Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Teva Pharmaceuticals USA, Inc.
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE 20 mg
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 [ s ee 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)]. 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 the National Pregna
Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5345 on the body, containing 10 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5345-01). Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg are available as two-piece, hard gelatin capsules, with white opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5346 on the body, containing 20 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5346-01). Methylphenidate Hydrochloride Extended-Release Capsules, 30 mg are available as two-piece, hard gelatin capsules, with ivory opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5347 on the body, containing 30 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5347-01). Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and light brown opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5348 on the body, containing 40 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5348-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules 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 methylphenidate hydrochloride extended-release capsules in the household trash.
Abbreviated New Drug Application
METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Methylphenidate Hydrochloride (meth″ il fen′ i date hye″ droe klor′ ide) Extended-Release Capsules LA CII What is the most important information I should know about methylphenidate hydrochloride extended- release capsules? Methylphenidate hydrochloride extended-release capsules are a federal controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules may harm others, and is against the law. Tell your doctor if you or your child have ever 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: • 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 methylphenidate hydrochloride extended-release capsules. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with methylphenidate 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 methylphenidate hydrochloride extended-release capsules. • 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, Прочитајте комплетан документ
METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES LA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES LA. METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES FOR ORAL USE, CII INITIAL U.S. APPROVAL: 1955 WARNING: ABUSE AND DEPENDENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, 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). RECENT MAJOR CHANGES Boxed Warning 1/2019 Contraindications (4) 1/2019 Warnings and Precautions (5) 1/2019 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsules are 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 methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended. (2.3) For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended- release tablets: Dosage is based on current dose regimen. (2.4) If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules. (2.4) DOSAGE FORMS AND STRENGTHS Extended-release c Прочитајте комплетан документ