DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- dexmethylphenidate hydrochloride capsule, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Avera McKennan Hospital

Designació comuna internacional (DCI):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Composición:

DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate hydrochloride extended-release capsules in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [see Clinical Studies (14) ]. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of atten

Resumen del producto:

20 mg Extended-Release Capsules (NDC 0781-2685-01) white (imprinted NVR D20) supplied in bottles of 100 NDC 69189-2685-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store dexmethylphenidate hydrochloride extended-release capsules at 25°C (77°F), excursions permitted 15°–30°C (59°–86°F). [See USP Controlled Room Temperature.] Dispense in tight container (USP).

Estat d'Autorització:

New Drug Application Authorized Generic

Informació per a l'usuari

HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
Avera McKennan Hospital
----------
MEDICATION GUIDE
Dexmethylphenidate Hydrochloride Extended-Release Capsules CII
Read the Medication Guide that comes with dexmethylphenidate
hydrochloride extended-release capsules
before you or your child starts taking it and each time you get a
refill. There may be new information.
This Medication Guide does not take the place of talking to your
doctor about your or your child’s
treatment with dexmethylphenidate hydrochloride extended-release
capsules.
What is the most
important
information I should
know about
dexmethylphenidate
hydrochloride
extended-release
capsules?
The following have
been reported with
use of
dexmethylphenidate
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 your 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
Children and
Teenagers
•
new psychotic
symptoms
(such as
hearing
voices,
believing
things that are
not true, are
suspicious) or
new manic
symptoms
Tell your doctor
about any mental
problems you or
your child have, or
about a family
history of suicide,
bipolar ill

Fitxa tècnica

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE-
DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
----------
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.
RECENT MAJOR CHANGES
Warnings and Precautions (5.10)
12/2013
Warnings and Precautions (5.11)
6/2013
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 5, 10, 15, 20, 25, 30, 35, and 40 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
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 increme