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bisacodyl, polyethylene glycol, lidocaine hcl and hydrocortisone acetate
Overview
What is Poly-Prep?
Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:
INGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream
What does Poly-Prep look like?
What are the available doses of Poly-Prep?
Sorry No records found.
What should I talk to my health care provider before I take Poly-Prep?
Sorry No records found
How should I use Poly-Prep?
Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
Apply product to the affected area(s) twice daily or as directed by a physician. The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. Do not over tighten. While holding the tube, squeeze the tube to fill the applicator until a small amount of cream/gel shows and lubricates the end of the tip with cream/gel. Gently insert the applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician).
Do not completely insert the applicator and tube into the anus or insert deep into the rectum. Do not insert a loose applicator tip into the anus or rectum. Once application is completed, the tube and applicator tip should be gently removed from the area and disposed. Note that an adequate amount of product for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application. Product should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician.
What interacts with Poly-Prep?
Polyethylene Glycol 3350, NF Powder for Oral Solution is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.
What are the warnings of Poly-Prep?
Carboplatin injection may cause fetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
What are the precautions of Poly-Prep?
General:
Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications. A diagnostic evaluation should include a structural examination of the colon. Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel habits.
Polyethylene Glycol 3350, NF Powder for Oral Solution should be administered after being dissolved in approximately 4-8 ounces of water, juice, soda, coffee, or tea.
Information for Patients:
Polyethylene Glycol 3350, NF Powder for Oral Solution softens the stool and increases the frequency of bowel movements by retaining water in the stool. It should always be taken by mouth after being dissolved in 4-8 ounces of water, juice, soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur, consult your physician.
Two to 4 days may be required to produce a bowel movement. This product should be used for 2 weeks or less or as directed by a physician. Prolonged, frequent or excessive use of Polyethylene Glycol 3350, NF Powder for Oral Solution may result in electrolyte imbalance and dependence on laxatives.
Laboratory Tests:
No clinically significant effects on laboratory tests have been demonstrated.
Drug Interactions:
No specific drug interactions have been demonstrated.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term carcinogenicity studies, genetic toxicity studies and reproductive toxicity studies in animals have not been performed with Polyethylene Glycol 3350, NF Powder for Oral Solution.
Pregnancy:
Animal reproductive studies have not been performed with Polyethylene Glycol 3350, NF Powder for Oral Solution. It is also not known whether Polyethylene Glycol 3350, NF Powder for Oral Solution can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Polyethylene Glycol 3350, NF Powder for Oral Solution should only be administered to a pregnant woman if clearly needed.
Pediatric Use:
Safety and effectiveness in pediatric patients has not been established.
Geriatric Use:
There is no evidence for special considerations when Polyethylene Glycol 3350, NF Powder for Oral Solution is administered to elderly patients.
In geriatric nursing home patients a higher incidence of diarrhea occurred at the recommended 17 gram dose. If diarrhea occurs, Polyethylene Glycol 3350, NF Powder for Oral Solution should be discontinued.
What are the side effects of Poly-Prep?
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.
What should I look out for while using Poly-Prep?
Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any components of the preparation.
For external use only. Not for ophthalmic use.
Keep out of reach of children.
Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicted because of ototoxicty associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
What might happen if I take too much Poly-Prep?
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. The oral LD is >50 gm/Kg in mice, rats and rabbits.
How should I store and handle Poly-Prep?
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream KIT contains 20 Single-Use 1/4 oz (7 g) Tubes, Applicators and Cleansing Wipes. NDC 59088-819-20.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Non-Clinical Toxicology
Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any components of the preparation.For external use only. Not for ophthalmic use.
Keep out of reach of children.
Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicted because of ototoxicty associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
No specific drug interactions have been demonstrated.
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing’s syndrome, hyperglycemia, and glycosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of potent topical steroids applied to a large surface area, or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression. If noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If irritation develops, topical steroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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