Laxolite

About

Polyethylene glycol 4000 is a medicine for treating disimpaction and maintenance therapy for children with constipation. It is Marketed by J.B. Chemicals & Pharmaceuticals Ltd.

Polyethylene glycol 4000 is a non-toxic, chemically inert and water soluble polymer. It is minimally absorbed in the gastro-intestinal tract. Water molecules in the intestinal tract are bound to the polymer by hydrogen bonds, thereby increasing the volume of the stool and softening its consistency, and, ultimately, relieving constipation. It makes bowel movement more comfortable due to water lubricating effect and rehydrating softened stools.

Indications of Polyethylene glycol 4000

Polyethylene glycol 4000 is indicated for the treatment of constipation (both disimpaction & maintenance therapy) in children.

For the treatment of constipation - 25ml daily, increasing to 50ml (max/day) if required.

Dosage and Method of Administration

• Dose for Paediatric (aged > 6 months)
• For disimpaction: 8gm per 20ml
• For maintenance therapy: 4gm per 10ml
• Dose for Paediatric (aged 1 to <4 years)
• For disimpaction: 8- 16 gm per 20-40ml
• For maintenance therapy: 4-8gm per 10-20ml
• Dose for Paediatric (aged 4 to <8 years)
• For disimpaction: 16-30 gm per 40-80ml
• For maintenance therapy: 8-16gm per 20-40ml
• Dose for Paediatric (>8 years)
• For disimpaction: 20-30 gm per 50-100ml
• For maintenance therapy: 10-20gm per 25-50ml
• Polyethylene glycol 4000 liquid is ready for use and requires no dilution.
• It can be mixed with any beverage like water, fruit juice, milk etc. & should be consumed immediately.
• The duration of therapy should not exceed 3 months.
• PEG 4000 preferably should be administered as a single dose in the morning or the dose can be split between morning and evening doses.

Contraindications

PEG 4000 is contraindicated in following cases those who have –

• Hypersensitivity to macrogol (polyethylene glycol) or any of the other ingredients
• Existing severe inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)
• Toxic megacolon; presence or risk of digestive perforation;
• Ileus or suspicion of symptomatic stenosis or intestinal obstruction;
• Painful abdominal conditions of unknown cause.

Warnings and Precautions

• PEG 4000 should be stopped immediately, if patients develops allergic reactions (e.g. anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema).
• Risk of diarrhoea during treatment is possible; hence physician should be consulted before initiating treatment, if the patient has impaired renal or hepatic function, is otherwise prone to electrolyte disturbances.

Drug Interactions

PEG 400 may possibly cause transient reductions in the absorption of other medicinal products, particularly those with a narrow therapeutic index or a short half-life (e.g. digoxin, antiepileptics, coumarins and immunosuppressive agents), leading to decreased efficacy of these products.

Undesirable Side effects/ Overdose

• PEG 4000 show adverse reactions which are only related to the gastrointestinal tract that occur most commonly.
• Common adverse events includes:
• Abdominal pain and diarrhea (≥ 1 to < 10% of children)
• Vomiting, abdominal distension and nausea (≥ 0.1 to < 1% of children).

Pharmacodynamic and Pharmacokinetic Properties

Polyethylene glycol 4000 is minimally absorbed from the GI tract. Studies have reported that PEG shows onset of action by 24-48 hours. It is biologically inert and is also not metabolized by the colonic bacteria.PEG is excreted in faeces (approx. 93%) from the body with elimination half-life of 4 – 6h.

Water molecules in the intestinal tract are bound to the polymer by hydrogen bonds, thereby increasing the volume of the stool and softening its consistency, and, ultimately, relieving constipation PEG makes bowel movement more comfortable due to water lubricating effect and rehydrating softened stools.

The use of PEG 4000 has been shown to have exert following pharmacological actions:

• Improves colonic transit and/or stool frequency
• Improves faecal consistency and increases stool water output,.
• Has little effect on intestinal microbial composition,
• It is free of clinically relevant electrolyte disturbances (i.e. very small or no loss of sodium, potassium and chloride in the stool).

Journal update

• Macrogol (polyethylene glycol) 4000 without electrolytes in the symptomatic treatment of chronic constipation: a profile of its use

• Lactulose versus polyethylene glycol for disimpaction therapy in constipated children, a randomized controlled study

• Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative

• Comparison of the effectiveness of polyethylene glycol 4000 without electrolytes and magnesium hydroxide in the treatment of chronic functional constipation in children