DEXMETHYLPHENIDATE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sammensetning:

DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. - Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. 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 MOAI, 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 tablets, 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/adh

Produkt oppsummering:

Dexmethylphenidate Hydrochloride Tablets, 2.5 mg are blue, round-shaped, convex, unscored tablets, debossed with “93” on one side and “5275” on the other side, available in bottles of 100 (NDC 0093-5275-01). Dexmethylphenidate Hydrochloride Tablets, 5 mg are yellow, round-shaped, convex, unscored tablets, debossed with “93” on one side and “5276” on the other side, available in bottles of 100 (NDC 0093-5276-01). Dexmethylphenidate Hydrochloride Tablets, 10 mg are white to off-white, round-shaped, convex, unscored tablets, debossed with “93” on one side and “5277” on the other side, available in bottles of 100 (NDC 0093-5277-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride tablets 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 with an undesirable, nontoxic 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 tablets in the household trash.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Dexmethylphenidate (dex'' meth il fen' i date)
Hydrochloride (hye''droe klor' ide) Tablets CII
What is the most important information I should know about
dexmethylphenidate
hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets are a federal controlled
substance (CII) because
it can be abused or lead to dependence. Keep dexmethylphenidate
hydrochloride tablets in a
safe place to prevent misuse and abuse. Selling or giving away
dexmethylphenidate
hydrochloride tablets 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 tablets.
Your doctor should check you or your child’s blood pressure and
heart rate regularly
during treatment with dexmethylphenidate hydrochloride tablets.
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 tablets.
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 mental problems you or your child have, or
about a family
history of suicide, bipolar illness, or depression.
Call your

Preparatomtale

DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE HYDROCHLORIDE
TABLET
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMETHYLPHENIDATE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS.
DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 2001
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING DEXMETHYLPHENIDATE HYDROCHLORIDE, 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).
RECENT MAJOR CHANGES
Boxed Warning
1/2019
Contraindications (4)
1/2019
Warnings and Precautions (5) 1/2019
INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride is a central nervous system (CNS)
stimulant indicated for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) (1).
DOSAGE AND ADMINISTRATION
Administer orally twice daily, 4 hours apart with or without food (2)
For patients new to methylphenidate: Recommend starting dose of 5 mg
once daily (2.5 mg twice daily) (2.2).
For patients currently taking methylphenidate: Initiate
dexmethylphenidate hydrochloride therapy with half (1/2) the
current total daily dose of methylphenidate (2.3).
Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day
(10 mg twice daily) (2.2).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, and 10 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other components of
dexmethylphenidate hydrochloride tablets (4).
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the preceding 14 days (4).
WARNINGS AND PRECAUTIONS
_Serious Cardiovascular Events:_ Sudden death has been reported in
association with CNS-stimulant treat