Intuniv 1 mg prolonged-release tablets
Intuniv 2 mg prolonged-release tablets
Intuniv 3 mg prolonged-release tablets
Intuniv 4 mg prolonged-release tablets
Intuniv 1 mg tablet
Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.
Intuniv 2 mg tablet
Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.
Intuniv 3 mg tablet
Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.
Intuniv 4 mg tablet
Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.
Excipient(s) with known effect
Each 1 mg tablet contains 22.41 mg of lactose (as monohydrate).
Each 2 mg tablet contains 44.82 mg of lactose (as monohydrate).
Each 3 mg tablet contains 37.81 mg of lactose (as monohydrate).
Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Prolonged-release tablet
Intuniv 1 mg tablet
7.14mm round, white to off-white tablets debossed with '1MG' on one side and '503' on the other side.
Intuniv 2 mg tablet
12.34mm x 6.10mm oblong shaped, white to off-white tablets debossed with '2MG' on one side and “503” on the other side.
Intuniv 3 mg tablet
7.94mm round, green tablets debossed with '3MG' on one side and '503' on the other side.
Intuniv 4 mg tablet
12.34mm x 6.10mm oblong shaped, green tablets debossed with '4MG' on one side and '503' on the other side.
Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
Pre-treatment screening:
Prior to prescribing, it is necessary to conduct a baseline eva luation to identify patients at increased risk of somnolence and sedation, hypotension and bradycardia, QT-prolongation arrhythmia and weight increase/risk of obesity. This eva luation should address a patient's cardiovascular status including blood pressure and heart rate, documenting comprehensive history of concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see section 4.4).
Posology
Careful dose titration and monitoring is necessary at the start of treatment with Intuniv since clinical improvement and risks for several clinically significant adverse reactions (syncope, hypotension, bradycardia, somnolence and sedation) are dose- and exposure-related. Patients should be advised that somnolence and sedation can occur, particularly early in treatment or with dose increases. If somnolence and sedation are judged to be clinically concerning or persistent, a dose decrease or discontinuation should be considered.
For all patients, the recommended starting dose is 1 mg of guanfacine, taken orally once a day.
The dose may be adjusted in increments of not more than 1 mg per week. Dose should be individualised according to the patient's response and tolerability.
Depending on the patient's response and tolerability for Intuniv the recommended maintenance dose range is 0.05-0.12 mg/kg/day. The recommended dose titration for children and adolescents is provided below (see tables 1 and 2). Dose adjustments (increase or decrease) to a maximum tolerated dose within the recommended optimal weight-adjusted dose range based upon clinical judgement of response and tolerability may occur at any weekly interval after the initial dose.
Monitoring during titration
During dose titration, weekly monitoring for signs and symptoms of somnolence and sedation, hypotension and bradycardia should be performed.
Ongoing monitoring
During the first year of treatment, the patient should be assessed at least every 3 months for:
• Signs and symptoms of:
o somnolence and sedation
o hypotension
o bradycardia
• weight increase/risk of obesity
It is recommended clinical judgement be exercised during this period. 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustments (see section 4.4).
Table 1
