DEXTROAMPHETAMINE SULFATE- dextroamphetamine capsule, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Mylan Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

DEXTROAMPHETAMINE SULFATE

रचना:

DEXTROAMPHETAMINE SULFATE 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Dextroamphetamine sulfate extended-release capsules are indicated in: Narcolepsy 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 organization; avoids tasks requiring sustained ment

उत्पाद समीक्षा:

Dextroamphetamine Sulfate Extended-Release Capsules are available containing 5 mg, 10 mg or 15 mg of dextroamphetamine sulfate, USP. The 5 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DA 5 in black ink on cap and body. They are available as follows: NDC 0378-1070-01 bottles of 100 capsules The 10 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DA 10 in black ink on cap and body. They are available as follows: NDC 0378-1071-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over DA 15 in black ink on cap and body. They are available as follows: NDC 0378-1072-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. For additional copies of the printed patient information/medication guide, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE CAPSULE, EXTENDED RELEASE
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Dextroamphetamine Sulfate Extended-Release Capsules
(dexˮ troe am fetʹ a meen sulʹ 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, or
about a

उत्पाद विशेषताएं

DEXTROAMPHETAMINE SULFATE- DEXTROAMPHETAMINE CAPSULE, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
----------
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_,_1_-amphetamine sulfate, a
sympathomimetic amine of the amphetamine group. Chemically,
dextroamphetamine is (+)-α-
Methylphenethylamine sulfate (2:1), and is present in all forms of
dextroamphetamine 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 a caramel opaque cap and a white opaque body,
contains dextroamphetamine sulfate,
USP. The 5-mg capsule is axially printed with MYLAN over DA 5 in black
ink on cap and body. The
10-mg capsule is axially printed with MYLAN over DA 10 in black ink on
cap and body. The 15-mg
capsule is axially printed with MYLAN over DA 15 in black ink on cap
and body.
INACTIVE INGREDIENTS: Each extended-release capsule contains black
iron oxide, ethylcellulose, gelatin,
hypromellose, red iron oxide, sodium lauryl sulfate, sugar spheres
(corn starch and sucrose), talc,
titanium dioxide and yellow iron oxide.
In addition, the black imprinting ink contains ammonium hydroxide,
black iron oxide, propylene glycol
and shellac glaze.
CLINICAL PHARMACOLOGY
Amphetamines are noncatecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral
actions include elevations of systolic and diastolic blood pressures
and weak bronchodilator and
respiratory s