- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The average clearance (1.45 l/hour/kg) of artenimol is a little bit faster in paediatric patients than in adult patients (1.34 l/hour/kg), while the average volume of distribution in paediatric patients (0.705 l/kg) is lower than in adults (0.801 l/kg).
Piperaquine absorption rate constant and terminal half-life in children were predominantly similar to those seen in adults. However, the apparent clearance was faster (1.30 versus 1.14 l/hour/kg) and the apparent total volume of distribution was lower in the paediatric population (623 versus 730 l/kg).
(SmPC Eurartesim)
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Treatment of uncomplicated malaria |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Very common (> 10%): cough, influenza, fever.
Common (1–10%): irregular heartbeat, prolonged QTc interval. Respiratory infection. Ear infection. Conjunctivitis. Vomiting, abdominal pain, diarrhoea. anorexia. asthenia. Skin rash, dermatitis. Anemia, thrombocytopenia, leukopenia (including neutropenia), leukocytosis.
Uncommon (0.1–1%): cardiac conduction disorder, heart murmur. Headache, convulsions. Nosebleeds, rhinorrhoea. Nausea, stomatitis. joint pain. Itching, acanthosis. Hepatomegaly, hepatitis, jaundice, liver function test abnormalities. Splenomegaly, lymphadenopathy. Thrombocytosis, hypochromasia.
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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
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 in children
Be alert for hemolysis and anemia, which can occur up to one month after treatment with i.v. artesunate and oral artemisinin-based combination therapy (ACT, including artenimol/piperaquine) may occur. Risk factors include young age (< 5 years) and prior artesunate treatment. Instruct the patient to be alert for signs and symptoms of hemolysis and anemia, such as paleness, jaundice, dark urine, fever, dyspnoea, dizziness, confusion and fatigue.
Special precaution is advised in young children when vomiting, as they are likely to develop electrolyte disturbances. These may increase the QTc-prolonging effect of artenimol/piperaquine.
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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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| Aminoquinolines | ||
|---|---|---|
| P01BA01 | ||
| P01BA02 | ||
| Biguanides | ||
|---|---|---|
| P01BB51 | ||
| P01BB01 | ||
| Methanolquinolines | ||
|---|---|---|
| P01BC02 | ||
| P01BC01 | ||
| Diaminopyrimidines | ||
|---|---|---|
| P01BD01 | ||
| Artemisinin and derivatives, plain | ||
|---|---|---|
| P01BE03 | ||
| Artemisinin and derivatives, combinations | ||
|---|---|---|
| P01BF01 | ||
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References
- Sigma-Tau Industrie Farmaceutiche Riunite S.p.A., SmPC Eurartesim (EU/1/11/716/005) 27-10-2011, www.cbg-meb.nl
- Alfasigma S.p.A., SmPC Eurartesim (EU/1/11/716/005) Rev 15, 04-09-2025, www.ema.europa.eu
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Changes
Changes
