Ketoconazole

Generic name
Ketoconazole
Brand name
ATC Code
D01AC08
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Ketoconazole

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No detectable amounts of ketoconazole in the serum in children aged < 1 year [Brodell 1998]
After topical application, the serum concentration of ketoconazole is 1-2% of the serum concentration for systemic administration. Percutaneous absorption is minimal and peaks after 2-3 hours. There is no accumulation in the plasma. [Taieb 1990]

In infants aged 1-5 months with seborrhagic dermatitis, plasma concentrations of up to 0.133 mg/l have been measured [SPC of Nizoral]
 

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Fungal infection van the skin, seborrhoeic dermatitis
  • Cutaneous
    • 1 month up to 18 years

      • 2%: apply once or twice daily

      • Duration of treatment:

        2-4 weeks

    • Term neonate

      • 2%: apply once or twice daily

      • Duration of treatment:

        2-4 weeks

    • 1 month up to 18 years
      [2] [3] [5]

      • 2%: apply once or twice daily

      • Duration of treatment:

        2-4 weeks

    • Term neonate
      [2] [3] [5]

      • 2%: apply once or twice daily

      • Duration of treatment:

        2-4 weeks

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Burning sensation, erythema, itching, contact dermatitis, eye irritation (for the shampoo)

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIFUNGALS FOR TOPICAL USE

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
D01AA01
Imidazole and triazole derivatives
D01AC01
D01AC02
D01AC20
D01AC09
Other antifungals for topical use
D01AE14
D01AE13
D01AE15
IMIDAZOLE AND TRIAZOLE DERIVATIVES
D01AC01
D01AC02
D01AC20
D01AC09
OTHER ANTIFUNGALS FOR TOPICAL USE
D01AE14
D01AE13
D01AE15

References

  1. Sheffield RC, et al, Clinical inquiries. What's the best treatment for cradle cap?, J Fam Pract, 2007, Mar;56(3), 232-3
  2. Taieb A, et al, Topical ketoconazole for infantile seborrhoeic dermatitis, Dermatologica, 1990, 181(1), 26-32
  3. Cohen S, Should we treat infantile seborrhoeic dermatitis with topical antifungals or topical steroids?, Arch Dis Child, 2004, Mar;89(3), 288-9
  4. Brodell RT, et al, The safety of ketoconazole shampoo for infantile seborrheic dermatitis, Pediatr Dermatol, 1998, Sep-Oct;15(5), 406-7
  5. Nederlands Huisartsen Genootschap (NHG), NHG Standaard Dermatomycosen, https://richtlijnen.nhg.org/standaarden/dermatomycosen#samenvatting-richtlijnen-beleid, 2022 (feb)
  6. EurimPharm Arzneimittel GmbH, SmPC Fungoral 2% Creme (62088.00.00), 09/15
  7. Uptodate: UpToDate®, Pediatric Drug information: Ketoconazole topical Topic 16005 Version 146.0, accessed 03/19
  8. Dermapharm AG, SmPC, Ketozolin 2% Shampoo (86873.00.00), 01/18
  9. Hexal AG, SmPC, Ket ® med 20 mg/g Shampoo (63006.00.00), 09/16
  10. Johnson & Johnson GmbH, SmPC, Terzolin 2 % Creme (15003.00.00), 09/15
  11. Johnson & Johnson GmbH, SmPC, Nizoral 2 % Creme (1585.00.01), 09/15
  12. STADA GmbH, SmPC, Terzolin® 2% Lösung zur Anwendung auf der Kopfhaut (15921.00.00), 01/19

Changes

Therapeutic Drug Monitoring


Overdose