Amphetamines Have A High Potential For Abuse. Administration Of
Amphetamines For Prolonged Periods Of Time May Lead To Drug Dependence.
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 Amphetamine May Cause Sudden Death And Serious Cardiovascular
Adverse Events.
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE.
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 AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR
ADVERSE EVENTS.
Description
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
a once daily extended-release, single-entity amphetamine product.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
combines the neutral sulfate salts of dextroamphetamine and amphetamine, with
the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate
monohydrate. The Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules® capsule contains two types of drug-containing
beads designed to give a double-pulsed delivery of amphetamines, which prolongs
the release of amphetamine from Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules compared to the conventional ADDERALL® (immediate-release) tablet formulation.
EACH CAPSULE CONTAINS:
5 mg
10 mg
15 mg
20 mg
25 mg
30 mg
Dextroamphetamine Saccharate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amphetamine Aspartate Monohydrate
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Dextroamphetamine Sulfate USP
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Amphetamine Sulfate USP
1.25 mg
2.5 mg
3.75 mg
5.0 mg
6.25 mg
7.5 mg
Total amphetamine base equivalence
3.1 mg
6.3 mg
9.4 mg
12.5 mg
15.6 mg
18.8 mg
Inactive Ingredients and Colors: The inactive ingredients in
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic
acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin
capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10
mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30
mg capsules also contain red iron oxide and yellow iron oxide.
Clinical Pharmacology
Pharmacodynamics Amphetamines are non-catecholamine sympathomimetic amines with
CNS stimulant activity. The mode of therapeutic action in Attention Deficit
Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block
the reuptake of norepinephrine and dopamine into the presynaptic neuron and
increase the release of these monoamines into the extraneuronal space. Pharmacokinetics Pharmacokinetic studies of Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules have been conducted in healthy adult and
pediatric (6-12 yrs) subjects, and adolescent (13-17 yrs) and pediatric patients
with ADHD. Both ADDERALL® (immediate-release) tablets and
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following
administration of ADDERALL® (immediate-release), the peak
plasma concentrations occurred in about 3 hours for both d-amphetamine and
l-amphetamine.
The time to reach maximum plasma concentration (Tmax)
for Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
about 7 hours, which is about 4 hours longer compared to ADDERALL® (immediate-release). This is consistent with the
extended-release nature of the product.
Figure 1 Mean d-amphetamine and l-amphetamine plasma
concentrations following administration of Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules (MAS-ER) 20 mg (8am) and
ADDERALL® (immediate-release) 10 mg bid (8am and 12 noon)
in the fed state.
A single dose of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules 20 mg capsules provided comparable plasma concentration profiles of
both d-amphetamine and l-amphetamine to ADDERALL®
(immediate-release) 10 mg bid administered 4 hours apart.
The mean elimination half-life for d-amphetamine is 10 hours in adults; 11
hours in adolescents aged 13-17 years and weighing less than or equal to 75
kg/165 lbs; and 9 hours in children aged 6 to 12 years. For the l-amphetamine,
the mean elimination half-life in adults is 13 hours; 13 to 14 hours in
adolescents; and 11 hours in children aged 6 to 12 years. On a mg/kg body weight
basis, children have a higher clearance than adolescents or adults (See Special Populations).
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
demonstrates linear pharmacokinetics over the dose range of 20 to 60 mg in
adults and adolescents weighing greater than 75 kg/165lbs, over the dose range
of 10 to 40 mg in adolescents weighing less than or equal to 75 kg/165 lbs, and
5 to 30 mg in children aged 6 to 12 years. There is no unexpected accumulation
at steady state in children.
Food does not affect the extent of absorption of d-amphetamine and
l-amphetamine, but prolongs Tmax by 2.5 hours (from 5.2
hrs at fasted state to 7.7 hrs after a high-fat meal) for d-amphetamine and 2.1
hours (from 5.6 hrs at fasted state to 7.7 hrs after a high fat meal) for
l-amphetamine after administration of Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules 30 mg. Opening the capsule and sprinkling the contents
on applesauce results in comparable absorption to the intact capsule taken in
the fasted state. Equal doses of Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules strengths are bioequivalent. Metabolism and Excretion
Amphetamine is reported to be oxidized at the 4 position of the benzene ring
to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form
alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and
4-hydroxy-amphetamine are both active and each is subsequently oxidized to form
4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form
phenylacetone, which ultimately forms benzoic acid and its glucuronide and the
glycine conjugate hippuric acid. Although the enzymes involved in amphetamine
metabolism have not been clearly defined, CYP2D6 is known to be involved with
formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic,
population variations in amphetamine metabolism are a possibility.
Amphetamine is known to inhibit monoamine oxidase, whereas the ability of
amphetamine and its metabolites to inhibit various P450 isozymes and other
enzymes has not been adequately elucidated. In vitro
experiments with human microsomes indicate minor inhibition of CYP2D6 by
amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more
metabolites. However, due to the probability of auto-inhibition and the lack of
information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the
potential for amphetamine or its metabolites to inhibit the metabolism of other
drugs by CYP isozymes in vivo can be made.
With normal urine pHs approximately half of an administered dose of
amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine
and approximately another 30%-40% of the dose is recoverable in urine as
amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of
amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs
result in less ionization and reduced renal elimination, and acidic pHs and high
flow rates result in increased renal elimination with clearances greater than
glomerular filtration rates, indicating the involvement of active secretion.
Urinary recovery of amphetamine has been reported to range from 1% to 75%,
depending on urinary pH, with the remaining fraction of the dose hepatically
metabolized. Consequently, both hepatic and renal dysfunction have the potential
to inhibit the elimination of amphetamine and result in prolonged exposures. In
addition, drugs that effect urinary pH are known to alter the elimination of
amphetamine, and any decrease in amphetamine's metabolism that might occur due
to drug interactions or genetic polymorphisms is more likely to be clinically
significant when renal elimination is decreased, (See PRECAUTIONS). Special Populations
Comparison of the pharmacokinetics of d- and l-amphetamine after oral
administration of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules in pediatric (6-12 years) and adolescent (13-17 years) ADHD patients
and healthy adult volunteers indicates that body weight is the primary
determinant of apparent differences in the pharmacokinetics of d- and
l-amphetamine across the age range. Systemic exposure measured by area under the
curve to infinity (AUC∞) and maximum plasma concentration
(Cmax) decreased with increases in body weight, while
oral volume of distribution (Vz/F), oral clearance
(CL/F), and elimination half-life (t 1/2) increased with
increases in body weight. Pediatric Patients
On a mg/kg weight basis, children eliminated amphetamine faster than adults.
The elimination half-life (t1/2) is approximately 1 hour
shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than
in adults. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules, which was attributed to the
higher dose administered to children on a mg/kg body weight basis compared to
adults. Upon dose normalization on a mg/kg basis, children showed 30% less
systemic exposure compared to adults. Gender
Systemic exposure to amphetamine was 20-30% higher in women (N=20) than in
men (N=20) due to the higher dose administered to women on a mg/kg body weight
basis. When the exposure parameters (Cmax and AUC) were
normalized by dose (mg/kg), these differences diminished. Age and gender had no
direct effect on the pharmacokinetics of d- and l-amphetamine. Race
Formal pharmacokinetic studies for race have not been conducted. However,
amphetamine pharmacokinetics appeared to be comparable among Caucasians (N=33),
Blacks (N=8) and Hispanics (N=10).
Clinical Trials
Children
A double-blind, randomized, placebo-controlled, parallel-group study was
conducted in children aged 6-12 (N=584) who met DSM-IV®
criteria for ADHD (either the combined type or the hyperactive-impulsive type).
Patients were randomized to fixed dose treatment groups receiving final doses of
10, 20, or 30 mg of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules or placebo once daily in the morning for three weeks. Significant
improvements in patient behavior, based upon teacher ratings of attention and
hyperactivity, were observed for all Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules doses compared to patients who received placebo, for
all three weeks, including the first week of treatment, when all
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
subjects were receiving a dose of 10 mg/day. Patients who received
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
showed behavioral improvements in both morning and afternoon assessments
compared to patients on placebo.
In a classroom analogue study, patients (N=51) receiving fixed doses of 10
mg, 20 mg or 30 mg Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules demonstrated statistically significant improvements in teacher-rated
behavior and performance measures, compared to patients treated with
placebo. Adolescents
A double-blind, randomized, multi-center, parallel-group, placebo-controlled
study was conducted in adolescents aged 13-17 (N=327) who met DSM-IV® criteria for ADHD. The primary cohort of patients (n=287,
weighing ≤ 75kg/165lbs) was randomized to fixed dose treatment groups and
received four weeks of treatment. Patients were randomized to receive final
doses of 10 mg, 20 mg, 30 mg, and 40 mg Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules or placebo once daily in the morning; patients
randomized to doses greater than 10 mg were titrated to their final doses by 10
mg each week. The secondary cohort consisted of 40 subjects weighing
>75kg/165lbs who were randomized to fixed dose treatment groups receiving
final doses of 50 mg and 60 mg Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules or placebo once daily in the morning for 4 weeks. The
primary efficacy variable was the ADHD-RS-IV total scores for the primary
cohort. Improvements in the primary cohort were statistically significantly
greater in all four primary cohort active treatment groups (Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules 10 mg, 20 mg, 30 mg, and 40 mg)
compared with the placebo group. There was not adequate evidence that doses
greater than 20 mg/day conferred additional benefit. Adults
A double-blind, randomized, placebo-controlled, parallel-group study was
conducted in adults (N=255) who met DSM-IV® criteria for
ADHD. Patients were randomized to fixed dose treatment groups receiving final
doses of 20, 40, or 60 mg of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules or placebo once daily in the morning for four weeks. Significant
improvements, measured with the Attention Deficit Hyperactivity Disorder-Rating
Scale (ADHD-RS), an 18- li scale that measures the core symptoms of ADHD, were
observed at endpoint for all Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules doses compared to patients who received placebo for all four weeks.
There was not adequate evidence that doses greater than 20 mg/day conferred
additional benefit.
Indications
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules in the treatment of ADHD was established on the basis of two controlled
trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to
17, and one controlled trial in adults who met DSM-IV®
criteria for ADHD (see CLINICAL PHARMACOLOGY), along with
extrapolation from the known efficacy of ADDERALL®, the
immediate-release formulation of this substance.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive
symptoms that caused impairment and were present before age 7 years. The
symptoms must cause clinically significant impairment, e.g., in social,
academic, or occupational functioning, and be present in two or more settings,
e.g., school (or work) and at home. The symptoms must not be better accounted
for by another mental disorder. For the Inattentive Type, at least six of the
following symptoms must have persisted for at least 6 months: lack of attention
to details/careless mistakes; lack of sustained attention; poor ulener;
failure to follow through on tasks; poor organization; avoids tasks requiring
sustained mental effort; loses things; easily distracted; forgetful. For the
Hyperactive-Impulsive Type, at least six of the 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.
Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no
single diagnostic test. Adequate diagnosis requires the use not only of medical
but of 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 child and not solely on the presence of the required number of
DSM-IV® characteristics. Need for Comprehensive Treatment Program Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules 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 children with this
syndrome. Stimulants are not intended for use in the child who exhibits 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 child's
symptoms. Long-Term Use The effectiveness of Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules for long-term use, i.e., for more than 3 weeks in
children and 4 weeks in adolescents and adults, has not been systematically
evaluated in controlled trials. Therefore, the physician who elects to use
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules for
extended periods should periodically re-evaluate the long-term usefulness of the
drug for the individual patient.
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 and 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 (see CONTRAINDICATIONS). 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) [see ADVERSE EVENTS], 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 pre-existing psychotic disorder. Bipolar Illness
Particular care should be taken in using stimulants to treat ADHD patients
with comorbid bipolar disorder because of concern for possible induction of
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 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 3482 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 naturaulic 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. In a controlled trial of
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules in
adolescents, mean weight change from baseline within the initial 4 weeks of
therapy was –1.1 lbs. and –2.8 lbs., respectively, for patients receiving 10 mg
and 20 mg Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules.
Higher doses were associated with greater weight loss within the initial 4 weeks
of treatment. Published data are inadequate to determine whether chronic use of
amphetamines may cause a similar suppression of growth, however, it is
anticipated that they will likely have this effect as well. Therefore, growth
should be monitored during treatment with stimulants, and patients who are not
growing or gaining 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 the 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. Visual Disturbance Difficulties with accommodation and blurring of vision have been
reported with stimulant treatment.
Precautions
General The least amount of amphetamine feasible should be prescribed or
dispensed at one time in order to minimize the possibility of overdosage.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
should be used with caution in patients who use other sympathomimetic
drugs. Tics 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. 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 amphetamine and should counsel them in its appropriate use. A
patient Medication Guide is available for Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
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. Drug Interactions Acidifying agents
These 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 agents
Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase
absorption of amphetamines. Co-administration of Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules and gastrointestinal alkalinizing agents, such
as antacids, should be avoided. 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. Proton Pump Inhibitors
act on proton pumps by blocking acid production thereby reducing gastric
acidity. In the presence of a proton pump inhibitor, the median Tmax of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules was shortened from 5 hours to 2.75 hours. Therefore, co-administration
of Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules and
proton pump inhibitors should be avoided. Antidepressants, tricyclic
Amphetamines may enhance the activity of tricyclic antidepressants 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. 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 toxic neurological effects and malignant hyperpyrexia can occur,
sometimes with fatal results. Antihistamines
Amphetamines may counteract the sedative effect of antihistamines. Antihypertensives
Amphetamines may antagonize the hypotensive effects of
antihypertensives. Chlorpromazine
Chlorpromazine blocks dopamine and norepinephrine receptors, 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 receptors, thus inhibiting the central stimulant
effects of amphetamines. Lithium carbonate
The anorectic and 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 and Impairment of
Fertility No evidence of carcinogenicity was found in studies in which
d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in
the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day
in female mice, and 5 mg/kg/day in male and female rats. These doses are
approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended
human dose of 30 mg/day [child] on a mg/m 2 body surface
area basis.
Amphetamine, in the enantiomer ratio present in ADDERALL®
(immediate-release)(d- to l- ratio of 3:1), was not clastogenic in the
mouse bone marrow micronucleus test in vivo and was
negative when tested in the E. coli component of the
Ames test in vitro. d,l-Amphetamine (1:1 enantiomer
ratio) has been reported to produce a positive response in the mouse bone marrow
micronucleus test, an equivocal response in the Ames test, and negative
responses in the in vitro sister chromatid exchange
and chromosomal aberration assays.
Amphetamine, in the enantiomer ratio present in ADDERALL® (immediate-release)(d- to l- ratio of 3:1), did not adversely
affect fertility or early embryonic development in the rat at doses of up to 20
mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day
on a mg/m2 body surface area basis). PregnancyPregnancy Category C Amphetamine, in the enantiomer ratio present in ADDERALL® (d- to l- ratio of 3:1), had no apparent effects on
embryofetal morphological development or survival when orally administered to
pregnant rats and rabbits throughout the period of organogenesis at doses of up
to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8
times, respectively, the maximum recommended human dose of 30 mg/day [child] on
a mg/m2 body surface area basis. Fetal malformations and
death have been reported in mice following parenteral administration of
d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose
of 30 mg/day [child] on a mg/m2 basis) or greater to
pregnant animals. Administration of these doses was also associated with severe
maternal toxicity.
A number of studies in rodents indicate that prenatal or early postnatal
exposure to amphetamine (d- or d,l-), at doses similar to those used clinically,
can result in long-term neurochemical and behavioral alterations. Reported
behavioral effects include learning and memory deficits, altered locomotor
activity, and changes in sexual function.
There are no adequate and well-controlled studies in pregnant women. There
has been one report of severe congenital bony deformity, tracheo-esophageal
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. Amphetamines 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. Usage in Nursing Mothers Amphetamines are excreted in human milk. Mothers taking
amphetamines should be advised to refrain from nursing. Pediatric Use Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
indicated for use in children 6 years of age and older. Use in Children Under Six Years of Age Effects of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules in 3-5 year olds have not been studied. Long-term effects of
amphetamines in children have not been well established. Amphetamines are not
recommended for use in children under 3 years of age. Geriatric Use Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules has
not been studied in the geriatric population.
Adverse Events
Drug Abuse And Dependence
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsules 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 levels many times higher than
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 may include
severe dermatoses, marked insomnia, irritability, hyperactivity, and personality
changes. The most severe manifestation of chronic intoxication is psychosis,
often clinically indistinguishable from schizophrenia.
Overdosage
Individual patient response to amphetamines varies widely. Toxic
symptoms may occur idiosyncratically at low doses. Symptoms
Manifestations of acute overdosage with amphetamines include restlessness,
tremor, hyperreflexia, rapid respiration, confusion, assaultiveness,
hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and
depression usually follow the central nervous system 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.
The prolonged release of mixed amphetamine salts from Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release (MAS-ER) Capsules should be considered when
treating patients with overdose.
Dosage And Administration
Dosage should be individualized according to the therapeutic
needs and response of the patient. Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release (MAS-ER) Capsules should be administered at the lowest
effective dosage. Children In children with ADHD who are 6 years of age and older and are
either starting treatment for the first time or switching from another
medication, start with 10 mg once daily in the morning; daily dosage may be
adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the
judgment of the clinician a lower initial dose is appropriate, patients may
begin treatment with 5 mg once daily in the morning. The maximum recommended
dose for children is 30 mg/day; doses greater than 30 mg/day of
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsuleshave not been studied in children. Amphetamines are not recommended for
children under 3 years of age. Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release (MAS-ER) Capsules has not been studied in children under 6
years of age. Adolescents The recommended starting dose for adolescents who are 13-17 years
of age with ADHD is 10 mg/day. The dose may be increased to 20 mg/day after one
week if ADHD symptoms are not adequately controlled. Adults In adults with ADHD who are either starting treatment for the
first time or switching from another medication, the recommended dose is 20
mg/day.
Patients Currently Using ADDERALL®- Based on
bioequivalence data, patients taking divided doses of immediate-release
ADDERALL®, for example twice a day, may be switched to
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsules at the same total daily dose taken once daily. Titrate at weekly
intervals to appropriate efficacy and tolerability as indicated.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsules may be taken whole, or the capsule may be opened and the entire
contents sprinkled on applesauce. If the patient is using the sprinkle
administration method, the sprinkled applesauce should be consumed immediately;
it should not be stored. Patients should take the applesauce with sprinkled
beads in its entirety without chewing. The dose of a single capsule should not
be divided. The contents of the entire capsule should be taken, and patients
should not take anything less than one capsule per day.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsules may be taken with or without food.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release (MAS-ER)
Capsules should be given upon awakening. Afternoon doses should be avoided
because of the potential for insomnia.
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 Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release (MAS-ER) Capsules are available as:
5 mg- Clear/blue (imprinted M. Amphet Salts 5 mg),
Bottles of 10
NDC 54868-6227-1
Bottles of 30
NDC 54868-6227-0
10 mg- Blue/blue (imprinted M. Amphet Salts 10 mg),
Bottles of 10
NDC 54868-6033-0
Bottles of 30
NDC 54868-6033-1
Bottles of 90
NDC 54868-6033-2
15 mg- Blue/white (imprinted M. Amphet Salts 15 mg),
Bottles of 10
NDC 54868-6192-0
Bottles of 30
NDC 54868-6192-1
20 mg- Orange/orange (imprinted M. Amphet
Salts 20 mg),
Bottles of 10
NDC 54868-6028-0
Bottles of 30
NDC 54868-6028-1
Bottles of 60
NDC 54868-6028-2
25 mg- Orange/white (imprinted
M. Amphet Salts 25 mg),
Bottles of 10
NDC 54868-6029-0
Bottles of 30
NDC 54868-6029-1
Bottles of 60
NDC 54868-6029-2
30 mg-
Natural/orange (imprinted M. Amphet Salts 30 mg),
Bottles of 10
NDC 54868-6034-0
Bottles of 30
NDC 54868-6034-1
Dispense in a tight, light-resistant container as defined in the
USP.
Store at 25º C (77º F). Excursions permitted to 15-30º C (59-86º F) [see USP
Controlled Room Temperature]
Animal Toxicology
Acute administration of high doses of amphetamine (d- or d,l-) has been shown to
produce long-lasting neurotoxic effects, including irreversible nerve fiber
damage, in rodents. The significance of these findings to humans is unknown.
Manufactured for Global Pharmaceuticals, Division of IMPAX
Laboratories, Inc.,Philadelphia, PA 19124 USASupplied by Shire LLC,
Florence, KY 41042Made in USAFor more information contact IMPAX
Laboratories, Inc., at1-800-934-6729
Pharmacist: Medication Guide to be dispensed to
patients
ADDERALL® is a registered trademark of Shire LLC,
under license to Duramed Pharmaceuticals, Inc.
Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OKÂ Â Â Â 74146
Medication Guide
Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules ( mixed salts of a single- entity amphetmanine
product)
Read the Medication Guide that comes with Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine 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 you or
your child's treatment with Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules.
What is the most important
information I should know about Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules?
Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules is a stimulant medicine. The following have
been reported with use of 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 Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules.
Your doctor should check you or your child's
blood pressure and heart rate regularly during treatment with Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules.
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 Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules.
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 Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules,
especially seeing or hearing things that are not real, believing things that are
not real, or are suspicious.
What Is Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules?
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
a once daily central nervous system stimulant
prescription medicine. It is used for the treatment of
Attention Deficit Hyperactivity Disorder(ADHD). Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules may help increase attention and
decrease impulsiveness and hyperactivity in patients with ADHD.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine 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 Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules in a safe place to prevent misuse
and abuse. Selling or giving away Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules 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 Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules?
Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules 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 Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules has
not been studied in children less than 6 years old.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
not recommended for use in children less than 3 years old.
Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules may not be right for you or your child. Before starting
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
tell your or your child's doctor about all health conditions (or a family
history of) including:
heart problems, heart defects, or high blood pressure
mental problems including psychosis, mania, bipolar illness, or
depression
tics or Tourette's syndrome
liver or kidney problems
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 Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules be taken with other medicines?
Tell your doctor about all of the medicines that you or your
child takes including prescription and non-prescription medicines, vitamins, and
herbal supplements. Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules 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 Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules.
Your doctor will decide whether Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules can be taken with other medicines.
Especially tell your doctor if you or your child takes:
anti-depression medicines including MAOIs
anti-psychotic medicines
lithium
narcotic pain medicines
seizure medicines
blood thinner medicines
blood pressure medicines
stomach acid medicines
cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a ul of your
medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules without talking to your doctor
first.
How should Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules be taken?
Take Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules exactly as prescribed. Your doctor may adjust the dose until it
is right for you or your child.
Take Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
once a day in the morning when you first wake up Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules is an extended release capsule. It releases
medicine into your body throughout the day.
Swallow Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
capsules whole with water or other liquids. If you or your child cannot swallow
the capsule, open it and sprinkle the medicine over a spoonful of applesauce.
Swallow all of the applesauce and medicine mixture without chewing immediately.
Follow with a drink of water or other liquid. Never chew or
crush the capsule or the medicine inside the capsule.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules can
be taken with or without food.
From time to time, your doctor may stop Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules treatment for a while to check ADHD
symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure
while taking Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules.
Children should have their height and weight checked often while taking
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules.
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules
treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules or overdoses, call your doctor or
poison control center right away, or get emergency treatment.
What are possible side effects of Dextroamphetamine
Saccharate, Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and,
Amphetamine Sulfate Extended-Release Capsules?
See "What is the most important
information I should know about Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules?" 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
Common side effects include:
headache
decreased appetite
stomach ache
nervousness
trouble sleeping
mood swings
weight loss
dizziness
dry mouth
fast heart beat
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules may
affect you or your child's ability to drive or do other dangerous
activities.
Talk to your doctor if you or your child has side effects that are bothersome
or do not go away.
This is not a complete ul 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 Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules?
Store Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules in
a safe place at room temperature, 59 to 86° F (15 to 30° C).
Keep Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules and all medicines out of the reach of children.
General information about Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules
Medicines are sometimes prescribed for purposes other than those uled in a
Medication Guide. Do not use Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules for a condition for which it was not prescribed. Do not give
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules 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 Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules. If
you would like more information, talk with your doctor. You can ask your doctor
or pharmacist for information about Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules that was written for healthcare professionals. For
more information, you may also contact IMPAX Laboratories Inc., at
1-800-934-6729.
What are the ingredients in Dextroamphetamine Saccharate,
Amphetamine Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine
Sulfate Extended-Release Capsules?
Inactive Ingredients: gelatin capsules, hydroxypropyl
methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc,
and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and
titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue
#2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow
iron oxide
Manufactured for Global Pharmaceuticals, Division of IMPAX Laboratories,
Inc., Philadelphia, PA 19124 USASupplied by Shire LLC, Florence, KY
41042Rev. 10/09974-01 108964
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
(Mixed Salts of a Single-EntityAmphetamine Product)
Extended-Release Capsules
CII
5 mg
Rx only
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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