NDC 0115-1702 Dextroamphetamine Sulfateextended-release Extended-release

Dextroamphetamine Sulfate

NDC Product Code 0115-1702

NDC CODE: 0115-1702

Proprietary Name: Dextroamphetamine Sulfateextended-release Extended-release What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dextroamphetamine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dextroamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills. This drug is also used to treat a certain sleeping disorder (narcolepsy) to help you stay awake during the day. It should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder.

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW CAP AND A CLEAR BODY)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
327;CP;5MG
Score: 1

NDC Code Structure

  • 0115 - Amneal Pharmaceuticals Of New York Llc
    • 0115-1702 - Dextroamphetamine Sulfateextended-release

NDC 0115-1702-10

Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

NDC Product Information

Dextroamphetamine Sulfateextended-release Extended-release with NDC 0115-1702 is a a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The generic name of Dextroamphetamine Sulfateextended-release Extended-release is dextroamphetamine sulfate. The product's dosage form is capsule, extended release and is administered via oral form.

Labeler Name: Amneal Pharmaceuticals Of New York Llc

Dosage Form: Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule II (CII) Substances What is the Drug Enforcement Administration (DEA) CII Schedule?
The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.

Dextroamphetamine Sulfateextended-release Extended-release Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROAMPHETAMINE SULFATE 5 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)
  • ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amneal Pharmaceuticals Of New York Llc
Labeler Code: 0115
FDA Application Number: NDA017078 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-02-1976 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dextroamphetamine Sulfateextended-release Extended-release Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 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 as the neutral sulfate.Structural formula:Each extended-release capsule is so prepared that an
initial dose is released promptly and the remaining medication is
released gradually over a prolonged period. Each small spherical
capsule, contains dextroamphetamine sulfate. The 5 mg capsule is
imprinted “327” on the YELLOW cap, and
“CP” and “5 mg” on the body. The
10 mg capsule is imprinted “328” on the ORANGE cap,
and “CP” and “10 mg” on the
body. The 15 mg capsule is imprinted “329” on the
RED cap, and “CP” and “15 mg” on
the body. Product reformulation in 1996 has caused a minor change in the
color of the time-released pellets within each capsule. Inactive
ingredients now consist of cetyl alcohol, D&C Yellow No. 10,
dibutyl sebacate, ethylcellulose, FD&C Red No. 40, FD&C
Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of
other inactive ingredients.

Clinical Pharmacology:

Amphetamines are noncatecholamine, 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 that 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.Dextroamphetamine sulfate extended release capsules are
formulated to release the active drug substance in vivo in a more gradual fashion than
the standard formulation, as demonstrated by blood levels. The
formulation has not been shown superior in effectiveness over the same
dosage of the standard, noncontrolled-release formulations given in
divided doses.

Pharmacokinetics:

The pharmacokinetics of the tablet and extended-release
capsule were compared in 12 healthy subjects. The extent of
bioavailability of the extended-release capsule was similar
compared to the immediate-release tablet. Following
administration of three 5-mg tablets, average maximal
dextroamphetamine plasma concentrations (Cmax) of
36.6 ng/mL were achieved at approximately
3 hours.  Following administration of one
15-mg extended-release capsule, maximal dextroamphetamine plasma
concentrations were obtained approximately 8 hours
after dosing. The average Cmax was
23.5 ng/mL. The average plasma T½
was similar for both the tablet and extended-release capsule and
was approximately 12 hours.In 12 healthy subjects, the rate and extent of
dextroamphetamine absorption were similar following
administration of the extended-release capsule formulation in
the fed (58 to 75 gm fat) and fasted state.

Indications And Usage:

Dextroamphetamine sulfate is indicated in:

Attention Deficit Disorder With Hyperactivity

As an integral part of a total treatment program that
typically includes other measures (psychological, educational,
social) for patients (ages 6 years to
16 years) with this syndrome. 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
2 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 6 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 6 of the following symptoms
must have persisted for at least 6 months: fidgeting/squirming;
leaving seat; inappropriate running/climbing; difficulty with
quiet activities; “on the go”; excessive
talking; blurting answers; can't wait turn; intrusive.
The Combined Type requires both inattentive and
hyperactive-impulsive criteria to be met.

The extended-release capsule
formulation is not recommended for pediatric patients younger
than 6 years of age.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. Extended-release capsules may be used
for once-a-day dosage wherever appropriate.Where possible,
drug administration should be interrupted occasionally to
determine if there is a recurrence of behavioral symptoms
sufficient to require continued therapy.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown,
and there is no single diagnostic test. Adequate
diagnosis requires the use of medical and special
psychological, educational, and social resources.
Learning may or may not be impaired. The diagnosis must
be based upon a complete history and evaluation of the
patient and not solely on the presences of the required
number of DSM-IV characteristics.

Need For Comprehensive Treatment Program

Dextroamphetamine sulfate is indicated as an
integral part of a total treatment program for ADHD that
may include other measures (psychological, educational,
social) for patients with this syndrome. Drug treatment
may not be indicated for all patients with this
syndrome. Stimulants are not intended for use in
patients who exhibit symptoms secondary to environmental
factors and/or other primary psychiatric disorders,
including psychosis. Appropriate educational placement
is essential and psychosocial intervention is often
helpful. When remedial measures alone are insufficient,
the decision to prescribe stimulant medication will
depend upon the physician’s assessment of the
chronicity and severity of the patient’s
symptoms.

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.Known hypersensitivity or idiosyncrasy to amphetamine.In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions]Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Drug Interactions].

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 to 4 mmHg) and average heart
rate (about 3 to 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.

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 older than 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, 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 ulceration 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. 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 with MAOI drugs is contraindicated [see Contraindications].Discontinue treatment with dextroamphetamine sulfate and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine sulfate with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine sulfate 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.

General

The least amount feasible should be prescribed or
dispensed at 1 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 Sulfate Extended Release Capsules. 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 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.Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Acidifying Agents

Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic Blockers

Adrenergic blockers are inhibited by
amphetamines.

Alkalinizing Agents

Increase blood levels and potentiate the action of amphetamine. Co-administration of dextroamphetamine sulfate and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides).

Tricyclic Antidepressants

May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.

Cyp2d6 Inhibitors

The concomitant use of dextroamphetamine sulfate and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate 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 initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate 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 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 initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate 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

Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer dextroamphetamine sulfate concomitantly or within 14 days after discontinuing MAOI [see Contraindications and Warnings]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Proton Pump Inhibitors

Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.

Antihistamines

Amphetamines may counteract the sedative effect
of antihistamines.

Antihypertensives

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.

Ethosuximide

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.

Carcinogenesis/Mutagenesis

Mutagenicity studies and long-term studies in animals to
determine the carcinogenic potential
of dextroamphetamine sulfate have not been
performed.

Teratogenic Effects

Pregnancy Category C. Dextroamphetamine
sulfate 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 1 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
sulfate 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.Dextroamphetamine sulfate is not recommended for
use in pediatric patients younger than 6 years of age with
Attention Deficit Disorder with Hyperactivity described under
INDICATIONS AND USAGE.Clinical experience suggests that in psychotic children,
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 children 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
child. The decision to prescribe amphetamines should depend on
the physician’s assessment of the chronicity and
severity of the child’s symptoms and their
appropriateness for his or 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.

Cardiovascular

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.

Gastrointestinal

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.

Musculoskeletal

Rhabdomyolysis.

Skin And Subcutaneous Tissue Disorders

Alopecia.

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

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. 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.TreatmentConsult with a Certified Poison Control Center for up to date guidance and advice.

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 (Bedford Laboratories) 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.Since much of
the extended-release capsule medication is coated for gradual
release, therapy directed at reversing the effects of the ingested drug
and at supporting the patient should be continued for as long as
overdosage symptoms remain. Saline cathartics are useful for hastening
the evacuation of pellets that have not already released
medication.

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.

Narcolepsy

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 an
optimal response is obtained. If bothersome adverse reactions
appear (e.g., insomnia or anorexia), dosage should be
reduced. Extended-release capsules may be used for
once-a-day dosage wherever appropriate.

How Supplied

Dextroamphetamine Sulfate Extended-Release Capsules are supplied
as follows:Dextroamphetamine Sulfate
Extended-Release Capsules, 5 mg: Small, spherical, light
orange pellets and dark orange pellets contained in a size #4 gelatin
capsule. Capsules are imprinted “327” on the yellow cap, and “CP” and “5 mg” on the body.   Bottles of 90    (NDC 0115-1702-10)Dextroamphetamine Sulfate
Extended-Release Capsules, 10 mg: Small, spherical, light
orange pellets and dark orange pellets contained in a size #4 gelatin
capsule. Capsules are imprinted “328” on the orange cap, and “CP” and “10 mg” on the body.   Bottles of 90    (NDC 0115-1703-10)Dextroamphetamine Sulfate
Extended-Release Capsules, 15 mg: Small, spherical, light
orange pellets and dark orange pellets contained in a size #3 gelatin
capsule. Capsules are imprinted “329” on the red cap, and “CP” and “15 mg” on the body.   Bottles of 90    (NDC 0115-1704-10)Store at controlled room temperature between
20° to 25°C (68° to
77°F) [See USP].Dispense in a tight, light-resistant container.Manf. by:Catalent Pharma SolutionsWinchester, KY
40391Dist. by:Impax GenericsHayward, CA 945441924-01Rev. May, 2017For additional copies of the printed patient information/medication guide, please visit www.impaxlabs.com or contact us at 1-800-934-6729.

Medication Guidedextroamphetamine Sulfate Extended-Release Capsules Cii

Read the Medication Guide that comes
with Dextroamphetamine Sulfate Extended-Release
Capsules before you or your child starts taking it 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 your or
your child’s treatment with Dextroamphetamine Sulfate
Extended-Release Capsules.

What Are Dextroamphetamine Sulfate Extended-Release Capsules?

Dextroamphetamine Sulfate Extended-Release
Capsules are a central nervous system stimulant
prescription medicine. It is used for
the treatment of Attention-Deficit Hyperactivity Disorder
(ADHD).Dextroamphetamine Sulfate
Extended-Release Capsules may help increase attention
and decrease impulsiveness and hyperactivity in patients with
ADHD.Dextroamphetamine Sulfate Extended-Release
Capsules should be used as a part of a total treatment
program for ADHD that may include counseling or other
therapies.Dextroamphetamine Sulfate Extended-Release
Capsules are also used in the treatment of a sleep
disorder called narcolepsy.

* Please review the disclaimer below.