Posted by Phillipa on November 21, 2008, at 19:54:16
Thought this might be of some interest to those with ADHD or parents of children. Hope You enjoy. Phillipa
FDA Approvals
FDA Approves Focalin XR for ADHD
November 21, 2008 The US Food and Drug Administration has approved dexmethylphenidate HCl extended-release capsules (Focalin XR, Novartis) for the treatment of attention-deficit/hyperactivity disorder (ADHD), according to a November 12 Novartis news release. The 30-minute onset of action is thought to benefit young patients because it helps control symptoms during the early morning while they are preparing for school and attending classes."The morning is a critical time for families," said Alice Mao, MD, associate professor of psychiatry at the Baylor College of Medicine in Houston, Texas. "The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine."
Clinical trial research supporting the new labeling includes data from a study of 86 children with ADHD aged 6 to 12 years. In that study, compared with placebo the dexmethylphenidate HCl extended-release capsules were associated with significant improvements in attention, deportment, and academic productivity measured 30 minutes postdose.
Prevalence of ADHD among US children is about 3% to 6%. The associated symptoms of poor attention and of hyperactive and impulsive behavior often impair school performance.
Caregivers report that behavioral problems in their child or adolescent with ADHD are typically more severe in the morning than at other times, according to a 2007 Harris survey of 1001 caregivers of young patients with ADHD. This survey showed greater impairments during morning hours in 12 of 16 common behaviors, including poor concentration, messiness, interrupting others, failing to complete tasks, and speaking out of turn.
"The 30-minute onset of action can help children with ADHD improve their morning academic productivity in school," said Rafael Muniz, MD, senior medical director, Novartis Pharmaceuticals Corp. "Focalin XR also allows them to effectively manage their symptoms for up to 12 hours getting them through school and homework time."
Prescribing information from the Novartis site states that dexmethylphenidate HCl extended release is a central nervous system stimulant indicated for the treatment of ADHD in patients aged 6 years and older. The drug should be given cautiously to patients with a history of drug dependence or alcoholism, because chronic abusive use can result in marked tolerance and psychological dependence.
Dexmethylphenidate HCl extended release is intended for oral administration once daily in the morning, swallowed whole or capsule contents sprinkled on applesauce, but not crushed, chewed, or divided. Methylphenidate-naive patients should start treatment with the drug at 5 mg/day for children and 10 mg/day for adults, titrated weekly in 5-mg increments to a maximum of 20 mg/day for children and in 10-mg increments to a maximum of 20 mg/day for adults.
For patients already receiving methylphenidate, dexmethylphenidate HCl extended-release capsules should be started at half the current total daily dose of methylphenidate. Those already receiving dexmethylphenidate immediate release should switch to the same daily dose of dexmethylphenidate HCl extended release.
The drug should not be used during or within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor. Reported serious adverse events of central nervous system stimulant treatment include sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction in adults taking stimulant drugs at usual doses for ADHD; hypertension; tachycardia; psychotic symptoms; long-term growth suppression; and seizures.
Common adverse reactions (at least 5% and twice as common as in placebo-treated patients) are dyspepsia, decreased appetite, headache, and anxiety for pediatric patients and dry mouth, dyspepsia, headache, and anxiety for adult patients.
On the basis of animal data, dexmethylphenidate HCl extended-release capsules may cause fetal harm. Caution should be exercised regarding the drug's use in nursing women.
poster:Phillipa
thread:864543
URL: http://www.dr-bob.org/babble/20081114/msgs/864543.html