Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Trigen Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies (14)] . Methylphenidate hydrochloride extended-release tablets are contraindicated in patients: - with a known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6.2)] . - receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, inclu
How Supplied Methylphenidate hydrochloride extended-release tablets are available as: Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from humidity.
New Drug Application
Trigen Laboratories, LLC ---------- MEDICATION GUIDE MEDICATION GUIDE Methylphenidate hydrochloride extended-release tablets (METH-il-FEN-i-date) for oral use, CII What is the most important information I should know about methylphenidate hydrochloride extended-release tablets? Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including: • Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride extended-release tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride extended- release tablets or when it is used in ways that are not approved, such as snorting or injection. • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment. • Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give methylphenidate hydrochloride extended-release tablets to anyone else. See “What are methylphenidate hydrochloride extended-release tablets?” for more information. • Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride extended-release tablets?” for more information. • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serio Прочитать полный документ
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE TRIGEN LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS FOR ORAL USE, CII INITIAL U.S. APPROVAL: 2000 WARNING: ABUSE, MISUSE, AND ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS HAVE A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, CAN RESULT IN OVERDOSE AND DEATH (5.1, 9.2, 10): BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED DRUG. THROUGHOUT TREATMENT, REASSESS EACH PATIENT’S RISK AND FREQUENTLY MONITOR FOR SIGNS AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION. RECENT MAJOR CHANGES Boxed Warning 10/2023 Dosage and Administration (2.1, 2.3) 10/2023 Warnings and Precautions (5.1, 5.2, 5.9, 5.10, 5.11) 10/2023 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older (1). DOSAGE AND ADMINISTRATION Administer once daily in the morning with or without food. (2.2) Swallow whole with liquid. Do not chew, divide, or crush. (2.2) Recommended dosage for patients new to methylphenidate (2.3): Pediatric patients 6 to 17 years Starting dosage is 18 mg once Прочитать полный документ