DEXMETHYLPHENIDATE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

DEXMETHYLPHENIDATE HYDROCHLORIDE (UNII: 1678OK0E08) (DEXMETHYLPHENIDATE - UNII:M32RH9MFGP)

Saadav alates:

Sandoz Inc

INN (Rahvusvaheline Nimetus):

DEXMETHYLPHENIDATE HYDROCHLORIDE

Koostis:

DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)] . Pregnancy Category C In studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels (AUCs) of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose (MRHD) of 20 mg/day. Racemic methylphen

Toote kokkuvõte:

Dexmethylphenidate hydrochloride tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows: Bottles of 100………………………………………………….NDC 0781-5676-01 Bottles of 100………………………………………………….NDC 0781-5689-01 Bottles of 100………………………………………………….NDC 0781-5691-01 Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 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 dexmethylphenidate 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 dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride in the household trash. T2019-34 October 2019

Volitamisolek:

New Drug Application Authorized Generic

Infovoldik

Sandoz Inc
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MEDICATION GUIDE
Dexmethylphenidate Hydrochloride
Tablets CII
(dex-METH-il-FEN-i-date hy-dro-chlo-ride)
What is the most important information I should know about
Dexmethylphenidate hydrochloride tablets?
Dexmethylphenidate hydrochloride tablets are a federal controlled
substance (CII) because it can be abused
or lead to dependence. Keep dexmethylphenidate hydrochloride tablets
in a safe place to prevent misuse and
abuse. Selling or giving away dexmethylphenidate 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 dexmethylphenidate
hydrochloride tablets.
Your doctor should check your or your child’s blood pressure and
heart rate regularly during treatment with
dexmethylphenidate 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 dexmethylphenidate 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,
bipolar illness, or depression.
Call your doctor right away if you or yo

Toote omadused

DEXMETHYLPHENIDATE HYDROCHLORIDE- DEXMETHYLPHENIDATE HYDROCHLORIDE
TABLET
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXMETHYLPHENIDATE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS.
DEMETHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 2001
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride is a central nervous system (CNS)
stimulant indicated for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) (1).
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
TABLETS: 2.5 mg, 5 mg, and 10 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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CNS STIMULANTS, INCLUDING DEXMETHYLPHENIDATE 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).
Boxed Warning 1/2019
Contraindications (4) 1/2019
Warnings and Precautions (5) 1/2019
Administer orally twice daily, 4 hours apart with or without food (2)
For patients new to methylphenidate: Recommend starting dose of 5 mg
once daily (2.5 mg twice daily (2.1))
For patients currently taking methylphenidate: Initiate
dexmethylphenidate hydrochloride therapy with half (1/2) the
current total daily dose of methylphenidate (2.3)
Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day
(10 mg twice daily) (2.1)
Known hypersensitivity to methylphenidate or other components of
dexmethylphenidate hydrochloride (4)
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the preceding 14 days
(4)
_Serious Cardiovascular Events_: Sudden death has been reported in
association with CNS s