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

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Amneal Pharmaceuticals of New York LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Dextroamphetamine sulfate is 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 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; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program Dextroamphetamine sulfate is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. Known hypersensitivity or idiosyncrasy to amphetamine. In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions]. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Drug Interactions]. Dextroamphetamine sulfate is a Schedule II controlled substance. Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

Обзор продуктов:

Dextroamphetamine Sulfate Extended-Release Capsules are supplied as follows: Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. They are available as: Bottles of 90:                                    NDC 0115-9927-10 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. They are available as: Bottles of 90:                                    NDC 0115-9928-10 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. They are available as: Bottles of 90:                                    NDC 0115-9929-10 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 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2019-00 For additional copies of the printed medication guide, please visit www.amneal.com or contact us at 1-877-835-5472.

Статус Авторизация:

New Drug Application Authorized Generic

тонкая брошюра

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
Amneal Pharmaceuticals of New York LLC
----------
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 has 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 ment

Характеристики продукта

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE- DEXTROAMPHETAMINE
SULFATE CAPSULE, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK 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 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
capsule, with brown cap and natural body, contains 5 mg, 10 mg or 15
mg
dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with
IX and 5 mg on
the brown cap and is imprinted in white with 673 and 5 mg on the
natural body. The 10
mg capsule is imprinted in white with IX and 10 mg on the brown cap
and is imprinted in
white with 674 and 10 mg on the natural body. The 15 mg capsule is
imprinted in white
with IX and 15 mg on the brown cap and is imprinted in white with 675
and 15 mg on
the natural 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
Blue No. 1, FD&C Red
No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol,
povidone, sodium
lauryl sulfate, sugar spheres, and trace a