METHYLPHENIDATE HYDROCHLORIDE CD- methylphenidate hydrochloride capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

methylphenidate hydrochloride (UNII: 4B3SC438HI) (methylphenidate - UNII:207ZZ9QZ49)

Tilgjengelig fra:

Kremers Urban Pharmaceuticals Inc.

INN (International Name):

methylphenidate hydrochloride

Sammensetning:

methylphenidate hydrochloride 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Methylphenidate HCl Extended-Release Capsules CD contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with glaucoma. Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome (see ADVERSE REACTIONS). Methylphenidate HCl Extended-Release Capsules CD is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discon

Produkt oppsummering:

Methylphenidate HCl Extended-Release Capsules CD are available in six strengths: 10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule. 20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule. 30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule. 40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule. 50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule. 60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Keep out of the reach of children.

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Kremers Urban Pharmaceuticals Inc.
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MEDICATION GUIDE
METHYLPHENIDATE HCL EXTENDED-
RELEASE CAPSULES CD CII
Read the Medication Guide that comes with Methylphenidate HCl
Extended-Release Capsules CD 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 HCl Extended-Release Capsules CD.
What is the most important information I should know about
Methylphenidate HCl Extended-Release
Capsules CD?
The following have been reported with use of methylphenidate HCl, USP
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 Methylphenidate
HCl Extended-Release Capsules CD.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment with
Methylphenidate HCl Extended-Release Capsules CD.
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 HCl
Extended-Release Capsules CD.
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
Children and Teenagers
•
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 doctor right away if you or your child have any new or
worsening mental symptom

Preparatomtale

METHYLPHENIDATE HYDROCHLORIDE CD- METHYLPHENIDATE HYDROCHLORIDE
CAPSULE,
EXTENDED RELEASE
KREMERS URBAN PHARMACEUTICALS INC.
----------
METHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES CD
CII
Once Daily
Rx only
DESCRIPTION
Methylphenidate HCl Extended-Release Capsules CD is a central nervous
system (CNS) stimulant. The
extended-release capsules comprise both immediate-release (IR) and
extended-release (ER) beads such
that 30% of the dose is provided by the IR component and 70% of the
dose is provided by the ER
component. Methylphenidate HCl Extended-Release Capsules CD is
available in six capsule strengths
containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg
(9 mg IR; 21 mg ER), 40 mg
(12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR;
42 mg ER) of methylphenidate
hydrochloride for oral administration.
Chemically, methylphenidate HCl is _d_,_l_ (racemic)-_threo_-methyl
α-phenyl-2-piperidineacetate
hydrochloride. Its empirical formula is C
H NO •HCl. Its structural formula is:
Methylphenidate HCl USP is a white, odorless, 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.
Methylphenidate HCl Extended-Release Capsules CD also contains the
following inert ingredients:
Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene
glycol, ethylcellulose
aqueous dispersion, dibutyl sebacate, gelatin, and titanium dioxide.
The individual capsules contain the following color agents:
10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide
20 mg capsules: FD&C Blue No. 2
30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide
40 mg capsules: FDA/E172 Yellow Iron Oxide
50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Methylphenidate HCl is a central nervous system (CNS) stimulant. The
mode of therapeutic action in
Attention Deficit Hyperactivity Disorder (ADHD) is not known.
Meth