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Clioquinol (Topical)


VA CLASSIFICATION
Primary: DE101
Secondary: DE102

Commonly used brand name(s): Vioform.

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

*Not commercially available in the U.S.



Category:


Antibacterial (topical){16}

antifungal (topical){16}

Indications

Note: Because topical clioquinol is not commercially available in the U.S., the bracketed information in this monograph reflects the lack of labeled (approved) indications for this medication.

Accepted

[Dermatomycoses, superficial (treatment)]{16}
[Eczema, infected (treatment)]{16}
[Pyoderma, infected (treatment)]{16} or
[Burns, mild, infected (treatment)]{16}— Clioquinol is indicated for the treatment of nonextensive superficial infections. {16}

[Skin infections, bacterial, minor (prophylaxis and treatment)]
[Tinea barbae (treatment)]
[Tinea capitis (treatment)] or
[Ulcer, dermal (treatment)]—Clioquinol is used in the topical prophylaxis and treatment of minor bacterial skin infections and in the topical treatment of tinea barbae, tinea capitis, and dermal ulcer. {01}

—In serious skin infections, a concomitant use of systemic antibacterial or antifungal agents may be indicated {16}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    305.5 {07} {16}

Mechanism of action/Effect:

Broad-spectrum antibacterial with antifungal properties. {16} Clioquinol is bacteriostatic {16}, however, the precise mechanism of its action is unknown.


Other actions/effects:

Also possesses mild irritant properties.

Absorption:

Topical absorption is rapid and extensive, especially when the skin is covered with an occlusive dressing {10} or if the medication is applied to extensive or eroded areas of the skin {16}. Clioquinol is absorbed through the skin in sufficient amounts to affect thyroid function tests. Application of clioquinol to extensive or eroded areas of the skin may lead to increased protein-bound iodine (PBI) levels within 1 week {16}. In addition, elevated PBI levels may occur when relatively small areas of the skin are treated with clioquinol for more than 1 week {16}.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to chloroxine, hydroxyquinoline or other quinoline derivatives {16}, iodine {16}, or iodine-containing preparations may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

It is not known whether clioquinol is distributed into breast milk. {16} However, problems in humans have not been documented.

Pediatrics

Use is not recommended in infants and children up to 2 years of age. {02} {06} {16}

Clioquinol may produce false-positive ferric chloride test results for phenylketonuria (PKU) {16} if clioquinol is present in the neonate's diaper or urine. {06}


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){16}    (may produce false-positive test results if clioquinol is present in neonate's diaper or urine {06} {16})


» Thyroid function determinations{16}    (may cause significant elevation of serum protein-bound iodine [PBI] {16} or butanol-extractable iodine {16} [BEI] and a decrease in radioactive iodine [RAI] {16} uptake; at least 1 {16} to 3 months should elapse between discontinuation of clioquinol and administration of these tests. {05} {09} Other thyroid function tests such as T 3 resin sponge tests or T 4 determinations are not affected {16})


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
Hepatic failure or
Renal failure    (caution is necessary when using clioquinol in patients with hepatic or renal failure {16})


Sensitivity to clioquinol{16}


Side/Adverse Effects

Note: If signs and symptoms resembling those of thyrotoxicosis occur with use of clioquinol, the preparation should be withdrawn immediately {16}.

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}{06}{09}{16} (burning{16} , itching{16} , skin rash, redness{16} , swelling, or other signs of irritation not present before therapy or becoming worse during therapy{16})





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

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

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to clioquinol {16}, chloroxine, hydroxyquinolines or other quinoline derivatives {16}, iodine {16}, or iodine-containing preparations





Use in children—Not recommended in infants and children up to 2 years of age {16}


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

» Not using medication in or around eyes; should accidental contact with eyes occur, flushing eyes with water {16}

» Not bandaging or applying an occlusive dressing to the affected area(s), because it can aggravate the existing skin infection, and because of the possible increase in protein-bound iodine levels {16}



Proper administration technique for ointment

» Compliance with full course of therapy

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

» Proper storage

Precautions while using this medication
» Not using for more than 1 week; checking with physician if skin infection does not improve in 1 week, or if it becomes worse {16}

» Not using on extensive areas of the skin or eroded, open skin lesions, because of the possibility of increased protein-bound iodine levels {16}

Clioquinol may turn yellow in color when exposed to air and may stain fabrics, skin, hair, and nails yellow {16}; bleaching may not remove stain


Side/adverse effects
Signs of potential side effects, especially skin sensitization


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


Topical Dosage Forms

Note: Because topical clioquinol is not commercially available in the U.S., the bracketed information in this monograph reflects the lack of labeled (approved) indications for this medication.



CLIOQUINOL OINTMENT USP

Usual adult and adolescent dose
[Antibacterial]
Topical, to the skin, two or three times a day. {16}

[Antifungal]
Topical, to the skin, two or three times a day. {16}


Usual pediatric dose
Infants and children up to 2 years of age—Use is not recommended. {16}
Children 2 years of age and over—See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


3% (OTC) [Vioform (petrolatum) (sorbitan esters)]{05}{09}{14}{16}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F) {16}, unless otherwise specified by manufacturer. Store in a collapsible tube or tight, light-resistant container. Protect from freezing and excessive heat {16}.

Incompatibilities:
Clioquinol is incompatible with oxidizing agents.

Auxiliary labeling:
   • For external use only. {16}
   • Continue medication for full time of treatment.
   • Do not use in or around the eyes. {16}



Revised: 05/26/1999



References
  1. Indications Index review, 1986.
  1. Vioform package insert (Ciba—US). PDR Physicians" desk reference 1988. Oradell, NJ: Medical Economics Co. p. 891.
  1. Open.
  1. Iodochlorhydroxyquin. In: Hebel SK, editor. Drug facts amd comparisons. St. Louis: Facts and Comparisons Inc. p. 577.
  1. Vioform (Ciba). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties 1988. Ottawa: Canadian Pharmaceutical Association. p. 995.
  1. Vioform (Ciba). In: PDR Physicians" desk reference 1989. Oradell, NJ: Medical Economics Co. p. 869.
  1. Griffiths MC, editor. USAN and the USP dictionary of drug names 1989. Rockville, MD: The United States Pharmacopeial Convention Inc; 1988. p. 136.
  1. Open.
  1. Vioform package insert (Ciba-Geigy—Canada), Rec 12/88.
  1. Pediatrics. 1984 June; 73(6): 880.
  1. Open.
  1. Open.
  1. Open.
  1. Vioform cream and ointment (Ciba). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties 1991. Ottawa: Canadian Pharmaceutical Association. p. 1311.
  1. Vioform cream and ointment (Ciba). In: PDR Physicians' desk reference 1991. Oradell, NJ: Medical Economics Co. p. 874.
  1. Vioform ointment package insert (Novartis—Canada), Rev 8/98, Rec 9/98.
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