Atovaquone + proguanil

Generic name
Atovaquone + proguanil
Brand name
ATC Code
P01BB51
Compare …

Atovaquone + proguanil

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following pharmacokinetic parameters were determined in children (>5 kg):

  Atovaquon Proguanil
Vd (l/kg) 8,8 20 - 79
T1/2 (h) 24 - 48  12 - 15
Cl (l/h) 0,5 - 6,3 8,7 - 64

The Clearance after oral intake of atovaquone and proguanil increases with increasing body weight and is approximately 70% higher in a 40 kg person than in a 20 kg person.

[SmPC Malarone® Junior Filmtabletten 62,5 mg/25 mg]

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

Prophylaxis for malaria
  • Oral
    • 5 up to 9 kg

      • Atovaquon/proguanil: 31,25 /12,5 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 9 up to 11 kg

      • Atovaquon/proguanil: 46,875 /18,75 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 11 up to 21 kg

      • Atovaquon/proguanil: 62,5/25 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 21 up to 31 kg

      • Atovaquon/proguanil: 125/50 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 31 up to 41 kg

      • Atovaquon/proguanil: 187,5/75 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • ≥ 41 kg

      • Atovaquon/proguanil: 250/100 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 5 up to 9 kg
      [3]

      • Atovaquon/proguanil: 31,25 /12,5 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 9 up to 11 kg
      [3]

      • Atovaquon/proguanil: 46,875 /18,75 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 11 up to 21 kg
      [2]

      • Atovaquon/proguanil: 62,5/25 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 21 up to 31 kg
      [2]

      • Atovaquon/proguanil: 125/50 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • 31 up to 41 kg
      [2]

      • Atovaquon/proguanil: 187,5/75 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

    • ≥ 41 kg
      [2]

      • Atovaquon/proguanil: 250/100 mg/day in 1 dose

      • Duration of treatment:

        Prophylaxis of malaria must:
        •start 24 to 48 hours before entering the malaria risk area
        • continue throughout the stay
        •continue until 7 days after leaving the high-risk area

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
When used prophylactically
GFR 30-50 ml/min/1.73 m2
100 percentage of single dose and dosing interval : 24 uur
When used prophylactically
GFR 10-30 ml/min/1.73 m2
Do not administer
When used prophylactically
GFR < 10 ml/min/1.73 m2
Do not administer
When used prophylactically

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

Side effects

No information is present at this moment.

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

Contra-indications in children

Contraindicated for prophylactic use in severely reduced renal function (creatinine clearance < 30 ml/min).

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

In the event of vomiting within one hour after intake, give a new dose.

The tablet or tablets should preferably be taken at the same time every day, in their entirety with food or a dairy beverage. Malarone Junior should preferably be taken whole; in cases of swallowing problems in younger children, the tablets can be crushed right before intake and taken with food.

If no food can be tolerated, the tablets can also be taken without food; the systemic exposure to atovaquone is then decreased by a factor of 2-3.

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
Artemisinin and derivatives, combinations
P01BF01
P01BF05

References

  1. Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
  2. GlaxoSmithKline BV, SPC Malarone Junior (RVG 28319) en Malarone (RVG 25386) 28-03-2016, www.geneesmiddeleninformatiebank.nl
  3. LCR, Malariabulletin , April 2024
  4. LCR, Malariabulletin, April 2024

Changes

Therapeutic Drug Monitoring


Overdose