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DEXTROAMPHETAMINE SULFATE TABLETS USP, CII | Dextroamphetamine Sulfate [Teva Pharmaceuticals USA, Inc.] | BioPortfolio

13:51 EST 27th January 2019 | BioPortfolio
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0952

0953

Rx only

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.

Dextroamphetamine sulfate, USP 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 dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows:

(CHN)∙HSO M.W. 368.49

Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and microcrystalline cellulose.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

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 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 C was 23.5 ng/mL. The average plasma T was 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.

Dextroamphetamine Sulfate Tablets USP are indicated for:

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).

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Stimulants, including dextroamphetamine sulfate tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulcerations and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort (see Drug Interactions). Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism (see CLINICAL PHARMACOLOGY). The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to dextroamphetamine sulfate tablets. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 (see Drug Interactions).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of dextroamphetamine sulfate tablets with MAOI drugs is contraindicated (see CONTRAINDICATIONS).

Discontinue treatment with dextroamphetamine sulfate tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine sulfate tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine sulfate tablets with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

The least amount feasible should be prescribed or dispensed at one 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 dextroamphetamine. 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.

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 are inhibited by amphetamines.

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.

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.

The concomitant use of dextroamphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during dextroamphetamine sulfate tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the CYP2D6 inhibitor (see WARNINGS, OVERDOSAGE). Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

The concomitant use of dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets 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.

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.

Amphetamines may counteract the sedative effect of antihistamines.

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

The stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Amphetamines potentiate the analgesic effect of meperidine.

Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Amphetamines enhance the adrenergic effect of norepinephrine.

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

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

In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of dextroamphetamine sulfate have not been performed.

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, 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. 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.

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.

Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

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.

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Urticaria.

Impotence, changes in libido, frequent or prolonged erections.

Rhabdomyolysis

Dextroamphetamine sulfate 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.

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 LD 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.

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.

Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

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.

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, dextroamphetamine sulfate 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 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.

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; 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 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.

Dextroamphetamine Sulfate Tablets USP are available as:

5 mg: Peach, round, flat-faced, beveled-edge, scored tablet, debossed with 952/5 on the scored side and stylized b on the other side. Available in bottles of 100 (NDC: 0555-0952-02).

10 mg: Pink, round, flat-faced, beveled-edge, scored tablet, debossed with 953/10 on the scored side and stylized b on the other side. Available in bottles of 100 (NDC: 0555-0953-02).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DEA Order Form Required.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. C 9/2016

DEXTROAMPHETAMINE SULFATE TABLETS USP, CII

(DEX-troe-am-FET-uh-meen SULL-fate)

Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets before you or your child starts taking them 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 you or your child’s treatment with Dextroamphetamine Sulfate Tablets.

What are Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine Sulfate Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine Sulfate Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dextroamphetamine Sulfate Tablets are also used in the treatment of a sleep disorder called narcolepsy.

Who should not take Dextroamphetamine Sulfate Tablets?

Dextroamphetamine Sulfate Tablets should not be taken if you or your child:

Dextroamphetamine Sulfate Tablets are not recommended for use in children less than 3 years old.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets tell your or your child’s doctor about all health conditions (or a family history of) including:

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Dextroamphetamine Sulfate Tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dextroamphetamine Sulfate Tablets 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 Dextroamphetamine Sulfate Tablets.

Your doctor will decide whether Dextroamphetamine Sulfate Tablets can be taken with other medicines.

Especially tell your doctor if you or your child take:

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Dextroamphetamine Sulfate Tablets without talking to your doctor first.

How should Dextroamphetamine Sulfate Tablets be taken?

What are possible side effects of Dextroamphetamine Sulfate Tablets?

See “What is the most important information I should know about Dextroamphetamine Sulfate Tablets?” for information on reported heart and mental problems.

Other serious side effects include:

Common side effects include:

Dextroamphetamine Sulfate Tablets may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Dextroamphetamine Sulfate Tablets?

General information about Dextroamphetamine Sulfate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Tablets for a condition for which they were not prescribed. Do not give Dextroamphetamine Sulfate Tablets 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 Dextroamphetamine Sulfate Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Tablets that was written for healthcare professionals. For more information about Dextroamphetamine Sulfate Tablets, please contact Teva Pharmaceuticals at 1-888-838-2872.

What are the ingredients in Dextroamphetamine Sulfate Tablets?

Active Ingredient: dextroamphetamine sulfate

  What is the most important information I should know about Dextroamphetamine Sulfate Tablets? The following have been reported with use of Dextroamphetamine Sulfate Tablets 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 Dextroamphetamine Sulfate Tablets. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Tablets. 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 Dextroamphetamine Sulfate Tablets. 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 Dextroamphetamine Sulfate Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. 3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]: Fingers or toes may feel numb, cool, painful Fingers or toes may change color from pale, to blue, to red Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Dextroamphetamine Sulfate Tablets. Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets tell your or your child’s doctor about all health conditions (or a family history of) including: circulation problems in fingers and toes.
  Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine Sulfate Tablets in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Tablets 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.

Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and microcrystalline cellulose.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. B 9/2016

Dextroamphetamine Sulfate Tablets USP 5mg 100 Tablets Label Text

NDC 0555-0952-02

Dextroamphetamine Sulfate

Tablets USP 5 mg

CII

PHARMACIST: DISPENSE THEACCOMPANYING MEDICATION GUIDETO EACH PATIENT.

Rx only

100 Tablets

TEVA

Dextroamphetamine Sulfate Tablets USP 10mg 100 Tablets Label Text

NDC 0555-0953-02

Dextroamphetamine Sulfate Tablets USP 10 mg

CII

PHARMACIST: DISPENSE THEACCOMPANYING MEDICATION GUIDETO EACH PATIENT.

Rx only

100 Tablets

TEVA

Manufacturer

Teva Pharmaceuticals USA, Inc.

Active Ingredients

Source

Drugs and Medications [106 Associated Drugs and Medications listed on BioPortfolio]

Dextroamphetamine sulfate [ethex corporation]

Dextroamphetamine Sulfate Tablets, USP, 5 mg and 10 mg

Dextroamphetamine sulfate [physicians total care, inc.]

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES - CII

Dextroamphetamine sulfate [wilshire pharmaceuticals, inc.]

Dextroamphetamine Sulfate Tablets, USP CII

Dextroamphetamine sulfate [aurolife pharma, llc]

Dextroamphetamine Sulfate Tablets, USP CII Rx Only

Na [ethex corporation]

NA

Clinical Trials [914 Associated Clinical Trials listed on BioPortfolio]

Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.

Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

Dextroamphetamine-Cocaine Behavioral Intervention - 5

The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-Deficit Hyperactivity Disorder (ADHD)

Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study...

Safety of SPD465 in Treating Adults With ADHD.

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

PubMed Articles [846 Associated PubMed Articles listed on BioPortfolio]

Treatment of Hypothalamic Obesity with Dextroamphetamine: A Case Series.

A limited number of published case reports suggest a positive effect of dextroamphetamine, an adrenergic agonist affecting both the central nervous system (CNS) and peripheral nervous system, on physi...

Impact of total carbon/sulfate on methane production and sulfate removal from co-digestion of sulfate-containing wastewater and corn stalk.

During the process of preparing furfural by straw depolymerization with dilute sulfuric acid, large amounts of high temperature sulfate-rich organic wastewater were produced. It cannot be treated dire...

Bacterial community structure and predicted function in an acidogenic sulfate-reducing reactor: Effect of organic carbon to sulfate ratios.

A lab-scale acidogenic sulfate-reducing reactor with N stripping was continuously operated to uncover its microbial mechanism treating highly sulfate-containing organic wastewaters. Results showed tha...

Efficient reduction of nitrobenzene by sulfate-reducer enriched biocathode in microbial electrolysis cell.

This study aimed to enhance treatment of wastewater containing nitrobenzene (NB) and sulfate using biocathode enriched with sulfate-reducing bacteria in microbial electrolysis cell (MEC). Artificial w...

A novel carbon monoxide fed moving bed biofilm reactor for sulfate rich wastewater treatment.

In this study, a moving bed biofilm reactor was used for biodesulfuruization using CO as the sole carbon substrate. The effect of hydraulic retention time (HRT), sulfate loading rate and CO loading ra...

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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


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