FOCALINXR- dexmethylphenidate hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Composition:

DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two 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 two 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 six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to

Product summary:

5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Dispense in tight container (USP).

Authorization status:

New Drug Application

Patient Information leaflet

FOCALINXR - DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
Physicians Total Care, Inc.
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MEDICATION GUIDE
FOCALIN XR
(dexmethylphenidate hydrochloride) extended-release capsules CII
Read the Medication Guide that comes with FOCALIN XR 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
FOCALIN XR.
What is the most important information I should know about FOCALIN XR?
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 FOCALIN XR.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during treatment
with FOCALIN XR.
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 FOCALIN XR.
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 illness, or depression.
Call your doctor right away if you or your child have any new or
worsening mental symptoms or
problems while taking FOCALIN XR, especially seeing or hearing things
that are not real, believing
things that are not real,

Summary of Product characteristics

FOCALINXR - DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOCALIN XR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FOCALIN XR.
FOCALIN XR (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_
FOCALIN XR 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
Focalin XR is a CNS stimulant indicated for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in patients
aged 6 years and older (1) (1)
DOSAGE AND ADMINISTRATION
Focalin XR is intended for oral administration once daily in the
morning. Focalin XR capsules may be swallowed whole,
or capsule contents can be sprinkled on applesauce. Focalin XR and/or
their contents should not be crushed, chewed, or
divided (2)
For patients new to methylphenidate: Begin treatment with Focalin XR
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 already using methylphenidate: Initiate Focalin XR
therapy with half (1/2) the current total daily dose of
methylphenidate. (2.2)
Patients already using Focalin (dexmethylphenidate) immediate release:
switch to the same daily dose of Focalin XR.
(2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 5, 10, 15, 20, 30, and 40 mg (3)
CONTRAINDICATIONS
Agitation, marked anxiety, and tension (4.1)
Known hypersensitivity to methylphenidate or product components (4.2)
Glaucoma (4.3)
History of motor tics or a family history or diagnosis of Tourette’s