METHYLPHENIDATE HYDROCHLORIDE tablet METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release 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 or methylphenidate hydrochloride extended-release tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6)] . - 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 and methylphenidate hydrochloride extended-release

Product summary:

Methylphenidate Hydrochloride Tablets USP 5 mg tablets available as a round, white unscored tablet debossed with 5 on one side and a  on the other side Bottles of 100........................NDC 0406-1142-01 10 mg tablets available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side Bottles of 100........................NDC 0406-1144-01 20 mg tablets available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side Bottles of 100........................NDC 0406-1146-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container with child-resistant closure. Methylphenidate Hydrochloride Extended-Release Tablets USP 10 mg extended-release tablets available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side Bottles of 100........................NDC 0406-1445-01 20 mg extended-release tablets available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side Bottles of 100........................NDC 0406-1473-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant container with child-resistant closure. Note : Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets are color-additive free. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets by a medicine take-back 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 or methylphenidate hydrochloride extended-release 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 or methylphenidate hydrochloride extended-release tablets in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED
RELEASE
SpecGx LLC
----------
MEDICATION GUIDE
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised:
09/2022
Methylphenidate Hydrochloride Tablets USP
Methylphenidate Hydrochloride Extended-Release Tablets USP
(METH il FEN i date) CII
What is the most important information I should know about
methylphenidate hydrochloride tablets and methylphenidate
hydrochloride extended-release tablets?
Methylphenidate hydrochloride tablets and methylphenidate
hydrochloride extended-release tablets are federal controlled
substances (CII) because they can be abused or lead to
dependence. Keep methylphenidate hydrochloride tablets and
methylphenidate hydrochloride extended-release tablets in a safe
place to prevent misuse and abuse. Selling or giving away
methylphenidate hydrochloride tablets and methylphenidate
hydrochloride extended-release tablets may harm others, and is
against the law.
Tell your doctor if you or your child have ever 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
and methylphenidate hydrochloride extended-release tablets.
Your doctor should check you or your child’s blood pressure and
heart rate regularly during treatment with methylphenidate
hydrochloride tablets and methylphenidate hydrochloride
extended-release tablets.
Call your doctor right away if you or your child has any signs of
heart problems, such as chest pain, sho

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
SPECGX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE TABLETS AND METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METHYLPHENIDATE
HYDROCHLORIDE TABLETS AND METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE
TABLETS.
METHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE 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 TABLETS AND
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 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.
_Methylphenidate Hydrochloride Extended-Release Tablets_ (2.2):
May switch to methylphenidate hydrochloride extended-release tablets
when the 8-hour dosage of
methylphenidate hydrochloride extended-release tablets corresponds to
the titrated 8-hour dosage of
methyl