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Hydrocortisone 1%-Iodoquinol 1% Cream | HYDROCORTISONE IODOQUINOL [Syntenza Pharmaceuticals LLC] | BioPortfolio

13:29 EST 27th January 2019 | BioPortfolio
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Rx Only

Each gram of Hydrocortisone 1% – Iodoquinol 1% Cream contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a greaseless base of cetyl alcohol, glyceryl monostearate SE, isopropyl myristate, lanolin alcohol, mineral oil, polyoxyl 40 stearate, polysorbate 20, polysorbate 60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate. Paraben free.

Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-,(11ß)-] with the molecular formula CHO and is represented by the following structural formula:

and iodoquinol, 5,7-diiodo-8-quinolinol (CHINO) is represented by the following structure:

Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.

Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of anti-inflammatory activity is unclear. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Iodoquinol has both antifungal and antibacterial properties.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as a glucuronide.

INDICATIONS AND USAGE
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis, bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation.

Hydrocortisone 1% – Iodoquinol 1% Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep tube tightly closed.

If irritation develops, the use of Hydrocortisone 1% – Iodoquinol 1% Cream should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine.

Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy.

Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of hydrocortisone or iodoquinol.

In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been conducted with iodoquinol.

Animal reproductive studies have not been conducted with Hydrocortisone 1% – Iodoquinol 1% Cream. It is not known whether Hydrocortisone 1% – Iodoquinol 1% Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Hydrocortisone 1% – Iodoquinol 1% Cream should be given to a pregnant woman only if clearly needed.

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 Hydrocortisone 1% – Iodoquinol 1% Cream is administered to a nursing woman.

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence:

Burning Perioral dermatitis
Itching Allergic contact dermatitis
Irritation Maceration of the skin
Dryness Secondary infection
Folliculitis Skin atrophy
Hypertrichosis Striae
Acneiform eruptions Miliaria
Hypopigmentation

Apply to affected area 3 to 4 times daily in accordance with physician's directions.

Hydrocortisone 1% – Iodoquinol 1% Cream is available as follows: 1 oz. tube (NDC 72056-040-64)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Manufactured for: Syntenza Pharmaceuticals LLC Edina, MN 55436, USA

Rev. 06/18

SYNTENZA

NDC 72056-040-64

Hydrocortisone 1%-Iodoquinol 1% Cream

Net Wt. 1 oz. (28.4 g) Rx Only

Manufacturer

Syntenza Pharmaceuticals LLC

Active Ingredients

Source

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Clinical Trials [207 Associated Clinical Trials listed on BioPortfolio]

Administration of Hydrocortisone in Young Healthy Male Volunteers

The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an...

Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.

We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of...

Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder

To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions) and overall symptomatology in patients meeting criteria of complex chronic PTSD.

Administration of Hydrocortisone for the Treatment of Septic Shock

The purpose of this study : 1)to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administr...

Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.

PubMed Articles [40 Associated PubMed Articles listed on BioPortfolio]

Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.

Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical tria...

Hydrocortisone for Preventing Mortality and Bronchopulmonary Dysplasia in Preterm Infants with or without Chorioamnionitis Exposure: A Meta-Analysis of Randomized Trials.

 This study sought to assess whether infants exposed to chorioamnionitis are the optimal population to benefit the most from early postnatal hydrocortisone delivery in preventing bronchopulmonary dy...

Cortisol affects pain sensitivity and pain-related emotional learning in experimental visceral but not somatic pain: a randomized controlled study in healthy men and women.

Despite growing interest in the role of stress mediators in pain chronicity, the effects of the stress hormone cortisol on acute pain remain incompletely understood. In a randomized, double-blind, pla...

Effects of hydrocortisone administration on leptin and adiponectin synthesis in dogs.

To determine effects of hydrocortisone administration on serum leptin and adiponectin concentrations, abdominal fat distribution, and mRNA expression of leptin and adiponectin in abdominal adipose tis...

Adrenal insufficiency, be aware of drug interactions!

A 42-year-old man with complaints of muscle soreness and an increased pigmentation of the skin was referred because of a suspicion of adrenal insufficiency. His adrenocorticotropic hormone and cortiso...

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