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DEXEDRINE is indicated in:
Narcolepsy: Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
Attention Deficit Disorder with Hyperactivity: The SPANSULE capsule formulation is not recommended for pediatric patients younger than 6 years of age.
In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.
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.
Known hypersensitivity or idiosyncrasy to amphetamine.
In patients known to be hypersensitive to amphetamine, or other components of DEXEDRINE.
Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis
The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the possibility of overdosage.
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for DEXEDRINE. 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.
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.
Endocrine: Impotence, changes in libido, frequent or prolonged erections.
Skin and Subcutaneous Tissue Disorders: Alopecia.
Acidifying Agents: Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).
Adrenergic Blockers: Adrenergic blockers are inhibited by amphetamines.
Alkalinizing Agents: Increase blood levels and potentiate the action of amphetamine. Co-administration of DEXEDRINE and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides).
Tricyclic Antidepressants: May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.
Serotonergic Drugs: The concomitant use of DEXEDRINE and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DEXEDRINE initiation or dosage increase. If serotonin syndrome occurs, discontinue DEXEDRINE and the concomitant serotonergic drug(s) [see Warnings and Precautions]. Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.
Proton Pump Inhibitors: Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole.
Antihistamines: Amphetamines may counteract the sedative effect of antihistamines.
Antihypertensives: Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
Ethosuximide: Amphetamines may delay intestinal absorption of ethosuximide.
Meperidine:Amphetamines potentiate the analgesic effect of meperidine.
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.