METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- methylphenidate hydrochloride capsule, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

Dostupno od:

SpecGx LLC

INN (International ime):

METHYLPHENIDATE HYDROCHLORIDE

Sastav:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Methylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Methylphenidate HCl extended-release capsules are contraindicated in patients with: - Known hypersensitivity to methylphenidate or other component of methylphenidate HCl extended-release capsules. Angioedema has been reported in patients treated with methylphenidate HCl extended-release capsules. Anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6)] . - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7)] . - Methylphenidate HCl extended-release capsules contain sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not

Proizvod sažetak:

How Supplied Methylphenidate HCl extended-release capsules are available in six strengths (see Table 4): Strength Capsule Color (cap/body) Imprinting on Capsule Cap Imprinting on Capsule Body Capsules per Bottle NDC Number 10 mg dark green/white “M” in a box over “1810” in white letters “10 mg” in black letters 100 NDC 0406-1810-01 20 mg medium blue/white “M” in a box over “1820” in white letters “20 mg” in black letters 100 NDC 0406-1820-01 30 mg maroon/white “M” in a box over “1830” in white letters “30 mg” in black letters 100 NDC 0406-1830-01 40 mg yellow ivory/white “M” in a box over “1840” in black letters “40 mg” in black letters 100 NDC 0406-1840-01 50 mg purple/white “M” in a box over “1850” in white letters “50 mg” in black letters 100 NDC 0406-1850-01 60 mg white/white “M” in a box over “1860” in black letters “60 mg” in black letters 100 NDC 0406-1860-01 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate HCl extended-release capsules 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 methylphenidate HCl extended-release capsules 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 methylphenidate HCl extended-release capsules in the household trash.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

HYDROCHLORIDE CAPSULE
SpecGx LLC
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MEDICATION GUIDE
Methylphenidate HCl Extended-Release Capsules, CII
(METH il FEN i date)
What is the most important information I should know about
methylphenidate HCl extended-release capsules?
Methylphenidate HCl extended-release capsules can cause serious side
effects, including:
•
Abuse and dependence. Methylphenidate HCl extended-release capsules,
other methylphenidate containing
medicines, and amphetamines have a high chance for abuse and can cause
physical and psychological
dependence. Your healthcare provider should check your child for signs
of abuse and dependence before
and during treatment with methylphenidate HCl extended-release
capsules.
•
Tell your healthcare provider if your child has ever abused or been
dependent on alcohol,
prescription medicines, or street drugs.
•
Your healthcare provider can tell you more about the differences
between physical and
psychological dependence and drug addiction.
•
Heart-related problems, including:
•
sudden death in children who have heart problems or heart defects
•
increased blood pressure and heart rate
Your healthcare provider should check your child carefully for heart
problems before starting treatment with
methylphenidate HCl extended-release capsules. Tell your healthcare
provider if your child has any heart
problems, heart defects, high blood pressure, or has a family history
of these problems.
Your healthcare provider should check your child’s blood pressure
and heart rate regularly during treatment
with methylphenidate HCl extended-release capsules.
Call your healthcare provider or go to the nearest hospital emergency
room right away if your child has any
signs of heart problems such as chest pain, shortness of breath, or
fainting during treatment with
methylphenidate HCl extended-release capsules.
•
Mental (psychiatric) problems, including:
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new psychotic symptoms (such as hearing voices, or seeing or believin

Svojstava lijeka

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- METHYLPHENIDATE
HYDROCHLORIDE CAPSULE
SPECGX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HCL
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING METHYLPHENIDATE HCL 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
Methylphenidate HCl extended-release capsules are a central nervous
system (CNS) stimulant indicated
for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
in pediatric patients 6 to 15 years of
age (1)
DOSAGE AND ADMINISTRATION
Take orally once daily in the morning, before breakfast (2.3)
Swallow whole with the aid of liquids, or sprinkle contents onto a
small amount of applesauce and give
immediately (2.3)
Do not crush or chew the capsule or capsule contents (2.3)
Recommended starting dose is 20 mg once daily. Dosage may be increased
10-20 mg at weekly
intervals; do not exceed 60 mg per day (2.2)
DOSAGE FORMS AND STRENGTHS
_Extended-release capsules:_ 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
(3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other components of
methylphenidate HCl extended-
release capsules (4)
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the
preceding 14 days (4)
Use in patients with patients with hereditary problems of fructose
intolerance, glucose-galactose
malabsorption, or sucrase-isomaltase insufficiency (4)
WARNINGS AND PRECAUTIONS
_Serious Cardiovascular