Application Nr Approved Date Route Status External Links
ANDA203583 2015-09-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Attention Deficit Hyperactivity Disorder (adhd) Methylphenidate Hcl Extended-Release Capsules Are Indicated For The Treatment Of Attention Deficit Hyperactivity Disorder (adhd). The Efficacy Of Methylphenidate Hcl Extended-Release Capsules In The Treatment Of Adhd Was Established In One Controlled Trial Of Children Aged 6 To 15 Who Met Dsm-Iv Criteria For Adhd (see Clinical Pharmacology ). A Diagnosis Of Attention Deficit Hyperactivity Disorder (adhd; Dsm-Iv) Implies The Presence Of Hyperactive-Impulsive Or Inattentive Symptoms That Caused Impairment And Were Present Before Age 7 Years. The Symptoms Must Cause Clinically Significant Impairment, E.g., In Social, Academic, Or Occupational Functioning, And Be Present In Two Or More Settings, E.g., School (or Work) And At Home. The Symptoms Must Not Be Better Accounted For By Another Mental Disorder. For The Inattentive Type, At Least Six Of The Following Symptoms Must Have Persisted For At Least 6 Months: Lack Of Attention To Details/careless Mistakes; Lack Of Sustained Attention; Poor Listener; Failure To Follow Through On Tasks; Poor Organization; Avoids Tasks Requiring Sustained Mental Effort; Loses Things; Easily Distracted; Forgetful. For The Hyperactive-Impulsive Type, At Least Six Of The Following Symptoms Must Have Persisted For At Least 6 Months: Fidgeting/squirming; Leaving Seat; Inappropriate Running/climbing; Difficulty With Quiet Activities; “on The Go;” Excessive Talking; Blurting Answers; Can’t Wait Turn; Intrusive. The Combined Types Requires Both Inattentive And Hyperactive-Impulsive Criteria To Be Met. Special Diagnostic Considerations Specific Etiology Of This Syndrome Is Unknown, And There Is No Single Diagnostic Test. Adequate Diagnosis Requires The Use Not Only Of Medical But Of Special Psychological, Educational, And Social Resources. Learning May Or May Not Be Impaired. The Diagnosis Must Be Based Upon A Complete History And Evaluation Of The Child And Not Solely On The Presence Of The Required Number Of Dsm-Iv Characteristics. Need For Comprehensive Treatment Program Methylphenidate Hcl Extended-Release Capsules Are Indicated As An Integral Part Of A Total Treatment Program For Adhd That May Include Other Measures (psychological, Educational, Social) For Patients With This Syndrome. Drug Treatment May Not Be Indicated For All Children With This Syndrome. Stimulants Are Not Intended For Use In The Child Who Exhibits Symptoms Secondary To Environmental Factors And/or Other Primary Psychiatric Disorders, Including Psychosis. Appropriate Educational Placement Is Essential And Psychosocial Intervention Is Often Helpful. When Remedial Measures Alone Are Insufficient, The Decision To Prescribe Stimulant Medication Will Depend Upon The Physician’s Assessment Of The Chronicity And Severity Of The Child’s Symptoms. Long-Term Use The Effectiveness Of Methylphenidate Hcl Extended-Release Capsules For Long-Term Use, I.e., For More Than 3 Weeks, Has Not Been Systematically Evaluated In Controlled Trials. Therefore, The Physician Who Elects To Use Methylphenidate Hcl Extended-Release Capsules For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration ).

All Formulated Excipients (14 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Oleic Acid OLEIC ACID Molecular CTG-Component or coating , MISC-Miscellaneous GRAS-Generally recognized as safe.
3. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
4. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
5. Gelatin GELATIN Unresolved
6. Shellac SHELLAC Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Hypromelloses HYPROMELLOSES Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
11. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
12. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
13. Fd&c Yellow No. 6 FD&C YELLOW NO. 6 Molecular DYE-Dye
14. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE ZINC2522648