METHYLPHENIDATE HYDROCHLORIDE (LA)- methylphenidate hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] . - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee 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 methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregna

Product summary:

Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5345 on the body, containing 10 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5345-01). Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg are available as two-piece, hard gelatin capsules, with white opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5346 on the body, containing 20 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5346-01). Methylphenidate Hydrochloride Extended-Release Capsules, 30 mg are available as two-piece, hard gelatin capsules, with ivory opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5347 on the body, containing 30 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5347-01). Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and light brown opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5348 on the body, containing 40 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5348-01). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate 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 methylphenidate hydrochloride 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 hydrochloride extended-release capsules in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Methylphenidate Hydrochloride (meth″ il fen′ i date hye″ droe
klor′ ide)
Extended-Release Capsules LA CII
What is the most important information I should know about
methylphenidate hydrochloride extended-
release capsules?
Methylphenidate hydrochloride extended-release capsules are a federal
controlled substance (CII)
because it can be abused or lead to dependence. Keep methylphenidate
hydrochloride extended-release
capsules in a safe place to prevent misuse and abuse. Selling or
giving away methylphenidate
hydrochloride extended-release capsules may harm others, and is
against the law. Tell your doctor if you
or your child have ever 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:
•
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 methylphenidate
hydrochloride extended-release capsules.
Your doctor should check you or your child’s blood pressure and
heart rate regularly during treatment
with methylphenidate 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 methylphenidate
hydrochloride extended-release capsules.
•
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,

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES LA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES LA.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING METHYLPHENIDATE 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).
RECENT MAJOR CHANGES
Boxed Warning
1/2019
Contraindications (4)
1/2019
Warnings and Precautions (5) 1/2019
INDICATIONS AND USAGE
Methylphenidate hydrochloride 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 12 years of age. (1)
DOSAGE AND ADMINISTRATION
Administer orally once daily in the morning. (2.2)
Capsules may be swallowed whole, or opened and the entire contents
sprinkled on applesauce. (2.2)
Should not be crushed, chewed, or divided. (2.2)
Patients new to methylphenidate: Start at 20 mg daily, titrating the
dose weekly in 10-mg increments. Doses above 60
mg daily are not recommended. (2.3)
For patients currently using methylphenidate hydrochloride tablets or
methylphenidate hydrochloride extended-
release tablets: Dosage is based on current dose regimen. (2.4)
If switching from other methylphenidate products, discontinue
treatment and titrate with methylphenidate
hydrochloride extended-release capsules. (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-release c