Europe — EMA
Glycerine Enfants Fagron (Glycerol)
Glycerine Enfants Fagron is a glycerol‑based rectal vehicle for pediatric formulations, providing lubrication and hygroscopic support for safe drug delivery.
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What is Glycerol?
Glycerine Enfants Fagron contains glycerol as the active ingredient and is supplied as a rectal vehicle for pediatric formulations. It is an over‑the‑counter excipient marketed in the European Union. The product is formulated to provide a hygroscopic, lubricating medium that facilitates rectal administration of medicines for children. It does not contain a defined drug strength. It is supplied in a sterile container for single‑use or multiple‑use under pharmacy conditions.
What is Glycerol used for?
Glycerine Enfants Fagron is used as a vehicle to aid the rectal delivery of medicinal preparations intended for children.
- Provides a hygroscopic base that helps dissolve or suspend active ingredients for rectal suppositories. - Enhances lubrication of the rectal mucosa, facilitating comfortable insertion of dosage forms. - Serves as a compatible solvent for a variety of pediatric drugs, including antipyretics, analgesics and antispasmodics. - Allows compounding pharmacists to adjust viscosity for specific formulation requirements. - Supports stability of moisture‑sensitive compounds by maintaining a controlled water activity environment.
What are the side effects of Glycerol?
Side‑effect information for Glycerine Enfants Fagron reflects observations made with glycerol used as a rectal excipient; most reactions are mild and related to local irritation.
Common: - Mild local irritation or erythema at the application site, usually resolving without treatment. - Transient sensation of warmth, tingling, or mild burning in the rectal area that subsides within minutes. - Slight increase in stool softness or frequency, reflecting the osmotic effect of glycerol.
Serious: - Allergic contact dermatitis presenting as rash, itching, swelling, or vesicle formation that may require medical evaluation. - Persistent rectal bleeding not attributable to the underlying medication, indicating possible mucosal injury. - Severe abdominal cramping or pain unresponsive to standard measures, which should be assessed by a healthcare professional.
What precautions apply to Glycerol?
When using Glycerine Enfants Fagron as a rectal vehicle for pediatric formulations, several precautionary measures should be observed to ensure safety and efficacy.
- Verify that the product is within its expiration date and stored according to the manufacturer’s instructions. - Use only with formulations specifically prepared for rectal administration in children. - Ensure the rectal dosage form is appropriate for the child’s age and weight, following pharmacy compounding guidelines. - Monitor the child for signs of local irritation or allergic reaction after each administration. - Avoid use in children with known hypersensitivity to glycerol or related compounds.
What does Glycerol interact with?
Glycerine Enfants Fagron may interact with other rectally administered agents or systemic medications; awareness of potential interactions helps prevent reduced efficacy or adverse effects.
Avoid: - Co‑administration with rectal preparations containing high concentrations of other hygroscopic agents that could alter osmotic balance. - Use with rectal formulations that contain irritant preservatives, which may increase the risk of mucosal damage.
Use with caution: - Concurrent use of systemic medications that can cause diarrhea, as glycerol’s laxative effect may exacerbate fluid loss. - Administration alongside drugs that are highly sensitive to pH changes, because glycerol can modestly affect local pH. - Use in patients receiving anticoagulant therapy if rectal bleeding occurs, requiring closer monitoring.



