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Paxneury is a brand name for Guanfacine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paxneury 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. Paxneury must be used as a part of a comprehensive ADHD treatment programme, typically…
Verbatim from this product's EMA label. Tap a section to expand.
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 evaluation to identify patients at increased risk of somnolence and sedation, hypotension and bradycardia, QT-prolongation arrhythmia and weight increase/risk of obesity.
4). Posology Careful dose titration and monitoring is necessary at the start of treatment 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 4 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.
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.
4). 5 kg and above Max Dose = 7 mg 1 mg 2 mg 3 mg 4 mg 5 mg 6 mg 7 mgb a Adolescent subjects must weigh at least 34 kg. 5 kg and above may be titrated to a 7 mg/day dose after the subject has completed a minimum of 1 week of therapy on a 6 mg/day dose and the physician has performed a thorough review of the subject’s tolerability and efficacy.
2 %). 7 %). The adverse reactions somnolence and sedation occurred predominantly at the start of treatment and may typically last for 2-3 weeks and longer in some cases. Tabulated list of adverse reactions The following table presents all adverse reactions based on clinical trials and spontaneous reporting.
All adverse reactions from post-marketing experience are italicised. The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Table 4. 2 % of guanfacine-treated patients. 7 % of all guanfacine-treated patients. The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment 12 and diminished gradually thereafter. 1, respectively).
Consequently, as part of routine monitoring height, weight and BMI should be monitored at the start of treatment and every 3 months during the first year, then 6 monthly taking into consideration clinical judgement with maintenance of a growth chart.
Thorough QT /QTc study The effect of 2 dose levels of immediate-release guanfacine (4 mg and 8 mg) on QT interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adults. An apparent increase in mean QTc was observed for both doses.
This finding has no known clinical relevance. 1 %) among guanfacine patients. The clinical relevance of this finding is uncertain. Blood pressure and heart rate increase upon discontinuation of guanfacine Blood pressure and pulse may increase following discontinuation of guanfacine.
4). In a maintenance of efficacy study in children and adolescents, increases in mean systolic and diastolic blood pressure of approximately 3 mmHg and 1 mmHg, respectively, above original baseline were observed upon discontinuation of guanfacine.
Hypotension, bradycardia and syncope Guanfacine can cause syncope, hypotension and bradycardia. 7). Prior to initiation of treatment, patient’s cardiovascular status including heart rate and blood pressure parameters, family history of sudden cardiac death/unexplained death, should be assessed to identify patients at increased risk of hypotension, bradycardia, and QT-prolongation/risk of arrhythmia.
Monitoring of heart rate and blood pressure parameters should continue on a weekly basis during dose titration and stabilisation and at least every 3 months for the first year, taking into consideration clinical judgement. 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustment.
Caution is advised when treating patients with guanfacine who have a history of hypotension, heart block, bradycardia, or cardiovascular disease, or who have a history of syncope or a condition that may predispose them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration.
5). Patients should be advised to drink plenty of fluid. Blood pressure and heart rate increase upon discontinuation Blood pressure and pulse may increase following discontinuation of guanfacine. 8). 2). Blood pressure and pulse should be monitored when reducing the dose or discontinuing treatment.
1 %) among guanfacine patients. The clinical relevance of this finding is uncertain. 5). 8). Sedation and somnolence Guanfacine may cause somnolence and sedation predominantly at the start of treatment and could typically last for 2-3 weeks and longer in some cases.
2), and every 3 months during the first year, taking into consideration clinical judgement. 5). Patients should not drink alcohol whilst taking guanfacine. 7). Suicidal ideation There have been post-marketing reports of suicide-related events (including suicidal ideation, attempts and completed suicide) in patients treated with guanfacine.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4), and consider trial periods off medication to assess the patient’s functioning without pharmacotherapy, preferably during times of school holidays. Downward titration and discontinuation 5 Patients/caregivers should be instructed not to discontinue guanfacine without consulting their physician.
4). 1). Missed dose If a dose is missed, the prescribed dose can resume the next day. If two or more consecutive doses are missed, re-titration is recommended based on the patient’s tolerability to guanfacine. Switching from other formulations of guanfacine Immediate-release guanfacine tablets should not be substituted on a mg/mg basis, because of differing pharmacokinetic profiles.
Special populations Adults and elderly The safety and efficacy of guanfacine in adult and the elderly with ADHD has not been established. Therefore, guanfacine should not be used in this group. 2). The impact of hepatic impairment on the pharmacokinetics of guanfacine in paediatric patients (children and adolescents 6-17 years old) was not assessed.
Renal impairment Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an end stage renal disease (GFR<15 ml/min) or requiring dialysis. 2). Children under 6 years The safety and efficacy of guanfacine in children aged less than 6 years have not yet been established.
No data are available. Patients treated with CYP3A4 and CYP3A5 inhibitors/inducers CYP3A4/5 inhibitors have been shown to have a significant effect on the […]
However, individuals may have larger increases than reflected by the mean changes. 1). Adult patients Guanfacine has not been studied in adults with ADHD. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In most cases, patients had underlying psychiatric disorders. Therefore, it is recommended that caregivers and physicians monitor patients for signs of suicide-related events, including at dose initiation/optimisation and drug discontinuation.
Patients and caregivers should be encouraged to report any distressing thoughts or feelings at any time to their healthcare professional. Aggression Aggressive behaviour or hostility has been reported in clinical trials and in the post-marketing experience of guanfacine.
Patients treated with guanfacine should be monitored for the appearance of aggressive behaviour or hostility. Effects on height, weight and Body Mass index (BMI) Children and adolescents treated with guanfacine may show an increase in their BMI.
Therefore, monitoring of height, weight and BMI should be done prior to initiation of therapy and then every 3 months for the first year, taking into consideration clinical judgement. 6 monthly monitoring should follow thereafter, with more frequent monitoring following any dose adjustment.
Excipients Paxneury contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.