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Proctofoam (Hydrocortisone Acetate / Pramoxine Hydrochloride) - Summary



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

See all Proctofoam indications & dosage >>


Published Studies Related to Proctofoam (Hydrocortisone / Pramoxine)

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.

Effect of transdermal iontophoresis codelivery of hydrocortisone on metoclopramide pharmacokinetics and skin-induced reactions in human subjects. [1999.10]
The effects of transdermal iontophoresis (IP) codelivery of hydrocortisone (HC) on metoclopramide hydrochloride (MCP) pharmacokinetics and on skin-induced reactions were evaluated in a randomized, crossover clinical study. MCP, an antiemetic, low molecular weight, cationic drug intended for systemic delivery, was delivered from the anode of IP systems at a constant current of 100 microA/cm(2)...

Arginine blocks the inhibitory effect of hydrocortisone on circulating growth hormone levels in patients with acromegaly. [1993.05]
In patients with acromegaly, circulating growth hormone (GH) levels and GH responses to GH-releasing hormone (GHRH) are decreased by long-term administration of pharmacological doses of glucocorticoids. The aim of our study was to investigate the acute effects of intravenous (i.v.) infusion of hydrocortisone combined either with saline or arginine infusion on circulating GH levels in acromegaly...

Prevention of peritoneal adhesions in rats with verapamil, hydrocortisone sodium succinate, and phosphatidylcholine. [1992.01]
OBJECTIVE: To assess the effectiveness of verapamil, hydrocortisone sodium succinate, and phosphatidylcholine in the prevention of experimental adhesions... CONCLUSION: Adhesions that developed in rats after laparotomy and intraperitoneal irrigation with saline at 40 degrees C can be significantly reduced by phosphatidylcholine.

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Clinical Trials Related to Proctofoam (Hydrocortisone / Pramoxine)

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

Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock [Recruiting]
The purpose of the study is:

- to correlate salivary cortisol to free serum cortisol (as salivary cortisol is

considered to be almost complete free cortisol) and,

- to correlate free serum cortisol to total serum cortisol levels

Both in patients with septic shock (severe sepsis requiring vasopressors).

We believe that:

- total serum cortisol does not correlate with free serum cortisol in patient with septic

shock and,

- that salivary cortisol correlates with free serum cortisol and can be used to determine

the level of free serum cortisol.

Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis [Recruiting]

Cortisol Control of Human Inflammatory Responses to Endotoxin [Completed]
The purpose of the research is to study a common and dangerous medical condition called 'septic shock' that often occurs in critically ill patients. In order to learn about septic shock in humans, we will administer a substance called 'endotoxin' to participants in this study. Endotoxin causes a temporary period of inflammation in the human body, a brief 'virtual' infection. This is an established method for the investigation of inflammation properties. We are interested in how the natural hormone, cortisol, can affect the human response to endotoxin. We know that when cortisol is given at the same time as endotoxin it can decrease the inflammation that occurs due to endotoxin. In this study we will test whether or not cortisol, when given the day before the endotoxin, will work to change the inflammation that occurs due to endotoxin. In order to test this, two-thirds of the study participants will receive cortisol on the day before they receive the endotoxin and one-third of the study participants will receive a placebo (no medication) before the endotoxin.

Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia [Completed]
This study is based on clinical findings that some patients with fibromyalgia have a tendency towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this study is that the administration of a very low-dose of cortisol which has no side effects corrects this deficiency and results in an improvement of symptoms

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Page last updated: 2011-12-09

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