Poly-Prep

Poly-Prep Uses, Dosage, Side Effects, Food Interaction and all others data.

Bisacodyl works by stimulating enteric nerves to cause colonic contractions. It is also a contact laxative; it increases fluid and salt secretion. Action of bisacodyl on small intestine is negligible; stimulant laxatives mainly promote evacuation of the colon.

Patients should be counselled regarding abdominal pain, nausea, vomiting, or a change in bowel function that lasts longer than 2 weeks. It has a wide therapeutic index, as patients can take 5-15 mg orally. Patients taking bisacodyl should be counselled before taking the medication if they are already experiencing abdominal pain, nausea, vomiting, or a change in bowel function lasting longer than 2 weeks. Patients should also be counselled to stop taking the medication if they experience rectal bleeding or no bowel movement in 12 hours.

Hydrocortisone binds to the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Specifically glucocorticoids induce lipocortin-1 (annexin-1) synthesis, which then binds to cell membranes preventing the phospholipase A2 from coming into contact with its substrate arachidonic acid. This leads to diminished eicosanoid production. The cyclooxygenase (both COX-1 and COX-2) expression is also suppressed, potentiating the effect. In other words, the two main products in inflammation Prostaglandins and Leukotrienes are inhibited by the action of Glucocorticoids. Glucocorticoids also stimulate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events: epithelial adhesion, emigration, chemotaxis, phagocytosis, respiratory burst and the release of various inflammatory mediators (lysosomal enzymes, cytokines, tissue plasminogen activator, chemokines etc.) from neutrophils, macrophages and mastocytes. Additionally the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Hydrocortisone is the most important human glucocorticoid. It is essential for life and regulates or supports a variety of important cardiovascular, metabolic, immunologic and homeostatic functions. Topical hydrocortisone is used for its anti-inflammatory or immunosuppressive properties to treat inflammation due to corticosteroid-responsive dermatoses. Glucocorticoids are a class of steroid hormones characterised by an ability to bind with the cortisol receptor and trigger a variety of important cardiovascular, metabolic, immunologic and homeostatic effects. Glucocorticoids are distinguished from mineralocorticoids and sex steroids by having different receptors, target cells, and effects. Technically, the term corticosteroid refers to both glucocorticoids and mineralocorticoids, but is often used as a synonym for glucocorticoid. Glucocorticoids suppress cell-mediated immunity. They act by inhibiting genes that code for the cytokines IL-1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8 and TNF-alpha, the most important of which is the IL-2. Reduced cytokine production limits T cell proliferation. Glucocorticoids also suppress humoral immunity, causing B cells to express lower amounts of IL-2 and IL-2 receptors. This diminishes both B cell clonal expansion and antibody synthesis. The diminished amounts of IL-2 also leads to fewer T lymphocyte cells being activated.

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.

Poly-Prep
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Poly-Prep
Generic	Bisacodyl + polyethylene glycol + lidocaine hcl + hydrocortisone acetate
Type	Kit
Therapeutic Class
Manufacturer
Available Country	United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Bisacodyl is used for Constipation; Preparation for radiography; antepartum & postpartum care; Preparation for sigmoidoscopy or proctoscopy; colonoscopy; hemorrhoids & anal fissures. All conditions which require defecation to be facilitated.

Hydrocortisone Acetate is used for:

Primary irritant dermatitis
Contact allergic dermatitis
Eczema: atopic, infantile, discoid, stasis
Seborrheic dermatitis
Lichen simplex and pruritus ani
Flexural psoriasis
Skin irritations, itching and rashes, for example those caused by insect bites, minor thermal burns, sunburn, etc

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.

Poly-Prep is also used to associated treatment for these conditions: Constipation, Occasional Constipation, Bowel irregularity, Bowel preparation therapyAcute, Inflammatory Superficial Cutaneous Lesions caused by susceptible bacteria, Adrenal cortical hypofunctions, Anal Fissures, Anal inflammation, Androgenital syndrome, Conjunctivitis, Conjunctivitis allergic, Corneal Inflammation, Dermatitis infected, Diaper Dermatitis, Eczema infected, Episcleritis, Hemorrhoids, Iridocyclitis, Iritis, Ocular Inflammation, Ocular Irritation, Postoperative pain, Proctitis, Pruritus, Pruritus Ani, Radiation Induced Proctitis, Rheumatoid Arthritis, Scleritis, Skin Infections, Skin Irritation, Superficial ocular bacterial infections caused by susceptible bacteria, Thyroiditis, Ulcerative Colitis, Anal eczema, Bacterial blepharitis, Corneal clouding, Corticosteroid responsive Dermatosis of the anal region, Corticosteroid-responsive dermatoses, Cryptitis, Localized uninfected hemorrhoids, Mild Anal Fissures, Pruritus associated with bowel movements, Skin and skin-structure infections caused by susceptible bacteria, Postoperative Eye CareChronic Constipation, Constipation, Dry Eye Syndrome (DES), Dry Eyes, Occasional Constipation, Bowel preparation therapy, Eye lubrication

How Poly-Prep works

Bisacodyl is deacetylated to the active bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM) by an intestinal deacetylase. BHPM can stimulate parasympathetic nerves in the colon directly to increase motility and secretions.

Bisacodyl stimulates adenylate cyclase, increasing cyclic AMP, leading to active transport of chloride and bicarbonate out of cells. Sodium ions, potassium ions, and water passively leave the cell; while sodium and chloride ions are unable to be reabsorbed.

Water is also be transported from the luminal side of cells into the vasculature by aquaporin 3. Bisacodyl decreases expression of aquaporin 3, preventing water from moving into the vasculature, which may contribute to increased water in the colon.

Bisacodyl directly stimulates parasympathetic nerves in the colon, stimulating contraction of longitudinal smooth muscle but not circular smooth muscle.

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

Poly-Prep dosage

Constipation:

Adult: 1-2 tab (5-10 mg) daily, relief in 6-12 hr.
Adult/Pediatric: 1 suppository (10 mg) daily, relief in 15-30 min.
Children <10 yr: 1 tab (5 mg) or 1 suppository (5 mg) daily.

For complete bowel clearance:

>10 yr: 2-4 tab the night before & 1 adult suppository on the day of the procedure.
<10 yr: 1 tab the night before & 1 pediatric suppositoryon the day of the procedure.

The max daily dose should not be exceeded.

Hydrocortisone cream should be applied in a thin smear to the affected area one to two times per day or as directed by the physician. The recommended duration of treatment is usually two weeks. For rectal use apply to the irritated anorectal tissue in the morning and at evening and after each bowel movement for two to six days.

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

Abdominal discomfort & diarrhea.

Hydrocortisone Acetate 1% cream is usually well-tolerated, but if signs of hypersensitivity appear, application should be stopped.

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

Patients experiencing an overdose of bisacodyl may present with more severe diarrhea and electrolyte imbalance. Patients should be treated with symptomatic and supportive measures.

The oral LD₅₀ in rats is 4320 mg/kg, and in mice is 17500 mg/kg.

Side effects include inhibition of bone formation, suppression of calcium absorption and delayed wound healing

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

Caution should be taken in pregnancy and children.

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur. As with all corticosteroids, prolonged application to the face is undesirable.

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

Do not give antacids or milk within 1 hour of taking the drug (enteric coated)

No specific drug interactions have been demonstrated.

Volume of Distribution

Data regarding the volume of distribution of bisacodyl is not readily available. However, the volume of distribution of the active metabolite, BHPM, in lactating women is 181 L after a single dose and 289 L at steady state.

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

Oral formulations of bisacodyl are only 16% bioavailable. A 10 mg enteric coated oral tablet reaches a C_max of 26 ng/mL with a T_max of 8 hours, while a 10 mg oral solution reaches a C_max of 237 ng/mL with a T_max of 1.7 hours. A 10 mg suppository reaches a C_max of 0-64 ng/mL.

In lactating women, 10mg of oral bisacodyl reaches a C_max of 20.5-195 ng/mL, with a T_max of 3-4 hours, and a geometric mean AUC after a single dose of 471 h*ng/mL. After multiple doses, the geometric mean AUC decreases to 311 h*ng/mL.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

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

Data regarding the half life of bisacodyl is not readily available. The half life of the active metabolite, BHPM, in lactating women was 7.3 h after a single 10 mg oral dose and 10.0 h after multiple doses.

6-8 hours

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

Data regarding the clearance of bisacodyl is not readily available. The apparent plasma clearance of the active metabolite, BHPM, in lactating women after a single 10 mg oral dose is 272 mL/min and after multiple doses is 412 mL/min.

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

Elimination Route

The majority of bisacodyl is eliminated in the feces. 13.8-17.0% of a bisacodyl dose is eliminated in the urine as the active metabolite BHPM.

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

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

Bisacodyl has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. No data are available from controlled human pregnancy studies. Bisacodyl should only be given during pregnancy when need has been clearly established.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.

There is inadequate evidence for safety in human pregnancy. It is recommended that topical corticosteroids should not be used extensively during pregnancy. It is highly unlikely that sufficiently high blood levels of Hydrocortisone are achieved during topical therapy to reach breast milk.

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

Bisacodyl is contraindicated in ileus, intestinal obstruction, acute surgical abdominal conditions, severe dehydration. Appendicitis & acute inflammatory bowel diseases.

Contraindicated in infections (bacterial; viral; fungal), skin ulcers, hypersensitivity to the preparation

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

Acute Overdose

A laxative is a medicine used to produce bowel movements. Laxative overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

Most laxative overdoses in children are accidental. However, some people regularly take overdoses of laxatives to try to lose weight.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued

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.