LISDEXAMFETAMINE DIMESYLATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT761GEGS) (LISDEXAMFETAMINE - UNII:H645GUL8KJ)

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lisdexamfetamine dimesylate capsules are indicated for the treatment of: - Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] - Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . Limitations of Use : - Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4)]. - Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions (5.2)] . Lisdexamfetamine dimesylate capsules are contraindicated in patients with: - Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dime

Product summary:

Lisdexamfetamine Dimesylate Capsules: Bottles of 100.................................................. NDC 0406-5113-01 Bottles of 100.................................................. NDC 0406-5114-01 Bottles of 100.................................................. NDC 0406-5115-01 Bottles of 100.................................................. NDC 0406-5116-01 Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired lisdexamfetamine dimesylate capsules by a medicine take-back program.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SpecGx LLC
----------
MEDICATION GUIDE
Lisdexamfetamine Dimesylate Capsules, CII
(lis-DEX-am-FET-a-meen dye-MES-i-late)
What is the most important information I
should know about lisdexamfetamine
dimesylate capsules?
Lisdexamfetamine dimesylate capsules may
cause serious side effects, including:
•
Abuse and dependence.
Lisdexamfetamine dimesylate
capsules, other amphetamine
containing medicines, and
methylphenidate have a high chance
for abuse and may 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 lisdexamfetamine
dimesylate capsules.
•
Tell your healthcare provider if
you or your child have ever
abused or been dependent on
alcohol, prescription medicines,
or street drugs.
•
Your healthcare provider can
tell you more about the
differences between physical
and psychological dependence
and drug addiction.
•
Heart-related problems including:
•
sudden death, stroke, and heart
attack in adults
•
sudden death in children who
have heart problems or heart
defects
•
increased blood pressure and
heart rate
Your healthcare provider should check you or
your child carefully for heart problems before
starting treatment with lisdexamfetamine
dimesylate capsules. Tell your healthcare
provider if you or your child have any heart
problems, heart defects, high blood pressure,
or 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
lisdexamfetamine dimesylate capsules.
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
lisdexamfetamine dimesylate capsules.
•
Mental (psychiatric) problems,
including:
•
new or worse behavior and
thought problems
•
new or worse bipolar illness
•
new psychotic symptoms (such
as hearing voices, or s

Summary of Product characteristics

LISDEXAMFETAMINE DIMESYLATE- LISDEXAMFETAMINE DIMESYLATE CAPSULE
SPECGX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LISDEXAMFETAMINE
DIMESYLATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LISDEXAMFETAMINE DIMESYLATE CAPSULES.
LISDEXAMFETAMINE DIMESYLATE CAPSULES, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 2007
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING LISDEXAMFETAMINE DIMESYLATE CAPSULES, OTHER
AMPHETAMINE-CONTAINING PRODUCTS, AND METHYLPHENIDATE HAVE A HIGH
POTENTIAL FOR
ABUSE AND DEPENDENCE. (5.1, 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)
RECENT MAJOR CHANGES
Indications and Usage (1)
08/2021
Warnings and Precautions (5.5) 08/2021
INDICATIONS AND USAGE
Lisdexamfetamine dimesylate capsules are a central nervous system
(CNS) stimulant indicated for the
treatment of (1):
Attention Deficit Hyperactivity Disorder (ADHD) in adults and
pediatric patients 6 years and older
Moderate to severe binge eating disorder (BED) in adults
Limitations of Use:
Pediatric patients with ADHD younger than 6 years of age experienced
more long-term weight loss than
patients 6 years and older (8.4)
Lisdexamfetamine dimesylate capsules are not indicated for weight
loss. Use of other
sympathomimetic drugs for weight loss has been associated with serious
cardiovascular adverse
events. The safety and effectiveness of lisdexamfetamine dimesylate
capsules for the treatment of
obesity have not been established. (5.2)
DOSAGE AND ADMINISTRATION
Indication Population
Initial Dose
Titration
Schedule
Recommended
Dose
Maximum
Dose
ADHD (Adults and pediatric patients 6 tears
and older) (2.2)
30 mg every
morning
10 mg or 20 mg
weekly
30 mg to 70 mg
per day
70 mg per
day
BED (Adults) (2.3)
30 mg every
morning
20 mg weekly
50 mg to 70 mg
per day
70 mg per
day
Prior to treatment, assess for presence