DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- 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:

Par Pharmaceuticals, Inc.

INN (International Name):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Composition:

DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dexmethylphenidate Hydrochloride Extended-release Capsules is 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-

Product summary:

Dexmethylphenidate Hydrochloride Extended-release Capsules are available as follows: 15 mg capsules – white opaque cap and body, imprinted in black ink “par” on cap and “428” on body; supplied in bottles of 100 (NDC 49884-428-01) and 1000 (NDC 49884-428-10). 30 mg capsules – white opaque cap and body, imprinted in green ink “par” on cap and “430” on body; supplied in bottles of 100 (NDC 49884-430-01) and 1000 (NDC 49884-430-10). Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). 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 takeback 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
Par Pharmaceuticals, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Dexmethylphenidate (dex meth ill FEN i date) Hydrochloride
Extended-Release Capsules CII
What is the most important information I should know about
Dexmethylphenidate Hydrochloride
Extended-Release Capsules?
Dexmethylphenidate Hydrochloride Extended-Release Capsules is 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, believing things that
are not true, are
suspicious) o

Summary of Product characteristics

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE-
DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
PAR PHARMACEUTICALS, INC.
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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, 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 is a
central nervous system (CNS) stimulant indicated for
the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
patients aged 6 years and older (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
the current total daily dosage of methylphenidate (2.2).
Patients currently on dexmethylphenidate 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
Extend