LISDEXAMFETAMINE DIMESYLATE capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Ascent Pharmaceuticals, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 dimesyla

Produktu pārskats:

Lisdexamfetamine dimesylate capsules: • Lisdexamfetamine dimesylate capsules 10 mg: Hard Gelatin Capsule Shell Size "3" Pink Opaque Cap imprinted with AC in Black ink and Pink Opaque body imprinted with 10 in black ink filled with White to Off-white powder. Bottles of 100         NDC 43602-306-01 • Lisdexamfetamine dimesylate capsules 20 mg: Hard Gelatin Capsule Shell Size "3" Ivory Opaque Cap imprinted with AC in Black ink and Ivory Opaque body imprinted with 20 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-307-60 Bottles of 500         NDC 43602-307-05 • Lisdexamfetamine dimesylate capsules 30 mg: Hard Gelatin Capsule Shell Size "3" Orange Opaque Cap imprinted with AC in Black ink and White Opaque body imprinted with 30 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-308-60 Bottles of 500         NDC 43602-308-05 • Lisdexamfetamine dimesylate capsules 40 mg: Hard Gelatin Capsule Shell Size "3" Blue Green Opaque Cap imprinted with AC in Black ink and White Opaque body imprinted with 40 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-309-60 Bottles of 500         NDC 43602-309-05 • Lisdexamfetamine dimesylate capsules 50 mg: Hard Gelatin Capsule Shell Size "3" Blue Opaque Cap imprinted with AC in Black ink and White Opaque body imprinted with 50 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-310-60 Bottles of 500         NDC 43602-310-05 • Lisdexamfetamine dimesylate capsules 60 mg: Hard Gelatin Capsule Shell Size "2" Aqua Blue Opaque Cap imprinted with AC in Black ink and Aqua Blue Opaque body imprinted with 60 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-311-60 Bottles of 500         NDC 43602-311-05 • Lisdexamfetamine dimesylate capsules 70 mg: Hard Gelatin Capsule Shell Size "2" White Opaque Cap imprinted with AC in Black ink and Blue Transparent body imprinted with 70 in black ink filled with White to Off-white powder. Bottles of 60           NDC 43602-312-60 Bottles of 500         NDC 43602-312-05 Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC and 30ºC (59 to 86ºF) [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.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Ascent Pharmaceuticals, Inc.
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MEDICATION GUIDE
Lisdexamfetamine dimesylate
(lis dex” am fet’ a meen dye-MES-i-late)
Capsules, CII
What is the most important information I should know about
lisdexamfetamine dimesylate capsules?
Lisdexamfetamine dimesylate capsules may cause serious side effects,
including:
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.
Tell your healthcare provider about any mental problems you or your
child have or about a family
history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any
new or worsening mental
symptoms or problems during treatment with lisdexamfetamine dimesylate
capsules, especially hearing
voices, seeing or believing things that are not real, or new manic
symptoms.
What are lisdexamfetamine dimesylate capsules?
Lisdexamfetamine dimesylate capsules are a central nervous system
(CNS) stimulant prescription
medicine used for the treatment of:
•
Attention Deficit Hyperactivity Disorder (ADHD) in adults and children
6 years of age and older.
Lisdexamfetamine dimesylate capsules may help increase attention and
decrease impulsiveness
and hyperactivity in people with ADHD.
•
Moderate to severe binge eating disorder (BED) in adults.
Lisdexamfetamine dimesylate capsules
may help reduce the number of binge eating days in people with BED.
Lisdexamfe

Produkta apraksts

LISDEXAMFETAMINE DIMESYLATE- LISDEXAMFETAMINE DIMESYLATE CAPSULE
ASCENT PHARMACEUTICALS, INC.
----------
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) 7/2021
Warnings and Precautions (5.5) 7/2021
INDICATIONS AND USAGE
Lisdexamfetamine dimesylate capsules are a central nervous system
(CNS) stimulant indicated for the
treatment of (1): (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: (1)
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
(2)
INDICATED POPULATION INITIAL DOSE TITRATION
SCHEDULE RECOMMENDED
DOSE MAXIMUM DOSE
ADHD (Adults and pediatric
patients (2)
6 years and older) (2.2) (2)
30 mg every
morning
10 mg or 20 mg
weekly (2)
30 mg to 70 mg per
day (2)
50 mg to 70 mg
per day
BED (Adults) (2.3)
30 mg every
morning
20 mg weekly
50 mg to 70 mg per
day
70