METHYLPHENIDATE HYDROCHLORIDE- 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:

CorePharma, LLC

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with marked anxiety, tension and agitation, since the drug may aggravate these symptoms. Methylphenidate hydrochloride extended-release capsules are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Methylphenidate hydrochloride extended-release capsules contain sucrose. Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with glaucoma. Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome (see ADVERSE REACTIONS). Methylphenidate hydrochloride extended-release capsules are contraindicated during treatment with monoamine oxidase inhibitors, and also

Product summary:

Methylphenidate Hydrochloride Extended-release Capsules are available in six strengths: 10 mg, green cap and white body, opaque capsules, imprinted with CP over 401 on the cap and 10 mg on the body.             NDC 64720-401-10       Bottle of 100 Capsules 20 mg, blue cap and white body, opaque capsules, imprinted with CP over 402 on the cap and 20 mg on the body.             NDC 64720-402-10       Bottle of 100 Capsules 30 mg, brown cap and white body, opaque capsules, imprinted with CP over 403 on the cap and 30 mg on the body.             NDC 64720-403-10       Bottle of 100 Capsules 40 mg, yellow cap and white body, opaque capsules, imprinted with CP over 404 on the cap and 40 mg on the body.             NDC 64720-404-10       Bottle of 100 Capsules 50 mg,  navy blue cap and white body, opaque capsules, imprinted with CP over 405 on the cap and 50 mg on the body.             NDC 64720-405-10       Bottle of 100 Capsules 60 mg, white, opaque capsule imprinted with CP over 406 on the cap and 60 mg on the body.             NDC 64720-406-10       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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
CorePharma, LLC
----------
MEDICATION GUIDE
METHYLPHENIDATE HYDROCHLORIDE
(METH" IL FEN' I DATE HYE" DROE KLOR' IDE)
EXTENDED-RELEASE CAPSULES CII
Read the Medication Guide that comes with methylphenidate
hydrochloride extended-release capsules
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.
What is the most important information I should know about
methylphenidate hydrochloride extended-
release capsules?
The following have been reported with use of methylphenidate
hydrochloride, 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
hydrochloride extended-release capsules.
Your doctor should check your 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.
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 yo

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE CAPSULE,
EXTENDED
RELEASE
COREPHARMA, LLC
----------
ONCE DAILY
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES CII
RX ONLY
DESCRIPTION
Methylphenidate hydrochloride extended-release capsules are a central
nervous system (CNS)
stimulant. The extended-release capsules comprise beads each with both
immediate-release (IR) and
extended-release (ER) components such that 30% of the dose is provided
by the IR component and 70%
of the dose is provided by the ER component. Methylphenidate
hydrochloride extended-release
capsules are available in six 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 hyrochloride is _d_,_l
_(racemic)-_threo_-methyl α-phenyl-2-piperidineacetate
hydrochloride. Its empirical formula is C
H NO •HCl. Its structural formula is:
Methylphenidate hydrochloride, 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 hydrochloride extended-release capsules also contain
the following inert ingredients:
Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene
glycol, ethyl cellulose,
cetyl alcohol, sodium lauryl sulfate, 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: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3
30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide,
FDA/E172 Yellow Iron
Oxide
40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40
50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron
Oxide
CLINICAL PHARMACOLOGY
14
19
2
PHARMACODYNAMIC