DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release
국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
환자 정보 전단 유효 성분:
DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)
제공처:
Teva Pharmaceuticals USA, Inc.
INN (국제 이름):
DEXMETHYLPHENIDATE HYDROCHLORIDE
구성:
DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg
관리 경로:
ORAL
처방전 유형:
PRESCRIPTION DRUG
치료 징후:
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . - Hypersensitivity to methylphenidate or other components of dexmethylphenidate 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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-8
제품 요약:
Dexmethylphenidate hydrochloride extended-release capsules are available as follows: 5 mg: Two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5550” on body in bottles of 100 (NDC 0093-5550-01). 10 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5551” on body in bottles of 100 (NDC 0093-5551-01). 15 mg: Two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5552” on body in bottles of 100 (NDC 0093-5552-01). 20 mg: Two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5553” on body in bottles of 100 (NDC 0093-5553-01). 25 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5045” on body in bottles of 100 (NDC 0093-5045-01). 30 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5554” on body in bottles of 100 (NDC 0093-5554-01). 35 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5046” on body in bottles of 100 (NDC 0093-5046-01). 40 mg: Two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5562” on body in bottles of 100 (NDC 0093-5562-01). 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 Dexmethylphenidate hydrochloride extended-release capsules by a medicine take-back 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 extended-release capsules with an undesirable, non-toxic 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 extended-release capsules in the household trash.
승인 상태:
Abbreviated New Drug Application
환자 정보 전단
release
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Dexmethylphenidate (dex" meth il fen' i date) Hydrochloride (hye" droe
klor' ide)
Extended-Release Capsules CII
What is the most important information I should know about
dexmethylphenidate hydrochloride extended-release capsules?
Dexmethylphenidate hydrochloride extended-release capsules are a
federal controlled substance (CII) because it can be
abused or lead to dependence. Keep dexmethylphenidate hydrochloride
extended-release capsules in a safe place to prevent
misuse and abuse. Selling or giving away dexmethylphenidate
hydrochloride extended-release capsules 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
extended-release capsules.
Your doctor should check you 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
•
new psychotic symptoms (such as hearing voices, b
전체 문서 읽기
제품 특성 요약
DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE
HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
TEVA PHARMACEUTICALS USA, INC.
----------
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, FOR ORAL
USE, CII
INITIAL U.S. APPROVAL: 2005
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING DEXMETHYLPHENIDATE 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).
INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride extended-release capsules are a
central nervous system (CNS)
stimulant indicated for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) (1).
DOSAGE AND ADMINISTRATION
Patients new to methylphenidate: Recommended starting dose is 5 mg
once daily for pediatric patients
and 10 mg once daily for adults with or without food in the morning
(2.2).
Patients currently on methylphenidate: Dexmethylphenidate
hydrochloride extended-release capsules
dosage is half (1/2) the current total daily dosage of methylphenidate
(2.2).
Patients currently on dexmethylphenidate hydrochloride
immediate-release tablets: Give the same
daily dose of dexmethylphenidate hydrochloride extended-release
capsules (2.2).
Titrate weekly in increments of 5 mg in pediatric patients and 10 mg
in adult patients (2.2).
Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg
in adults (2.2).
Capsules may be swallowed whole or opened and the entire contents
sprinkled on applesauce (2.3).
DOSAGE FORMS AND STRENGTHS
Extended-Release Capsules: 5
전체 문서 읽기
