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:

Sandoz Inc

INN (International Name):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Composition:

DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. 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 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations ). Embryo-fetal

Product summary:

Dexmethylphenidate hydrochloride extended-release capsules are available as follows: Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 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 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.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
Sandoz Inc
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MEDICATION GUIDE
Dexmethylphenidate 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 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 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 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) or new manic symptoms
Tell your doctor about any menta

Summary of Product characteristics

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE-
DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
SANDOZ 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_
•
•
RECENT MAJOR CHANGES
Boxed Warning 1/2019
Contraindications (4) 1/2019
Warnings and Precautions (5) 1/2019
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
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35
mg, and 40 mg of dexmethylphenidate
hydrochloride (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
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).
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 immediate-release tablets:
Give the same daily dose of
dexmethylphenidate hydrochloride extended-release capsules (2.2).
Ti