Macrogol/ Sodium Sulphate/ Sodium Chloride/ Potassium Chloride/ Ascorbic Acid/ Sodium Ascorbate

Registered South African indications: 

• Bowel cleansing

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product 
• Gastrointestinal obstruction or perforation
• Disorders of gastric emptying
• Ileus
• Phenylketonuria 
• Glucose-6-phosphate dehydrogenase deficiency 
• Toxic megacolon
• Unconscious patients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Impaired gag reflex
• Tendency to aspiration or regurgitation
• Impaired consciousness
• Cardiovascular impairment (NYHA grade III or IV)
• Arrhythmias or risk factors thereof
• Thyroid disease
• Dehydration
• Severe acute inflammatory bowel disease
• Debilitated patients
• Cardiovascular risk factors 
• Risk factors for electrolyte disturbance
• Sodium controlled diet
• Potassium controlled diet

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

Bowel cleansing

Sachet A: Macrogol/ Sodium Sulphate/ Sodium Chloride/ Potassium Chloride
100/7.5/2.691/1.015 (g)
Sachet B: Sodium Ascorbate/ Ascorbic Acid
5.9/4.7 (g)

• Oral (sol): Sachet A and B dissolved together in 1L water, taken over 1-2hrs; THEN repeat

It is strongly recommended that one litre of clear liquid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk is also taken during the course of treatment

See additional prescribing points

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no data on the use of this preparation during pregnancy.  The preparation should only be used during pregnancy if considered essential

Breastfeeding

• Caution
• There are no data on the use of this preparation during breastfeeding. The preparation should only be used during breastfeeding if considered essential

Renal Impairment

• Caution; no dose adjustment recommended
• Fluid and electrolyte abnormalities may occur; Monitor closely

Hepatic Impairment

• Caution; no dose adjustment recommended 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Sleep disorder
• Seizures 
• Malaise

Cardiovascular Disorders

• Transient increase in blood pressure
• Arrhythmia
• Palpitations

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Abdominal distension
• Anal discomfort
• Dyspepsia
• Dysphagia
• Flatulance
• Retching

Hepatobiliary Disorders

• Abnormal hepatic function tests

Endocrine and Metabolic Disorders

• Electrolyte disturbances
• Dehydration
• Thirst
• Hunger

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Urticaria
• Pruritus
• Rash
• Erythema

Immune, Blood and Lymphatic System Disorders

• Allergic reaction 
• Anaphylactic reaction
• Pyrexia
• Rigors

Oral medication

• Electrolytes
• Serum glucose
• Renal function
• Urine osmolality

Specific cases may require

• Fluid balance
• ECG

Administration directions

• Either taken as 1L in the evening before and 1L in the early morning of the day of the clinical procedure
  OR
• 2L in the evening preceding the clinical procedure
• There should be at least 1hr between the end of intake of fluid and the start of the colonoscopy
• No solid food should be taken from the start of the course of treatment until after the clinical procedure

Macrogol, sodium sulphate and high doses of ascorbic acid exert an osmotic action in the gut, which induces a laxative effect. Macrogol increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is a propulsive colonic transportation of the softened stools. The electrolytes present in the formulation as well as the supplementary clear liquid intake ensure that there are no clinically significant variations of sodium, potassium or water, and thus no dehydration risk.

COMBINATION PREPARATIONS

Sachet A: Macrogol/ Sodium Sulphate/ Sodium Chloride/ Potassium Chloride
Sachet B: Sodium Ascorbate/ Ascorbic Acid

Powder (per sachet A) 100g/7.5g/2.691g/1.015g
Powder (per sachet B) 5.9g/4.7g

• Moviprep (Pharmacare Limited) originator