DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Mylan Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Composition:

DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . 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/. 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 development studies in rats showed delaye

Descriptif du produit:

Dexmethylphenidate Hydrochloride Extended-Release Capsules are available containing 5 mg, 10 mg, 15 mg, 20 mg, 30 mg or 40 mg of dexmethylphenidate hydrochloride. The 5 mg capsules are hard-shell gelatin capsules with a dark blue opaque cap and dark blue opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 5 in white ink on cap and body. They are available as follows: NDC 0378-4080-01 bottles of 100 capsules The 10 mg capsules are hard-shell gelatin capsules with a light brown opaque cap and light brown opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 10 in black ink on cap and body. They are available as follows: NDC 0378-4081-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a gray opaque cap and gray opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 15 in black ink on cap and body. They are available as follows: NDC 0378-4082-01 bottles of 100 capsules The 20 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 20 in black ink on cap and body. They are available as follows: NDC 0378-4083-01 bottles of 100 capsules The 30 mg capsules are hard-shell gelatin capsules with a light brown opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 30 in black ink on cap and body. They are available as follows: NDC 0378-4084-01 bottles of 100 capsules The 40 mg capsules are hard-shell gelatin capsules with a gray opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DE 40 in black ink on cap and body. They are available as follows: NDC 0378-4085-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription. 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.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

RELEASE
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Dexmethylphenidate Hydrochloride Extended-Release Capsules CII
(dex meth″ il fen′ i date hye″ droe klor′ ide)
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 they 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) or new manic
symp

Résumé des caractéristiques du produit

DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
MYLAN 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._
•
•
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
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DOSAGE FORMS AND STRENGTHS
Extended-Release Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg and 40 mg
of dexmethylphenidate hydrochloride (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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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
the current total daily dosage of methylphenidate (2.2).
Patients currently on dexmethylphenidate hydrochloride
immediate-release tablets: Give the same daily dose of
dexmethylphenidate hydrochloride extended-release capsules (