DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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)

Saadav alates:

Lannett Company, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. 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  effort; loses things; easily distracted; forge

Toote kokkuvõte:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg: Blue, round tablet, debossed with two partial bisects and a full score with “0”, score, “5” on one side and “LCI” on the other side. 100 count bottle                                 NDC 0527-0760-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 7.5 mg: Blue, round tablet, debossed with two full scores on one side and “7.5” above “LCI” on the other side. 100 count bottle                                NDC 0527-0761-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10 mg: Blue, round tablet, debossed with two full scores on one side and “10” above “LCI” on the other side. 100 count bottle                                NDC 0527-0762-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 12.5 mg: Peach, round tablet, debossed with two full scores on one side and “12.5” above “LCI” on the other side. 100 count bottle                                NDC 0527-0763-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 15 mg: Peach, round tablet, debossed with two full scores on one side and “15” above “LCI” on the other side. 100 count bottle                                NDC 0527-0764-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20 mg: Peach, round tablet, debossed with two full scores on one side and “20” above “LCI” on the other side. 100 count bottle                                NDC 0527-0765-37 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 30 mg: Peach, round tablet, debossed with two full scores on one side and “30” above “LCI” on the other side. 100 count bottle                                NDC 0527-0766-37 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Dispense with Medication Guide available at: www.lannett.com/med-guide/dextro-amp-tabs  CIB72058D Rev. 10/23

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE SACCHARATE,
AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
Lannett Company, Inc.
----------
Dispense with Medication Guide available at:
www.lannett.com/med-guide/dextro-amp-tabs
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

Toote omadused

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE,
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
LANNETT COMPANY, INC.
---------- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE
ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS,
CII
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine
sulfate and amphetamine sulfate tablets has 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 WARNINGS and
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 monohydrate.
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
1.25 mg 1.875 mg 2.5 mg
3.125 mg 3.75 mg
5