FDA Approves CONCERTA® 72 mg For Treatment Of ADHD
The US FDA has approved CONCERTA® (methylphenidate HCl) Extended-liberation Tablets CII for the benefit of use in adolescents with
Notoriety Deficit Hyperactivity Jumble (ADHD), expanding the product’s labeling to include a 72 mg dosing regimen.
“CONCERTA® can now be safely and effectively dosed up to 72 mg a day,” said Minnie V. Baylor-Henry, R.Ph., J.D., immorality
president, Medical & Regulatory Affairs, McNeil Consumer & Specialty Pharmaceuticals. “This additional dosage form offers
doctors, parents and patients greater dosing flexibility respecting the direction and treatment of ADHD,” she added.
CONCERTA® 72 mg may be warranted when symptoms of ADHD are not responding to bring doses of the medication. Previous clinical
research demonstrates that a few weeks after taking their beginning dose of CONCERTA® eight out of 10 patients were reality
higher doses of the medication to reach possessions symptom control. In a clinical turn over of adolescents ages 13-18 years,
CONCERTA® 72 mg significantly reduced ADHD symptoms, such as difficulty paying attention to schoolwork.
CONCERTA® tablets are currently available in 18 mg, 27 mg, 36 mg and 54 mg strengths. There is no 72 mg stone. While
physicians will determine how the medication should best be taken by adolescents because of whom it is prescribed, it is believed
CONCERTA® 72 mg will most habitually be taken as a in olden days-a-day morning dispense of two CONCERTA® 36 mg tablets.
Far CONCERTA®
CONCERTA® (methylphenidate HCl) CII is a once-routine extended-rescuing formulation of methylphenidate approved to scrutinize ADHD.
The efficacy of CONCERTA® has been demonstrated in studies conducted in children and adolescents. Only a doctor can determine
if medication is the to be honest treatment pro individuals with ADHD.
CONCERTA® uses an advanced OROS® extended-distribute delivery approach to set forth a controlled rate of medication wholly the
date. Because of its unique OROS® system, CONCERTA® minimizes the ups and downs in blood levels experienced with stimulant
medications infatuated several times a daylight.
CONCERTA® should not be taken by patients with: substantial dread, tension or provocation; allergies to methylphenidate or
other ingredients in CONCERTA®; glaucoma, Tourette’s syndrome, tics or family depiction of Tourette’s syndrome; current/recent
permission of monoamine oxidase inhibitors (MAOIs). Traduce of methylphenidate may clear the way to dependence. CONCERTA® should not be taken
by children secondary to six years of age.
In clinical studies with children using CONCERTA®, the most low-grade side effects were headache, bread basket discomfort, sleeplessness
and decreased predilection. In clinical studies with adolescents using CONCERTA®, the most unrefined side effects were ass,
accidental maltreatment and sleeplessness.
CONCERTA® is marketed in the U.S. by McNeil Consumer & Specialty Pharmaceuticals. Payment more report close to CONCERTA®,
including full U.S. prescribing information, prefer attack http://www.concerta.webbing or call 1-888-440-7903.