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FDA Approves New Extended-Release Ritalin

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Dec. 6, 1999 (Atlanta) -- The FDA has approved an extended-release form of Ritalin (methylphenidate) that may remove the need for midday dosing in people with attention deficit hyperactivity disorder (ADHD).

It will be marketed under the name Metadate. The 10 mg dose will "offer physicians more flexible dosing options that can help determine each patient's optimum Ritalin dose. This is important," according to a press release from the drug's manufacturer, "because it may help patients achieve behavioral improvement using the lowest flexible dose."

There is already a 20 mg dose of extended-release Ritalin available to help control ADHD, but it cannot be cut in half. Many individuals with ADHD often have a "window" of effectiveness for their medication, which means a fine balance between too much and too little of the drug. This 10 mg dose gives doctors, and patients, another option.

Because it is extended-release, the 10 mg Ritalin dose will slowly release its contents, perhaps lessening the need for a midday dose. Short-acting Ritalin gets into the system quicker, but must be taken several times daily to maintain effectiveness. This can sometimes prove difficult for a child who is resistant to taking medication, or cannot get the school to administer the drug at the proper time.

ADHD may afflict as many as 5% of school-aged children in the U.S. Ritalin, a stimulant, is the most-widely prescribed medication for the treatment of ADHD symptoms such as inappropriate levels of attention and concentration, distractibility, and impulsivity. Ritalin and other stimulants in its class such as Adderall (amphetamine mixed salts), Dexedrine (dextroamphetamine sulfate), and Cylert (pemoline), have been shown to help about 70% of the people with ADHD.

As with the other stimulants, there are possible side effects of Metadate, according to the manufacturer, so it should only be considered "after conducting a complete history and evaluation of the patient." Side effects include nervousness and insomnia.

 

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