DEXMETHYLPHENIDATE HYDROCHLORIDE capsule extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)

Предлага се от:

Avera McKennan Hospital

INN (Международно Name):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Композиция:

DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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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 CII FOR
ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: DRUG DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES SHOULD BE
GIVEN CAUTIOUSLY TO PATIENTS
WITH A HISTORY OF DRUG DEPENDENCE OR ALCOHOLISM. CHRONIC ABUSIVE USE
CAN LEAD TO MARKED TOLERANCE AND
PSYCHOLOGICAL DEPENDENCE, WITH VARYING DEGREES OF ABNORMAL BEHAVIOR.
INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride extended-release capsules are a CNS
stimulant indicated for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6
years and older (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 5, 10, 15, 20, 30 and 40 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Dexmethylphenidate hydrochloride extended-release capsules are
intended for oral administration once daily in the
morning. Dexmethylphenidate hydrochloride extended-release capsules
may be swallowed whole, or capsule
contents can be sprinkled on applesauce. Dexmethylphenidate
hydrochloride extended-release capsules and/or their
contents should not be crushed, chewed, or divided. (2)
For patients new to methylphenidate: Begin treatment with
dexmethylphenidate hydrochloride extended-release
capsules at 5 mg/day for pediatrics and 10 mg/day for adults,
titrating the dose weekly in 5 mg increments for
pediatrics and in 10 mg increments for adults. Doses above 30 mg/day
in children and 40 mg/day in adults have not
been studied. (2.1)
For patients a