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

Interactions
PK
Renal impairment
References

Isotretinoin

Generic name
Isotretinoin
Brand name
ATC Code
D10BA01

Pharmacokinetics in children

Es sind keine pharmakokinetischen Daten bei Kindern bekannt.

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

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Available formulations

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Dosages

CAVE: PREGNANCY PREVENTION PROGRAMM FOR THIS DRUG
  • Route of administration not applicable
    • 12 years up to 18 years

      • See warnings and precautions section.
Severe acne vulgaris
  • Oral
    • 12 years up to 18 years
      • Initial dose: 0.5 mg/kg/day in 1 - 2 doses.
      • Maintenance dose: Dose adjustment depending on clinical response and side effects to 0.5 - 1 mg/kg/day in 1 - 2 doses.
      • Directions for administration:

        Take with food

        • In the event of relapse (no earlier than 8 weeks after discontinuation of therapy): A further treatment phase with the same daily dose and the same cumulative treatment dose can be considered.
        • No additional clinical benefit is expected above a cumulative treatment dose of 120-150 mg / kg.

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Renal impaiment in children > 3 months

In patients with severe renal impairment, treatment should be started with a lower dose (e.g. 10 mg/day).The dose should then be increased up to 1 mg/kg/day or up to the maximum dose tolerated by the patient.

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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

Arthralgia, myalgia, back pain (especially in children and adolescents) [SmPC]

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

Contra-indications in children

Isotretinoin is strictly contraindicated in:

  • pregnant women
  • Women of childbearing potential, unless all of the conditions of the pregnancy prevention program are met.

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

Warnings & precautions in children

Pregnancy Prevention Program

Isotretinoin is teratogenic. Isotretinoin is contraindicated in women of childbearing potential unless all of the following conditions of the pregnancy prevention program are met:

  • The childbearing ability must be assessed individually for all female patients.
  • The patient understands the teratogenic risk.
  • The patient understands the need for strict monthly monitoring.
  • The patient understands and accepts the need for reliable, continuous contraception for one month prior to treatment, throughout treatment and for one month after treatment has ended. At least one very reliable method of contraception (i.e. a user-independent method) or two complementary user-dependent methods of contraception must be used.
  • The individual situation of each patient should be assessed when choosing the method of contraception and the patient should be included in the discussion in order to ensure her cooperation and compliance with the chosen measures.
  • Even in the case of amenorrhea, the patient must follow all instructions for effective contraception.
  • The patient is informed about the possible consequences of pregnancy and understands them. She is aware that she must contact her doctor immediately if there is a possible risk that pregnancy has occurred or if pregnancy is suspected.
  • The patient understands the need and accepts to have regular pregnancy tests before and during treatment, ideally monthly, and one month after the end of treatment.
  • The patient confirms that she understands the dangers and precautions required when using isotretinoin.
  • These requirements also apply to women who are currently not sexually active, unless the prescribing doctor sees compelling reasons that there is no risk of pregnancy occurring.

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Interactions

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

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References

  1. Pelpharma, SmPC Ciscutan 5 mg Kps. (1-29997), 03/2020
  2. Mylan B.V., SmPC Isotretinoine (RVG 27573/4) 25-01-2024, www.geneesmiddeleninformatiebank.nl

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Changes

Changes