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Analpram HC (Hydrocortisone Acetate / Pramoxine Hydrochloride Topical) - Summary



Analpram HC® Cream 1% is a topical preparation containing hydrocortisone acetate 1% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents.

Topcial corticosteroids are indicated for the relief of the infallmatory and pruruitic manifestations of corticosteroids-responsive dermatoses.

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Published Studies Related to Analpram HC (Hydrocortisone / Pramoxine)

Comparative trial of moisturizer containing licochalcone A vs. hydrocortisone lotion in the treatment of childhood atopic dermatitis: a pilot study. [2011.06]
CONCLUSION: The effectiveness of LA lotion is equal to that of HC lotion. It was suggested that moisturizer containing LA could be used both for treatment of acute and maintenance phase in mild-to-moderate childhood AD. (c) 2010 The Authors. Journal of the European Academy of Dermatology and Venereology (c) 2010 European Academy of Dermatology and Venereology.

Comparative trial of moisturizer containing licochalcone A vs. hydrocortisone lotion in the treatment of childhood atopic dermatitis: a pilot study. [2010.09.14]
Background Although moisturizer usage has been considered a mainstay of treatment for atopic dermatitis (AD) patients, few clinical studies have been investigated... It was suggested that moisturizer containing LA could be used both for treatment of acute and maintenance phase in mild-to-moderate childhood AD.

Biological and hemodynamic effects of low doses of fludrocortisone and hydrocortisone, alone or in combination, in healthy volunteers with hypoaldosteronism. [2010.08]
Low doses of hydrocortisone (HC) and fludrocortisone (FC) administered together improve the prognosis after septic shock; however, there continues to be disagreement about the utility of FC for this indication. The biological and hemodynamic effects of HC (50 mg intravenously) and FC (50 microg orally) were assessed in 12 healthy male volunteers with saline-induced hypoaldosteronism in a placebo-controlled, randomized, double-blind, crossover study performed according to a 2 x 2 factorial design...

A pilot study comparing hydrocortisone premedication to concomitant azathioprine treatment in preventing loss of response to infliximab. [2009.09]
OBJECTIVES: Antibodies to infliximab may lead to loss of response to infliximab (IFX) in Crohn's disease. Azathioprine (AZA) coadministration prevents the formation, whereas hydrocortisone (HC) premedication reduces the levels of antibodies to IFX. This pilot study aims at assessing the efficacy of these strategies to prevent loss of response to IFX... CONCLUSION: This prospective 2-year pilot study has not confirmed superiority of any available strategy to maintain the efficacy of IFX.

Modified-release hydrocortisone to provide circadian cortisol profiles. [2009.05]
CONTEXT: Cortisol has a distinct circadian rhythm regulated by the brain's central pacemaker. Loss of this rhythm is associated with metabolic abnormalities, fatigue, and poor quality of life. Conventional glucocorticoid replacement cannot replicate this rhythm. OBJECTIVES: Our objectives were to define key variables of physiological cortisol rhythm, and by pharmacokinetic modeling test whether modified-release hydrocortisone (MR-HC) can provide circadian cortisol profiles. SETTING: The study was performed at a Clinical Research Facility... CONCLUSION: By defining circadian rhythms and using modern formulation technology, it is possible to allow a more physiological circadian replacement of cortisol.

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Clinical Trials Related to Analpram HC (Hydrocortisone / Pramoxine)

The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism [Recruiting]
This study aims at assessing the effect of today's standard of hydrocortisone dosage versus previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL and IHCL) after a standardised fat load followed by a short-term aerobic exercise in patients with corticotropic pituitary insufficiency.

Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia [Recruiting]

Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia [Completed]
This study will test a new, extended release form of hydrocortisone called Chronocort in patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and prednisone) are currently used to treat CAH, but finding the best dose of these drugs that effectively lowers androgens without causing undesirable side effects, such as weight gain and slow growth rate in children, is often difficult to achieve. Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this study. Children 16 years of age and older are eligible with confirmation by bone age that they are no longer growing. Participants undergo the following tests and procedures during two inpatient visits one month apart at the NIH Clinical Center:

- Medical history and physical examination.

- Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients

begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day for 1 month.

- Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for

frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for chemistries, blood count, pregnancy test in women, and for serial tests (up to 26 samples in a 24-hour period) to measure hormone levels.

- 24-hour urine test.

- Height and weight measurements.

Between the two hospitalizations, patients are contacted by NIH weekly to check for possible side effects from Chronocort. Two weeks after the first visit, patients also will have blood drawn by their regular doctor or a local clinic. A few days before the second hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and well being. About 30 days after discharge from the second hospitalization, patients are followed up with a telephone call to see how they are doing.

Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency [Completed]
This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration [Completed]
The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.

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Page last updated: 2011-12-09

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