhea lasting >24 hours
• Headache
• Rectal irritation

Serious (Rare):

• Electrolyte disturbances:
  Hyponatremia, hypokalemia, metabolic acidosis
• Seizures (linked to hyponatremia)
• Anaphylaxis or hypersensitivity reactions
• Aspiration pneumonia (in patients with swallowing disorders)

• Oral Medications:
  Rapid bowel evacuation may reduce absorption of orally administered drugs. Avoid administration of other medications within 1 hour before and after PEG-electrolyte intake.
• Diuretics, ACE Inhibitors, or NSAIDs:
  May increase risk of fluid/electrolyte disturbances.
• Enzyme Systems:
  No known interaction with CYP450 enzymes. Not metabolized hepatically.
• Alcohol:
  Avoid alcohol, as it may worsen dehydration or gastrointestinal irritation.

• ACG 2023 Colonoscopy Guidelines:
  Split-dose PEG-electrolyte lavage regimen is preferred method for bowel prep due to better efficacy and patient tolerability.
• FDA Label Updates (2022–2023):
  Enhanced warnings on hyponatremia and seizure risk, especially in elderly or renally impaired individuals.
• European Society of Gastrointestinal Endoscopy (ESGE):
  Recommends low-volume PEG-electrolyte alternatives or adjuncts (e.g., bisacodyl) in poor prep candidates.

• Temperature:
  Store powder at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Humidity & Light:
  Keep in a dry, sealed container away from moisture and direct sunlight.
• Handling Instructions:
• Reconstituted solution must be used within 48 hours if refrigerated.
• Do not freeze.
• Shake well before each dose if refrigerated.
• Discard any unused solution after 48 hours.
• Reconstitution Requirements:
  Mix the full contents of the powder with 4 liters of water (not other fluids). Ensure complete dissolution before use.