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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E), AMPHETAMINE ASPARTATE (UNII: H527KAP6L5) (AMPHETAMINE - UNII:CK833KGX7E)

Available from:

Physicians Total Care, Inc.

INN (International Name):

DEXTROAMPHETAMINE SULFATE

Composition:

DEXTROAMPHETAMINE SULFATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release 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 PHARMACOLOGY), along with extrapolation from the known efficacy of ADDERALL® , the immediate-release formulation of this substance. 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

Product summary:

Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER) Capsules are available as: 5 mg- Clear/blue (imprinted M. Amphet Salts 5 mg), 10 mg- Blue/blue (imprinted M. Amphet Salts 10 mg), 15 mg- Blue/white (imprinted M. Amphet Salts 15 mg), 20 mg- Orange/orange (imprinted M. Amphet Salts 20 mg), 25 mg- Orange/white (imprinted M. Amphet Salts 25 mg), 30 mg- Natural/orange (imprinted M. Amphet Salts 30 mg), Dispense in a tight, light-resistant container as defined in the USP. Store at 25º C (77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature]

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE SULFATE CAPSULE,
EXTENDED RELEASE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules ( mixed salts of a
single- entity amphetmanine product)
Read the Medication Guide that comes with Dextroamphetamine
Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine 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 you or your child's treatment
with Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate
and, Amphetamine Sulfate Extended-Release Capsules.
What is the most important information I should know about
Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-
Release Capsules?
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules is 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
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules.
Your doctor should check you or your c

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE -
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE
SULFATE AND
AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
----------
CII
RX ONLY
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE. 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 AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
DESCRIPTION
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules is a once daily
extended-release, single-entity
amphetamine product. Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules combines the neutral
sulfate salts of dextroamphetamine and amphetamine, with the dextro
isomer of amphetamine saccharate
and d,l-amphetamine aspartate monohydrate. The Dextroamphetamine
Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules
capsule contains two types of drug-containing beads designed to give a
double-pulsed delivery of
amphetamines, which prolongs the release of amphetamine from
Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-
Release Capsules compared to the conventional ADDERALL
(immediate-release) tablet formulation.
EACH CAPSULE CONTAINS:
5 MG
10 MG
15 MG
20 MG
25 MG
30 MG
Dextroamphetamine Saccharate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amphetamine Aspartate Monohydrate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Dextroamphetamine Sulfate USP
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amp