Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules CII

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

McKesson Corporation dba RX Pak

INN (Alþjóðlegt nafn):

METHYLPHENIDATE HYDROCHLORIDE

Samsetning:

METHYLPHENIDATE HYDROCHLORIDE 40 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

METADATE CD is contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. METADATE CD is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. METADATE CD contains sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. METADATE CD is contraindicated in patients with glaucoma. METADATE CD is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette's syndrome (see ADVERSE REACTIONS). METADATE CD is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). METADATE CD is contraindicated in patients with severe hypertension, angina pectoris, cardiac arrhythmias, heart failure, recent myocardial infarc

Vörulýsing:

METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 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.       NDC 53014-579-07      Bottle of 100 Capsules 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.       NDC 53014-580-07      Bottle of 100 Capsules 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.       NDC 53014-581-07      Bottle of 100 Capsules 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.       NDC 53014-582-07      Bottle of 100 Capsules 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.       NDC 53014-583-07      Bottle of 100 Capsules 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.       NDC 53014-584-07      Bottle of 100 Capsules 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.

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

METADATE CD- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
Mckesson Rxpak Inc
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MEDICATION GUIDE
METADATE CD®
(methylphenidate HCl, USP) Extended-Release Capsules CII
Read the Medication Guide that comes with METADATE 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 METADATE CD.
What is the most important information I should know about Metadate
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 METADATE
CD.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment
with METADATE 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 METADATE 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 symptoms or
problems while taking METADATE CD, especially seeing or hearing things
that are not real, believing
things that are not real, or are suspicious.
3.

Vara einkenni

METADATE CD- METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
MCKESSON RXPAK INC
----------
METADATE CD
(METHYLPHENIDATE HCL, USP)
EXTENDED-RELEASE CAPSULES
CII
Rx Only
Once Daily
DESCRIPTION
METADATE 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.
METADATE 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.
METADATE 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.
Methylphenidate is thought to block the
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reuptake of norepinephrine and dopamine into the presynaptic neuron
and increase the re