Macrogol/ Sodium Chloride/ Sodium Bicarbonate/ Potassium Chloride

Registered South African indications:

• Constipation
• Faecal impaction

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Intestinal perforation
• Obstruction due to 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, ulcerative colitis and toxic megacolon
• Not recommended for children below 2 years of age

Cautions

• Pregnancy
• Renal impairment
• Hepatic impairment
• Elderly
• Impaired cardiovascular function

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

Chronic constipation

Macrogol/ Sodium Chloride/ Sodium Bicarbonate/ Potassium Chloride
6.563g/175.4/89.3/25.1 (mg)

• Oral (pdr): 2-6 sachets, dly in divided doses

Faecal impaction

Macrogol/ Sodium Chloride/ Sodium Bicarbonate/ Potassium Chloride
6.563g/175.4/89.3/25.1 (mg)

• Oral (pdr): 16 sachets, dly; Treatment duration: 3 days

Sachets should be consumed within a 6 hour period

Stop treatment once disimpaction (the passage of a large volume of stools) has occurred 

Paed. forms avail. in SA and covered in this monograph: pdr

Chronic constipation

Macrogol/ Sodium Chloride/ Sodium Bicarbonate/ Potassium Chloride
6.563g/175.4/89.3/25.1 (mg)

• Younger than 2 years: Not established for use
• Between 2-6 years: 1 sachet, dly
• Between 7-11 years: 2 sachets, dly
• Older than 12 years: See adult dosage

Dose can be adjusted according to individual response, but should not exceed 4 sachets a day

Faecal impaction

Macrogol/ Sodium Chloride/ Sodium Bicarbonate/ Potassium Chloride
6.563g/175.4/89.3/25.1 (mg)

Sachets should be consumed within a 12 hour period

Stop treatment once disimpaction (the passage of a large volume of stools) has occurred

Pregnancy

• Caution; no evidence of risk in studies
• There are limited amounts of data from the use of macrogol/ sodium chloride/ sodium bicarbonate/ potassium chloride in pregnant women. Studies in animals have shown no indirect reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. Within the context of animal trials, no teratogenic effects were observed. Furthermore, as macrogol 3350 is barely absorbed, macrogol/ sodium chloride/ sodium bicarbonate/ potassium chloride may be administered to pregnant women after careful risk-benefit assessment

Breastfeeding

• Compatible
• No human data are available on whether macrogol 3350 is excreted in human milk. Macrogol 3350 is barely absorbed. Macrogol/ sodium chloride/ sodium bicarbonate/ potassium chloride can be taken by breastfeeding women if deemed necessary

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

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

Endocrine and Metabolic Disorders

• Hyperkalaemia
• Hypokalaemia

Skin and Subcutaneous Tissue Disorders

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

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylactic reactions

Anti-epileptics

None routine

Macrogol
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 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.

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

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 carbohydrate and storage of energy reserves.

COMBINATION PREPARATIONS

Macrogol/ Sodium chloride/ Sodium bicarbonate/ Potassium chloride

Sachet 6.563g/175.4mg/89.3mg/25.1mg

• Pegicol Plain (Pharmacare) originator

Sachet 6.563g/175.4mg/89.3mg/23.3mg

• Purgoped (Anmarate)