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

Interactions
PK
Renal impairment
References

Riociguat

Generic name
Riociguat
Brand name
ATC Code
C02KX05

Pharmacokinetics in children

  Adults  Children 6-18 years1
Bioavailability2 94%  
Cmax 1-1,5 hour  
Vd 30 L 26 L
Cl 3-6 l/hour 2,48 l/hour
T1/2 7 hour (in healthy subjects) 12 hour (in patients) 8,24 hour
  1. estimated using pharmacokinetic population models
  2. The bioavailability (AUC and Cmax) of orally administered riociguat in the form of a crushed tablet mixed with applesauce or water is comparable to that of a whole tablet

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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

Pulmonary arterial hypertension
  • Oral
    • 6 years up to 18 years and ≥ 50 kg
      • Initial dose: 3 mg/day in 3 doses. for 2 weeks.
      • Maintenance dose: Adjust initial dose every 2 weeks in increments of 0.5 mg/dose (1.5 mg/day) based on systolic blood pressure and tolerance to 4.5 - 7.5 mg/day in 3 doses.
        • Do not increase the dose if systolic blood pressure is < 90 mmHg for ages 6-11 or < 95 mmHg for ages 12-18.
        • If the patient also shows symptoms of hypotension, reduce the dose by 0.5 mg 3 times a day.

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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

The side-effect profile in children is similar to that in adults.

The most common side-effects in children are hypotension and headaches.

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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

No information available on specific warnings and precautions in children.

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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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Serotonin antagonists
C02KD01
Antihypertensives for pulmonary arterial hypertension
C02KX02
C02KX01
C02KX04

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Reference

  1. Bayer AG, SmPC Adempas (EU/1/13/907/001) Rev 14, 1-08-2024, www.ema.europa.eu

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Changes

Changes