Macrogol 3350 and 4000


Generic Medicine Info
Indications and Dosage
Oral
Constipation
Adult: As macrogol 4000 powder for oral solution: 10-20 g once daily, preferably in the morning. Dose may be adjusted from 10 g every other day up to 20 g once daily according to response. As macrogol 3350 powder for oral solution: 17 g once daily for up to 1 week. Dosage and treatment duration recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: As macrogol 4000 powder for oral solution: ≥8 years Same as adult dose. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Reconstitution
As macrogol 4000 powder for oral solution: Dissolve 10 g in approx 50 mL of water. As macrogol 3350 powder for oral solution: Dissolve 17 g in 120-240 mL of water or other beverage (e.g. juice, soda, coffee, tea). Mix well and administer immediately. Recommendations for reconstitution may vary among individual products and between countries (refer to specific product or local guidelines).
Contraindications
Hypersensitivity. Severe inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), ileus, known or suspected intestinal obstruction, symptomatic stenosis, toxic megacolon, intestinal perforation or risk of intestinal perforation, abdominal pain of unknown cause.
Special Precautions
Patient with impaired gag reflex and those prone to regurgitation or aspiration. Patients who are at increased risk of water-electrolyte balance disturbances (e.g. taking diuretics). Avoid mixing with starch-based thickeners (to enhance appropriate intake) in patients with dysphagia. Prolonged use is not recommended. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions, including rash, urticaria, angioedema, and anaphylactic shock (rare); electrolyte imbalance (e.g. hyponatraemia, hypokalaemia) and/or dehydration, especially in elderly patients.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, flatulence, bloating, abdominal pain or distension, defaecation urgency, faecal incontinence.
Skin and subcutaneous tissue disorders: Pruritus, erythema.
Patient Counseling Information
Ensure adequate hydration during treatment.
Monitoring Parameters
Rule out an organic disorder and evaluate for symptoms of bowel obstruction before treatment initiation. Assess for signs of hypersensitivity reaction, fluid/electrolyte changes, and severe diarrhoea or abdominal pain.
Overdosage
Symptoms: Diarrhoea, vomiting, abdominal pain. In severe diarrhoea, electrolyte imbalance and weight loss may occur. Management: Correct electrolyte disturbances in case of excessive fluid loss caused by diarrhoea or vomiting.
Drug Interactions
May transiently decrease the absorption of digoxin, anti-epileptics, coumarins, and immunosuppressants which may lead to reduced efficacy.
Food Interaction
May counteract the thickening effect of starch in starch-based food thickeners, resulting in a thin watery liquid that when swallowed by patients with dysphagia increases the risk of aspiration.
Action
Description:
Mechanism of Action: Macrogols are stable and non-toxic compounds that have a range of properties based on their molecular weight. High molecular weight macrogols, such as macrogol 3350 and macrogol 4000, are long linear polymers with osmotic activity. They retain water in the stool through hydrogen bonding, leading to an increased volume of intestinal fluids and consequent laxative effect and improved stool frequency.
Synonym(s): Macrogol 3350: Polyethylene glycol 3350. Macrogol 4000: Polyethylene glycol 4000.
Onset: 24-48 hours.
Pharmacokinetics:
Absorption: Minimally absorbed.
Excretion: Macrogol 3350: Mainly via faeces (93%); urine (0.2%).
Storage
Store between 15-30°C.
MIMS Class
Laxatives, Purgatives
ATC Classification
A06AD15 - macrogol ; Belongs to the class of osmotically acting laxatives.
References
Anon. Hyperosmotic Laxatives. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/09/2023.

Anon. Polyethylene Glycol 3350. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/09/2023.

Anon. Polyethylene Glycol 4000. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/09/2023.

Buckingham R (ed). Macrogols. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/09/2023.

Dulcobalance 10 g, Powder for Oral Solution in Sachet (IPSEN Consumer HealthCare). MHRA. https://products.mhra.gov.uk. Accessed 13/09/2023.

Forlax 10 g Powder for Oral Solution (EP Plus Group Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/09/2023.

Joint Formulary Committee. Macrogol 3350. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/09/2023.

MiraLAX Powder, for Solution (Bayer HealthCare LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 24/01/2024.

Surelax (Amherst Laboratories, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 24/01/2024.

Transisoft 8.5 g Powder for Oral Solution in Sachet (Laboratoires MAYOLY SPINDLER). MHRA. https://products.mhra.gov.uk. Accessed 24/01/2024.

Disclaimer: This information is independently developed by MIMS based on Macrogol 3350 and 4000 from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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