DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet DEXTROAMPHE

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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)

Fáanlegur frá:

SpecGx LLC

INN (Alþjóðlegt nafn):

DEXTROAMPHETAMINE SACCHARATE

Samsetning:

DEXTROAMPHETAMINE SACCHARATE 1.25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Mixed Salts of a Single Entity Amphetamine Product 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; forgetful. For the Hyperactive-Impulsive Type, at least six of the fol

Vörulýsing:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) are supplied as follows: 5 mg: White to cream colored/mottled pillow shaped tablet, debossed with a “5” and a partial quadrisect on one side and a  on the other side.  Bottles of 100….NDC 0406-8891-01  7.5 mg:  White to cream colored/mottled pillow shaped tablet, debossed with a “7.5” and a partial quadrisect on one side and a  on the other side.  Bottles of 100….NDC 0406-8884-01  10 mg:  White to cream colored/mottled pillow shaped tablet, debossed with a “10” and a partial quadrisect on one side and a  on the other side. Bottles of 100….NDC 0406-8892-01 12.5 mg:  White to cream colored/mottled octagon shaped tablet, debossed with a “12.5” and a partial quadrisect on one side and a   on the other side.  Bottles of 100….NDC 0406-8886-01  15 mg:  White to cream colored/mottled octagon shaped tablet, debossed with a “15” and a partial quadrisect on one side and a  on the other side.  Bottles of 100….NDC 0406-8885-01  20 mg:  White to cream colored/mottled octagon shaped tablet, debossed with a “20” and a partial quadrisect on one side and a  on the other side.  Bottles of 100….NDC 0406-8893-01 30 mg:  White to cream colored/mottled octagon shaped tablet, debossed with a “30” and a partial quadrisect on one side and a  on the other side.  Bottles of 100….NDC 0406-8894-01 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]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. DSM-IV and Evekeo are trademarks of their respective owners. Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA Rev 10/2023 Mallinckrodt™ Pharmaceuticals     An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20D11.pdf or by calling 1-800-778-7898 for alternate delivery options.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE- DEXTROAMPHETAMINE
SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND
AMPHETAMINE
SULFATE TABLET
SpecGx LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Dextroamphetamine Saccharate
Amphetamine Aspartate
Dextroamphetamine Sulfate
Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product), CII
(dex” troe am fet' a meen sac cha 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 Mixed Salts
of a Single Entity
Amphetamine Product?
Mixed Salts of a Single Entity Amphetamine Product may cause serious
side effects, including:
•
Abuse, misuse, and addiction. Mixed Salts of a Single Entity
Amphetamine Product has a high
chance for abuse and misuse and may lead to substance use problems,
including addiction.
Misuse and abuse of Mixed Salts of a Single Entity Amphetamine
Product, 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 Mixed
Salts of a Single Entity
Amphetamine Product 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 Mixed Salts of a Single
Entity Amphetamine
Product and will monitor you or your child during treatment.
•
Mixed Salts of a Single Entity Amphetamine Product may lead to
physical dependence
after prolonged use, even if taken as directed by your healthcare
provider.
•
Do not give Mixed Salts of a Single Entity Amphetamine Product to
anyone else. See
“What is Mixed Salts of a Single Entity Amphetamine Product?” for
more information.
•
Keep Mixed Salts of a Single Entity Amphetamine Product in a safe
place and properly
dispose of any unused medicine. See “How should I store Mixed Salts
of a Single Entity
A

Vara einkenni

DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE-
DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND
DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET
SPECGX LLC
----------
DEXTROAMPHETAMINE SACCHARATE
AMPHETAMINE ASPARTATE
DEXTROAMPHETAMINE SULFATE
AMPHETAMINE SULFATE TABLETS
(MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT), CII
(5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG, AND 30 MG)
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
Mixed Salts of a Single Entity Amphetamine Product 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
Mixed Salts of a
Single Entity Amphetamine Product, 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 Mixed Salts of a Single Entity Amphetamine Product,
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 Mixed Salts of a Single Entity Amphetamine
Product
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 mg
7.5 mg
Dextroamphetamine1.25
1.875 mg
2.5
3.125
3.75
5 mg
7.5 mg
Sulfate USP
mg
1.875 mg
mg
mg
mg
5 mg
7.5 mg
Amphetamine
Sulf