Focalin for Adults
Although Focalin is not approved for use in adults with ADHD, a healthcare provider may prescribe Focalin to treat adult ADHD if he or she believes that the medicine is appropriate for that person's particular situation. Using Focalin for adults with ADHD is considered an "off-label" use of the medication. An off-label use means that a prescription medication is used to treat a disease or condition other than what the FDA has approved it to treat.
Focalin® (dexmethylphenidate hydrochloride) is a prescription medication licensed to treat attention deficit hyperactivity disorder (ADHD) in children and teenagers. Focalin is not approved to treat adult ADHD.
Focalin has not been adequately studied in adults. However, a healthcare provider may prescribe Focalin to an adult in certain situations. Using Focalin to treat ADHD in adults is considered an "off-label" use of the medication. An off-label use means that a prescription medicine is used to treat a disease or condition other than what it has been approved to treat by the U.S. Food and Drug Administration (FDA).
Although the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor's ability to prescribe the medication for different conditions, in different doses, or for different lengths of time. The practice of prescribing medication for periods of time or for conditions that are not FDA-approved is known as "off-label" use. Your healthcare provider will prescribe a medicine for an off-label use when he or she feels that the medicine is appropriate for your situation.
While such use often occurs in the treatment of many conditions, you should feel comfortable about asking your doctor if he or she is using a medication or combination of medications in a manner that is not approved by the FDA.