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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SpecGx LLC

INN (International Name):

DEXTROAMPHETAMINE SULFATE

Composition:

DEXTROAMPHETAMINE SULFATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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;

Product summary:

Dextroamphetamine Sulfate Extended-Release Capsules Each capsule, with white opaque cap and white opaque body, contains dextroamphetamine sulfate. The 5 mg capsule is imprinted with an ® on the cap and is imprinted 8960 5 mg on the body in black. The 10 mg capsule is imprinted with an ® on the cap and is imprinted 8961 10 mg on the body in blue. The 15 mg capsule is imprinted with an ® on the cap and is imprinted 8962 15 mg on the body in pink.       5 mg     Bottles of 100……………….NDC 0406-8960-01     10 mg     Bottles of 100……………….NDC 0406-8961-01     15 mg     Bottles of 100……………….NDC 0406-8962-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].   Dispense in a tight, light-resistant container with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company. © 2022 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 02/2022                Mallinckrodt™ Pharmaceuticals                                                                      An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D09.pdf or by calling 1-800-778-7898 for alternate delivery options.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
SpecGx LLC
----------
MEDICATION GUIDE
Dextroamphetamine Sulfate Extended-Release Capsules, CII
(DEX-troe-am-FET-uh-meen SULL-fate)
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,

Summary of Product characteristics

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
SPECGX LLC
----------
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 extended-release capsule 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 capsules as
the neutral
sulfate.
Structural formula:
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES
Each dextroamphetamine sulfate 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 capsule, with white opaque cap and white opaque body, contains
dextroamphetamine sulfate USP. The 5 mg capsule is imprinted with an
on the cap
and is imprinted 8960 5 mg on the body in black. The 10 mg capsule is
imprinted with an
on the cap and is imprinted 8961 10 mg on the body in blue. The 15 mg
capsule is
imprinted with an
on the cap and is imprinted 8962 15 mg on the body in pink.
®
®
®
Inactive ingredients consist of sugar spheres, titanium dioxide,
gelatin, shellac glaze-
45%, SD-45 alcohol, iron oxide black, propylene glycol, FD&C Blue
#2/Indigo Carmine
Lake, FD&C Red #40/Allura Red AC Lake, FD&C Blue #1/Brilliant Blue FCF
Lake, D&C
Yellow #10 Lake, SD3A alcohol, shellac, dehydrated alcohol, isopropyl
alcohol, butyl
alcohol, strong ammonia solution, FD&C Blue #2 Aluminum Lak