DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- dextroamphetamine sulfate capsule, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Tillgänglig från:

Lineage Therapeutics Inc

INN (International namn):

DEXTROAMPHETAMINE SULFATE

Sammansättning:

DEXTROAMPHETAMINE SULFATE 5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Dextroamphetamine sulfate is indicated in: As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoid tasks requiring sustained mental effort; loses things; easily distracted;

Produktsammanfattning:

Dextroamphetamine Sulfate Extended-Release Capsules are supplied as follows: Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg: Small, spherical, light orange pellets and dark orange pellets contained in a size #4 gelatin capsule. Capsules are imprinted “327” on the yellow cap, and “CP” and “5 mg” on the body.    Bottles of 90    (NDC 54505-327-09) Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg: Small, spherical, light orange pellets and dark orange pellets contained in a size #4 gelatin capsule. Capsules are imprinted “328” on the orange cap, and “CP” and “10 mg” on the body.    Bottles of 90    (NDC 54505-328-09) Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg: Small, spherical, light orange pellets and dark orange pellets contained in a size #3 gelatin capsule. Capsules are imprinted “329” on the red cap, and “CP” and “15 mg” on the body.    Bottles of 90    (NDC 54505-329-09) Store at controlled room temperature between 20° to 25°C (68° to 77°F)[See USP]. Dispense in a tight, light-resistant container. Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 for: Lineage Therapeutics Inc. Horsham, PA 19044 LB# 822-07                                          Rev. March, 2017 For additional copies of the printed patient information/medication guide, please visit www.lineagetherapeutics.com or contact us at 1-888-894-6528.

Bemyndigande status:

New Drug Application Authorized Generic

Bipacksedel

EXTENDED RELEASE
Lineage Therapeutics Inc
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MEDICATION GUIDE
CII
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES
Read the Medication Guide that comes with Dextroamphetamine Sulfate
Extended-Release
Capsules before you or your child starts taking it and each time you
get a refill. There may be new
information. This Medication Guide does not take the place of talking
to your doctor about your or your
child’s treatment with Dextroamphetamine Sulfate Extended-Release
Capsules.
What is the most important information I should know about
Dextroamphetamine Sulfate Extended-
Release Capsules?
The following have been reported with use of Dextroamphetamine Sulfate
Extended-Release Capsules
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
Dextroamphetamine Sulfate Extended-Release Capsules.
Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment
with Dextroamphetamine Sulfate Extended-Release Capsules.
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 Dextroamphetamine
Sulfate Extended-Release Capsules.
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
Children and Teenagers
•
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 y

Produktens egenskaper

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
LINEAGE THERAPEUTICS INC
----------
DEXTROAMPHETAMINE SULFATE EXTENDED RELEASE CAPSULES CII
RX ONLY
WARNING:
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID
TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-
THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION:
Dextroamphetamine sulfate is the dextro isomer of the compound
_d,l_-amphetamine sulfate, a
sympathomimetic amine of the amphetamine group. Chemically,
dextroamphetamine is _d_-alpha-
methylphenethylamine, and is present in all forms of dextroamphetamine
sulfate as the neutral sulfate.
Structural formula:
Each extended-release capsule is so prepared that an initial dose is
released promptly and the remaining
medication is released gradually over a prolonged period. Each small
spherical capsule, contains
dextroamphetamine sulfate. The 5 mg capsule is imprinted “327” on
the YELLOW cap, and “CP” and “5
mg” on the body. The 10 mg capsule is imprinted “328” on the
ORANGE cap, and “CP” and “10 mg” on
the body. The 15 mg capsule is imprinted “329” on the RED cap, and
“CP” and “15 mg” on the body.
Product reformulation in 1996 has caused a minor change in the color
of the time-released pellets
within each capsule. Inactive ingredients now consist of cetyl
alcohol, D&C Yellow No. 10, dibutyl
sebacate, ethylcellulose, FD&C Red No. 40, FD&C Yellow No. 6, gelatin,
hypromellose,
polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres,
and trace amounts of other inactive
ingredients.
CLINICAL PHARMACOLOGY:
Amphetamines are noncatecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral
actions include elevations