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All about: DextroStat

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Generic Name: dextroamphetamine sulfate
Dosage Form: Tablets, usp cii

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.

DextroStat Description

DextroStat® (dextroamphetamine sulftate) is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methyl-phenethylamine, and is present in all forms of DextroStat®as the neutral sulfate. It has a chemical formula of (C9H13N)2·H2SO4 and a molecular weight of 368.50.

Structural Formula:

Each tablet, for oral administration, contains dextroamphetamine sulfate USP, 5 mg or 10 mg. Each tablet also contains the following inactive ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, sucrose. 10 mg tablet contains sodium starch glycolate. 5 mg and 10 mg tablets contain FD&C Yellow #5 (tartrazine).

DextroStat - Clinical Pharmacology

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics

The single ingestion of two 5 mg tablets by healthy volunteers produced and average peak dextroamphetamine blood level of 29.2 ng/mL at 2 hours post-administration. The average half-life was 10.25 hours. The average urinary recovery was 45% in 48 hours.

Indications and Usage for DextroStat

Dextroamphetamine sulfate tablets are indicated:

  1. In Narcolepsy.
  2. In Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Precautions

General

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension.

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

These products contain FD&C Yellow No.5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of hypersensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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.

Drug Interactions

Acidifying agents - Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic blockers - Adrenergic blockers are inhibited by amphetamines.

Alkalinizing agents - Gastro-intestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, tricyclic - Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

MAO inhibitors - MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

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 DextroStat®(dextroamphetamine sulfate) have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Dextroamphetamine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, 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. Dextroamphetamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Nursing Mothers

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

Pediatric Use

Long-term effects of amphetamines in pediatric patients have not been well established. Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic pediatric patients, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in pediatric patients and their families should precede use of stimulant medications.

Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the pediatric patient. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the pediatric patient's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

Adverse Reactions

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.

Drug Abuse and Dependence

Dextroamphetamine sulfate tablets are 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 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. This is rare with oral amphetamines.

Overdosage

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

TREATMENT- Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.

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

Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, DextroStat® (dextroamphetamine sulfate) may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily does may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily, daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

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

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

How is DextroStat Supplied

DextroStat®, (dextroamphetamine sulfate) Tablets are available as follows:

5 mg Yellow, Round, Scored Tablet debossed "RP" on one side and "51" on the other side.

NDC #:54092-448-01 for 100s

10 mg Yellow, Round, Double-Scored tablet debossed "RP" on one side and "52" on the other side.

NDC #: 54092-452-01 for 100s

Dispense in a tight container as defined in the USP.

Store at 25° C (77° F). excursions 15-30° C (59-86° F).

DEA Order Form Required.

Manufactured by:

Shire US Inc.

725 Chesterbrook Blvd.

Wayne, PA 19087

Made in USA

©2005, Shire US Inc.

448 0107 002

Rev. 1/05 00126


DextroStat (dextroamphetamine sulfate)
PRODUCT INFO
Product Code 54092-448 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
dextroamphetamine sulfate (dextroamphetamine) Active 5 MILLIGRAM  In 1 TABLET
acacia Inactive  
corn starch Inactive  
lactose monohydrate Inactive  
magnesium stearate Inactive  
sucrose Inactive  
FD&C Yellow #5 (tartrazine) Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color YELLOW Score 2
Shape ROUND Symbol false
Imprint Code RP;51 Coating false
Size 9mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 54092-448-01 100 TABLET In 1 BOTTLE None

DextroStat (dextroamphetamine sulfate)
PRODUCT INFO
Product Code 54092-452 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
dextroamphetamine sulfate (dextroamphetamine) Active 10 MILLIGRAM  In 1 TABLET
acacia Inactive  
corn starch Inactive  
lactose monohydrate Inactive  
magnesium stearate Inactive  
sucrose Inactive  
sodium starch glycolate Inactive  
FD&C Yellow #5 (tartrazine) Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color YELLOW Score 4
Shape ROUND Symbol false
Imprint Code RP;52 Coating false
Size 10mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 54092-452-01 100 TABLET In 1 BOTTLE None

Revised: 08/2006

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