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Clioquinol and hydrocortisone: Drug information

Clioquinol and hydrocortisone: Drug information
(For additional information see "Clioquinol and hydrocortisone: Patient drug information" and see "Clioquinol and hydrocortisone: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ala-Quin
Pharmacologic Category
  • Antibiotic, Topical;
  • Antifungal Agent, Topical;
  • Corticosteroid, Topical
Dosing: Adult
Dermatologic disorders

Dermatologic disorders: Topical: Apply a thin film 2 to 4 times daily.

Vioform Hydrocortisone [Canadian product]: Apply a thin film 2 to 3 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Clioquinol and hydrocortisone: Pediatric drug information")

Note: Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually.

Dermatologic disorders

Dermatologic disorders:

Children ≥2 years and Adolescents: Clioquinol 3%/hydrocortisone 0.5% cream: Topical: Apply a thin film to affected area 2 to 4 times daily.

Canadian labeling: Vioform Hydrocortisone (clioquinol 3%/hydrocortisone 1%) cream: Topical: Children ≥2 years and Adolescents: Apply a thin film 2 to 3 times daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported with combination product; frequency not defined.

Dermatologic: Allergic skin reaction, dyschromia, epidermal thinning, hair discoloration, skin rash

Hematologic & oncologic: Nonthrombocytopenic purpura

Contraindications

Hypersensitivity to iodochlorhydroxyquin, hydrocortisone, chloroxine, iodine, iodine-containing preparations, or related compounds; eye lesions; tuberculosis of the skin; herpes simplex, vaccinia, eczema vaccinia, varicella, or other viral infections of the skin.

Canadian labeling: Additional contraindications (not in US labeling): Syphilitic skin infections; application to large areas, ulcerated areas, or to the eye; children <2 years.

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Sensitization: Topical use has been associated with irritation (rare); discontinue use if irritation occurs.

• Superinfection: Prolonged use may result in overgrowth of nonsusceptible organisms requiring appropriate therapy.

• Staining: May stain skin and fabrics; may discolor (yellowing) hair and fingernails (rare).

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, and/or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

• Thyroid disease: Use caution in patients with thyroid disease.

Special populations:

• Pediatric: Topical application poses a potential risk of toxicity to infants and children; striae has been reported with use of some corticosteroids in infants and children. Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Appropriate response: Re-evaluate patient if no response within 1 to 2 weeks.

• Appropriate use: Avoid use on large or eroded areas, use for >1 week, and use of occlusive dressings.

Warnings: Additional Pediatric Considerations

Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients. Monitor closely for adverse effects in patients who require longer duration of therapy (>14 days), a dosing frequency of 3 to 4 times daily, application to >5% to 10% of body, or use of an occlusive dressing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Ala-Quin: Clioquinol 3% and Hydrocortisone 0.5% (28.4 g); Clioquinol 3% and hydrocortisone 0.5% (80 g [DSC]) [contains cetyl alcohol, polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Cream (Ala-Quin External)

3-0.5% (per gram): $17.95

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only; avoid contact with eyes. Apply a thin film to clean, dry skin and rub in gently. Can stain skin and fabric. Use of occlusive dressings is not recommended.

Administration: Pediatric

Topical: For external use only; avoid contact with eyes. Apply a thin film to clean, dry skin and rub in gently. May stain skin, hair, nails, and fabric. Wash hands after application unless site of treatment.

Use: Labeled Indications

Dermatologic disorders: Acute and chronic dermatologic disorders including 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.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women (Reed, 1997).

Breastfeeding Considerations

Systemically administered corticosteroids are excreted in breast milk and endogenous hydrocortisone is also found in human milk. It is not known if systemic absorption following topical administration results in detectable quantities in human milk. Use with caution while breast-feeding; do not apply to nipples (Reed, 1997).

Monitoring Parameters

Observe affected area for increased irritation; growth in children.

Mechanism of Action

Clioquinol is a broad spectrum antibacterial and antifungal agent; hydrocortisone is a corticosteroid that decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Topical corticosteroids are absorbed percutaneously. The extent is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, and the use of occlusive dressings

Metabolism: Hepatic

Excretion: Urine, bile

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Dermocort;
  • (AU) Australia: Hydroform;
  • (BR) Brazil: Cliotisona | Hidrocorte | Vioformio-hidrocortisona;
  • (CO) Colombia: Cortinol d;
  • (EG) Egypt: Dermocort | Vioderm Hydrocort;
  • (GB) United Kingdom: Barquinol h c | Dioderm c | Vioform hydrocortisone;
  • (HK) Hong Kong: Cliocort | Euro hydroform | Hydrocortisone with clioquinol | Hydroform;
  • (ID) Indonesia: Kalviocort | Vio-cortone | Viocortiderm;
  • (IE) Ireland: Vioform hydrocortisone ointment;
  • (IN) India: Cortoquinol;
  • (JO) Jordan: Dermocort;
  • (KW) Kuwait: Vioform hydrocortisone;
  • (MX) Mexico: Ultracortin | Vioformo-Cort;
  • (MY) Malaysia: Barquinol hc;
  • (PK) Pakistan: Clioquinol hydrocortisone;
  • (QA) Qatar: Cliocort | Vioderm Hydrocortisone;
  • (SA) Saudi Arabia: Dermocort | Vioform hydrocortisone;
  • (SG) Singapore: Hydroderm-C | Hydroform
  1. Ala-Quin (clioquinol and hydrocortisone) [prescribing information]. Johnson City, TN: Crown Laboratories Inc; October 2015.
  2. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  3. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  4. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  5. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  6. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  7. Reed, BR. Dermatologic Drugs, Pregnancy, and Lactation. A Conservative Guide. Arch Dermatol. 1997;133(7):894-898. [PubMed 9236528]
  8. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  9. Vioform Hydrocortisone (clioquinol and hydrocortisone) [product monograph]. St-Laurent, Quebec, Canada: Paladin Labs Inc; January 2015.
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