DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE

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DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE

Overview

What is DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

A single entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium.

The 5, 7.5 and 10 mg also contain FD&C blue no.1 aluminum lake.

The 12.5, 15, 20 and 30 mg also contain FD&C yellow no. 6 aluminum lake.

What does DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE look like?

What are the available doses of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

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What should I talk to my health care provider before I take DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

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How should I use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

What interacts with DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

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).

What are the warnings of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

Serious Cardiovascular Events

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see ADVERSE REACTIONS], 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.

Psychiatric Adverse Events

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

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of 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 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 3482 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.

Long-Term Suppression of Growth

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 will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, 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.

Visual Disturbance

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

What are the precautions of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

General

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets should be used with caution in patients who use other sympathomimetic drugs.

Tics

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.

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 amphetamine or dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.

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.

Drug Interactions

Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines.

(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. Co-administration of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and gastrointestinal alkalizing agents, such as antacids, should be avoided. 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.

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 receptors, 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 receptors, thus inhibiting the central stimulant effects of amphetamines.

The anorectic and 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.

Amphetamine 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.

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.

Carcinogenesis/Mutagenesis and Impairment of Fertility

No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m body surface area basis.

Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (immediate-release) (d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test and was negative when tested in the E. coli component of the Ames test . D, l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (immediate-release)(d- to l- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day on a mg/m body surface area basis).

Pregnancy

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.

Usage in Nursing Mothers

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

Pediatric Use

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS.

Geriatric Use

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets has not been studied in the geriatric population.

What are the side effects of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

Cardiovascular

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

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke.

Gastrointestinal

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

Allergic

Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine

Impotence, changes in libido.

What should I look out for while using DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

What might happen if I take too much DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at low doses.

How should I store and handle DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE?

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENStore at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.KEEP OUT OF REACH OF CHILDRENDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and four partial bisects on the other side debossed with . Available in bottles of:7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:12.5 mg: Peach, oval, biconvex tablet debossed with stylized over separated by a full score on one side and four partial bisects on the other side debossed with Available in bottles of:15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized over on one side and two partial bisects and a full score on the other side debossed with .Available in bottles of:20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with .Available in bottles of:30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized over and two partial bisects and a full score on the other side debossed with . Available in bottles of:Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Non-Clinical Toxicology

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).

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets should be used with caution in patients who use other sympathomimetic drugs.

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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