DEXTROAMPHETAMINE SULFATE capsule, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mayne Pharma Inc.

INN (שם בינלאומי):

DEXTROAMPHETAMINE SULFATE

הרכב:

DEXTROAMPHETAMINE SULFATE 5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Dextroamphetamine sulfate extended-release capsules are indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity 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 the 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 organ

leaflet_short:

Dextroamphetamine Sulfate Extended-Release Capsules are available as follows: 5 mg -  Capsules with a light brown opaque cap and body are printed with  and 0303 on both cap and body in black ink and contain 5 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-344-90). 10 mg - Capsules with a light brown opaque cap and light orange transparent body are printed with  and 0304 on both cap and body in black ink and contain 10 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-345-90). 15 mg -  Capsules with a light brown opaque cap and light orange transparent body are printed with  and 0305 on both cap and body in black ink and contain 15 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 51862-346-90). Store at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Mayne Pharma Greenville, NC 27834 Rev. A 3/2019

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
Mayne Pharma Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Sulfate (dex'' troe am fet' a meen sul' fate)
Extended-Release Capsules CII
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

מאפייני מוצר

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
MAYNE PHARMA 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, USP 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 extended-release 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 5 mg capsule, with a light brown opaque cap and body, contains 5
mg of dextroamphetamine
sulfate, USP. The 5 mg capsule is printed with
and 0303 on both cap and body in black ink.
Each 10 mg capsule, with a light brown opaque cap and light orange
transparent body, contains 10 mg of
dextroamphetamine sulfate, USP. The 10 mg capsule is printed with
and 0304 on both cap and body
in black ink.
Each 15 mg capsule, with a light brown opaque cap and light orange
transparent body, contains 15 mg of
dextroamphetamine sulfate, USP. The 15 mg capsule is printed with
and 0305 on both cap and body
in black ink.
Inactive ingredients: denatured alcohol, ammonium hydroxide,
ethylcellulose, gelatin, hydroxypropyl
cellulose, hypromellose, medium chain triglycerides, oleic acid,
polyethylene glycol and sugar
spheres (which contain sucrose and corn starch).
The capsule shells of the 5 mg, 10 mg and 15 mg contain black ir