Polyethylene Glycol/ Sodium Bicarbonate/ Sodium Chloride/ Potassium Chloride

Registered South African indications:

• Chronic constipation

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Intestinal perforation or obstruction due to a structural or functional disorder of the gut wall
• Ileus
• Gastric retention
• Peptic ulceration
• Severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis 
• Toxic megacolon
• Patients under 12 years of age

South African recommendations

Fluid and dietary considerations

• The fluid content when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained
• The product should not be used continuously unless directed by a doctor
• Frequent or prolonged use of laxatives may result in dependence and loss of normal bowel function

Symptoms and medical conditions

• Should not be used in the presence of abdominal pain, nausea or vomiting
• If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure), treatment should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately
• If there is a sudden change in bowel habits that has persisted for a period greater than 2 weeks, a medical practitioner should be consulted
• Treatment should be discontinued and medical advice obtained if rectal bleeding occurs or if there is a failure to have a bowel movement after treatment, as these may indicate a serious condition

Drug interactions and absorption

• The absorption of other medicines could transiently be reduced due to a decrease in gastrointestinal transit rate
• Adverse drug reactions are possible. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure), treatment should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately

Gastrointestinal reactions

• Reactions related to the gastrointestinal tract occur most commonly. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of this product. Diarrhoea usually responds to dose reduction

Sodium content

• Contains 8,125 mmol sodium per dose, equivalent to 9.3% of the WHO recommended maximum daily intake for sodium
• The maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium
• This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet

Effects on ability to drive and use machines

• This product has no influence on the ability to drive and use machines. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that this product does not adversely affect their ability to do so safely

Forms avail. in SA and covered in this monograph: pdr

Chronic constipation

Polyethylene glycol/ Sodium bicarbonate/ Sodium chloride/ Potassium chloride
13.125g/178.5mg/350.7mg/46.6mg (per sachet)

• Oral (pdr): 1-3 sachets/day, in divided doses; Treatment duration: Does not normally exceed 2 weeks

Extended use in severe chronic or resistant constipation
- Secondary to multiple sclerosis or Parkinson’s disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics

Polyethylene glycol/ Sodium bicarbonate/ Sodium chloride/ Potassium chloride
13.125g/178.5mg/350.7mg/46.6mg (per sachet)

• Oral (pdr): 1-2 sachets/day, in divided doses

Extended use may be necessary in the care of patients with severe chronic or resistant constipation

Reconstitute with 125ml water

Course may be repeated if necessary

Not established for use in children below 12 years (see contraindications)

Pregnancy

• Safe
• There are limited amount of data from the use of this agent in pregnant women. Studies in animals have shown indirect reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to polyethylene glycol is negligible. This combination agent can be used during pregnancy

Breastfeeding

• Compatible
• No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to polyethylene glycol is negligible. This combination agent can be used during pregnancy

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting
• Dyspepsia
• Abdominal distension
• Borborygmi
• Flatulence 
• Anorectal discomfort

Endocrine and Metabolic Disorders

• Hyperkalaemia 
• Hypokalaemia

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions
• Angioedema
• Urticaria
• Pruritus
• Rash
• Erythema
• Peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylactic reactions

• Antiepileptics

None routine

Polyethylene glycol
Macrogol or polyethylene glycol acts as an osmotic agent that draws water into the bowel lumen. This causes water retention in the stool and subsequent increase in stool frequency 

Sodium bicarbonate
Sodium bicarbonate has antacid properties and neutralises gastric acid with the production of carbon dioxide

Sodium chloride
Sodium chloride is the principle salt involved in maintaining the osmotic tension in blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissues

Potassium chloride
Potassium is the principle cation of intracellular fluid. Potassium ions are involved in numerous cellular metabolic processes, including intracellular tonicity, transmission of nerve impulses, contraction of cardiac, smooth, and skeletal muscles and renal function. It is also involved in synthesis of protein, metabolism of carbohydrates and storage of energy reserves 

Polyethylene glycol, Sodium bicarbonate, Sodium chloride and Potassium chloride is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

COMBINATION PREPARATIONS

Polyethylene glycol/ Sodium bicarbonate/ Sodium Chloride/ Potassium Chloride

Powder (per sachet) 13.125g/ 178.5mg/ 350.7mg/ 46.6mg

• Movicol ( Pharmacare Limited)
• Purgolene (Cipla)