Dextroamphetamine Full Prescribing Information
Brand Name: Dexedrine, Dextrostat
Generic Name: Dextroamphetamine
Dexedrine is used for treatment of ADHD and narcolespy. Usage, dosage, side effects of Dexedrine.
Dexedrine Patient Information (in plain English)
Dextroamphetamine (Dexedrine) is an amphetamine, belonging to the group of medicines called central nervous system (CNS) stimulants. They are used to treat attention-deficit hyperactivity disorder (ADHD) or attention-deficit disorder without hyperactivity (ADD). Amphetamines increase attention and decrease restlessness in patients who are overactive, unable to concentrate for very long or are easily distracted, and have unstable emotions. These stimulant medicines are used as part of a total treatment program that also includes social, educational, and psychological treatment.
Dextroamphetamine is also used in the treatment of narcolepsy (uncontrollable desire for sleep or sudden attacks of deep sleep).
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.
Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example.
Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.
Studies do not permit conclusions as to the relative importance of the drug and nondrug factors on weight loss.
The single ingestion of two 5 mg tablets by healthy volunteers produced an average peak dextroamphetamine blood level at 2 hours post-administration.
Ingestion of a sustained release capsule containing 15 mg radiolabeled dextroamphetamine sulfate by healthy volunteers produced a peak blood level at 8 to 10 hours post-administration.
Dexedrine is used in treatment of Attention Deficit Hyperactivity Disorder (ADHD & ADD) and Narcolepsy.
Drug treatment is not indicated for all children with Attention-Deficit Hyperactivity Disorder. Stimulants are not appropriate for the treatment of children who are exhibiting symptoms which are secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Suitable educational placement and psychosocial intervention are important. The prescription of stimulant medication will depend upon the physician's evaluation of the chronicity and severity of symptoms in a child whose disorder has proved refractory to remedial measures alone.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Amphetamines should not be used for weight loss or weight control or to combat unusual tiredness or weakness or replace rest. When used for these purposes, they may be dangerous to your health.
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. THEY SHOULD THUS BE TRIED ONLY IN WEIGHT REDUCTION PROGRAMS FOR PATIENTS IN WHOM ALTERNATIVE THERAPY HAS BEEN INEFFECTIVE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME IN OBESITY 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.
These medicines are available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs this medicine.
When tolerance to the "anorectic" effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
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.
The presence of tics or Tourette's syndrome should be ruled out before administering amphetamines to children.
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 FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Pregnancy & Nursing: There are no adequate and well-controlled studies in pregnant women. Dextroamphetamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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.
Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.
Pediatric Use: Amphetamines are not recommended for use in Attention-Deficit Hyperactivity Disorder in children under 6 years of age. Long-term effects of amphetamines in children have not been well established.
Chronic administration of amphetamines may be associated with growth inhibition; 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.
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.
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/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.
Interference with Cognitive or Motor Performance: 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.
Caution should be exercised when co-prescribing amphetamines and other drugs since clinically significant interactions with a number of drugs have been reported. In some instances, potentiations of CNS and cardiac effects could be life threatening. Dosages should be closely monitored.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes furazolidone, guanethidine, urinary alkalinizers, and medicine for depression. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.
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 when amphetamines are used for other than the anorectic effect.
Endocrine: Impotence, changes in libido.
Dextroamphetamine 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.
Signs and Symptoms
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.
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.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Regitine, CIBA) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Do not exceed the recommended dosage or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may cause serious side effects. Keep all doctor and laboratory appointments while you are using this medicine.
IF YOU ARE TAKING THIS MEDICINE for ADHD or ADD and your symptoms do not improve or if they become worse, check with your doctor.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
- Take your last dose of the day 4 to 6 hours before bedtime unless your doctor tells you differently.
- If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
Not recommended for this use in children under 3 years of age.
Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted.
For patients taking the short-acting form of this medicine: Take the last dose for each day at least 6 hours before bedtime to help prevent trouble in sleeping. For patients taking the long-acting form of this medicine: Take the daily dose about 10 to 14 hours before bedtime to help prevent trouble in sleeping.
In children 6 years of age or older, Daily dosage may range from 2.5 to 40 mg, although some older children may require more than 40 mg daily for optimal response. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Spansule capsules may be used for once-a-day dosage wherever appropriate. With tablets, give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Not recommended for this use in children under 6 years of age.
In children 6 years of age or 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/day.
Most hyperactive children require medication for several years, although once symptoms have been controlled, it may be possible to reduce dosage or to interrupt drug therapy during the summer months and at other times when the child is under less stress. Hyperkinetic children appear to be able to tolerate comparatively high dosages of dextroamphetamine with few adverse reactions, possibly because they excrete the drug more rapidly than other patients.
Adults: At first, 5 milligrams (mg) one to three times a day. Your doctor may increase your dose if needed.
Adults: At first, 5 mg one to three times a day. Your doctor may increase your dose to 60 mg, if needed.
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.
Children 6 to 12 years of age: start with 5 mg daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained.
If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Spansule capsules may be used for once-a-day dosage wherever appropriate. With tablets, give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Sustained release capsules
Each sustained release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, contains dextroamphetamine sulfate as follows: 5 mg, 10 mg, and 15 mg.
Each triangular, orange, scored tablet contains dextroamphetamine sulfate, 5 mg.
Dexedrine Patient Information (in plain English)
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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Writer, H. (2009, January 3). Dextroamphetamine Full Prescribing Information, HealthyPlace. Retrieved on 2019, August 20 from https://www.healthyplace.com/other-info/psychiatric-medications/dextroamphetamine-dexedrine-full-prescribing-information