DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE capsule, extended releas

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE ASPARTATE MONOHYDRATE (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E)

Tillgänglig från:

Barr Laboratories Inc.

INN (International namn):

DEXTROAMPHETAMINE SACCHARATE

Sammansättning:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

MAS-ER Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of MAS-ER Capsules in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see CLINICAL STUDIES (14)] . A diagnosis of 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 two 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 six 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 t

Produktsammanfattning:

5 mg capsules - Clear/blue (imprinted M. Amphet Salts 5 mg), bottles of 100, NDC 0555-0790-02 10 mg capsules - Blue/blue (imprinted M. Amphet Salts 10 mg), bottles of 100, NDC 0555-0787-02 15 mg capsules - Blue/white (imprinted M. Amphet Salts 15 mg), bottles of 100, NDC 0555-0791-02 20 mg capsules - Orange/orange (imprinted M. Amphet Salts 20 mg), bottles of 100, NDC 0555-0788-02 25 mg capsules - Orange/white (imprinted M. Amphet Salts 25 mg), bottles of 100, NDC 0555-0792-02 30 mg capsules - Natural/orange (imprinted M. Amphet Salts 30 mg), bottles of 100, NDC 0555-0789-02 Dispense in a tight, light-resistant container as defined in the USP. Store at 25° C (77° F). Excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]

Bemyndigande status:

New Drug Application Authorized Generic

Bipacksedel

SULFATE, AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE,
EXTENDED RELEASE
Barr Laboratories Inc.
----------
MEDICATION GUIDE
Read the Medication Guide that comes with MAS-ER 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 you or your child's treatment with MAS-ER
Capsules.
What is the most important information I should know about MAS-ER
Capsules?
MAS-ER Capsules are a stimulant medicine. The following have been
reported with use of 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 MAS-ER Capsules.
Your doctor should check you or your child's blood pressure and heart
rate regularly during treatment with
MAS-ER 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 MAS-ER 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 family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you or your child have any new or
worsening mental symptoms or problems
while taking MAS-ER Capsules, especially seeing or hearing things that
are not re

Produktens egenskaper

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE, AND
AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE
BARR LABORATORIES INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE,
AMPHETAMINE SULFATE
EXTENDED-RELEASE CAPSULES (MAS-ER CAPSULES) SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MAS-
ER CAPSULES.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE
CAPSULES, CII
INITIAL U.S. APPROVAL: 2001
WARNING: POTENTIAL FOR ABUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
Amphetamines have a high potential for abuse; prolonged administration
may lead to dependence. (9)
Misuse of amphetamines may cause sudden death and serious
cardiovascular adverse reactions.
INDICATIONS AND USAGE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE
SULFATE, AMPHETAMINE SULFATE extended-release capsules (MAS-ER
Capsules), a CNS stimulant, is indicated for
the treatment of attention deficit hyperactivity disorder (ADHD). (1)
Children (ages 6-12): Efficacy was established in one 3-week
outpatient, controlled trial and one analogue classroom,
controlled trial in children with ADHD. (14)
Adolescents (ages 13-17): Efficacy was established in one 4-week
controlled trial in adolescents with ADHD. (14)
Adults: Efficacy was established in one 4-week controlled trial in
adults with ADHD. (14)
DOSAGE AND ADMINISTRATION
Pediatric patients (ages 6-17): 10 mg once daily in the morning. The
maximum dose for children 6-12 is 30 mg once
daily. (2.1, 2.2, 2.3)
Adults: 20 mg once daily in the morning. (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg (3)
CONTRAINDICATIONS
Advanced arteriosclerosis (4)