DEXEDRINE (Capsule, Extended Release)
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses���particularly with the SPANSULE capsule form���should be avoided because of the resulting insomnia.<br/>Narcolepsy:: Usual dose is 5 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, DEXEDRINE may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an 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 an 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.<br/>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, by tablet; 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. 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. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE as the neutral sulfate.<br/>SPANSULE Capsules:: Each SPANSULE 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, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB on the clear body. The 10-mg capsule is imprinted 10 mg���3513���on the brown cap and is imprinted 10 mg���SB���on the clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown cap and is imprinted 15 mg and SB on the clear body. A narrow bar appears above and below 15 mg and 3514. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.<br/>Tablets:: Each triangular, orange, scored tablet is debossed SKF and E19 and contains dextroamphetamine sulfate, 5 mg. Inactive ingredients consist of calcium sulfate, FD&C Yellow No. 5 (tartrazine), FD&C Yellow No. 6, gelatin, lactose, mineral oil, starch, stearic acid, sucrose, talc, and trace amounts of other inactive ingredients.
Amphetamines are noncatecholamine, 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 that 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. DEXEDRINE SPANSULE capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given in divided doses.<br/>Pharmacokinetics:: The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5-mg tablets, average maximal dextroamphetamine plasma concentrations (C) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15-mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cwas 23.5 ng/mL. The average plasma Twas similar for both the tablet and sustained-release capsule and was approximately 12 hours. In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
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).
DEXEDRINE SPANSULE capsules:: Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB on the clear body. The 10-mg capsule is imprinted 10 mg���3513���on the brown cap and is imprinted 10 mg���SB���on the clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown cap and is imprinted 15 mg and SB on the clear body. A narrow bar appears above and below 15 mg and 3514. Available: 5 mg, 10 mg, and 15 mg in bottles of 100. DEXEDRINE SPANSULE capsules are manufactured by Catalent Pharma Solutions, Albuquerque, NM 87107. Store at controlled room temperature between 20��and 25��C (68��and 77��F) [see USP]. Dispense in a tight, light-resistant container. 5 mg 100s: NDC 0007-3512-20 5 mg 90s: NDC 0007-3512-59 10 mg 90s: NDC 0007-3513-59 15 mg 90s NDC 0007-3514-59<br/>DEXEDRINE Tablets:: Triangular, orange, scored, debossed SKF and E19. Available: 5 mg in bottles of 100. DEXEDRINE Tablets are manufactured by Abbott Laboratories, North Chicago, IL 60064. Store between 15��and 30��C (59��and 86��F). Dispense in a tight, light-resistant container. 5 mg 100s: NDC 0007-3519-20 Medication Guide DEXEDRINE' (dextroamphetamine sulfate) SPANSULE sustained-release capsules and Tablets CII Read the Medication Guide that comes with DEXEDRINE 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 your or your child's treatment with DEXEDRINE. What is the most important information I should know about DEXEDRINE? The following have been reported with use of DEXEDRINE and other 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 DEXEDRINE. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with DEXEDRINE. 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 DEXEDRINE. 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 DEXEDRINE, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. What Is DEXEDRINE? DEXEDRINE is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). DEXEDRINE may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. DEXEDRINE should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. DEXEDRINE is also used in the treatment of a sleep disorder called narcolepsy. DEXEDRINE is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DEXEDRINE in a safe place to prevent misuse and abuse. Selling or giving away DEXEDRINE 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 DEXEDRINE? DEXEDRINE 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 antidepression medicine called a monoamine oxidase inhibitor or MAOI. ���Is sensitive to, allergic to, or had a reaction to other stimulant medicines DEXEDRINE is not recommended for use in children less than 3 years old. DEXEDRINE may not be right for you or your child. Before starting DEXEDRINE tell your or your child's doctor about all health conditions (or a family history of) including: ���Heart problems, heart defects, 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 DEXEDRINE be taken with other medicines? Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. DEXEDRINE 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 DEXEDRINE Your doctor will decide whether DEXEDRINE can be taken with other medicines. Especially tell your doctor if you or your child takes: ���Anti-depression medicines including MAOIs ���Blood pressure medicines ���Antacids ���Seizure medicines Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking DEXEDRINE without talking to your doctor first. How should DEXEDRINE be taken? ���Take DEXEDRINE exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. ���DEXEDRINE comes as a capsule or tablet. oDEXEDRINE SPANSULE capsules are usually taken once a day in the morning. DEXEDRINE SPANSULE is an extended release capsule. It releases medicine into your body throughout the day. oDEXEDRINE tablets are usually taken two to three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart. ���From time to time, your doctor may stop DEXEDRINE' treatment for a while to check ADHD symptoms. ���Your doctor may do regular checks of the blood, heart, and blood pressure while taking DEXEDRINE. Children should have their height and weight checked often while taking DEXEDRINE. DEXEDRINE treatment may be stopped if a problem is found during these check-ups. ���If you or your child takes too much DEXEDRINE or overdoses, call your doctor or poison control center right away, or get emergency treatment. What are possible side effects of DEXEDRINE? See���What is the most important information I should know about DEXEDRINE?���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: ���Fast heart beat ���Decreased appetite ���Tremors ���Headache ���Trouble sleeping ���Dizziness ���Stomach upset ���Weight loss ���Dry mouth DEXEDRINE 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 list of possible side effects. Ask your doctor or pharmacist for more information. How should I store DEXEDRINE? ���Store DEXEDRINE SPANSULE capsules in a safe place at room temperature, 68��to 77��F (20��to 25��C). Protect from light. ���Store DEXEDRINE Tablets in a safe place at room temperature, 59��to 86��F (15��to 30��C). Protect from light. ���Keep DEXEDRINE and all medicines out of the reach of children. General information about DEXEDRINE Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXEDRINE for a condition for which it was not prescribed. Do not give DEXEDRINE 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 DEXEDRINE. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXEDRINE that was written for healthcare professionals. For more information about DEXEDRINE, please contact GlaxoSmithKline (makers of DEXEDRINE) at 1-888-825-5249 or visit www.gsk.com. What are the ingredients in DEXEDRINE? Active Ingredient: Dextroamphetamine sulfate Inactive Ingredients: SPANSULE Capsules: Cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene glycol, povidone, silicon dioxide, sodium laurate sulfate, and sugar spheres Tablets: Calcium sulfate, FD&C Yellow No. 5, FD&C Yellow No. 6, gelatin, lactose, mineral oil, starch, stearic acid, sucrose, and talc This Medication Guide has been approved by the U.S. Food and Drug Administration. DXD:2MG GlaxoSmithKline Research Triangle Park, NC 27709 ��2007, GlaxoSmithKline. All rights reserved. November 2007 DXD:L59PI
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. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
dailymed-ingredient:D&C_Yellow_No._10, dailymed-ingredient:FD&C_Blue_No._1, dailymed-ingredient:FD&C_Blue_No._1_aluminum_lake, dailymed-ingredient:FD&C_Red_No._40, dailymed-ingredient:FD&C_Yellow_No._6, dailymed-ingredient:cetyl_alcohol, dailymed-ingredient:dibutyl_sebecate, dailymed-ingredient:ethylcellulose, dailymed-ingredient:gelatin, dailymed-ingredient:hypromellose, dailymed-ingredient:povidone, dailymed-ingredient:propylene_glycol, dailymed-ingredient:silicon_dioxide, dailymed-ingredient:sodium_lauryl_sulfate, dailymed-ingredient:sugar_spheres
General:: The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the possibility of overdosage. The tablets 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.<br/>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 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.<br/>Drug Interactions::<br/>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.<br/>Adrenergic blockers:: Adrenergic blockers are inhibited by amphetamines.<br/>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.<br/>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.<br/>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.<br/>Antihistamines:: Amphetamines may counteract the sedative effect of antihistamines.<br/>Antihypertensives:: Amphetamines may antagonize the hypotensive effects of antihypertensives.<br/>Chlorpromazine:: Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.<br/>Ethosuximide:: Amphetamines may delay intestinal absorption of ethosuximide.<br/>Haloperidol:: Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.<br/>Lithium carbonate:: The stimulatory effects of amphetamines may be inhibited by lithium carbonate.<br/>Meperidine:: Amphetamines potentiate the analgesic effect of meperidine.<br/>Methenamine therapy:: Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.<br/>Norepinephrine:: Amphetamines enhance the adrenergic effect of norepinephrine.<br/>Phenobarbital:: Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.<br/>Phenytoin:: Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.<br/>Propoxyphene:: In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.<br/>Veratrum alkaloids:: Amphetamines inhibit the hypotensive effect of veratrum alkaloids.<br/>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.<br/>Carcinogenesis/Mutagenesis:: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of DEXEDRINE have not been performed.<br/>Pregnancy::<br/>Teratogenic Effects:: Pregnancy Category C. DEXEDRINE 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 inrats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been 1 report of severe congenital bony deformity, tracheoesophageal 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. DEXEDRINE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<br/>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.<br/>Nursing Mothers:: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.<br/>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 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. 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 or 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.
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 LDof 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.
DEXEDRINE (Capsule, Extended Release)
Cardiovascular:: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.<br/>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.<br/>Gastrointestinal:: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.<br/>Allergic:: Urticaria.<br/>Endocrine:: Impotence, changes in libido.
DEXEDRINE is indicated in:<br/>Narcolepsy:<br/>Attention Deficit Disorder with Hyperactivity:: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years 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.