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

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

American Health Packaging

INN (Међународно име):

DEXTROAMPHETAMINE SULFATE

Састав:

DEXTROAMPHETAMINE SULFATE 15 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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; poo

Резиме производа:

Dextroamphetamine Sulfate Extended-Release Capsules – Each capsule, with white opaque cap and white opaque body, contains dextroamphetamine sulfate. The 15 mg capsule is imprinted with an ® on the cap and is imprinted 8962 15 mg on the body in pink. Unit dose packages of 30 (3 x 10) NDC 60687-150-21 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt. DEA Order Form Required.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
American Health Packaging
----------
MEDICATION GUIDE
8415021/0718F
Dextroamphetamine Sulfate Extended-Release Capsules
(DEX-troe-am-FET-uh-meen SULL-fate)
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 pro

Карактеристике производа

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
AMERICAN HEALTH PACKAGING
----------
DEXTROAMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES
CII
RX ONLY
8415021/0718OS
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.
Active Ingredient: dextroamphetamine sulfate USP
Inactive Ingredients: 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 Lake, D&C Red #7 Calcium Lake, hydroxypropyl
methylcellulose/hypromellose,
macrogol/polyethylene glycol, purified water, ethylcellulose, ammonium
hydroxide 28%, medium chain
triglycerides, oleic acid
CLINICAL PHARMACOLOGY
Amphetamines are noncatecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral
actions include e