DEXTROAMPHETAMINE SULFATE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)
Available from:
Zydus Pharmaceuticals (USA) 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: - Narcolepsy . - 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. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympath
Product summary:
Dextroamphetamine Sulfate Tablets USP are available as: 5 mg: Peach, round, flat-faced, bevel edged, scored tablet, debossed "N" score "941" on one side and plain on the other side. NDC 68382-941-01…………….Bottles of 100 Tablets 10 mg: Pink, round, flat-faced, bevel edged, scored tablet, debossed "N" score "942" on one side and plain on the other side. NDC 68382-942-01…………….Bottles of 100 Tablets 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. DEA Order Form Required. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 P10138-3                   01/2017
Authorization status:
Abbreviated New Drug Application
Authorization number:
68382-941-01, 68382-942-01

DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate tablet

Zydus Pharmaceuticals (USA) Inc.

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MEDICATION GUIDE

DEXTROAMPHETAMINE SULFATE TABLETS USP, CII

(DEX-troe-am-FET-uh-meen SULL-fate)

Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets before you or your child

starts taking them 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 child's treatment with Dextroamphetamine

Sulfate Tablets.

What is the most important information I should know about Dextroamphetamine Sulfate Tablets?

The following have been reported with use of Dextroamphetamine Sulfate Tablets and other 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 have 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

Sulfate Tablets.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with

Dextroamphetamine Sulfate Tablets.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness

of breath, or fainting while taking Dextroamphetamine Sulfate Tablets.

2. Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious)

or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide,

bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems

while taking Dextroamphetamine Sulfate Tablets, especially seeing or hearing things that are not real,

believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

Fingers or toes may feel numb, cool, painful

Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to

temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on

fingers or toes while taking Dextroamphetamine Sulfate Tablets.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting

Dextroamphetamine Sulfate Tablets tell your or your child's doctor about all health conditions (or a family

history of) including:

circulation problems in fingers and toes.

What are Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets are a central nervous system stimulant prescription medicine. It is used

for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine Sulfate Tablets

may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine Sulfate Tablets should be used as a part of a total treatment program for ADHD that

may include counseling or other therapies.

Dextroamphetamine Sulfate Tablets are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to

dependence. Keep Dextroamphetamine Sulfate Tablets in a safe place to prevent misuse and abuse. Selling or

giving away Dextroamphetamine Sulfate Tablets may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on

alcohol, prescription medicines or street drugs.

Revised: 1/2020

Document Id: 1f625e2e-879a-4d77-9ed8-58e3b2d71ff4

34391-3

Set id: 0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e

Version: 6

Effective Time: 20200101

Zydus Pharmaceuticals (USA) Inc.

DEXTROAMPHETAMINE SULFATE- dextroamphetamine sulfate tablet

Zydus Pharmaceuticals (USA) Inc.

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DEXTROAMPHETAMINE SULFATE - dextroamphetamine sulfate tablet

CII

Rx only

WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF

AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG

DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE

PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR

NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS

SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS

CARDIOVASCULAR ADVERSE EVENTS.

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:

(C9H13N)2·H2SO4 M.W. 368.49

Inactive Ingredients

Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and

microcrystalline cellulose.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

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

produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects

relate to the condition of the central nervous system.

Pharmacokinetics

The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects.

The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-

release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine

plasma concentrations (C

) of 36.6 ng/mL were achieved at approximately 3 hours. Following

administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma

concentrations were obtained approximately 8 hours after dosing. The average C

was 23.5 ng/mL.

The average plasma T

was similar for both the tablet and sustained-release capsule and was

approximately 12 hours.

In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following

administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension,

hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive

crises may result).

WARNINGS

Serious Cardiovascular Events

Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart

Problems

Children and Adolescents

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children

and adolescents with structural cardiac abnormalities or other serious heart problems. Although some

serious heart problems alone carry an increased risk of sudden death, stimulant products generally

should not be used in children or adolescents with known serious structural cardiac abnormalities,

cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place

them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at

usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults

have a greater likelihood than children of having serious structural cardiac abnormalities,

cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac

problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see

CONTRAINDICATIONS).

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and

average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes

alone would not be expected to have short-term consequences, all patients should be monitored for

larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose

underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g.,

those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular

arrhythmia (see CONTRAINDICATIONS).

Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications

should have a careful history (including assessment for a family history of sudden death or ventricular

arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further

cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram).

Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms

suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in

patients with a pre-existing psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar

disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to

initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately

screened to determine if they are at risk for bipolar disorder; such screening should include a detailed

psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in

children and adolescents without a prior history of psychotic illness or mania can be caused by

stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal

role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of

multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with

events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of

stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has

been reported in clinical trials and the postmarketing experience of some medications indicated for the

treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior

or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or

worsening of, aggressive behavior or hostility.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either

methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic

subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the

ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per

week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm

less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth

rebound during this period of development. Published data are inadequate to determine whether chronic

use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they

likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants,

and patients who are not growing or gaining height or weight as expected may need to have their

treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with

prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very

rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence

of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud's Phenomenon

Stimulants, including dextroamphetamine sulfate tablets, used to treat ADHD are associated with

peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent

and mild; however, very rare sequelae include digital ulcerations and/or soft tissue breakdown. Effects

of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports

at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs

and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation

for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation

(e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome

Serotonin Syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in

combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine

oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine

reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,

buspirone, and St. John's Wort [see DRUG INTERACTIONS]. Amphetamines and amphetamine

derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and

display minor inhibition of CYP2D6 metabolism [see CLINICAL PHARMACOLOGY]. The potential

for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may

increase the risk with increased exposure to dextroamphetamine sulfate tablets. In these situations,

consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see

DRUG INTERACTIONS].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations,

delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness,

diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus,

hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting,

diarrhea).

Concomitant use of dextroamphetamine sulfate tablets with MAOI drugs is contraindicated [see

CONTRAINDICATIONS].

Discontinue treatment with dextroamphetamine sulfate tablets and any concomitant serotonergic agents

immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant

use of dextroamphetamine sulfate tablets with other serotonergic drugs or CYP2D6 inhibitors is

clinically warranted, initiate dextroamphetamine sulfate tablets with lower doses, monitor patients for

the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the

increased risk for serotonin syndrome.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

PRECAUTIONS

General

The least amount feasible should be prescribed or dispensed at one time in order to minimize the

possibility of overdosage.

Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as

operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Prescribers or other health professionals should inform patients, their families, and their caregivers

about the benefits and risks associated with treatment with dextroamphetamine and should counsel them

in its appropriate use. A patient Medication Guide is available for dextroamphetamine. The prescriber

or health professional should instruct patients, their families, and their caregivers to read the

Medication Guide and should assist them in understanding its contents. Patients should be given the

opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they

may have. The complete text of the Medication Guide is reprinted at the end of this document.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]

Instruct patients beginning treatment with dextroamphetamine sulfate tablets about the risk of

peripheral vasculopathy, including Raynaud's Phenomenon, and associated signs and symptoms:

fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity

to temperature in fingers or toes.

Instruct patients to call their physician immediately with any signs of unexplained wounds

appearing on fingers or toes while taking dextroamphetamine sulfate tablets.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Drug Interactions

Acidifying Agents

Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit

juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium

acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule,

thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of

amphetamines.

Adrenergic Blockers

Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agent

Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines.

Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-

ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of

agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, Tricyclic

Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with

desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the

concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

CYP2D6 Inhibitors

The concomitant use of dextroamphetamine sulfate tablets and CYP2D6 inhibitors may increase the

exposure of dextroamphetamine sulfate tablets compared to the use of the drug alone and increase the

risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of

serotonin syndrome particularly during dextroamphetamine sulfate tablets initiation and after a dosage

increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the CYP2D6

inhibitor [see WARNINGS, OVERDOSAGE]. Examples of CYP2D6 Inhibitors include paroxetine and

fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Serotonergic Drugs

The concomitant use of dextroamphetamine sulfate tablets and serotonergic drugs increases the risk of

serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin

syndrome, particularly during dextroamphetamine sulfate tablets initiation or dosage increase. If

serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the concomitant

serotonergic drug(s) [see WARNINGS and PRECAUTIONS]. Examples of serotonergic drugs include

selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI),

triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort.

MAO Inhibitors

MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This

slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other

monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive

crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with

fatal results.

Antihis tamines

Amphetamines may counteract the sedative effect of antihistamines.

Antihypertens ives

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant

effects of amphetamines, and can be used to treat amphetamine poisoning.

Ethos uximide

Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects

of amphetamines.

Lithium Carbonate

The stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Meperidine

Amphetamines potentiate the analgesic effect of meperidine.

Methenamine Therapy

Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in

methenamine therapy.

Norepinephrine

Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital

Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may

produce a synergistic anticonvulsant action.

Phenytoin

Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce

a synergistic anticonvulsant action.

Propoxyphene

In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal

convulsions can occur.

Veratrum Alkaloids

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is

greatest in the evening.

Amphetamines may interfere with urinary steroid determinations.

Carcinogenes is /Mutagenes is

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of

dextroamphetamine sulfate have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Dextroamphetamine has been shown to have embryotoxic and teratogenic effects when administered to

A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic

effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor

in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled

studies in pregnant women, there has been one report of severe congenital bony deformity,

tracheoesophageal fistula, and anal atresia (Vater association) in a baby born to a woman who took

dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dextroamphetamine

should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low

birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria,

including agitation, and significant lassitude.

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain

from nursing.

Pediatric Use

Long-term effects of amphetamines in pediatric patients have not been well established.

Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention

Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic pediatric patients, administration of amphetamines may

exacerbate symptoms of behavior disturbance and thought disorder.

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome.

Therefore, clinical evaluation for tics and Tourette's syndrome in pediatric patients and their families

should precede use of stimulant medications.

Data are inadequate to determine whether chronic administration of amphetamines may be associated

with growth inhibition; therefore, growth should be monitored during treatment.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should

be considered only in light of the complete history and evaluation of the pediatric patient. The decision

to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity

of the pediatric patient's symptoms and their appropriateness for his/her age. Prescription should not

depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually

not indicated.

ADVERSE REACTIONS

Cardiovas cular

Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of

cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia,

euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's

syndrome.

Gas trointes tinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Anorexia and weight loss may occur as undesirable effects.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Mus culos keletal

Rhabdomyolysis

DRUG ABUSE AND DEPENDENCE

Dextroamphetamine sulfate is a Schedule II controlled substance.

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe

social disability have occurred. There are reports of patients who have increased the dosage to many

times that recommended. Abrupt cessation following prolonged high dosage administration results in

extreme fatigue and mental depression; changes are also noted on the sleep EEG.

Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia,

irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication

is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

OVERDOSAGE

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as

an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce

severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD of dextroamphetamine sulfate is 96.8 mg/kg.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia,

rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is

usually preceded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of

acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of

activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or

peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine

increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria

is present. If acute, severe hypertension complicates amphetamine overdosage, administration of

intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually

result when sufficient sedation has been achieved.

Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat

amphetamine intoxication.

DOSAGE AND ADMINISTRATION

Amphetamines should be administered at the lowest effective dosage and dosage should be individually

adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcoleps y

Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does,

dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg

daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is

obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in

increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse

reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening;

additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity

Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in

increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may

be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases

will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a

recurrence of behavioral symptoms sufficient to require continued therapy.

HOW SUPPLIED

Dextroamphetamine Sulfate Tablets USP are available as:

5 mg: Peach, round, flat-faced, bevel edged, scored tablet, debossed "N" score "941" on one side and

plain on the other side.

NDC 68382-941-01…………….Bottles of 100 Tablets

10 mg: Pink, round, flat-faced, bevel edged, scored tablet, debossed "N" score "942" on one side and

plain on the other side.

NDC 68382-942-01…………….Bottles of 100 Tablets

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.

DEA Order Form Required.

Manufactured By:

Nesher Pharmaceuticals USA LLC

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

P10138-3 01/2017

MEDICATION GUIDE

DEXTROAMPHETAMINE SULFATE TABLETS USP, CII

(DEX-troe-am-FET-uh-meen SULL-fate)

Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets before you or your

child starts taking them 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 child's treatment with

Dextroamphetamine Sulfate Tablets.

What is the most important information I should know about Dextroamphetamine Sulfate

Tablets ?

The following have been reported with use of Dextroamphetamine Sulfate Tablets and other

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 have 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 Sulfate Tablets.

Your doctor should check your or your child's blood pressure and heart rate regularly during

treatment with Dextroamphetamine Sulfate Tablets.

Call your doctor right away if you or your child has any signs of heart problems such as

chest pain, shortness of breath, or fainting while taking Dextroamphetamine Sulfate

T ablets .

2. Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true,

are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of

suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental

symptoms or problems while taking Dextroamphetamine Sulfate Tablets, especially seeing

or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's

phenomenon]:

Fingers or toes may feel numb, cool, painful

Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to

temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds

appearing on fingers or toes while taking Dextroamphetamine Sulfate Tablets.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting

Dextroamphetamine Sulfate Tablets tell your or your child's doctor about all health

conditions (or a family history of) including:

circulation problems in fingers and toes.

What are Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets are a central nervous system stimulant prescription medicine. It is

used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine

Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with

ADHD.

Dextroamphetamine Sulfate Tablets should be used as a part of a total treatment program for ADHD that

may include counseling or other therapies.

Dextroamphetamine Sulfate Tablets are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be

abused or lead to dependence. Keep Dextroamphetamine Sulfate Tablets in a safe place to

prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Tablets may

harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been

dependent on alcohol, prescription medicines or street drugs.

Who should not take Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets should not be taken if you or your child:

have heart disease or hardening of the arteries

have moderate to severe high blood pressure

have hyperthyroidism

have an eye problem called glaucoma

are very anxious, tense, or agitated

have a history of drug abuse

are taking or have taken within the past 14 days an anti-depression medicine called a monoamine

oxidase inhibitor or MAOI.

is sensitive to, allergic to, or had a reaction to other stimulant medicines

Dextroamphetamine Sulfate Tablets are not recommended for use in children less than 3 years old.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting

Dextroamphetamine Sulfate Tablets tell your or your child's doctor about all health conditions (or

a family history of) including:

heart problems, heart defects, high blood pressure

mental problems including psychosis, mania, bipolar illness, or depression

tics or Tourette's syndrome

thyroid problems

seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Dextroamphetamine Sulfate Tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and

non-prescription medicines, vitamins, and herbal supplements.

Dextroamphetamine Sulfate Tablets and some medicines may interact with each other and cause serious

side effects. Sometimes the doses of other medicines will need to be adjusted while taking

Dextroamphetamine Sulfate Tablets.

Your doctor will decide whether Dextroamphetamine Sulfate Tablets can be taken with other medicines.

Especially tell your doctor if you or your child take:

anti-depression medicines including MAOIs

blood pressure medicines

antacids

seizure medicines

Know the medicines that you or your child take. Keep a list of your medicines with you to show your

doctor and pharmacist.

Do not start any new medicine while taking Dextroamphetamine Sulfate Tablets without talking to

your doctor first.

How should Dextroamphetamine Sulfate Tablets be taken?

Take Dextroamphetamine Sulfate Tablets exactly as prescribed. Your doctor may adjust the

dose until it is right for you or your child.

Dextroamphetamine Sulfate Tablets are usually taken two or three times a day. The first dose is

usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.

From time to time, your doctor may stop Dextroamphetamine Sulfate Tablets treatment for a while

to check ADHD symptoms.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking

Dextroamphetamine Sulfate Tablets. Children should have their height and weight checked often

while taking Dextroamphetamine Sulfate Tablets. Dextroamphetamine Sulfate Tablets treatment may

be stopped if a problem is found during these check-ups.

If you or your child take too much Dextroamphetamine Sulfate Tablets or overdoses, call

your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Dextroamphetamine Sulfate Tablets?

See "What is the most important information I should know about Dextroamphetamine Sulfate

Tablets?" for information on reported heart and mental problems.

Other serious side effects include:

slowing of growth (height and weight) in children

seizures, mainly in patients with a history of seizures

eyesight changes or blurred vision

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen

when medicines such as dextroamphetamine sulfate tablets are taken with certain other medicines.

Symptoms of serotonin syndrome may include:

agitation, hallucinations, coma or other changes in mental status

problems controlling your movements or muscle twitching

fast heartbeat

high or low blood pressure

sweating or fever

nausea or vomiting

diarrhea

muscle stiffness or tightness

Common side effects include:

fast heart beat

decreased appetite

tremors

headache

trouble sleeping

dizziness

stomach upset

weight loss

dry mouth

Dextroamphetamine Sulfate Tablets may affect your or your child's ability to drive or do other

dangerous activities.

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more

information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.

How should I store Dextroamphetamine Sulfate Tablets?

Store Dextroamphetamine Sulfate Tablets in a safe place at room temperature, 20° to 25°C (68° to

77°F).

Keep Dextroamphetamine Sulfate Tablets and all medicines out of the reach of children.

General information about Dextroamphetamine Sulfate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use Dextroamphetamine Sulfate Tablets for a condition for which they were not prescribed. Do not

give Dextroamphetamine Sulfate Tablets to other people, even if they have the same condition. It may

harm them and it is against the law. This Medication Guide summarizes the most important information

about Dextroamphetamine Sulfate Tablets. If you would like more information, talk with your doctor.

You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Tablets that

was written for healthcare professionals. For more information about Dextroamphetamine Sulfate

Tablets, please contact Nesher Pharmaceuticals (USA) LLC at 1-314-209-4700.

What are the ingredients in Dextroamphetamine Sulfate Tablets?

Active Ingredient: dextroamphetamine sulfate

Inactive Ingredients

Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and

microcrystalline cellulose.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured By:

Nesher Pharmaceuticals USA LLC

St. Louis, MO 63044

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

P10138-3 01/2017

PRINCIPAL DISPLAY PANEL - Bottle Label 5 mg

ZyGenerics

NDC 68382-941-01

Dextroamphetamine Sulfate CII

Tablets, USP

5 mg

PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH

PATIENT

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - Bottle Label 10 mg

ZyGenerics

NDC 68382-942-01

Dextroamphetamine Sulfate CII

Tablets, USP

10 mg

PHARMACIST: DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH

PATIENT

Rx only

100 Tablets

DEXTROAMPHETAMINE SULFATE

dextroamphetamine sulfate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 38 2-9 41

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO AMPHETAMINE SULFATE (UNII: JJ76 8 O327N) (DEXTROAMPHETAMINE -

UNII:TZ47U0 51FI)

DEXTROAMPHETAMINE

SULFATE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM SULFATE (UNII: WAT0 DDB50 5)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SUCRO SE (UNII: C151H8 M554)

STARCH, CO RN (UNII: O8 232NY3SJ)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

ORANGE (Peach)

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

N9 41

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 38 2-9 41-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/28 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 6 58 8

0 3/28 /20 16

DEXTROAMPHETAMINE SULFATE

dextroamphetamine sulfate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 38 2-9 42

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO AMPHETAMINE SULFATE (UNII: JJ76 8 O327N) (DEXTROAMPHETAMINE -

UNII:TZ47U0 51FI)

DEXTROAMPHETAMINE

SULFATE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM SULFATE (UNII: WAT0 DDB50 5)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SUCRO SE (UNII: C151H8 M554)

STARCH, CO RN (UNII: O8 232NY3SJ)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

PINK

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

N9 42

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 38 2-9 42-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/28 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 6 58 8

0 3/28 /20 16

Labeler -

Zydus Pharmaceuticals (USA) Inc. (156861945)

Registrant -

Nesher Pharmaceuticals (USA) LLC (969028351)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nesher Pharmaceuticals (USA)

ANALYSIS(6 8 38 2-9 41, 6 8 38 2-9 42) , MANUFACTURE(6 8 38 2-9 41, 6 8 38 2-

Zydus Pharmaceuticals (USA) Inc.

Nesher Pharmaceuticals (USA)

9 6 9 0 28 351

ANALYSIS(6 8 38 2-9 41, 6 8 38 2-9 42) , MANUFACTURE(6 8 38 2-9 41, 6 8 38 2-

9 42)

Revised: 1/2020

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