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Proctofoam HC (Hydrocortisone Acetate / Pramoxine Hydrochloride Rectal) - Summary



proctofoam® HC
(hydrocortisone acetate 1% and pramoxine hydrochloride 1%)
topical aerosol
Rx Only

Proctofoam®-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.Proctofoam®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

See all Proctofoam HC indications & dosage >>


Published Studies Related to Proctofoam HC (Hydrocortisone / Pramoxine Rectal)

The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy. [2011.02]
OBJECTIVE: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC... CONCLUSION: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.

The effectiveness of Proctofoam-HC for treatment of hemorrhoids in late pregnancy. [2009.07]
OBJECTIVE: Currently no topical anti-hemorrhoidal agents have been studied for effectiveness in pregnancy. This study evaluated the effectiveness of Proctofoam-HC used during the last trimester of pregnancy... CONCLUSIONS: Proctofoam-HC appears to provide effective treatment of hemorrhoids in late pregnancy.

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Clinical Trials Related to Proctofoam HC (Hydrocortisone / Pramoxine Rectal)

The Safety of Proctofoam-HC in the Third Trimester of Pregnancy [Recruiting]

Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse [Recruiting]
Preoperative bowel preparation for surgical management of pelvic floor disorders is performed inconsistently, and includes no prep, the use of dietary changes or bowel altering interventions. Retrospective studies of emergency colonic surgery first demonstrated a low rate of infectious complications without a bowel prep. Recently, data supporting the routine use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical outcomes are similar between patients that undergo a bowel preparation versus those that do not, indicating that the long held dogma of mechanical bowel preparation should be used selectively. Despite routine use, there is a paucity of literature addressing the approach to, and/or need for preoperative bowel management at the time of vaginal reconstructive or obliterative surgery. The majority of the pelvic floor disorder population is older, tending to have more bowel dysfunction (especially symptoms of constipation) than younger women.

The aim of this study is to evaluate preoperative bowel management strategy as it relates to the total care of the vaginal surgery patients' intra-and post-operative bowel function and overall patient experience. Two commonly used pre-operative bowel prep strategies: no preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value of bowel preparation or diet change in vaginal surgery, both from the physician's and patient's point of view. In this pilot study, subjects are randomized to either a clear liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after midnight, or NPO after midnight without any dietary changes or enemas.

Our aims are:

*Primary - To assess the surgeons' objective intraoperative evaluation of the effects of

bowel preparation (adequate visualization, stooling during case, difficulty with bowel

handling) *Secondary - (1)To characterize the patients' experience and acceptance of

preoperative bowel management regimen versus no preoperative bowel preparation(2) To characterize the patients' postoperative experience and determine if the preoperative bowel regimen affects time to first bowel movement/first normal stool as well as stool experience as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups (4)Characterize other descriptive qualities of the patients' operative experience(duration of case, length of hospital stay)

Children's Exposures/Health Effects/Diesel Exhaust [Recruiting]
The contribution of diesel exhaust (DE) to health, especially children's health, is of tremendous public health interest. DE has been associated with worsening asthma and allergies, among other important health effects. Reducing DE exposures has become a major regulatory initiative, and federal, state, and local jurisdictions are investing hundreds of millions of dollars in retrofitting diesel engines in school buses and other changes to reach this goal.

The U. S. Environmental Protection Agency's recent regulations require all on-road diesel vehicles to change to low emission engines and ultra-low-sulfur fuels by 2007 (US EPA '00). In spring 2003, the U. S. EPA announced a nationwide voluntary school bus retrofit initiative. In July 2003, the Washington Legislature enacted a statewide "Diesel Solutions" program that provides 25 million dollars by 2008 to retrofit school diesel buses with cleaner burning engines and fuels, making it one of the largest and most active voluntary school bus retrofit program in the country. If risk assessment estimates are accurate, these changes will have a large public health impact, especially on children who ride school buses daily. However, no studies to-date have rigorously examined school children's exposure to diesel exhaust (DE) and its health effects, nor such a significant change in vehicular pollution control. We propose to seize this opportunity of a large natural experiment taking place in the Puget Sound area and conduct a study to assess health effects from diesel bus exhaust before and after the retrofit of diesel bus fleets between 2005 and 2007. The specific aims of the study are to:

1. Determine whether asthmatic children changing to retrofitted buses with cleaner fuels and engines have a reduction in sub-clinical and clinical asthma severity.

2. Determine if increased levels of DE exposure lead to an increase in acute clinical and sub-clinical features of asthma in children.

3. Quantify the levels and changes in particle and toxic gas exposures to DE in 3 groups of children commuting to school by retrofitted buses or private cars, old diesel buses to be retrofitted later, and old diesel buses through the study.

Sub-aim 3: Use the time-activity information, personal exposure measurements, and on-bus monitoring data to construct an exposure model to predict individual exposures to DE for all subjects.

Bowel Preparation and Pelvic Organ Prolapse Surgery [Recruiting]
The purpose of this study is to find out if performing a bowel preparation prior to pelvic organ prolapse surgery has any effect on the return of bowel function after surgery.

Safety and Efficacy Study of CitraFleet (Sodium Picosulphate) as an Evacuating Treatment Prior to Colonoscopy. [Recruiting]
The purpose of this study is to determine any significant differences in the efficacy and acceptability between CitraFleet and Klean Prep® (polyethylene glycol) for the preparation of gastrointestinal subjects undergoing a colon examination.

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Page last updated: 2011-12-09

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