DEXTROAMPHETAMINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

DEXTROAMPHETAMINE SULFATE

Composition:

DEXTROAMPHETAMINE SULFATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextroamphetamine Sulfate Tablets USP are indicated for: 1.         Narcolepsy. 2.         Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). Controlled Substance Dextroamphetamine sulfate is a Schedule II controlled substance. Abuse Dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS). Dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, 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. Dependence Physical Dependence Dextroamphetamine sulfate may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including dextroamphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Dextroamphetamine sulfate may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Product summary:

Dextroamphetamine sulfate tablets, USP are available as: 5 mg: Peach, round, flat-faced, beveled-edge, scored tablet. Debossed with "n" on the scored side and "870"on the other side. Available in bottles of: 30 NDC 43386-870-03 100 NDC 43386-870-01 1000 NDC 43386-870-10 10 mg: Pink, round, flat-faced, beveled-edge, scored tablet. Debossed with "n" on the scored side and "871" on the other side. Available in bottles of: 30 NDC 43386-871-03 100 NDC 43386-871-01 1000 NDC 43386-871-10 Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: xxxxx Rev. 10/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lupin Pharmaceuticals,Inc.
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MEDICATION GUIDE
DEXTROAMPHETAMINE SULFATE (DEX-troe-am-FET-uh-meen SULL-fate) TABLETS
USP, CII
Revised: 1/2024
Document Id: fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02
34391-3
Set id: 9aea6b7c-729c-484d-b625-c3591b63b350
Version: 7
Effective Time: 20240130
Lupin Pharmaceuticals,Inc.

Summary of Product characteristics

DEXTROAMPHETAMINE SULFATE - DEXTROAMPHETAMINE SULFATE TABLET
LUPIN PHARMACEUTICALS,INC.
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RX ONLY
WARNING: ABUSE MISUSE AND ADDICTION
DEXTROAMPHETAMINE SULFATE 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 SULFATE, 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 SULFATE, 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 SULFATE 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
Dextroamphetamine sulfate, USP is the dextro isomer of the compound
_d,l_-
amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Chemically,
dextroamphetamine is d-alpha-methylphenethylamine, and is present in
all forms of
dextroamphetamine sulfate, USP as the neutral sulfate. The structural
formula is as
follows:
(C H
N) ∙H SO Molecular Weight: 368.49
INACTIVE INGREDIENTS
Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate,
Microcrystalline
Cellulose and Povidone.
The 5 mg also contains D&C yellow no. 10, Iron oxide yellow and Iron
oxide red.
The 10 mg also contains FD&C yellow no. 6 aluminium lake and FD&C red
no. 40
aluminium lake.
9
13
2
2
4
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS
stimulant
activity. Peripheral actions include elevations of systolic and
diastolic blood pressures
and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence which clearly establishes the
mechanism whereby
amphetamines produ