Macrogol
Regulatory sources consulted
- AEMPS-CIMA-FT-73081: https://cima.aemps.es/cima/dochtml/ft/73081/FT_73081.html
- ANSM-BDPM-RCP-66948867: https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=66948867&typedoc=R
- PubMed PMID:38391250 ↗
- PubMed PMID:39438126 ↗
- PubMed PMID:38137782 ↗
- AEMPS CIMA · nº registro 73081 ↗
- ANSM BDPM · CIS 66948867 ↗
Approved indications
- Symptomatic treatment of constipation in adults.
- Use as an oral contrast medium to optimize image quality in Small Intestine Contrast Ultrasonography (SICUS) for the diagnosis and monitoring of Crohn's Disease. · off-label
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease) and toxic megacolon.
- Gastrointestinal perforation or risk of perforation.
- Occlusive or subocclusive syndrome, symptomatic stenoses.
- Painful abdominal syndromes of indeterminate cause.
Clinical warnings
- In case of diarrhea, patients at risk of water-electrolyte imbalance (e.g., elderly, hepatic/renal impairment, diuretic use) should be monitored and electrolyte control considered. — ANSM
- Rare allergic-type manifestations and exceptional cases of anaphylactic shock have been reported, mainly with high doses of polyethylene glycol used in colonic exploration preparations. — ANSM
Drug interactions
- HighStarch-based thickenersV07A
Mechanism: Macrogol counteracts the thickening effect of starch, liquefying the mixture and increasing the risk of aspiration in patients with dysphagia.
Recommendation: Avoid co-administration in patients with dysphagia who require thickened liquids. Use alternative non-starch-based thickeners if necessary.
ANSM SPC
- LowOther oral medicationsN/A
Mechanism: The acceleration of intestinal transit may transiently reduce the absorption of other concomitantly administered oral drugs.
Recommendation: Administer other oral medications at least 2 hours before or after taking macrogol to minimize the potential interaction.
ANSM SPC
Adverse events
Common (≥1%)
diarrhea · liquid stools · abdominal pain · bloating
Rare but serious
allergic reactions (anaphylactic shock, angioedema, urticaria, rash) · dehydration · electrolyte disturbances (hyponatremia, hypokalemia)
Pregnancy and lactation
FDA category: Not Assigned
Due to negligible systemic absorption, the use of macrogol can be considered during pregnancy and lactation if clinically necessary. Animal studies have not shown teratogenic effects and a randomized clinical trial supports its use in pregnancy.
Recent literature (PubMed)
Ensayo clínico aleatorizado que compara polietilenglicol (PEG) 4000 con lactulosa para el estreñimiento crónico en el embarazo. Ambas opciones fueron efectivas, pero el PEG se asoció con una frecuencia significativamente menor de efectos secundarios como diarrea y heces blandas.
Estudio que utilizó un desafío oral con macrogol para evaluar el tránsito intestinal mediante RMN. Se encontró que un colon anormalmente grande es una característica importante en el estreñimiento, prediciendo una respuesta alterada a la alimentación y al tratamiento. El macrogol se usó como herramienta diagnóstica/de provocación.
Revisión sistemática y metaanálisis que evalúa el rendimiento diagnóstico de la Ultrasonografía con Contraste del Intestino Delgado (SICUS), donde se utiliza una solución de macrogol como medio de contraste oral. La técnica demostró una excelente sensibilidad (95%) y especificidad (77%) para el diagnóstico de la enfermedad de Crohn.