METHYLPHENIDATE HCL- methylphenidate hydrochloride solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

SpecGx LLC

DCI (Denominação Comum Internacional):

METHYLPHENIDATE HYDROCHLORIDE

Composição:

METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate HCl Oral Solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dy

Resumo do produto:

Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL NDC 0406-3005-50 Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL NDC 0406-3010-50 Dispense in tight container with child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Ritalin is a registered trademark of Novartis Corporation. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.   © 2017 Mallinckrodt. Manufactured by:  SpecGx LLC  Webster Groves, MO 63119 USA  L20M56 Rev 08/2017         Mallinckrodt TM Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M57.pdf or by calling 1-800-778-7898 for alternate delivery options.

Status de autorização:

New Drug Application Authorized Generic

Folheto informativo - Bula

METHYLPHENIDATE HCL- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
SpecGx LLC
----------
MEDICATION GUIDE
Methylphenidate HCl Oral Solution
(methylphenidate HCl oral solution) 5 mg/5 mL and 10 mg/5 mL
CII
Read the Medication Guide that comes with Methylphenidate HCl Oral
Solution 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 Oral
Solution.
What is the most important information I should know about
Methylphenidate HCl Oral Solution?
The following have been reported with use of methylphenidate HCl oral
solution 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 Oral Solution.
Your doctor should check you or your child’s blood pressure and
heart rate regularly during treatment with
Methylphenidate HCl Oral Solution.
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 Oral Solution.
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
3. Circulation problems in fingers and toes [Peripheral vasculopathy,
including Raynaud’s phenomenon]:
fingers or toes may feel numb, cool, painful, and/or may change color
from pale, to blue, to red.
•
Tell your doctor

Características técnicas

METHYLPHENIDATE HCL- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
SPECGX LLC
----------
METHYLPHENIDATE HCL ORAL SOLUTION
METHYLPHENIDATE HCL ORAL SOLUTION, 5 MG/5 ML
METHYLPHENIDATE HCL ORAL SOLUTION, 10 MG/5 ML
CII
RX ONLY
DESCRIPTION
Methylphenidate HCl Oral Solution is a mild central nervous system
(CNS) stimulant available as 5 mg/5
mL and 10 mg/5 mL oral solutions for oral administration.
Methylphenidate hydrochloride is methyl α-
phenyl-2-piperidineacetate hydrochloride, and its structural formula
is
METHYLPHENIDATE HYDROCHLORIDE
C
H NO • HCL MW = 269.77
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.
Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg
of methylphenidate
hydrochloride USP.
Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg
of methylphenidate
hydrochloride USP.
In addition, Methylphenidate HCl Oral Solution also contains the
following inactive ingredients: citric
acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified
water.
CLINICAL PHARMACOLOGY
Methylphenidate is a racemic mixture comprised of the _d-_ and
_l-threo_ enantiomers. The _d-threo_
enantiomer is more pharmacologically active than the _l-threo_
enantiomer.
14
19
2
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood,
but methylphenidate presumably
activates the brain stem arousal system and cortex to produce its
stimulant effect. Methylphenidate is
thought to block the reuptake of norepinephrine and dopamine into the
presynaptic neuron and increase
the release of these monoamines into the extraneuronal space.
There is neither specific evidence which clearly establishes the
mechanism whereby Methylphenidate
HCl Oral Solution produces its mental and behavioral effects in
children, nor conclusive evidence
regarding how these e