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 (LA) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of methylphenidate hydrochloride extended-release capsules (LA) in the treatment of ADHD was established in 1 controlled trial of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY ). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor

Product summary:

Methylphenidate Hydrochloride Extended-Release Capsules (LA) 20 mg: white/white (imprinted 200) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 30 mg: white/light blue (imprinted 201) Methylphenidate Hydrochloride Extended-Release Capsules (LA) 40 mg: white/dark blue (imprinted 202) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] Dispense in tight container (USP).

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
Rx Only
Read the Medication Guide that comes with methylphenidate
hydrochloride extended-release capsules (LA)
before you or your child starts taking it and each time you get a
refill. There may be new information. This
Medication Guide does not take the place of talking to your doctor
about your or your child's treatment with
methylphenidate hydrochloride extended-release capsules (LA).
What is the most important information I should know about
Methylphenidate Hydrochloride Extended-
Release Capsules (LA)?
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 (LA).
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment with
methylphenidate hydrochloride extended-release capsules (LA).
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 (LA).
•
Mental (Psychiatric) problems:
All Patients
•
new or worse behavior and thought problems
•
new or worse bipolar illness
•
new or worse aggressive behavior or hostility
Children and Teenagers
•
new psychotic symptoms (such as hearing voices, believing things that
are not true, are suspicious) or
new manic symptoms

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE (LA)- METHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
TEVA PHARMACEUTICALS USA, INC.
----------
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) CII
ONCE DAILY
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride, USP is a central nervous system (CNS)
stimulant.
Methylphenidate hydrochloride extended-release capsules (LA) are an
extended-release formulation of
methylphenidate with a bi-modal release profile. Each bead-filled
methylphenidate hydrochloride
extended-release capsule (LA) contains half the dose as
immediate-release beads and half as enteric-
coated, delayed-release beads, thus providing an immediate release of
methylphenidate and a second
delayed release of methylphenidate. Methylphenidate hydrochloride
extended-release 20, 30, and 40
mg capsules (LA) provide in a single dose the same amount of
methylphenidate as dosages of 10, 15, or
20 mg of methylphenidate hydrochloride tablets given twice a day.
The active substance in methylphenidate hydrochloride extended-release
capsules (LA) is methyl α-
phenyl-2-piperidineacetate hydrochloride, and its structural formula
is
Methylphenidate hydrochloride, USP is a white, odorless, fine
crystalline powder. Its solutions are
acid to litmus. It is freely soluble in water and in methanol, soluble
in alcohol, and slightly soluble in
chloroform and in acetone. Its molecular weight is 269.77.
INACTIVE INGREDIENTS: sugar spheres (which contain sucrose and
starch), hypromellose, cellulose
acetate butyrate, hypromellose acetate succinate, acetyltributyl
citrate, acetone, talc, and purified water.
Opaque gelatin capsules contain: titanium dioxide and gelatin. The 30
and 40 mg capsules contain D&C
Red #28 and FD&C Blue #1. The capsules are imprinted with black ink
which contains black iron oxide,
shellac and potassium hydroxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate hydrochloride, USP, the active ingredient in
methylphenidate hydrochloride extended-
release capsules (LA), is a central nervous system (CNS) st