Artemether + lumefantrine

Generic name
Artemether + lumefantrine
Brand name
ATC Code
P01BF01
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Artemether + lumefantrine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

Treatment of uncomplicated malaria
  • Oral
    • 5 up to 15 kg
      [1] [2]

      • 20 mg artemether + 120 mg lumefantrine (1 tablet) at 0, 8, 24, 36, 48 and 60 hours.

    • 15 up to 25 kg
      [1]

      • 40 mg artemether + 240 mg lumefantrine (2 tablets) at 0, 8, 24, 36, 48 and 60 hours.

    • 25 up to 35 kg
      [1]

      • 60 mg artemether + 360 mg lumefantrine (3 tablets) at 0, 8, 24, 36, 48 and 60 hours.

    • ≥ 35 kg
      [1]

      • 80 mg artemether + 480 mg lumefantrine (4 tablets) at 0, 8, 24, 36, 48 and 60 hours.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Children ≤ 12 years of age:
Very common (> 10%): headache, decreased appetite (both in about 17%). Cough (in ca. 23%). Vomiting (approx. 20%), abdominal pain.

Common (1-10%): dizziness. Palpitations, prolonged QT interval (ECG). Nausea, diarrhea. Sleep disturbances. Fatigue, asthenia. Muscle pain, joint pain. Skin rash. Increase in liver function values.

Uncommon (0.1-1%): clonus. Itching, urticaria.

Rare (0.01-0.1%): hypersensitivity reactions.

Further reported are: angioedema. Delayed hemolytic anemia (for several weeks after discontinuation of treatment).

Children > 12 years:
Very common (> 10%): headache, dizziness. Palpitations. Nausea, vomiting, abdominal pain. Fatigue, asthenia, decreased appetite. Muscle pain, joint pain.

Common (1-10%): paresthesia, clonus, gait disturbance. Insomnia. Cough. Diarrhea. Skin rash, itching. Prolonged QT interval (ECG).

Uncommon (0.1-1%): hypoaesthesia, ataxia. Drowsiness. Urticaria. Increased liver function values.

Further reported: hypersensitivity reactions, angioedema. Delayed hemolytic anemia (for several weeks after discontinuation of treatment).

[SmPC Riamet]

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

ANTIMALARIALS

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

Aminoquinolines
P01BA01
P01BA02
Biguanides
P01BB01
Methanolquinolines
P01BC02
P01BC01
Diaminopyrimidines
P01BD01
Artemisinin and derivatives, plain
P01BE03

References

  1. Novartis Pharma BV, SmPC Riamet (RVG 25773) 04-12-2020, www.geneesmiddeleninformatiebank.nl
  2. WHO, Guidelines for the treatment of malaria., www.who.int, 2015, 3rd edition

Changes

Therapeutic Drug Monitoring


Overdose