METHYLPHENIDATE HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Sammensetning:

METHYLPHENIDATE HYDROCHLORIDE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Methylphenidate hydrochloride and methylphenidate hydrochloride sustained-release are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Pregnancy Category C In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development

Produkt oppsummering:

Product: 63629-3166 NDC: 63629-3166-4 60 TABLET in a BOTTLE NDC: 63629-3166-1 30 TABLET in a BOTTLE NDC: 63629-3166-3 90 TABLET in a BOTTLE NDC: 63629-3166-2 100 TABLET in a BOTTLE

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Bryant Ranch Prepack
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MEDICATION GUIDE
METHYLPHENIDATE HYDROCHLORIDE
(METH-il-FEN-i-date)
tablets, USP CII
What is the most important information I should know about
methylphenidate hydrochloride?
Methylphenidate hydrochloride is a federal controlled substance (CII)
because it can be abused or lead to
dependence. Keep methylphenidate hydrochloride in a safe place to
prevent misuse and abuse. Selling or
giving away methylphenidate hydrochloride 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.
Your doctor should check you or your child’s blood pressure and
heart rate regularly during treatment
with methylphenidate hydrochloride.
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.
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,
bipolar illness, or depression.
Call your doctor right away if you or your child have any new or
worsening mental symptoms or
problems while taking methylphe

Preparatomtale

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HYDROCHLORIDE
TABLETS CII AND METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE
TABLETS CII SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE
TABLETS CII AND
METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE TABLETS CII..
METHYLPHENIDATE
HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
METHYLPHENIDATE HYDROCHLORIDE SUSTAINED-RELEASE TABLETS, FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Boxed Warning 1/2019
Contraindications (4) 1/2019
Warnings and Precautions (5) 1/2019
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):
•
•
_Methylphenidate Hydrochloride Sustained-Release Tablets _(2.2):
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
CNS stimulants, including methylphenidate hydrochloride and
methylphenidate hydrochloride sustained-
release, 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)
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 to 30 mg, administered 2 or 3 times
daily, preferably 30 to 45 minutes before
meals. Maximum total daily dosage is 60 mg.
May switch to methylphenidate hydrochloride sustainedre