DEXTROAMPHETAMINE SULFATE- 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:

Vensun Pharmaceuticals, LLC.

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; poor organ

Product summary:

Each capsule, with orange opaque cap and natural body, contains dextroamphetamine sulfate, USP. The Dextroamphetamine Sulfate Extended-release capsules are available as follows: 5 mg The 5-mg capsule is imprinted “P” on the orange opaque cap and is imprinted 596 on the natural body.         NDC 42543-500-01: Bottle of 100 capsules 10 mg The 10-mg capsule is imprinted “P” on the orange opaque cap and is imprinted 597 on the natural body.         NDC 42543-501-01: Bottle of 100 capsules 15 mg The 15-mg capsule is imprinted “P” on the orange opaque cap and is imprinted 598 on the natural body.         NDC 42543-502-01: Bottle of 100 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, February 2019 For additional copies of the printed patient information/medication guide, please contact Pharmaceutics International, Inc. at 1-877-276-5814.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
Vensun Pharmaceuticals, LLC.
----------
MEDICATION GUIDE
DEXTROAMPHETAMINE (dex'' troe am fet' a meen)
SULFATE
Extended-release Capsules
C-II
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

Summary of Product characteristics

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
VENSUN PHARMACEUTICALS, LLC.
----------
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES
C-II
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 Capsules (dextroamphetamine
sulfate) are the dextro
isomer of the compound _d,1_-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:
EXTENDED-RELEASE CAPSULES:
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 capsule, with orange opaque cap and natural body, contains
dextroamphetamine sulfate, USP.
The 5-mg capsule is imprinted “P” on the orange opaque cap and is
imprinted 596 on the natural body.
The 10-mg capsule is imprinted “P” on the orange opaque cap and is
imprinted 597 on the natural body.
The 15-mg capsule is imprinted “P” on the orange opaque cap and is
imprinted 598 on the natural body.
Orange/opaque capsule shell made of gelatin. Inactive ingredients
consist of colloidal silicon dioxide,
dibutyl sebacate, ethylcellulose, ethyl alcohol, FD&C Yellow # 6,
hypromellose, povidone, propylene
glycol, purified water, sugar spheres, talc, gelatin and titanium
dioxide. The 10 mg extended-release
capsule also contains FD&C Red # 40.
CLINICAL PHARMACOLOGY:
Amphetamines are noncatecholamine, sympat