Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Granules Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] . - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)]. 8.1 Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling t
Methylphenidate hydrochloride extended-release capsules are supplied as: 10 mg: Hard gelatin capsules, yellow opaque cap printed with “G 10mg” and white opaque body printed with “012” contains white to off-white pellets. Bottles of 100 NDC 70010-012-01 20 mg: Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with “013” contains white to off-white pellets. Bottles of 100 NDC 70010-013-01 30 mg: Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with “014” contains white to off-white pellets. Bottles of 100 NDC 70010-014-01 40 mg: Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with “015” contains white to off-white pellets. Bottles of 100 NDC 70010-015-01 60 mg: Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with “016” contains white to off-white pellets. Bottles of 30 NDC 70010-016-03 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP with a child-resistant closure.
Abbreviated New Drug Application
Granules Pharmaceuticals Inc. ---------- SPL MEDGUIDE SECTION Dispense with medication guide available at: https://granulespharma.com/product/methylphenidate-er- cap/ MEDICATION GUIDE Methylphenidate Hydrochloride Extended-Release Capsules for oral use,CII (METH-il-FEN-i-date HYE-droe-KLOR-ide) What is the most important information I should know about methylphenidate hydrochloride extended-release capsules? Methylphenidate hydrochloride extended-release capsules may cause serious side effects, including: • Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release capsules 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 capsules, 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 capsules 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 capsules and will monitor you or your child during treatment. • Methylphenidate hydrochloride extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give methylphenidate hydrochloride extended-release capsules to anyone else. See “What are methylphenidate hydrochloride extended-release capsules?” for more information. • Keep methylphenidate hydrochloride extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store methylphenidate hydrochloride extended-release capsules?” for more information. • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicine Baca dokumen lengkap
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE GRANULES PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1955 WARNING: ABUSE, MISUSE, AND ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 CAPSULES, CAN RESULT IN OVERDOSE AND DEATH ( 5.1, 9.2, 10). BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, 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) 10/2023 Warnings and Precautions ( 5.1, 5.2, 5.8, 5.9, 5.10) 10/2023 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsule is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age ( 1). DOSAGE AND ADMINISTRATION Administer orally once daily in the morning (2.2). Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce (2.2). Should not be crushed, chewed, or divided ( 2.2). Patients new to methylphe Baca dokumen lengkap