Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)
Avera McKennan Hospital
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg
ORAL
PRESCRIPTION DRUG
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate hydrochloride extended-release capsules in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies (14) ]. 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 2 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 6 of the following symptoms must have persisted for at least 6 months: lack of atten
20 mg Extended-Release Capsules (NDC 0781-2685-01) white (imprinted NVR D20) supplied in bottles of 100 NDC 69189-2685-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store dexmethylphenidate hydrochloride extended-release capsules at 25°C (77°F), excursions permitted 15°–30°C (59°–86°F). [See USP Controlled Room Temperature.] Dispense in tight container (USP).
New Drug Application Authorized Generic
HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Avera McKennan Hospital ---------- MEDICATION GUIDE Dexmethylphenidate Hydrochloride Extended-Release Capsules CII Read the Medication Guide that comes with dexmethylphenidate hydrochloride extended-release capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with dexmethylphenidate hydrochloride extended-release capsules. What is the most important information I should know about dexmethylphenidate hydrochloride extended-release capsules? The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines. 1. Heart-related problems: • sudden death in patients who have heart problems or heart defects • stroke and heart attack in adults • increased blood pressure and heart rate Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting dexmethylphenidate hydrochloride extended-release capsules. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride extended-release capsules. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking dexmethylphenidate hydrochloride extended-release capsules. 2. Mental (Psychiatric) problems: All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility Children and Teenagers • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar ill Olvassa el a teljes dokumentumot
DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES CII FOR ORAL USE INITIAL U.S. APPROVAL: 2005 WARNING: DRUG DEPENDENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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. RECENT MAJOR CHANGES Warnings and Precautions (5.10) 12/2013 Warnings and Precautions (5.11) 6/2013 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Extended-release capsules: 5, 10, 15, 20, 25, 30, 35, and 40 mg (3) CONTRAINDICATIONS • • • • • WARNINGS AND PRECAUTIONS • Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration once daily in the morning. Dexmethylphenidate hydrochloride extended-release capsules may be swallowed whole, or capsule contents can be sprinkled on applesauce. Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided. (2) For patients new to methylphenidate: Begin treatment with dexmethylphenidate hydrochloride extended-release capsules at 5 mg/day for pediatrics and 10 mg/day for adults, titrating the dose weekly in 5 mg increments for pediatrics and in 10 mg increme Olvassa el a teljes dokumentumot