Pharmacokinetics in children

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

Renal impaiment in children > 3 months

Mild to moderately reduced kidney function:

• < 40 kg: start with 10 mg/day in 1 doses. Based on effect and tolerability, the dosage can be increased to 20 mg/day
• ≥ 40 kg: start with 20 mg/day in 1 doses. Based on effect and tolerability, the dosage can be increased to 40 mg/day

Severe renal impairment ( < 40 kg and ≥ 40 kg): do not use

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 frequency, type and severity of side effects in children and adolescents are similar to those in adults.

Reported adverse events during the study phase:

• RCT: The most common adverse reactions, occurring in ≥2 children treated with tadalafil, were headache (29.4%), upper respiratory tract infection and influenza (both 17.6%), and arthralgia and epistaxis (both 11.8%)
• PK study: Serious adverse events were reported in 8 patients (42.1%). These were pulmonary hypertension (21.0%), viral infection (10.5%), and heart failure, gastritis, pyrexia, type 1 diabetes mellitus, febrile convulsions, presyncope, convulsions and ovarian cyst (both 5.3%). In no patient was treatment discontinued due to adverse events. Adverse events that occurred during treatment were reported in 18 patients (94.7%), and the most common adverse events that occurred during treatment (occur in ≥5 patients) were headache, pyrexia, viral upper respiratory tract infection, and vomiting. Two deaths were reported.
• Post marketing study: The incidence of adverse events (≥5 patients) were pulmonary hypertension (3.6%), headache (2.8%), heart failure and decreased platelet count (both 2.0%), epistaxis and upper respiratory tract infection (both 1.8%) bronchitis, diarrhea and abnormal liver function (both 1.5%), and gastroenteritis, gastroenteropathy with protein loss and increased aspartate aminotransferase (both 1.3%). The incidence of serious adverse events was 12.0% (≥3 patients), including pulmonary hypertension (3.6%), heart failure (1.5%) and pneumonia (0.8%)

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

• GENITO URINARY SYSTEM AND SEX HORMONES
• UROLOGICALS

UROLOGICALS

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

Reference

1. Eli Lilly Nederland B.V., SmPC Adcirca (EU/1/08/476/007) Rev 18, 09-07-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring

Overdose