|Mallinckrodt Launches Generic Version of CONCERTA® in U.S.|
Company to hold six-month exclusivity on 27, 36 and 54 milligram dosage strengths of ADHD treatment
Methylphenidate HCl ER Tablets are indicated for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of
age and older, adolescents and adults up to the age of 65 as an integral
part of a total treatment program for ADHD that may include other
measures (psychological, educational, social).
“This approval represents an important addition to our line of generic
pharmaceutical products, and we look forward to providing an affordable
treatment option to patients coping with ADHD,” said
As a result of the
IMPORTANT RISK INFORMATION FOR METHYLPHENIDATE HCl ER TABLETS
Methylphenidate HCl ER Tablets are indicated for the treatment of ADHD in children 6 years of age and older, adolescents and adults up to the age of 65.
IMPORTANT RISK INFORMATION
Methylphenidate HCl ER Tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Methylphenidate HCl ER Tablets are contraindicated in patients:
Serious adverse events, including sudden death, stroke and myocardial infarction, have been reported in patients taking usual doses.
The most common adverse reaction (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache and insomnia.
Health care professionals should monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.
Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Healthcare professionals should monitor for aggressive behavior.
Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
Methylphenidate HCl ER Tablets may cause long-term suppression of growth; monitor height and weight at appropriate intervals in pediatric patients.
Methylphenidate HCl ER Tablets also may cause gastrointestinal (GI) obstruction with preexisting GI narrowing.
Hematologic monitoring (periodic complete blood count, differential and platelet counts) are advised during prolonged therapy.
SEE FULL PRESCRIBING INFORMATION, INCLUDING ADDITIONAL IMPORTANT RISK INFORMATION ABOUT METHYLPHENIDATE HCl ER TABLETS, AT: www.mallinckrodt.com/WorkArea/DownloadAsset.aspx?id=2147483760
CONCERTA is a registered trademark of
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or Company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to effectively
introduce and market new products or keep pace with advances in
technology, the reimbursement practices of a small number of large
public and private insurers, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
intellectual property rights disputes, complex and costly regulation,
including healthcare fraud and abuse regulations and the Foreign Corrupt
Practices Act, manufacturing or supply chain problems or disruptions,
rising commodity costs, recalls or safety alerts and negative publicity