Product image of Glycerine Enfants Fagron (Glycerol) supplied by GNH India

Glycerine Enfants Fagron

Active Ingredient:
Glycerol
Origin:
EU

Glycerine Enfants Fagron (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.

Manufacturer / TM Owner

Laboratoires Sopreli Sprl

1
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Indications & Clinical Uses

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.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

It acts as a hygroscopic, lubricating vehicle that helps dissolve or suspend active ingredients and facilitates comfortable rectal administration in children.

Yes, it is classified as an OTC (over‑the‑counter) excipient and does not require a prescription.

While it is formulated for pediatric use, the product can be employed in adult rectal formulations if a pharmacist determines it is appropriate.

Store in a cool, dry place away from direct sunlight and keep the container tightly closed to maintain sterility.

It is suitable for rectal suppositories, enemas, and other liquid or semi‑solid rectal dosage forms intended for children.

Systemic absorption of glycerol from rectal administration is minimal and generally not clinically significant.

Discontinue use immediately and seek medical evaluation to assess the reaction and determine appropriate treatment.

It should be mixed only with drugs that are compatible with glycerol; pharmacists should verify compatibility before compounding.

No specific strength is listed; the product is supplied as a pure glycerol vehicle without a defined concentration.

Use in newborns should be decided by a pediatric specialist, taking into account the infant’s condition and the intended medication.

Watch for redness, burning, itching, or discomfort at the rectal site after administration.

Compatibility should be evaluated by a pharmacist, as glycerol may affect the viability of certain probiotic strains.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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