METHYLPHENIDATE- 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:

KVK-Tech, 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 10702-163-50 Methylphenidate Hydrochloride Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 10702-164-50 Dispense in tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Manufactured By:KVK-Tech, Inc. 110 Terry DriveNewtown, PA 18940 Item ID# 6226/03 Manufacturer’s Code: 10702 11/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KVK-Tech, Inc.
----------
MEDICATION GUIDE
Methylphenidate Hydrochloride Oral Solution CII
(meth″ il fen′ i date hye″ droe klor′ ide)
5 mg/5 mL and 10 mg/5 mL
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.
What is the most important information I should know about
Methylphenidate Hydrochloride
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 Hydrochloride Oral Solution.
Your doctor should check you or your child's blood pressure and heart
rate regularly during
treatment with Methylphenidate Hydrochloride 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
Hydrochloride 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
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

Summary of Product characteristics

METHYLPHENIDATE- METHYLPHENIDATE HYDROCHLORIDE SOLUTION
KVK-TECH, INC.
----------
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION CII
RX ONLY
DRUG ABUSE AND DEPENDENCE
Methylphenidate Hydrochloride should be given cautiously to
emotionally unstable patients, such
as those with a history of drug dependence or alcoholism, because such
patients may increase
dosage on their own initiative.
Chronically abusive use can lead to marked tolerance and psychic
dependence with varying
degrees of abnormal behavior. Frank psychotic episodes can occur,
especially with parenteral
abuse. Careful supervision is required during drug withdrawal, since
severe depression as well
as the effects of chronic overactivity can be unmasked. Long-term
follow-up may be required
because of the patient's basic personality disturbances.
DESCRIPTION
Methylphenidate Hydrochloride 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, 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 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: artificial grape flavor, glycerin, hydrochloric acid,
maltitol syrup, propylene glycol,
purified water, sodium hydroxide, and sorbitol. Hydrochloric acid may
be added to adjust pH.
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