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:

Accord Healthcare, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride tablets are indicated for the treatment of: - Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults - Narcolepsy - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)] . - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy. Heal

Product summary:

Methylphenidate Hydrochloride Tablets, USP Tablets 5 mg: White, round tablets, one side debossed with "W" and other side debossed with "281". Bottles of 100 with child-resistant closure, NDC 16729-478-01 Tablets 10 mg with a functional score: White, round tablets, one side debossed with "W282" and other side scored. Bottles of 100 with child-resistant closure, NDC 16729-479-01 Tablets 20 mg with a functional score: White, round tablets, one side debossed with "W283" and scored on other side. Bottles of 100 with child-resistant closure, NDC 16729-480-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard methylphenidate hydrochloride tablets in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Accord Healthcare, Inc.
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Dispense with Medication Guide available at
www.accordhealthcare.us/medication-guides
MEDICATION GUIDE
Methylphenidate Hydrochloride Tablets CII (meth" il fen' i date hye"
droe klor' ide)
What is the most important information I should know about
methylphenidate hydrochloride tablets?
Methylphenidate hydrochloride tablet is a federal controlled substance
(CII) because it can be abused or
lead to dependence. Keep methylphenidate hydrochloride tablets in a
safe place to prevent misuse and
abuse. Selling or giving away methylphenidate hydrochloride tablets
may harm others and is against the
law.
Tell your doctor if you or your child have abused or been dependent on
alcohol, prescription medicines,
or street drugs.
The following have been reported with use of methylphenidate
hydrochloride 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 tablets.
Your doctor should check you or your child’s blood pressure and
heart rate regularly during treatment
with methylphenidate hydrochloride tablets.
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 tablets.
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
•
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,
bi

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
ACCORD HEALTHCARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METHYLPHENIDATE HYDROCHLORIDE TABLETS.
METHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE, OTHER
METHYLPHENIDATE-
CONTAINING PRODUCTS, AND AMPHETAMINES, HAVE A HIGH POTENTIAL FOR ABUSE
AND
DEPENDENCE (5.1, 9.2, 9.3).
ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING, AND MONITOR FOR SIGNS
OF ABUSE AND
DEPENDENCE WHILE ON THERAPY (5.1, 9.2)
INDICATIONS AND USAGE
Methylphenidate hydrochloride is a central nervous system (CNS)
stimulant indicated for the treatment of
Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1).
DOSAGE AND ADMINISTRATION
_Methylphenidate Hydrochloride Tablets_ ( 2.2):
Pediatric Patients 6 Years and Older: Start with 5 mg twice daily
(before breakfast and lunch), titrating
the dose weekly in 5 to 10 mg increments. Dosages above 60 mg/day are
not recommended.
Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3
times daily, preferably 30 to 45
minutes before meals. Maximum total daily dosage is 60 mg.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, and 20 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other product components
of methylphenidate
hydrochloride tablets ( 4).
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the
preceding 14 days ( 4).
WARNINGS AND PRECAUTIONS
_Serious Cardiovascular Events_: Sudden death has been reported in
association with CNS-stimulant
treatment at usual doses in pediatric patients with structural cardiac
abnormalities or other serious
heart problems. In adults, sudden death, stroke, and myo