METHYLPHENIDATE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel laboratories, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Hydrochloride 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 dysfun

Product summary:

Methylphenidate Hydrochloride Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 40032-930-05 Methylphenidate Hydrochloride Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 40032-931-05 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. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI9300000102 Rev. 07/2015 MEDICATION GUIDE Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL and 10 mg/5 mL CII Read the Medication Guide that comes with Methylphenidate Hydrochloride 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 Hydrochloride Oral Solution.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE SOLUTION
NOVEL LABORATORIES, INC.
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METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, 5 MG/5 ML CII
METHYLPHENIDATE HYDROCHLORIDE 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 USP is a white to off white powder. It
is soluble in water, alcohol, and
chloroform.
Each mL of Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL
contains 1 mg of methylphenidate
hydrochloride USP.
Each mL of Methylphenidate Hydrochloride Oral Solution 10 mg/5 mL
contains 2 mg of
methylphenidate hydrochloride USP.
In addition, Methylphenidate Hydrochloride Oral Solution also contains
the following inactive
ingredients: PEG 1450, glycerin, phosphoric acid, grape flavor, 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.
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
Hydrochloride produces its mental and behavioral effects in children,
nor conclusive evidence
regarding how these effects relate to the condition of the central
nervous system.
PHARMACOKINETICS
ABS ORPTION
Methylphenidate Hydrochloride Oral Solution is readily absor