METHYLPHENIDATE HYDROCHLORIDE tablet METHYLPHENIDATE HYDROCHLORIDE SR- methylphenidate hydrochloride tablet, film coated, exten

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Sandoz Inc

DCI (Denominação Comum Internacional):

METHYLPHENIDATE HYDROCHLORIDE

Composição:

METHYLPHENIDATE HYDROCHLORIDE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Tablets 5 mg-round, yellow (SZ imprinted on one side and 783 on the other) Bottles of 100.......................................................................NDC 0781-5748-01 Tablets 10 mg-round, pale green, scored (SZ imprinted on one side and 789 on the other) Bottles of 100.......................................................................NDC 0781-5749-01 Tablets 20 mg-round, pale yellow, scored (SZ imprinted on one side and 790 on the other) Bottles of 100.......................................................................NDC 0781-5753-01 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature] Protect from moisture. Dispense in tight, light-resistant container (USP). SR Tablets 20 mg-round, white to off-white, film coated (SZ and 780 printed in black ink on one side). Bottles of 100.......................................................................NDC 0781-5754-01 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Protect from moisture. 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 and methylphenidate hydrochloride sustained-release 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 or methylphenidate hydrochloride sustained-release 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 or methylphenidate hydrochloride sustained-release in the household trash.

Status de autorização:

New Drug Application Authorized Generic

Folheto informativo - Bula

METHYLPHENIDATE HYDROCHLORIDE SR- METHYLPHENIDATE HYDROCHLORIDE
TABLET, FILM
COATED, EXTENDED RELEASE
Sandoz Inc
----------
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 yo

Características técnicas

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
METHYLPHENIDATE HYDROCHLORIDE SR- METHYLPHENIDATE HYDROCHLORIDE
TABLET, FILM
COATED, EXTENDED RELEASE
SANDOZ INC
----------
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. Maxi