DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE capsule, exte

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Camber Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine saccharate, amphetamine aspartate 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 aspartate 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 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 acco

Product summary:

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are supplied as follows: 5 mg extended release capsules: Hard Gelatin Capsule Shell Size “3” Blue Opaque Cap and Clear transparent body, imprinted with “5 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets. NDC 31722-185-01 bottles of 100 capsules 10 mg extended release capsules: Hard Gelatin Capsule Shell Size “3” Blue Opaque Cap and Blue transparent body, imprinted with “10 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets. NDC 31722-186-01 bottles of 100 capsules 15 mg extended release capsules: Hard Gelatin Capsule Shell Size “2” White Opaque Cap and Blue transparent body, imprinted with “15 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets. NDC 31722-187-01 bottles of 100 capsules 20 mg extended release capsules: Hard Gelatin Capsule Shell Size “2” Orange Opaque Cap and Orange transparent body, imprinted with “20 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets. NDC 31722-188-01 bottles of 100 capsules 25 mg extended release capsules: Hard Gelatin Capsule Shell Size “1” White Opaque Cap and Orange transparent body, imprinted with “25 mg” on cap and “T” on body in black ink filled with light to dark beige colored spherical pellets. NDC 31722-189-01 bottles of 100 capsules 30 mg extended release capsules: Hard Gelatin Capsule Shell Size "1" Yellow Opaque Cap imprinted with “30 mg” and White Opaque body imprinted with “T” in black ink filled with light to dark beige colored spherical pellets. NDC 31722-195-01 bottles of 100 capsules Dispense in a tight, light-resistant container as defined in the USP. Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- dextroamphetamine
saccharate, amphetamine aspartate monohydrate, dextroamphetamine
sulfate and amphetamine
sulfate capsule, extended release
Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate,
Dextroamphetamine Sulfate and
Amphetamine Sulfate Extended-Release Capsules, CII
(dex" troe am fet' a meen sak a rate/am fet' a meen a spar' tate /dex"
troe am fet' a meen sul' fate/am fet' a
meen sul' fate)
Read the Medication Guide that comes with dextroamphetamine
saccharate, amphetamine aspartate
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 childs treatment with
dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release capsules.
What is the most important information I should know about
dextroamphetamine saccharate, amphetamine
aspartate monohydrate, dextroamphetamine sulfate and amphetamine
sulfate extended-release capsules?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release 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 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
saccharate, amphetamine aspartate monohydrate, dextroamphetamine

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE
SULFATE- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
CAPSULE,
EXTENDED RELEASE
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROAMPHETAMINE
SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE
SULFATE
AND AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
EXTENDED-
RELEASE CAPSULES.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (MIXED SALTS OF A
SINGLE-ENTITY
AMPHETAMINE PRODUCT) EXTENDED-RELEASE CAPSULES, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 2001
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CNS STIMULANTS, INCLUDING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE
MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
EXTENDED-
RELEASE CAPSULES, OTHER AMPHETAMINE-CONTAINING PRODUCTS, AND
METHYLPHENIDATE,
HAVE A HIGH POTENTIAL FOR ABUSE AND DEPENDENCE (5.1, 9.3)
ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING AND MONITOR FOR SIGNS OF
ABUSE AND
DEPENDENCE WHILE ON THERAPY (9.2, 9.3).
RECENT MAJOR CHANGES
Boxed Warning
7/2019
Dosage and Administration (2.1)
7/2019
Warnings and Precautions (5.1)
7/2019
INDICATIONS AND USAGE
Dextroamphetamine saccharate, amphetamine aspartate monohydrate,
dextroamphetamine sulfate and
amphetamine sulfate extended-release capsules, a CNS stimulant, is
indicated for the treatment of
attention deficit hyperactivity disorder (ADHD). (1) (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)
Adolesc