Dexedrine Spansule Is It Possible to Use Theraputicly Again

What is Dexedrine Spansule and how is information technology used?

Dexedrine Spansule is a prescription medicine used to treat the symptoms of Attending Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Dexedrine Spansule may exist used lonely or with other medications.

Dexedrine Spansule belongs to a class of drugs called Stimulants, ADHD Agents.

Information technology is not known if Dexedrine Spansule is safe and effective in children younger than 3 years of historic period.

What are possible side effects of Dexedrine Spansule?

Side furnishings of Dexedrine Spansule include:

• hives,
• difficulty breathing,
• swelling of your face up, lips, natural language, or throat,
• chest pain,
• problem animate,
• lightheadedness,
• hallucination,
• new behavioral issues,
• aggression,
• hostility,
• paranoia,
• numbness,
• pain,
• cold feeling,
• unexplained wounds,
• skin color changes (pale, red, or blueish appearance) in your fingers or toes,
• seizure,
• musculus twitches,
• changes in your vision,
• fever,
• sweating,
• shivering,
• fast heart rate,
• musculus stiffness,
• twitching,
• loss of coordination,
• nausea,
• vomiting, and
• diarrhea

Get medical aid right away, if you lot have any of the symptoms listed above.

The most mutual side furnishings of Dexedrine Spansule include:

• dry mouth,
• upset stomach,
• loss of ambition,
• weight loss,
• headache,
• dizziness,
• tremors,
• fast heartbeats, and
• sleep problems (insomnia)

Tell the md if yous accept any side result that bothers you or that does not go abroad.

These are not all the possible side effects of Dexedrine Spansule. For more information, enquire your physician or pharmacist.

Call your dr. for medical advice about side effects. Yous may study side effects to FDA at 1-800-FDA-1088.

Alarm

AMPHETAMINES HAVE A High POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF Fourth dimension 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.

Description

DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the chemical compound d,1-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE equally the neutral sulfate. Structural formula:

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 chocolate-brown cap and clear body, contains dextroamphetamine sulfate. The five-mg capsule is imprinted five mg and 512 on the chocolate-brown cap and is imprinted 5 mg and ap on the clear body. The ten-mg sheathing is imprinted 10 mg-513-on the brownish cap and is imprinted 10 mg-ap-on the articulate body. The fifteen-mg sheathing is imprinted 15 mg and 514 on the brown cap and is imprinted 15 mg and ap on the clear trunk. A narrow bar appears above and below fifteen mg and 514. Product reformulation in 1996 has caused a pocket-size change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Xanthous No. x, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. half dozen, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.

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$119.99

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INDICATIONS

DEXEDRINE is indicated in:

Narcolepsy

Attention Deficit Disorder With Hyperactivity

As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients  (ages half-dozen years to 16 years) with this syndrome. A diagnosis of Attending Arrears Hyperactivity Disorder (ADHD; DSM-4) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were nowadays before age 7 years. The symptoms must cause clinically significant harm, e.g., in social, academic, or occupational functioning, and be nowadays in ii or more settings, east.g., school (or piece of work) and at dwelling house. The symptoms must non exist better accounted for by some other mental disorder. For the Inattentive Type, at least 6 of the post-obit symptoms must accept persisted for at least 6 months: lack of attention to details/devil-may-care mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor system; avoids tasks requiring sustained mental try; loses things; hands distracted; forgetful. For the Hyperactive-Impulsive Blazon, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with tranquillity activities; "on the go"; excessive talking; blurting answers; can't wait plough; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Acceptable diagnosis requires the apply of medical and special psychological, educational, and social resource. Learning may or may non be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and non solely on the presences of the required number of DSM-Iv characteristics.

Need For Comprehensive Treatment Program

DEXEDRINE is indicated as an integral role of a full treatment plan for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for utilise in patients who exhibit symptoms secondary to ecology factors and/or other principal psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures solitary are insufficient, the decision to prescribe stimulant medication volition depend upon the physician'due south assessment of the chronicity and severity of the patient's symptoms.

QUESTION

The abbreviated term ADHD denotes the condition commonly known equally: See Respond

DOSAGE AND Administration

Amphetamines should exist administered at the everyman effective dosage and dosage should be individually adjusted. Belatedly evening doses should be avoided because of the resulting insomnia.

Narcolepsy

Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response. Narcolepsy seldom occurs in children nether 12 years of age; however, when it does, DEXEDRINE may be used. The suggested initial dose for patients anile 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 historic period and older, start with x 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 announced (e.chiliad., insomnia or anorexia), dosage should be reduced. SPANSULE capsules may exist used for once-a-day dosage wherever appropriate.

Attention Deficit Disorder With Hyperactivity

The SPANSULE capsule conception is not recommended for pediatric patients younger than 6 years of age.

In pediatric patients 6 years of age and older, start with v 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 volition it be necessary to exceed a full of forty mg per day. SPANSULE capsules may be used for once-a-day dosage wherever appropriate. Where possible, drug administration should exist interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

HOW SUPPLIED

DEXEDRINE SPANSULE capsules

Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg sheathing is imprinted five mg and 512 on the brown cap and is imprinted five mg and ap on the articulate trunk. The 10-mg capsule is imprinted ten mg-513-on the brown cap and is imprinted ten mg-ap-on the clear trunk. The 15-mg capsule is imprinted 15 mg and 514 on the brown cap and is imprinted 15 mg and ap on the clear torso. A narrow bar appears in a higher place and below 15 mg and 514.

5 mg 90s: NDC 52054-512-09
10 mg 90s: NDC 52054-513-09
15 mg 90s: NDC 52054-514-09

Store at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP].

Dispense in a tight, light-resistant container.

Manufactured past: Catalent Pharma Solutions Winchester, KY 40391 For: Amedra Pharmaceuticals LLC Horsham, PA 19044. Revised: May 2017

SIDE Furnishings

Cardiovascular

Palpitations, tachycardia, elevation of blood pressure. At that place take been isolated reports of cardiomyopathy associated with chronic amphetamine utilize.

Cardinal 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'due south syndrome.

Gastrointestinal

Dryness of the rima oris, unpleasant sense of taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur equally undesirable effects.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido, frequent or prolonged erections.

Musculoskeletal

Rhabdomyolysis.

Skin and Subcutaneous Tissue Disorders

Alopecia.

Drug Abuse And Dependence

Dextroamphetamine sulfate is a Schedule II controlled substance. Amphetamines take been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who take increased the dosage to many times that recommended. Abrupt abeyance 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 nigh severe manifestation of chronic intoxication is psychosis, oftentimes clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

SLIDESHOW

ADHD Symptoms in Children Run across Slideshow

DRUG INTERACTIONS

Acidifying Agents

Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acrid HCl, ascorbic acrid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic Blockers

Adrenergic blockers are inhibited by amphetamines.

Alkalinizing Agents

Increase claret levels and potentiate the action of amphetamine. Co-assistants of DEXEDRINE and gastrointestinal alkalinizing agents should exist avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.grand., sodium bicarbonate) and urinary alkalinizing agents (eastward.g. acetazolamide, some thiazides).

Tricyclic Antidepressants

May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can exist potentiated. Monitor oft and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, Protriptyline.

CYP2D6 Inhibitors

The concomitant use of DEXEDRINE and CYP2D6 inhibitors may increase the exposure of DEXEDRINE 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 DEXEDRINE initiation and after a dosage increase. If serotonin syndrome occurs, discontinue DEXEDRINE and the CYP2D6 inhibitor [see WARNINGS, OVERDOSAGE]. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (too serotonergic drugs), quinidine, ritonavir.

Serotonergic Drugs

The concomitant use of DEXEDRINE and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during DEXEDRINE initiation or dosage increase. If serotonin syndrome occurs, discontinue DEXEDRINE and the concomitant serotonergic drug(southward) [run into 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.

MAO Inhibitors

Concomitant use of MAOIs and CNS stimulants tin can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Practice not administer DEXEDRINE concomitantly or inside 14 days after discontinuing MAOI [see CONTRAINDICATIONS and WARNINGS]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Proton Pump Inhibitors

Time to maximum concentration (Tmax) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adapt therapy based on clinical response. An case of a proton pump inhibitor is omeprazole.

Antihistamines

Amphetamines may counteract the allaying consequence of antihistamines.

Antihypertensives

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine

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

Ethosuximide

Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol

Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the primal stimulant furnishings of amphetamines.

Lithium Carbonate

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

Meperidine

Amphetamines potentiate the analgesic event of meperidine.

Methenamine Therapy

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

Norepinephrine

Amphetamines raise the adrenergic effect of norepinephrine.

Phenobarbital

Amphetamines may delay intestinal assimilation of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant activeness.

Phenytoin

Amphetamines may filibuster intestinal absorption of phenytoin; co-assistants of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene

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

Veratrum Alkaloids

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

Amphetamines can crusade a pregnant superlative in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

WARNINGS

Serious Cardiovascular Events

Sudden Expiry in Patients With Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children And Adolescents

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 center problems solitary carry an increased risk of sudden death, stimulant products generally should non be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious centre rhythm abnormalities, or other serious cardiac issues that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults

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 likewise unknown, adults take a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious center rhythm abnormalities, coronary artery affliction, or other serious cardiac problems. Adults with such abnormalities should as well generally non be treated with stimulant drugs (see CONTRAINDICATIONS).

Hypertension And Other Cardiovascular Conditions

Stimulant medications cause a modest increment in average blood pressure (virtually two-iv mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not exist expected to have curt-term consequences, all patients should be monitored for larger changes in middle rate and blood force per unit area. Caution is indicated in treating patients whose underlying medical atmospheric condition might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, centre failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).

Assessing Cardiovascular Status In Patients Being Treated With Stimulant Medications

Children, adolescents, or adults who are existence considered for treatment with stimulant medications should have a conscientious history (including assessment for a family history of sudden decease or ventricular arrhythmia) and concrete exam to assess for the presence of cardiac illness, and should receive further cardiac evaluation if findings advise such disease (e.m., electrocardiogram and echocardiogram). Patients who develop symptoms such equally exertional chest hurting, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

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

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of business organisation for possible consecration 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 decide 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.

Emergence Of New Psychotic Or Manic Symptoms

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 tin be caused past stimulants at usual doses. If such symptoms occur, consideration should exist given to a possible causal part of the stimulant, and discontinuation of treatment may be advisable. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.one% (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.

Aggression

Ambitious 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 in that location is no systematic evidence that stimulants crusade aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, ambitious behavior or hostility.

Long-Term Suppression Of Growth

Conscientious follow-up of weight and meridian in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication handling groups over 14 months, equally well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children older than 36 months (to the ages of x to xiii years), suggests that consistently medicated children (i.e., treatment for seven days per week throughout the yr) have a temporary slowing in growth charge per unit (on boilerplate, a total of well-nigh 2 cm less growth in elevation and 2.7 kg less growth in weight over iii years), without evidence of growth rebound during this period of development. Published data are inadequate to make up one's mind whether chronic use of amphetamines may cause a like suppression of growth, however, it is anticipated that they likely take this effect as well. Therefore, growth should exist monitored during handling with stimulants, and patients who are not growing or gaining height or 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 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.

Peripheral Vasculopathy, Including Raynaud's Miracle

Stimulants, including DEXEDRINE, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are normally intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Furnishings of peripheral vasculopathy, including Raynaud's phenomenon, were observed in mail service-marketing reports at unlike times and at therapeutic doses in all age groups throughout the class of treatment. Signs and symptoms more often than not improve subsequently reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Farther clinical evaluation (e.thou., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that bear upon the serotonergic neurotransmitter systems such every bit 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'southward Wort [see DRUG INTERACTIONS)]. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and brandish small-scale 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 gamble with increased exposure to DEXEDRINE. In these situations, consider an culling non-serotonergic drug or an alternative drug that does non inhibit CYP2D6 [see DRUG INTERACTIONS].

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

Concomitant use of DEXEDRINE with MAOI drugs is contraindicated [meet CONTRAINDICATIONS].

Discontinue treatment with DEXEDRINE and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant utilise of DEXEDRINE with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate DEXEDRINE 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.

Visual Disturbance

Difficulties with adaptation and blurring of vision accept been reported with stimulant handling.

PRECAUTIONS

Full general

The least corporeality viable should be prescribed or dispensed at 1 fourth dimension in lodge to minimize the possibility of overdosage.

Information For Patients

Amphetamines may impair the power of the patient to appoint in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore exist 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 apply. 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 agreement its contents. Patients should be given the opportunity to hash out the contents of the Medication Guide and to obtain answers to any questions they may accept. The complete text of the Medication Guide is reprinted at the end of this certificate.

Apportionment Problems in Fingers and Toes [Peripheral vasculopathy, including Raynaud's phenomenon]

• Instruct patients commencement handling with DEXEDRINE most the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from stake, to blue, to red.
• Instruct patients to study to their physician whatever new numbness, pain, skin color modify, or sensitivity to temperature in fingers or toes.
• Instruct patients to telephone call their medico immediately with whatsoever signs of unexplained wounds appearing on fingers or toes while taking DEXEDRINE.
• Farther clinical evaluation (e.g., rheumatology referral) may exist appropriate for certain patients.

Carcinogenesis/Mutagenesis

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of DEXEDRINE have non been performed.

Pregnancy

Teratogenic Furnishings

Pregnancy Category C. DEXEDRINE has been shown to take 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 man dose. While in that location are no acceptable and well-controlled studies in significant women, at that place 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 adventure to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal equally demonstrated by dysphoria, including agitation, and significant lassitude.

Nursing Mothers

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

Pediatric Utilise

Long-term furnishings of amphetamines in pediatric patients have non been well established.

DEXEDRINE is not recommended for use in pediatric patients younger than 6 years of age with Attention Deficit Disorder with Hyperactivity described nether INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.

Amphetamines take 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 utilise of stimulant medications.

Information are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should exist monitored during handling.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should exist considered only in low-cal of the consummate history and evaluation of the kid. The conclusion to prescribe amphetamines should depend on the physician's cess of the chronicity and severity of the child'southward symptoms and their appropriateness for his or her age. Prescription should not depend solely on the presence of one or more than of the behavioral characteristics.

When these symptoms are associated with astute stress reactions, handling with amphetamines is usually not indicated.

OVERDOSE

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous organisation stimulation. Serotonin syndrome has also been reported. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Eye for upward to date guidance and advice.

Treatment

Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, just is believed to increase run a risk of astute renal failure if myoglobinuria is present. If astute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. Even so, a gradual driblet in blood pressure will usually result when sufficient sedation has been accomplished. Chlorpromazine antagonizes the fundamental stimulant furnishings of amphetamines and can be used to treat amphetamine intoxication. Since much of the SPANSULE capsule medication is coated for gradual release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be continued for equally long as overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have non already released medication.

QUESTION

The abbreviated term ADHD denotes the status commonly known as: See Answer

CONTRAINDICATIONS

Advanced arteriosclerosis, symptomatic cardiovascular affliction, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug corruption.

Known hypersensitivity or idiosyncrasy to amphetamine.

In patients known to be hypersensitive to amphetamine, or other components of DEXEDRINE. Hypersensitivity reactions such every bit angioedema and anaphylactic reactions take been reported in patients treated with other amphetamine products [see Adverse REACTIONS]

Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [meet WARNINGS and DRUG INTERACTIONS].

CLINICAL PHARMACOLOGY

Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic claret pressures and weak bronchodilator and respiratory stimulant action. At that place is neither specific evidence that conspicuously establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive bear witness regarding how these furnishings chronicle to the status of the key nervous arrangement. DEXEDRINE SPANSULE Capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard conception, as demonstrated past blood levels. The conception has not been shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given in divided doses.

Pharmacokinetics

The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 salubrious subjects. The extent of bioavailability of the sustained-release capsule was like compared to the immediate-release tablet. Following assistants of three 5-mg tablets, average maximal dextroamphetamine plasma concentrations (Cmax) of 36.vi ng/mL were achieved at approximately 3 hours.

Following administration of one fifteen-mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T_½ was like for both the tablet and sustained-release sheathing 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 fatty) and fasted state.

SLIDESHOW

ADHD Symptoms in Children Meet Slideshow

PATIENT Data

DEXEDRINE®
(dextroamphetamine sulfate) SPANSULE® Sustained Release Capsules

Read the Medication Guide that comes with DEXEDRINE earlier you or your kid starts taking it and each fourth dimension you lot become a refill. In that location may be new data. This Medication Guide does non take the place of talking to your doc well-nigh your or your child'southward treatment with DEXEDRINE.

What is the most of import information I should know well-nigh DEXEDRINE?

The following have been reported with utilise of DEXEDRINE and other stimulant medicines.

1. Heart-related problems:

• Sudden death in patients who have centre problems or heart defects
• Stroke and middle assail in adults
• Increased blood pressure and heart charge per unit

Tell your doctor if you or your child take any heart issues, heart defects, high blood pressure, or a family history of these issues.

Your medico should cheque yous or your child carefully for center problems before starting DEXEDRINE.

Your doctor should check your or your kid'due south claret force per unit area and heart charge per unit regularly during treatment with DEXEDRINE.

Call your medico right abroad if you or your child has any signs of middle problems such equally chest hurting, shortness of breath, or fainting while taking DEXEDRINE.

ii. Mental (Psychiatric) problems:

All Patients

• new or worse behavior and thought problems
• new or worse bipolar disease
• 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 bug you or your child have, or well-nigh a family unit history of suicide, bipolar affliction, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or issues while taking DEXEDRINE, specially seeing or hearing things that are non real, believing things that are not real, or are suspicious.

three. Apportionment problems in fingers and toes [Peripheral vasculopathy, including Raynaud'south phenomenon]:

• fingers or toes may feel numb, absurd, painful
• fingers or toes may alter color from pale, to blue, to red

Tell your doc if you have or your child has numbness, pain, pare color change, or sensitivity to temperature in your fingers or toes.

Phone call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DEXEDRINE.

What is DEXEDRINE?

DEXEDRINE is a central nervous system stimulant prescription medicine. Information technology 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 handling program for ADHD that may include counseling or other therapies. DEXEDRINE is also used in the handling of a sleep disorder called narcolepsy.

DEXEDRINE is a federally controlled substance (CII) because information technology tin exist driveling or lead to dependence. Continue DEXEDRINE in a safe place to forbid misuse and abuse. Selling or giving abroad DEXEDRINE may impairment others, and is confronting the law.

Tell your doctor if you or your child have (or have a family unit history of) ever driveling or been dependent on booze, prescriptionmedicines or street drugs.

Who should not take DEXEDRINE?

DEXEDRINE should not exist taken if you or your child:

• Have heart disease or hardening of the arteries
• Have moderate to severe loftier claret pressure
• Have hyperthyroidism
• Accept 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 fourteen 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 utilise in children younger than 6 years sometime.

DEXEDRINE may not exist correct for yous or your child. Before starting DEXEDRINE tell your or your child's doctor about all health weather (or a family unit history of) including:

• Heart problems, middle defects, high blood pressure
• Mental problems including psychosis, mania, bipolar affliction, or depression
• Tics or Tourette's syndrome
• Thyroid bug
• Seizures or take had an abnormal brain wave test (EEG)
• Apportionment problems in fingers and toes

Tell your doc if you or your child is pregnant, planning to get significant, or breastfeeding.

Can DEXEDRINE be taken with other medicines?

Tell your doctor about all of the medicines that yous 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 volition need to be adapted while taking DEXEDRINE.

Your doctor will decide whether DEXEDRINE tin can be taken with other medicines.

Specially tell your doctor if you or your child takes:

• Anti-low medicines including MAOIs
• Blood force per unit area medicines
• Antacids
• Seizure medicines

Know the medicines that y'all or your child takes. Keep a list of your medicines with you to bear witness your dr. and chemist.

Practice not start any new medicine while taking DEXEDRINE without talking to your doctor first.

How should DEXEDRINE be taken?

• Take DEXEDRINE exactly equally prescribed. Your doctor may conform the dose until information technology is right for y'all or your child.
• DEXEDRINE comes equally a sheathing.
• DEXEDRINE SPANSULE capsules are usually taken once a twenty-four hour period in the morn. DEXEDRINE SPANSULE is an extended release capsule. It releases medicine into your torso throughout the mean solar day.
• From time to fourth dimension, your doctor may finish treatment with DEXEDRINE for a while to check ADHD symptoms.
• Your physician may practice regular checks of the blood, heart, and blood pressure while taking DEXEDRINE. Children should have their height and weight checked often while taking DEXEDRINE. Treatment with DEXEDRINE may be stopped if a problem is found during these cheque-ups.
• If you or your kid takes besides much DEXEDRINE or overdoses, telephone call your doc or poison control centre right away, or go emergency treatment

What are possible side effects of DEXEDRINE?

Run across "What is the most of import information I should know about DEXEDRINE?" for information on reported heart and mental issues.

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
• Tummy upset
• Weight loss
• Dry mouth

DEXEDRINE may touch on your or your kid's ability to bulldoze or do other dangerous activities.

Talk to your doctor if y'all or your child has side furnishings that are bothersome or do non go away.

This is non a complete list of possible side furnishings. Inquire your doctor or pharmacist for more than information. Call your doctor for medical advice about side effects. You may report side effects to FDA at one-800-FDA-1088.

How should I store DEXEDRINE?

• Store DEXEDRINE SPANSULE capsules in a prophylactic place at room temperature, 68° to 77°F (twenty° to 25°C). Protect from light.
• Go along DEXEDRINE and all medicines out of the reach of children.

General information almost DEXEDRINE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Exercise not apply DEXEDRINE for a status for which it was non prescribed. Do not requite DEXEDRINE to other people, even if they take the same condition. It may damage 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 enquire your medico or chemist for information about DEXEDRINE that was written for healthcare professionals. For more information virtually DEXEDRINE, please contact Amedra Pharmaceuticals at 1-888-894-6528 or visit www.amedrapharma.com.

What are the ingredients in DEXEDRINE?

Active Ingredient: Dextroamphetamine sulfate

Inactive Ingredients:

SPANSULE Capsules: Cetyl alcohol, D&C Yellow No. x, dibutyl sebacate, ethylcellulose, FD&C Bluish No. ane, FD&C Blue No. 1 aluminum lake, FD&C Red No. twoscore, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres and trace amounts of other inactive ingredients.

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

From

Report Issues to the Food and Drug Assistants

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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Source: https://www.rxlist.com/dexedrine-spansule-drug.htm

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