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Methylin promotional brochure © 2006 Alliant Pharmaceuticals, Inc. Methylin is a registered trademark of Mallinckrodt Inc. Give 'em the grape! Liquid & Chewable Medications for ADHD Methylin oral solution (Methylphenidate HCl) 5mg/5ml & 10mg/5ml Methylin chewable tablets (Methylphenidate HCl) 2.5mg, 5mg & 10mg ADHD Overview Attention-Deficit/Hyperactivity Disorder (ADHD) is a long term disorder caused by changes in brain chemistry. It is the most common behavioral disorder in school age children. The American Academy of Pediatrics estimates that 4% to 12% of school age children may have ADHD. ADHD is more common in boys than girls. In fact, the American Psychiatric Association reports that the ratio can be as high as 3 to 1 (3 boys to 1 girl). ADHD is often inherited. This means that other family members may have the disorder. It does NOT mean children in the same family will develop ADHD. How can you tell if your child has ADHD? ADHD is comprised of problems related to inattention, hyperactivity and impulsivity. Depending on the type and number of symptoms a child can have one of three ADHD diagnoses. These are: * ADHD-Hyperactive-Impulsive Type * ADHD-Inattentive Type * ADHD-Combined Type To be diagnosed with the Hyperactive-Impulsive Type, a child must exhibit 6 or more of the following symptoms for at least 6 months: * Fidgets with hands or feet or squirms in their seat * Has trouble staying in their seat * Runs around or climbs when not appropriate * Has difficulty playing or engaging in activities quietly * Is always on the go * Talks excessively To be diagnosed with the Inattentive Type, a child must exhibit 6 or more of the following symptoms for at least 6 months: * Is unable to pay close attention to details or makes careless mistakes * Has difficulty sustaining attention in task or play activities * Often does not seem to listen when spoken to * Is unable to follow through on instructions * Has difficulty with organization * Avoids tasks requiring sustained effort * Is easily distracted * Is often forgetful To have the Combined Type diagnosis, a child must meet at least 6 symptoms in each of the first two types. How can ADHD impact my child? Without diagnosis and proper management, ADHD can have devastating consequences, including failure in school, depression, violent behavior, substance abuse, relationship problems, and failure to keep a job. If you suspect you or a family member may have ADHD, you should speak with your doctor about proper evaluation, diagnosis, and treatment. "Frequently, problems are encountered in oral administration of medicines to children... these problems can be reduced by providing better tasting liquid formulations and/or chewable tablets. " 2 Easy to swallow liquid for younger children with ADHD Methylin Oral Solution for kids is the only grape-flavored liquid on the market for children with ADHD. Crushing tablets, spilling capsules, and hiding medicine in applesauce and other such foods is a thing of the past. If you're having trouble getting your child to take his or her medicine, maybe it's time to give them the grape. Flexible dosing for younger patients * Great grape flavor * 100% of patients said they would rather take their ADHD medication in the form of a liquid or an oral solution than crush their medication or mix it with applesauce. 3 * 83% of patients rated the taste of Methylin Oral Solution as positive. 3 52% of children age 6 through 12 have difficulty swallowing tablets 2 Easy to chew tablets for older children with ADHD * Easy dosing for older children * Great grape flavor * Excellent for kids who have difficulty swallowing pills * Great option for kids who could benefit from an add-on dose 26% of patients in one study of 6,158 participants reported difficulty in swallowing pills 4 References: 1. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV), American Psychiatric Association, Washington D.C., 1994. 2. Steffensen GK, Pachai A, Pedersen SE, "Oral administration of medicines to children - are there any problems?" Ugeskrift for Laeger 160(15):2249-2252, 1998. 3. Data on file, Alliant Pharmaceuticals, Inc. 4. Andersen 0, Zweidorff OK, Hjelde. T, Rodland EA, Problems when swallowing tablets: A Questionnaire study from general practice. Tidsskrift for Den Norske Laefeforening 115(8):947-949, 1995. Methylin Oral Solution & Methylin Chewable Tablets should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances. Contraindications to Methylin Oral Solution & Methylin Chewable Tablets include marked anxiety, tension, agitation, hypersensitivity to methylphenidate, glaucoma, motor tics, and a family history or diagnosis of Tourette's syndrome. Methylin Oral Solution & Methylin Chewable Tablets has not been studied in children under six years of age. Use cautiously in patients with hypertension. The safe use of Methylin Oral Solution & Methylin Chewable Tablets during pregnany has not been established. Nervousness and insomnia are the most common adverse reactions. In children, loss of appetite and abdominal pain may occur with prolonged therapy. Special Precautions: Nervousness and insomnia are the most common adverse reactions to methylphenidate. Additional effects may include, bur are not limited to, skin rash, loss of appetite, dizziness, and headache. Methylin Oral Solution has not been studied in children under 6 years of age. At all times this medication should be kept in a childproof bottle and out of the reach of children. Alliant Pharmaceuticals only advocates pharmacological therapy as a part of the comprehensive treatment program for ADHD. Only your physician can decide if Methylin Oral Solution or Methylin Chewable Tablets are right for you. If you have any questions, talk with your doctor or visit us at www.givemethegrape.com For special offers visit our web site at: www.givemethegrape.com or contact Alliant Pharmaceuticals at: 1-877-817-ADHD (2343) If any of the following apply to you, talk to your doctor about Methylin Oral Solution and Methylin Chewable Tablets. For pediatric ADHD patients: * Who cannot or will not swallow a tablet * Who are beginning treatment * Who prefer a great tasting GRAPE flavored medication For younger adolescent and adult ADHD patients: * Who do not like to take pills * Who do not like to take an all day stimulant on the weekends and only need control for sports events or church * Who are highly sensitive to medications and need a low or precise dose * Who are autistic or developmental disabled and need an easy to take formulation * Who need a medication they can take around meals to avoid appetite decline For adult ADHD patients: * Who have difficulty swallowing pills Organizations and web sites that offer information and/or support for people with ADHD Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) www.chadd.org 8181 Professional Place, Suite 150, Landover, MD 20785 Phone: 800.233.4050 Attention Deficit Disorder Association (ADDA) www.add.org P.O. Box 543, Pottstown, PA 19464 Phone: 484.945.2101 Learning Disabilties Association of America (LDA) www.ldaamerica.us 4156 Library Road, Pittsburgh, PA 15234 Phone: 412.341.1515 ADHD Web Sites www.adhdnews.com www.addwarehouse.com www.nimh.nih.gov/pub/icat/adhd.cfm www.aap.org/healthtopics/adhd.cfm Allant Pharmaceuticals, Inc 333 North Point Center, Suite 250, Alpharetta, GA 30022 www.alliantpharma.com © 2006 Alliant Pharmaceuticals, Inc. Methylin is a registered trademark of Mallinckrodt Inc. MET 221 ~ September 2008 Warning Letter to Mallinckrodt Inc. from FDA Division of Drug Marketing, Advertising, and Communications. |