Exelon (rivastigmine) patches - all strengths - Novartis Pharmaceuticals UK Ltd - revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.2 Posology and method of administration has been updated to state that 9.5 mg/24 hours is the recommended daily effective dose which should be continued for as long as the patient continues to demonstrate therapeutic benefit. If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 hours, the treating physician may consider increasing the dose to 13.3 mg/24 hours in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on ...
Source: NeLM - Mental Health - February 28, 2013 Category: Psychiatry Source Type: news
Abilify (aripiprazole) tablets, orodispersible tablets and oral solution - Otsuka and Bristol-Myers Squibb - revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
As a result of the new paediatric indication, section 1 has been updated to include an inverted black triangle with an asterisk (*) which signifies that:
* Intensive monitoring is requested only when used for the recently-licensed indication extension to paediatric patients.
Section 4.1 Therapeutic indications now includes additional/new indications for use as below:
ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar 1 Disorder in adolescents aged ...
Source: NeLM - Mental Health - February 28, 2013 Category: Psychiatry Source Type: news
What is the risk of interaction between opioid analgesics and monoamine oxidase inhibitors (MAOIs)?
Source: South West Medicines Information and Training
Area: Evidence > Medicines Q & A
. The use of most MAOIs with opioids is contraindicated by most, but not all manufacturers. (There are significant variations between UK and US literature).
. Pethidine is the only commonly used opioid to have been reported to cause serotonin syndrome when used with MAOIs.
. Some opioid analgesics are associated with a risk of serotonin syndrome in combination with MAOIs due to inhibition of serotonin re-uptake. Other combinations may result in opioid toxicity due to CYP450 enzyme inhibition by the MAOI.
. ...
Source: NeLM - Mental Health - February 25, 2013 Category: Psychiatry Source Type: news
Exelon (rivastigmine) capsules and oral solution and patches - all strengths - Novartis Pharmaceuticals UK Ltd - revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.8 Undesirable effects has been updated to include disseminated cutaneous hypersensitivity reactions (frequency not known). Additionally, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known) have been added as additional adverse reactions that have been observed in patients with Alzheimer's dementia using Exelon transdermal patches.
Depression has been removed as an adverse reaction experienced by patients with de...
Source: NeLM - Mental Health - February 25, 2013 Category: Psychiatry Source Type: news
Association between adherence to and persistence with atypical antipsychotics and psychiatric relapse among US Medicaid-enrolled patients with schizophrenia
Source: Journal of Pharmaceutical Health Services Research
Area: Evidence > Medicines Management > References
Objective: To assess the association between adherence and persistence with second-generation oral antipsychotics (SGOAs), psychiatric-related relapse and healthcare utilisation among patients with schizophrenia experiencing two or more psychiatric-related relapses.
Methods: A retrospective analysis of the US Medicaid Multi-State Database for 2004-2008. Patients with schizophrenia (aged 18-64) with two or more psychiatric-related relapses within 1 year after SGOA initiation were selected. Ass...
Source: NeLM - Mental Health - February 25, 2013 Category: Psychiatry Source Type: news
CHMP recommends approval of generic memantine products
Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the granting of a marketing authorisation for the following memantine products for the treatment of patients with moderate to severe Alzheimer's disease:
. Memantine LEK (Pharmathen S.A)
. Memantine Mylan (Generics (UK) Ltd)
. Nemdatine (Actavis Group PTC)
These products are all generics of Ebixa®, which has been authorised in the EU since May 2002. Studies have demonstrated the satisfactory quality of these products and ...
Source: NeLM - Mental Health - February 25, 2013 Category: Psychiatry Source Type: news
Inhaled loxapine (Adasuve®) for agitation associated with schizophrenia and bipolar disorder
Source: London New Drugs Group
Area: Evidence > Drug Specific Reviews
· Loxapine is a first-generation (typical) antipsychotic used for the symptomatic management of psychotic disorders.
· Loxapine inhalation is delivered via the breath-actuated Staccato® device, through which drug is quickly vaporised to form a small particle aerosol for systemic delivery after inhalation.
· In December 2012, the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for inhaled loxapine (Adasuve®) for the rapid control of m...
Source: NeLM - Mental Health - February 21, 2013 Category: Psychiatry Source Type: news
Inhaled loxapine (Adasuve®) for agitation associated with schizophrenia and bipolar disorder
Source: London New Drugs Group
Area: Evidence > Drug Specific Reviews
· Loxapine is a first-generation (typical) antipsychotic used for the symptomatic management of psychotic disorders.
· Loxapine inhalation is delivered via the breath-actuated Staccato® device, through which drug is quickly vaporised to form a small particle aerosol for systemic delivery after inhalation.
· In December 2012, the EU Committee for Medicinal Products for...
Source: NeLM - Mental Health - February 21, 2013 Category: Psychiatry Source Type: news
Maternal depression, antidepressant use in pregnancy and Apgar scores in infants
This study tested the hypothesis that birth complications, as reflected in a low Apgar score, are explained by the effect of the maternal disease. Researchers compared the Apgar score in eight risk groups, classified according to maternal depression and exposure ... (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - February 21, 2013 Category: Psychiatry Source Type: news
Cost-effectiveness of Medicare drug plans in schizophrenia and bipolar disorder
Source: American Journal of Managed Care
Area: Evidence > Medicines Management > References
Background: US Medicare Part D has a drug coverage gap, which imposes risks for discontinuing medications, particularly in mental health disorders where drug costs are high. However, some beneficiaries have generic drug coverage in the gap.
Objectives: To examine the health outcomes and cost-effectiveness of generic-drug coverage compared with no gap coverage in patients with bipolar disorder and schizophrenia.
Study Design: Markov model-based cost-effectiveness analysis using identical hypothetical cohorts to exa...
Source: NeLM - Mental Health - February 20, 2013 Category: Psychiatry Source Type: news
Elvanse® (lisdexamfetamine dimesylate) receives UK marketing authorisation for the treatment of ADHD in children and adolescents
Source: Shire plc
Area: News
The MHRA has granted a marketing authorisation to Shire plc for Elvanse® (lisdexamfetamine dimesylate) for the treatment of attention deficit/hyperactivity disorder (ADHD) in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate. Lisdexamfetamine is a once daily long-acting prodrug stimulant, which is due to be launched in the UK at the beginning March (further details on formulations, cost, dosing etc will not be available untill product launch). (Source: NeLM - Mental Health)
Source: NeLM - Mental Health - February 14, 2013 Category: Psychiatry Source Type: news
NHS Evidence expert commentary: Citalopram for the treatment of depression
Source: NHS Evidence
Area: News
The February edition of 'Eyes on Evidence', the free monthly e-bulletin from NHS Evidence covering major new published evidence as it emerges with an explanation about what it means for current practice, includes an expert commentary on new data from a Cochrane review of 37 RCTs which assessed the efficacy, acceptability and tolerability of citalopram compared with other antidepressants in the acute-phase treatment of major depression in over 6000 patients.
Citalopram did not differ from most antidepressants in the primary outcome, the number of patients who responded to treatmen...
Source: NeLM - Mental Health - February 14, 2013 Category: Psychiatry Source Type: news
Buprenorphine prescribing practices and exposures reported to a poison center - Utah, 2002-2011
Source: Journal of the American Medical Association
Area: Evidence > Medicines Management > References
The use of buprenorphine for the treatment of opioid dependence has increased in the United States as a result of the Drug Addiction Treatment Act of 2000, which allowed physicians to prescribe certain medications as part of office-based treatment for opioid addiction. To assess statewide increases in buprenorphine use and the number of reported exposures, the Utah Department of Health analysed data from the Utah Controlled Substance Database (CSD) and the Utah Poison Control Center (PCC).
The results of ...
Source: NeLM - Mental Health - February 13, 2013 Category: Psychiatry Source Type: news
Content and quality of 10?000 controlled trials in schizophrenia over 60 years
Source: Schizophrenia Bulletin
Area: Evidence > Medicines Management > References
Objective: To carry out an up-to-date comprehensive survey of the content and quality of intervention trials relevant to the treatment of people with schizophrenia.
Design: Data were extracted and analysed from 10,000 trials on the Cochrane Schizophrenia Group's Register.
Main Outcome Measures: Source, type and date of publication, country of origin, language, size of trial, interventions, and outcome measures.
Results: In the last decade, there has been a great increase in the number of trials relevant to schizophrenia and an ...
Source: NeLM - Mental Health - February 12, 2013 Category: Psychiatry Source Type: news
Abilify® (aripiprazole) 7.5mg/mL solution for injection (intramuscular) - Revised SPC
Source: eMC (electronic Medicines Compendium)
Area: Other Library Updates > SPC Changes
Section 4.4 of the SPC has also been updated to include reports from post-marketing data of pathological gambling. Patients with a prior history of pathological gambling may be at increased risk and should be monitored carefully.
Section 4.8 of the SPC has also been updated to include the following adverse reactions - psychiatric disorders, agitation, nervousness, pathological gambling, suicide attempt, suicidal ideation and completed suicide.
Please see SPC link for full prescribing information...
Source: NeLM - Mental Health - February 12, 2013 Category: Psychiatry Source Type: news
