Dexedrine - The Side Effects and Warnings
ADD/ADHD Symptoms

Dexedrine is a single entity amphetamine product combining the neutral salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, I-amphetamine asperate. Drugs of this class used in obesity are commonly known as ``anorectics'' or ``anorexigenics''.

Known Side effects:

Reactions within the body:

Is Dexedrine addictive?

Dextroamphetamine sulfate (Dexedrine) is a Schedule II controlled substance.

What is a Schedule II controlled substance?

The substances in this schedule have a high abuse potential with severe psychic or physical dependence liability. Schedule II controlled substances consist of certain narcotic, stimulant and depressant drugs. Some examples of Schedule II narcotic controlled substances are: opium, morphine, codeine, hydromorphone (Dilaudid), methadone, pantopon, meperidine (Demerol), cocaine, oxycodone (Percodan), and oxymorphone (Numorphan). Also in Schedule 11 are amphetamine (Dexedrine), methamphetamine (Desoxyn), phemnetrazine (Preludin), methylphenidate (Ritalin), amobarbital, pentobarbital, secobarbital, fentanyl (Sublimaze), sufentanil, etorphine hydrochloride, phenylacetone, dronabinol and nabilone.

Problems: Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

Overdosage:

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

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

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 (Regitine, CIBA) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved. Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

Dosage and Administration:

Regardless of indication, 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.

Attention Deficit Disorder with Hyperactivity: Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

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

Narcolepsy

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

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate, may be used. The suggested initial dose for patients aged 6-12 is 5 mg daily; daily dose 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 be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Exogenous Obesity

Usual adult dose is 5 mg to 30 mg per day in divided doses, taken 30 to 60 minutes before meals. Not recommended for use in children under 12 years of age.

Patient Information:

Amphetamines are used for narcolepsy, attention deficit disorder and obesity.

Do not take if you have hypertension. Inform your doctor if you are pregnant or nursing. To avoid insomnia, do not take this drug in the evening. May impair ability to perform hazardous tasks; patients should use caution while driving or operating machinery.

May cause insomnia, dizziness, over stimulation and GI upset. Inform your doctor or pharmacist if these effects occur.

Warning:

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.

Clinical Pharmacology:

Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodialator and respiratory stimulant action. 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. For example, other central nervous system actions or metabolic effects may be involved.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamine produces mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system dysfunction may or may not be warranted.

Clinical Studies:

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.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greater in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The origins of the increased weight loss due to the various possible drug effects are not established. The amount of weight loss associated with the use of an ``anorectic'' drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration, thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Indications and Usage:

Attention Deficit Disorder with Hyperactivity

Amphetamines are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms:

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 not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

In Narcolepsy

Exogenous obesity: As a short-term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy; e.g., repeated diets, group programs and other drugs. The limited usefulness of amphetamine (see Mechanism of Action) should be weighed against possible risks inherent in use of the drug, such as those described below.

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:

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. Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder. Data are inadequate to determined whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

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

Precautions:

General

Caution is to be exercised in prescribing amphetamine for patients with mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. (Mosby Inc. - Mosby's GenRx)

Pediatric Use: Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use as anorectic agents in children under 12 years of age, or in children 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

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.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/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.

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.

With the above in mind, note that Adderall was approved for unrestricted use for treatment of ADHD by the FDA in March, 1996, and will almost certainly become one of the more widely prescribed medications for this condition very soon. Adderall is the new name for a (Dexedrine) Dextroamphetamine/Amphetamine composite medication which has been around for more than 20 years. This formula was also used in a medication known as Obetrol, made in the past by Rexar and developed for "diet control." 

Brand Name: ADDERALL - DEXEDRINE
Generic Name: AMPHETAMINE MIXED SALTS
Category: RESPIRATORY AND CEREBRAL STIMULANTS

Drug/Laboratory Test Interactions

Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Amphetamine, have not been performed.

Pregnancy, Teratogenic Effects, Pregnancy Category C: Amphetamine 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. There are no adequate and well-controlled studies in pregnant women. 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.

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

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

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 antiobesity and stimulatory effects of amphetamines may be inhibited by lithiium 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 product a synergistic anticonvulsant action.

Phenytoin: Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene: In most cases of propoxyphene overdosage, amphetamine CNS stimulation is potential and fatal convulsions can occur.

Veratrum alkaloids: Amphetamines inhibit the hypertensive effect of veratrum alkaloids.

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