Pharmacokinetics in children

In pediatric patients (6-17 years):

Tmax: 5 h
T½: 18 h

The pharmacokinetics of guanfacine in children (6 to 12 years) and adolescents (13 to 17 years) with ADHD and adults are comparable.

[SmPC Intuniv]

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

In cases of severely reduced renal function (creatinine clearance less than 30 ml/min), dose reduction may be needed.

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%): sleepiness (in 41%), headaches (in 27%), lower abdominal pain and fatigue.

Common (1-10%): decreased appetite, weight gain. Depression, anxiety, affect lability, insomnia, insomnia, nightmare, irritability, sedation. Dizziness, lethargy. Bradycardia, (orthostatic) hypotension. Vomiting, diarrhea, nausea, constipation, dry mouth. Skin rash. Bedwetting.

Uncommon (0.1-1%): hypersensitivity. Agitation, hallucination. Convulsion, syncope. First degree AV block, tachycardia, sinus arrhythmia. Whiteness. Asthma. Dyspepsia. Itching. Pollakiuria. Asthenia, chest pain, decreased heart rate. Increased ALT.

Rare (0.01-0.1%: hypersomnia. Hypertension. Malaise.

Very rare (<0.01%): hypertensive encephalopathy (due to an increase in blood pressure after abrupt cessation of treatment).

Also  reported: erectile dysfunction.

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

Prior to treatment, assess the patient's increased risk of hypotension, bradycardia, arrhythmia with QT prolongation; To do this, make an inventory of the cardiovascular status, including heart rate, blood pressure and whether there is a family history of sudden death (due to the heart or unexplained). Use caution if you have a history of hypotension, heart block, bradycardia, history of QT prolongation, risk factors for torsade de pointes (such as hypokalaemia) or cardiovascular disease, or if you have a history of syncope or any condition that makes the patient more prone to syncope, such as (orthostatic) hypotension, bradycardia or dehydration. Advise patients to drink a lot. During dose titration, monitor heart rate and blood pressure weekly, at least every 3 months for the first year and then every 6 months (more frequently after dose adjustment). Continue to monitor blood pressure during tapering and after stopping treatment, as an increase in blood pressure may occur.

Check height, weight and BMI before treatment, every 3 months for the first year and every 6 months thereafter.

During dose titration, monitor weekly for symptoms of somnolence, sedation, hypotension and bradycardia. Evaluate at least every 3 months during the first year of treatment and then every 6 months for symptoms of somnolence, sedation, hypotension, bradycardia and weight gain / risk of obesity; monitor more frequently after each dose adjustment.

Use of this medicine has a moderate to severe influence on the ability to drive. Avoid operating machines, driving vehicles and cycling until the patient knows how he or she is responding to treatment.

Interactions

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

• CARDIOVASCULAR SYSTEM
• ANTIHYPERTENSIVES

ANTIADRENERGIC AGENTS, CENTRALLY ACTING

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. Shire Pharmaceuticals Ireland Limited, SmPC Intuniv (EU/1/15/1040/001-009) 08-11-2016, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring

Overdose