METHYLPHENIDATE HYDROCHLORIDE solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Bryant Ranch Prepack

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Methylphenidate hydrochloride oral solution is indicated for the treatment of: • Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older • Narcolepsy Methylphenidate hydrochloride oral solution is contraindicated in patients: • with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6)]. • receiving 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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD  medications, including methylphenidate hydro

পণ্য সারাংশ:

Methylphenidate Hydrochloride Oral Solution is a clear, colorless to pale yellow, grape flavored solution with no visible particulates available in the following strengths • 5 mg per 5 mL Bottles of 500 mL………..NDC 63629-1175-1 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride oral solution 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 oral solution 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 oral solution in the household trash.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Bryant Ranch Prepack
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Methylphenidate (METH-il-FEN-i-date) Hydrochloride Oral Solution
What is the most important information I should know about
methylphenidate hydrochloride oral
solution?
Methylphenidate hydrochloride oral solution can cause serious side
effects, including:
• Abuse and dependence. Methylphenidate hydrochloride oral solution,
other methylphenidate containing
medicines, and amphetamines have a high chance for abuse and can cause
physical and psychological
dependence. Your healthcare provider should check you or your child
for signs of abuse and dependence
before and during treatment with methylphenidate hydrochloride oral
solution.
o Tell your healthcare provider if you or your child have ever abused
or been dependent on
alcohol, prescription medicines, or street drugs.
o Your healthcare provider can tell you more about the differences
between physical and
psychological dependence and drug addiction.
• Heart-related problems, including:
o sudden death, stroke, and heart attack in adults
o sudden death in children who have heart problems or heart defects
o increased blood pressure and heart rate
Your healthcare provider should check you or your child carefully for
heart problems before starting
treatment with methylphenidate hydrochloride oral solution. Tell your
healthcare provider if you or your
child have any heart problems, heart defects, high blood pressure, or
have a family history of these
problems.
Your healthcare provider should check your or your child’s blood
pressure and heart rate regularly
during treatment with methylphenidate hydrochloride oral solution.
Call your healthcare provider or go to the nearest hospital emergency
room right away if you or your
child have any signs of heart problems such as chest pain, shortness
of breath, or fainting during treatment
with methylphenidate hydrochloride oral solution.
• Mental (psychiatric) problems, including:
o new or worse behavior and thought problems
o new or worse bipolar illness

পণ্য বৈশিষ্ট্য

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE
HYDROCHLORIDE SOLUTION
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION.
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE ORAL
SOLUTION, 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 oral solution is a central nervous
system (CNS) stimulant indicated for the
treatment of:
• Attention Deficit Hyperactivity Disorder (ADHD) in adults and
pediatric patients 6 years of age and older
(1)
• Narcolepsy (1)
DOSAGE AND ADMINISTRATION
• Pediatric patients 6 years and older: Starting dose is 5 mg twice
daily (before breakfast and lunch);
increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is
not recommended. (2.2)
• Adults: Administer in divided doses 2 or 3 times daily, preferably
30 to 45 minutes before meals.
Average dosage is 20 to 30 mg daily. Maximum recommended daily dosage
is 60 mg. (2)
DOSAGE FORMS AND STRENGTHS
_Oral solution:_ 5 mg per 5 mL and 10 mg per 5 mL. (3)
CONTRAINDICATIONS
• Known hypersensitivity to methylphenidate or other components of
methylphenidate hydrochloride oral
solution (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 Reactions:_ Sudden death has been reported
in association with CNS stimulant
treatment at recommended doses in pediatric pati