DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII- dextroamphetami

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amphetamine Aspartate Monohydrate (UNII: O1ZPV620O4) (AMPHETAMINE - UNII:CK833KGX7E), AMPHETAMINE SULFATE (UNII: 6DPV8NK46S) (AMPHETAMINE - UNII:CK833KGX7E), DEXTROAMPHETAMINE SACCHARATE (UNII: G83415V073) (DEXTROAMPHETAMINE - UNII:TZ47U051FI), DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Available from:

Alvogen Inc.

INN (International Name):

Amphetamine Aspartate Monohydrate

Composition:

Amphetamine Aspartate Monohydrate 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) 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 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 to follow through on tasks; poor organization; avoids tasks requiring sustained mental eff

Product summary:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg: Round, flat-faced, beveled-edge, white tablet. “74” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “4”. They are supplied as follows:  100 Tablets NDC 47781-174-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 7.5 mg: Round, flat-faced, beveled-edge, blue tablet. “75” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “5”. They are supplied as follows:  100 Tablets NDC 47781-175-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 10 mg: Round, flat-faced, beveled-edge, blue tablet. “76” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “6”. They are supplied as follows: 100 Tablets NDC 47781-176-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg: Round, flat-faced, beveled-edge, orange tablet. “77” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “7”. They are supplied as follows: 100 Tablets NDC 47781-177-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 15 mg: Round, flat-faced, beveled-edge, orange tablet. “78” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “8”. They are supplied as follows:   100 Tablets NDC 47781-178-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 20 mg: Round, flat-faced, beveled-edge, orange tablet. “79” is debossed on one side with a full and partial bisect, and “A” is debossed on the opposite side. The full bisect splits the “7” and “9”. They are supplied as follows:   100 Tablets NDC 47781-179-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 30 mg: Round, flat-faced, beveled-edge, orange tablet. "80" is debossed on one side with a full and partial bisect, and "A" is debossed on the opposite side. The full bisect splits the "8" and "0". They are supplied as follows: 100 Tablets NDC 47781-180-01 Dispense in a tight, light-resistant container. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SULFATE, AMPHETAMINE SULFATE TABLETS,CII- DEXTROAMPHETAMINE
SACCHARATE,
AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
TABLETS, 5 MG,CLL TABLET
Alvogen Inc.
----------
MEDICATION GUIDE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and
Amphetamine Sulfate Tablets, 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)
What is the most important information I should know about
Dextroamphetamine Saccharate,
Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine
Sulfate Tablets?
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and
Amphetamine Sulfate Tablets may cause serious side effects, including:
•
Abuse, misuse, and addiction. Dextroamphetamine Saccharate,
Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has a high
chance for abuse and
misuse and may lead to substance use problems, including addiction.
Misuse and abuse of
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and
Amphetamine Sulfate Tablets, other amphetamine containing medicines,
and methylphenidate
containing medicines, can lead to overdose and death. The risk of
overdose and death is increased
with higher doses of Dextroamphetamine Saccharate, Amphetamine
Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets or when it
is used in ways that are
not approved. such as snorting or injection.
•
Your healthcare provider should check you or your child's risk for
abuse, misuse, and
addiction before starting treatment with Dextroamphetamine Saccharate,
Amphetamine
Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
and will monitor
you or your child during treatment.
•
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate
and Amphetamine Sulfate Tablets may lead to physical dependence after
prolonged use,
even if taken as directed by your heal

Summary of Product characteristics

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 5 MG,CLL
TABLET
ALVOGEN INC.
----------
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CLL
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine
Sulfate and Amphetamine Sulfate Tablets have a high potential for
abuse and
misuse, which can lead to the development of a substance use disorder,
including
addiction. Misuse and abuse of CNS stimulants, including
Dextroamphetamine
Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and
Amphetamine Sulfate Tablets, can result in overdose and death (see
OVERDOSAGE), and this risk is increased with higher doses or
unapproved
methods of administration, such as snorting or injection.
Before prescribing Dextroamphetamine Saccharate, Amphetamine
Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, assess each
patient’s risk for abuse, misuse, and addiction. Educate patients
and their families
about these risks, proper storage of the drug, and proper disposal of
any unused
drug. Throughout Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets treatment,
reassess
each patient’s risk of abuse, misuse, and addiction and frequently
monitor for
signs and symptoms of abuse, misuse, and addiction (see WARNINGSand
DRUG
ABUSE AND DEPENDENCE).
DESCRIPTION
A single-entity amphetamine product combining the neutral sulfate
salts of
dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine
saccharate and d, l-amphetamine aspartate.
EACH TABLET CONTAINS
5 MG
7.5
MG
10
MG
12.5
MG
15
MG
20
MG
30
MG
Dextroamphetamine Saccharate
1.25
mg
1.875
mg
2.5
mg
3.125
mg
3.75
mg
5 mg
7.5
mg
Amphetamine Aspartate
Monohydrate Equivalent
1.25
mg
1.875
mg
2.5
mg
3.125