METHYLPHENIDATE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

bryant ranch prepack

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

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

Product summary:

Methylphenidate Hydrochloride 10 mg Tablets USP are available as follows: NDC NBR.                     TABLETS PER BOTTLE ---------------                     ------------------------------------- 63629-3279-1                           30 63629-3279-2                           90 63629-3279-3                           60 Protect from light. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature. Protect from moisture. Do not store above 30°C (86°F). Manufactured By: Mallinckrodt Inc., Hazelwood, MO 63042 USA. Distributed By: Bryant Ranch Prepack 12623 Sherman Way North Hollywood, CA 91605 Voice [phone]   Fax [phone] CII Methylin ™ (methylphenidate HCl tablets USP) Methylin ™ ER (methylphenidate HCl extended-release tablets USP) Read the Medication Guide that comes with Methylin™ and Methylin™ ER 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 Methylin™ and Methylin™ ER. What Is Methylin ™ and Methylin ™ ER? Methylin™ and Methylin™ ER is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Methylin™ and Methylin™ ER may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Methylin™ and Methylin™ ER should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Methylin™ and Methylin™ ER is also used in the treatment of a sleep disorder called narcolepsy. Who should not take Methylin ™ and Methylin ™ ER? Methylin ™ and Methylin ™ ER should not be taken if you or your child: Methylin™ and Methylin™ ER should not be used in children less than 6 years old because it has not been studied in this age group. Methylin ™ and Methylin ™ ER may not be right for you or your child. Before starting Methylin ™ and Methylin ™ ER tell your or your child's doctor about all health conditions (or a family history of) including: Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding. Can Methylin ™ and Methylin ™ ER be taken with other medicines? Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylin™ and Methylin™ ER and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Methylin™ and Methylin™ ER. Your doctor will decide whether Methylin™ and Methylin™ ER can be taken with other medicines. Especially tell your doctor if you or your child takes: Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking Methylin ™ and Methylin ™ ER without talking to your doctor first. How should Methylin ™ and Methylin ™ ER be taken? What are possible side effects of Methylin ™ and Methylin ™ ER? See “What is the most important information I should know about Methylin™ and Methylin™ ER?” for information on reported heart and mental problems. Other serious side effects include: Common side effects include: Talk to your doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Methylin ™ and Methylin ™ ER? General information about Methylin ™ and Methylin ™ ER Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylin™ and Methylin™ ER for a condition for which it was not prescribed. Do not give Methylin™ and Methylin™ ER to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Methylin™ and Methylin™ ER. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Methylin™ and Methylin™ ER that was written for healthcare professionals, or you can visit www.Mallinckrodt.com or call 1-800-778-7898. What are the ingredients in Methylin ™ and Methylin ™ ER? Active Ingredient: methylphenidate HCl Inactive Ingredients: Methylin™ tablets: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc. Methylin™ ER tablets: hydroxypropyl methylcellulose 2208, magnesium stearate, microcrystalline cellulose, and talc. This Medication Guide has been approved by the U.S. Food and Drug Administration. Mallinckrodt Inc., Hazelwood, MO 63042 USA.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET
DESCRIPTION
Methylphenidate hydrochloride is a mild central nervous system (CNS)
stimulant, available for oral
administration as tablets of 5 mg, 10 mg, and 20 mg and as
extended-release tablets of 10 mg and 20 mg.
Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate
hydrochloride.
Inactive Ingredients
Methylin
tablets: lactose monohydrate, magnesium stearate, microcrystalline
cellulose, and talc.
Methylin
ER tablets: hydroxypropyl methylcellulose 2208, magnesium stearate,
microcrystalline
cellulose, and talc.
CLINICAL PHARMACOLOGY
Methylphenidate is a mild central nervous system stimulant.
The mode of action in man is not completely understood, but
methylphenidate presumably activates the
brain stem arousal system and cortex to produce its stimulant effect.
There is neither specific evidence which clearly establishes the
mechanism whereby methylphenidate
produces its mental and behavioral effects in children, nor conclusive
evidence regarding how these
effects relate to the condition of the central nervous system.
Methylphenidate hydrochloride in the extended-release tablets is more
slowly but as extensively
absorbed as in the regular tablets. Relative bioavailability of the
extended-release tablet compared to
the methylphenidate hydrochloride tablet, measured by the urinary
excretion of methylphenidate
hydrochloride major metabolite (α-phenyl-2-piperidine acetic acid)
was 105% (49%-168%) in children
and 101% (85%-152%) in adults. The time to peak rate in children was
4.7 hours (1.3-8.2 hours) for the
extended-release tablets and 1.9 hours (0.3-4.4 hours) for the
tablets. An average of 67% of extended-
release tablet dose was excreted in children as compared to 86% in
adults.
In a clinical study involving adult subjects who received
extended-release tablets, plasma concentrations
of methylphenidate hydrochloride’s major metabolite appeared to be
greate