Aqualax

Approved Indications:

• Occasional Constipation (Adults and Children ≥17 years):
  Indicated for the treatment of occasional constipation. Produces a bowel movement typically within 1 to 3 days.
• Chronic Idiopathic Constipation (CIC) in Adults:
  FDA-approved in some formulations for use in adults with chronic constipation not caused by structural or metabolic conditions.
• Bowel Preparation (as part of PEG-electrolyte solution combinations):
  Used in combination formulations (e.g., PEG 3350 with electrolytes) for colon cleansing prior to colonoscopy or barium enema.

Clinically Accepted Off-label Uses:

• Pediatric Functional Constipation:
  Widely used in children under physician supervision for functional or chronic constipation due to favorable safety profile.
• Fecal Impaction in Elderly and Neurologically Impaired Patients:
  Used as a first-line osmotic laxative in geriatrics and in patients with neurogenic bowel dysfunction.

Adults (≥17 years):

• Dose for Occasional Constipation:
  Dissolve 17 grams (1 heaping tablespoon) of powder in 120–240 mL of water, juice, soda, coffee, or tea and drink once daily.
• Dose for Chronic Idiopathic Constipation:
  Same as above; use daily for up to 7 days, or as prescribed.

Pediatrics:

• Children ≥6 months to <17 years:
  Not FDA-approved for this age group but widely used off-label. Dosage based on weight:
• 0.4–0.8 g/kg/day, not to exceed 17 g/day unless directed by a physician.
• For fecal disimpaction: 1–1.5 g/kg/day in divided doses.

Elderly:

• No dose adjustment required. Monitor for electrolyte imbalance if used long-term.

Renal or Hepatic Impairment:

• No dose adjustment necessary. Minimal systemic absorption.

Administration Notes:

• Do not mix with hot liquids.
• Avoid use for more than 7 consecutive days without medical supervision.

Polyethylene Glycol 3350 is an osmotic laxative that works by retaining water in the stool through hydrogen bonding. This increases the water content and volume of the stool, making it softer and easier to pass. PEG 3350 is a large, inert molecule that is not absorbed systemically and acts locally in the colon. The resulting increase in osmotic pressure leads to enhanced peristalsis and bowel evacuation. Its lack of significant fermentation reduces gas production compared to other laxatives.

• Absorption:
  Negligible systemic absorption. Acts locally in the colon.
• Distribution:
  Not distributed systemically due to poor GI absorption.
• Metabolism:
  Not metabolized by intestinal flora or the liver.
• Excretion:
  Excreted unchanged in the feces.
• Onset of Action:
  Typically within 24 to 72 hours after first dose.
• Bioavailability:
  Not applicable due to minimal systemic absorption.
• Half-Life:
  Not systemically relevant.

• Pregnancy:
  No formal FDA category under current guidelines. PEG 3350 is considered safe in pregnancy due to lack of systemic absorption. No known teratogenic effects reported.
• Lactation:
  Considered safe during breastfeeding. Not excreted in breast milk due to lack of absorption.
• Recommendation:
  Can be used during pregnancy and lactation under medical supervision if clinically indicated.

• Primary Class: Osmotic Laxative
• Subclass: Polyethylene Glycol–based, Non-absorbed Bowel Evacuant

• Known hypersensitivity to polyethylene glycol or any component of the formulation
• Bowel obstruction or known/suspected intestinal perforation
• Ileus or toxic megacolon
• Severe inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease) in acute flare
• Patients with renal failure when used in large-volume PEG-electrolyte solutions without medical supervision

• Electrolyte Imbalance (Rare):
  While PEG 3350 does not usually alter electrolytes, prolonged or high-dose use may lead to dehydration or electrolyte abnormalities.
• Abdominal Symptoms:
  Use with caution in patients with persistent abdominal pain, nausea, or vomiting without medical evaluation.
• Pediatric Use:
  Though used off-label, long-term use in children should be monitored for nutritional and fluid/electrolyte balance.
• Allergic Reactions:
  Rare cases of urticaria, angioedema, and anaphylaxis reported.
• Chronic Use:
  Should not be used continuously for more than 7 days unless under medical supervision.

Common:

• Gastrointestinal:
• Bloating
• Abdominal cramping
• Flatulence
• Nausea
• Diarrhea

Less Common:

• Loose stools
• Excessive bowel movement
• Perianal irritation (from diarrhea)

Rare/Serious:

• Allergic reactions:
  Urticaria, rash, pruritus, or rarely, anaphylaxis
• Electrolyte disturbances:
  Hyponatremia or hypokalemia (especially in excessive use)
• Dehydration:
  If used in high doses without adequate fluid intake

• Minimal systemic interaction potential due to negligible absorption.
• Oral Medications:
  May delay absorption of concurrently administered oral drugs if taken at the same time. Recommend 1–2 hour spacing.
• Diuretics or NSAIDs (with PEG-electrolyte combinations):
  Monitor electrolytes closely when used concurrently, especially in high-risk patients.
• No known involvement of CYP450 enzyme system.

• 2023 ACG Guidelines on Constipation Management:
  PEG 3350 remains a first-line treatment for both occasional and chronic constipation due to its efficacy and safety.
• Pediatric Gastroenterology Consensus (2024):
  Supports off-label use of PEG 3350 in children, especially for functional constipation and disimpaction, with monitoring of fluid status.
• EMA and FDA Advisories (2022–2023):
  Reaffirmed safety profile and low risk of systemic toxicity. Added emphasis on short-term use without supervision.

• Temperature Range:
  Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C.
• Humidity and Light:
  Store in a dry place, tightly closed, away from moisture and direct sunlight.
• Handling Instructions:
• Keep container tightly sealed.
• Use within the expiration date on the label.
• Do not refrigerate or freeze the powder.
• Reconstitution:
  Reconstitute freshly before use each day. Discard any unused portion after 24 hours.