GaviLyte-N with Flavor Pack

Uses

This is white powder for reconstitution. It is a synthetic polyglycol having an average molecular weight of 3350. GaviLyte-N with Flavor Pack is an osmotic agent that causes water to be retained with the stool. GaviLyte-N with Flavor Pack appears to have no effect on the active absorption or secretion of glucose or electrolytes.

GaviLyte-N with Flavor Pack is used for the treatment of constipation. This should be used for 2 weeks or less or as directed by physician. GaviLyte-N with Flavor Pack 3350 is a prescription only laxative that has been prescribed by physician to treat constipation. This product should only be used by the person for whom it is prescribed.

GaviLyte-N with Flavor Pack is also used to associated treatment for these conditions: Chronic Constipation, Constipation, Dry Eye Syndrome (DES), Dry Eyes, Occasional Constipation, Bowel preparation therapy, Eye lubrication

How GaviLyte-N with Flavor Pack works

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.

Dosage

GaviLyte-N with Flavor Pack dosage

The usual dose of GaviLyte-N with Flavor Pack is 17 gm of powder per day (or as directed by physician) in a glass of water, juice, coke, coffee or tea. Each bottle of GaviLyte-N with Flavor Pack is supplied with a cup that is used to measure 17 gm or 8.5 gm of laxative powder when filled upto the marked line.

It should always be taken by mouth. Measure the dose using the supplied cup, stir and dissolve in a glass of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.

Duration of Treatment

GaviLyte-N with Flavor Pack achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consultation with physician is needed. GaviLyte-N with Flavor Pack is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the GaviLyte-N with Flavor Pack therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).

Side Effects

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

Toxicity

The oral LD₅₀ of PEG 3350 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.

Precaution

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating GaviLyte-N with Flavor Pack therapy. GaviLyte-N with Flavor Pack should be administered after being dissolved in water, juice, coke, coffee or tea.

Interaction

No specific drug interactions have been demonstrated.

Food Interaction

• Avoid alcohol. Withdrawing from alcohol increases the risk of seizures, which is also caused by the drug.
• Avoid milk and dairy products.
• Avoid solid foods. Consume only clear liquids from the start of drug treatment until after the colonoscopy.

Volume of Distribution

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean volume of distribution was 48,481 L.

Elimination Route

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 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.

Half Life

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean half life was 4.1 hours.

Clearance

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

Elimination Route

Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.

Pregnancy & Breastfeeding use

Pregnancy: It is not known whether Polyethylene glycol can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. Polyethylene glycol should only be administered to a pregnant woman if clearly needed.

Lactation: There is no information on the use of Polyethylene glycol while nursing. Consultation with a physician is necessary in case of breastfeeding.

Contraindication

Polyethylene glycol is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

Acute Overdose

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

Innovators Monograph

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