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OTC

FORTRANS

64G/5,7G/1,68G/1,46G/0,75G/SACHET/Powder for Oral Solution (Sachet)/POLYETHYLENE GLYCOL 4000/SULFATE DE SODIUM ANHYDRE/BICARBONATE DE SODIUM/CHLORURE DE SODIUM/CHLORURE DE POTASSIUM
IPSEN
ManufacturerVerified lab

IPSEN

Public retail price
N/ADZD
Reference price (TR): 143.00 DZD

Identification

Active ingredient (INN)
POLYETHYLENE GLYCOL 4000/SULFATE DE SODIUM ANHYDRE/BICARBONATE DE SODIUM/CHLORURE DE SODIUM/CHLORURE DE POTASSIUM
Internal code
10 L 086
Country of Origin
France
Pharmaceutical form
Powder for Oral Solution (Sachet)
Prescription List
OTC
Packaging
b/04 sachets
FORTRANS
Clinical View

DAWA Clinical Workbench v2.0

Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.

Description

Polyethylene glycol (PEG) is a synthetic polymer produced via polymerization of ethylene oxide molecules to make joining units of ethylene glycol by an ether linkage. 2, 3 PEGs are water-soluble polymers that can form hydrogen bonds in a ratio of 100 water molecules per one PEG molecule.

Molecular weights of

PEGs vary by time of the polymerization process and the molecular weight represents the weighted average of the individual PEG molecules.

PEGs differ in their physical and chemical properties depending on their molecular weight: PEGs are liquids when molecular weights are <1000 and the molecule turns to waxy solids with increasing molecular weights.

The most common preparations of PEGs include PEG and PEG 400.

PEGs have various applications in many fields, ranging from medical to industrial areas.

PEGs have a long history of gastroenterology: PEG is a common over-the-counter osmotic laxative used to relieve occasional constipation.

PEG is also used for cleansing of the colon in preparation for colonoscopy in adults.

The rationale of using

PEG in gastroenterology is due to the physical properties of the compound: its potent water-binding capacity, negligible intestinal absorption with increasing molecular mass, lack of significant toxicity, and limited intestinal enzymatic degradation or bacterial metabolism all make PEG a useful therapeutic agent for the treatment of occasional constipation and bowel cleansing for preparation in colonoscopy.

Indications

Polyethylene glycol is indicated for use as an over-the-counter osmotic laxative to relieve occasional constipation.

When used in combination with sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride, it is used for cleansing of the colon in preparation for colonoscopy in adults.

Pharmacodynamics

The osmotic effect of

PEG produces a copious watery diarrhea.

The onset of action of

PEG is about 1-2 hours after oral ingestion.

The colonic transit of polyethylene glycol occurs in a dose-dependent manner.

When used for bowel preparation before colonscopy, electrolytes are typically added in the oral solution to prevent dehydration and electrolyte disturbances.

As an over-the-counter laxative, the OTC product does not contain any salts that can be absorbed.

In a study involving healthy subjects, PEG 3350 had negligible effects on colonic fluid absorption or with the ability of the colonic mucosa to generate and sustain steep electrochemical gradients.

Mechanism of Action

Osmotic laxatives contain substances that are poorly absorbable and draw water into the lumen of the bowel.

Polyethylene glycol functions is an osmotic laxative that causes increased water retention in the lumen of the colon by binding to water molecules, thereby producing loose stools. 4, 5.

Absorption

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG in healthy subjects, the mean Cmax was 2.7 mcg/mL and the mean Tmax was 3 hours.

Typically, polyethylene glycols with a high molecular weight are poorly absorbed from the gastrointestinal tract following oral administration. 2, 3.

Volume of Distribution

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG in healthy subjects, the mean volume of distribution was 48,481 L.

Metabolism

Polyethylene glycol is a metabolically inert laxative that does not undergo intestinal enzymatic degradation or bacterial metabolism. 1, 4.

Route of Elimination

Following administration of an oral suspension containing 140 grams of PEG in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.

Half-life

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG in healthy subjects, the mean half life was 4.1 hours.

Clearance

There is limited information on the clearance rate of polyethylene glycols.

Adverse Effects

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Toxicity

The oral LD of

PEG in rats is 22000 mg/kg.

There is limited clinical information on the overdose of polyethylene glycols.

Based on the pharmacological action of the compound, severe diarrhea may be suspected.

Overdose of polyethylene glycols should be responded with symptomatic and supportive care.

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface.

Replace cap after using. remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions instill to 2 drops in the affected eye(s) as needed.

Alternatives