Clioquinol and Hydrocortisone (Topical)


VA CLASSIFICATION
Primary: DE250{03}

Commonly used brand name(s): Vioform-Hydrocortisone Cream; Vioform-Hydrocortisone Lotion; Vioform-Hydrocortisone Mild Cream; Vioform-Hydrocortisone Mild Ointment; Vioform-Hydrocortisone Ointment.

Another commonly used name is
iodochlorhydroxyquin and hydrocortisone
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial-antifungal-corticosteroid (topical)—
Note: Therapeutic efficacy of the corticosteroid depends on drug release from the vehicle, solubilization of the drug at the skin surface, and its subsequent percutaneous absorption through the outer barrier layer of the epidermis (stratum corneum) so that it can reach the site of action in the living epidermis and/or the dermis.
Factors influencing product selection include skin hydration, site, severity, age, and whether the lesion is moist or dry, as well as potency and strength of the product, and the method of application.



Indications

Accepted

Dermatitis, atopic (treatment);
Dermatitis, contact (treatment);
Eczema (treatment);
Folliculitis (treatment);
Intertrigo (treatment);
Pruritus, anogenital (treatment); or
Skin infections, bacterial, minor (treatment)—Clioquinol and hydrocortisone combination is indicated in the topical treatment of atopic dermatitis, contact dermatitis, eczema, folliculitis, intertrigo, anogenital pruritus, and minor bacterial skin infections. {04} {05} {06}

—FDA has classified clioquinol and hydrocortisone combination as being possibly effective for its labeled indications. The less-than-effective classifications require the submission of adequate and well-controlled studies to provide substantial evidence of effectiveness. {04} {05}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Clioquinol—305.50 {07}
    Hydrocortisone—362.47 {08}

Mechanism of action/Effect:

Clioquinol—A broad-spectrum antibacterial. Its precise mechanism of action is unknown.

Hydrocortisone—A corticosteroid that diffuses across cell membranes and complexes with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of mRNA (messenger RNA) and subsequent protein synthesis of various enzymes thought to be ultimately responsible for the anti-inflammatory effects of corticosteroids applied topically to the skin.


Other actions/effects:

Clioquinol—Also possesses mild irritant properties. {05} {06}

Absorption:

Clioquinol—Absorbed through the skin in sufficient amounts to affect thyroid function tests. {05}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to chloroxine, iodine, or iodine-containing preparations may be sensitive to this medication also. {05} {06} {10}

Pregnancy/Reproduction

Pregnancy—
Use of large amounts or for prolonged periods of time is not recommended since systemic absorption may occur.

Problems in humans have not been documented.

Fetal abnormalities have been documented in animal studies. {05}

Breast-feeding

It is not known whether clioquinol and hydrocortisone combination is distributed into breast milk. However, problems in humans have not been documented.

Pediatrics

Use is not recommended in infants and children up to 2 years of age. {02} {05}

Clioquinol may produce false-positive ferric chloride test results for phenylketonuria (PKU) if clioquinol is present in the neonate's diaper or urine. {05}

Since adrenal suppression and growth retardation due to the systemic absorption of topical corticosteroids have been documented in children, special care must be exercised in using these agents in the pediatric patient. It is recommended that only low-potency topical corticosteroids that are not fluorinated and that have a free 17-hydroxyl group be used in children unless there is a very specific indication for one of the other topical corticosteroids.

As a general rule, pediatric therapy continuing for longer than 2 weeks {11} and consisting of doses in excess of 2 daily applications (with low-potency corticosteroids) should be carefully evaluated by the physician. This is especially important if medication is applied to more than 5 to 10% of the body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing. {12}


Geriatrics


Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.


Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Ferric chloride tests for phenylketonuria (PKU){05}    (may produce false-positive test results if clioquinol is present in neonate's diaper or urine)


» Thyroid function determinations{05}    (clioquinol may cause significant elevation of serum protein-bound iodine [PBI] or butanol-extractable iodine [BEI] and a decrease in radioactive iodine [RAI] uptake; at least 1 month should elapse between discontinuation of clioquinol and administration of these tests. Other thyroid function tests such as T 3 resin sponge tests or T 4 determinations are not affected)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist

For clioquinol and hydrocortisone {05}:
    (Intolerance to clioquinol, hydrocortisone, chloroxine, iodine, or iodine-containing preparations)


For hydrocortisone only {05}:
» Herpes simplex
» Vaccinia, eczema vaccinatum, varicella, or other viral infections of the skin


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Skin sensitization{05} (blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation not present before therapy)

With prolonged use
    
Thinning of skin with easy bruising





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Clioquinol and Hydrocortisone (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:





Use in children—Use is not recommended in infants and children up to 2 years of age

Other medical conditions, especially herpes simplex, vaccinia, eczema vaccinatum, varicella, or other viral infections of the skin

Proper use of this medication
Before applying, washing affected area with soap and water, and drying thoroughly

» Not for ophthalmic use or use on infants and children under 2 years of age {02} {05}

Proper administration technique for cream, lotion, and ointment

» Not bandaging or otherwise wrapping treated area unless directed by physician

» Checking with physician before using medication on other skin problems

» Compliance with full course of therapy

» Not using more often or longer or on thin skin areas unless directed by physician

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within 1 to 2 weeks

» Taking special precautions when medication is used in children

May stain fabrics, skin, hair, and nails yellow {05}


Side/adverse effects
Signs of potential side effects, especially skin sensitization, and thinning of skin with easy bruising


General Dosing Information
Use of topical antibacterials may lead to skin sensitization, resulting in hypersensitivity reactions with subsequent topical use of the medication.

Preparations containing clioquinol 3% and hydrocortisone 0.5% should be used in the treatment of less severe lesions or in those that involve extensive areas of the body.

For maintenance therapy, applications may be administered less frequently if desired.

Occlusion, whether by an oleaginous ointment or by a thin film of polyethylene, promotes increased hydration of the stratum corneum and increased absorption.

This medication contains a low-potency adrenocorticoid (0.5 or 1% hydrocortisone) that is not fluorinated and has a free 17-hydroxyl group.


Topical Dosage Forms

CLIOQUINOL AND HYDROCORTISONE CREAM

Usual adult and adolescent dose
Antibacterial
Topical, to the skin, three or four times a day.

Antifungal
Topical, to the skin, three or four times a day.


Usual pediatric dose
Infants and children up to 2 years of age—Use is not recommended. {02}
Children 2 years of age and over—See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—
{04}{05}

3% of clioquinol and 0.5% of hydrocortisone (Rx) [Vioform-Hydrocortisone Mild Cream{05}{14}]


3% of clioquinol and 1% of hydrocortisone (Rx) [Vioform-Hydrocortisone Cream{05}{14}]

Canada—
{06}

3% of clioquinol and 0.5% of hydrocortisone (Rx) [Vioform-Hydrocortisone Mild Cream]


3% of clioquinol and 1% of hydrocortisone (Rx) [Vioform-Hydrocortisone Cream]

Packaging and storage:
Store below 30 °C (86 °F), in a well-closed, light-resistant container, unless otherwise specified by manufacturer. Protect from freezing. {05}

Incompatibilities:
Clioquinol is incompatible with oxidizing agents.

Auxiliary labeling:
   • For external use only.
   • Do not use in or around the eyes.
   • Continue medication for full time of treatment.

Additional information:
Clioquinol and hydrocortisone cream is available in a water-washable base {06} and is used primarily on moist, weeping lesions because of its slight drying effect. {02} {05}


CLIOQUINOL AND HYDROCORTISONE LOTION

Usual adult and adolescent dose
See Clioquinol and Hydrocortisone Cream.

Usual pediatric dose
See Clioquinol and Hydrocortisone Cream.

Strength(s) usually available
U.S.—
{05}

3% of clioquinol and 1% of hydrocortisone (Rx) [Vioform-Hydrocortisone Lotion{05}{14} (methylparaben) (propylparaben)]

Canada—
Not commercially available.

Packaging and storage:
Store below 30 °C (86 °F), in a well-closed, light-resistant container, unless otherwise specified by manufacturer. Protect from freezing. {05}

Incompatibilities:
Clioquinol is incompatible with oxidizing agents.

Auxiliary labeling:
   • Shake well.
   • For external use only.
   • Do not use in or around the eyes.
   • Continue medication for full time of treatment.

Additional information:
Clioquinol and hydrocortisone lotion is used primarily behind the ears and in intertriginous areas of the body. {02} {05}


CLIOQUINOL AND HYDROCORTISONE OINTMENT

Usual adult and adolescent dose
See Clioquinol and Hydrocortisone Cream.

Usual pediatric dose
See Clioquinol and Hydrocortisone Cream.

Strength(s) usually available
U.S.—
{05}

3% of clioquinol and 0.5% of hydrocortisone (Rx) [Vioform-Hydrocortisone Mild Ointment{05}{14}]


3% of clioquinol and 1% of hydrocortisone (Rx) [Vioform-Hydrocortisone Ointment{05}{14}]

Canada—
{06}

3% of clioquinol and 1% of hydrocortisone (Rx) [Vioform-Hydrocortisone Ointment]

Packaging and storage:
Store below 30 °C (86 °F), in a well-closed, light-resistant container, unless otherwise specified by manufacturer. Protect from freezing.

Incompatibilities:
Clioquinol is incompatible with oxidizing agents.

Auxiliary labeling:
   • For external use only.
   • Do not use in or around the eyes.
   • Continue medication for full time of treatment.

Additional information:
Clioquinol and hydrocortisone ointment is used primarily on dry lesions that are thickened and scaly. {02} {05}

Clioquinol and hydrocortisone ointment is available in a petrolatum-base, which may be more occlusive and may cause increased absorption.



Revised: 07/19/1994



References
  1. Indications Index review, 1986.
  1. Vioform-Hydrocortisone pkg insert, Ciba (U.S.), PDR 1988: 891.
  1. USP DI 1989, VA Medication Classification System: 2472.
  1. Package insert, Racet Cream (Lemmon), Rev 9/87, Rec 10/88.
  1. Package insert, Vioform-Hydrocortisone (Ciba), Rev 2/86, Rec 1/89.
  1. CPS 1988, Vioform-Hydrocortisone (Ciba): 995.
  1. USAN 1989: 136.
  1. USAN 1989: 278.
  1. USP Description and Solubility, 4/3/89.
  1. AMA Drug Evaluations, 6th ed.: 1511.
  1. AMA Drug Evaluations, 6th ed.: 1003.
  1. AHFS 1988: 2023.
  1. Hold
  1. PDR-91, Vioform-HC: 874, revised 2/86.
  1. PI Canada, Vioform-HC, Ciba: Rec 12/88.
  1. CPS-91, Vioform-HC, Ciba: 1311.
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