País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)
Sandoz Inc
DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg
ORAL
PRESCRIPTION DRUG
Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . Pregnancy Category C In studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels (AUCs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose (MRHD) of 20 mg/day. Racemic methylphen
Dexmethylphenidate hydrochloride tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows: Bottles of 100………………………………………………….NDC 0781-5676-01 Bottles of 100………………………………………………….NDC 0781-5689-01 Bottles of 100………………………………………………….NDC 0781-5691-01 Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix dexmethylphenidate hydrochloride with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard dexmethylphenidate hydrochloride in the household trash. T2019-34 October 2019
New Drug Application Authorized Generic
Sandoz Inc ---------- MEDICATION GUIDE Dexmethylphenidate Hydrochloride Tablets CII (dex-METH-il-FEN-i-date hy-dro-chlo-ride) What is the most important information I should know about Dexmethylphenidate hydrochloride tablets? Dexmethylphenidate hydrochloride tablets are a federal controlled substance (CII) because it can be abused or lead to dependence. Keep dexmethylphenidate hydrochloride tablets in a safe place to prevent misuse and abuse. Selling or giving away dexmethylphenidate hydrochloride tablets may harm others, and is against the law. Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines or street drugs. The following have been reported with use of methylphenidate 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 tablets. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with dexmethylphenidate hydrochloride tablets. 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 tablets. 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 • 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 illness, or depression. Call your doctor right away if you or yo Leia o documento completo
DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEMETHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 2001 WARNING: ABUSE AND DEPENDENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES INDICATIONS AND USAGE Dexmethylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1). DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS TABLETS: 2.5 mg, 5 mg, and 10 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • CNS STIMULANTS, INCLUDING DEXMETHYLPHENIDATE HYDROCHLORIDE, OTHER METHYLPHENIDATE CONTAINING PRODUCTS, AND AMPHETAMINES, HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE (5.1, 9.2, 9.3). ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING, AND MONITOR FOR SIGNS OF ABUSE AND DEPENDENCE WHILE ON THERAPY (5.1, 9.2). Boxed Warning 1/2019 Contraindications (4) 1/2019 Warnings and Precautions (5) 1/2019 Administer orally twice daily, 4 hours apart with or without food (2) For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily (2.1)) For patients currently taking methylphenidate: Initiate dexmethylphenidate hydrochloride therapy with half (1/2) the current total daily dose of methylphenidate (2.3) Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) (2.1) Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride (4) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4) _Serious Cardiovascular Events_: Sudden death has been reported in association with CNS s Leia o documento completo