Odigesic

Odigesic Uses, Dosage, Side Effects, Food Interaction and all others data.

Acediasulfone (INN) is an antimicrobial and antimalarial long-acting prodrug of dapsone.

Glycerin is a hyperosmotic laxative, given rectally, which usually produces a bowel movement within 15 minutes to 1 hour. Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding tissues. This produces a softer stool mass and increased bowel action. These products are used for fast, predictable relief of occasional constipation.

Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and fecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool. Polyethylene Glycol induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

The osmotic effect of PEG produces a copious watery diarrhea. The onset of action of PEG 3350 is about 1 to 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.

Trade Name Odigesic
Generic Dibucaine + Polyethylene Glycol + Acediasulfone + Dihydroxymethyl Carbamide + Glycerin
Weight 1.1%
Type Ear Drops
Therapeutic Class
Manufacturer Napha Pharma,pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Odigesic
Odigesic

Uses

For the relief of occasional constipation

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

Polyethylene Glycol is used for the treatment of constipation. This should be used for 2 weeks or less or as directed by physician. Polyethylene Glycol 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.

Odigesic is also used to associated treatment for these conditions: Cold Sore, Constipation, Dry Mouth, Dry Skin, Dry throat, Edema of the cerebrum, Hypertension Intracranial, Occasional Constipation, Ocular Discomfort, Ocular Hypertension, Ocular Irritation, Skin Infections, Sore Throat, Mouth soreness, Ocular burning, Bowel preparation therapy, Topical Antisepsis, Skin protectionChronic Constipation, Constipation, Dry Eye Syndrome (DES), Dry Eyes, Occasional Constipation, Bowel preparation therapy, Eye lubrication

How Odigesic works

When administered rectally, glycerin exerts a hygroscopic and/or local irritant action, drawing water from the tissues into the feces and reflexively stimulating evacuation. Glycerin decreases intraocular pressure by creating an osmotic gradient between the blood and intraocular fluid, causing fluid to move out of the aqueous and vitreous humors into the bloodstream.

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

Odigesic dosage

Children under 2 years: Consult a physician.

Children (2 to 6 years): only 1 Glycerin 1.15 suppository per 24 hours or as directed by a physician.

Adults and Children (From 6 years): only 1 Glycerin 2.30 suppository per 24 hours or as directed by a physician

Insert suppository well up into rectum. Suppository need to melt completely to produce laxative action.

The usual dose of Polyethylene Glycol 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 Polyethylene Glycol 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

Polyethylene Glycol 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. Polyethylene Glycol 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 Polyethylene Glycol 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

Glycerin when used rectally may cause rectal discomfort or a burning sensation

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

Glycerol has very low toxicity when ingested ; Rat LD50 (oral)-12600mg/kg Mice LD50 (oral )-4090mg/kg Human TDLo (oral) - 1428mg/kg

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 Polyethylene Glycol therapy. Polyethylene Glycol should be administered after being dissolved in water, juice, coke, coffee or tea.

Interaction

No specific drug interactions have been demonstrated.

Volume of Distribution

Glycerin is distributed throughout the blood. Although glycerin generally does not appear in ocular fluids, it may enter the orbital sac when the eye is inflamed, with a consequent decrease in osmotic effect.

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

Well absorbed orally, poorly absorbed rectally. Studies in humans and animals indicate glycerol is rapidly absorbed in the intestine and the stomach

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

30 - 45 minutes

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

Approx 7-14% of dose is excreted unchanged in the urine within 2.5 hr.

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 category C. There are no controlled data in human pregnancy

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

Sensitivity to the ingredients. Do not use unless the patient to be treated is, in fact, constipated.

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.

Storage Condition

Store below 25° C. Protect from moisture.

Innovators Monograph

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