Riociguat

Generic name
Riociguat
Brand name
ATC Code
C02KX05
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

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

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

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.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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.

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

OTHER ANTIHYPERTENSIVES

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

Serotonin antagonists
C02KD01
Antihypertensives for pulmonary arterial hypertension
C02KX02
C02KX01
C02KX04

Reference

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

Changes

Therapeutic Drug Monitoring


Overdose