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® PRESCRIBING INFORMATION Long-Term Suppression of Growth: Careful follow-up of weight and height in children ages 7 to 10 years who Drug/Laboratory Test Interactions MEDICATION GUIDE ® • If you or your child take too much ProCentra or overdoses, Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in ® ProCentra (dextroamphetamine sulfate) Oral Solution is naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months in the evening. ProCentra (pro-SEN-tra) call your doctor or poison control center right away, or get (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per Amphetamines may interfere with urinary steroid determinations. a federally controlled substance (CII) because it can be abused week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less (dextroamphetamine sulfate) Oral Solution, 5 mg/5 mL CII ® emergency treatment. Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during or lead to dependence. Keep ProCentra in a safe place to carcinogenic potential of dextroamphetamine sulfate have not been performed. ® ® this period of development. Published data are inadequate to determine whether chronic use of amphetamines Read the Medication Guide that comes with ProCentra before you prevent misuse and abuse. Selling or giving away ProCentra® What are possible side effects of ProCentra ? may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Pregnancy: Teratogenic Effects: Pregnancy Category C. Dextroamphetamine sulfate has been shown to have WARNING Rx Only Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately or your child starts taking it and each time you get a refill. There may harm others, and is against the law. See “What is the most important information I should know AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR gaining height or weight as expected may need to have their treatment interrupted. 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the ® drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no may be new information. This Medication Guide does not take the about ProCentra ?” for information on reported heart and PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR Seizures: There is some clinical evidence that stimulants may lower the convulsive threshold in patients with ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON- adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony Tell your doctor if you or your child have (or have a family history mental problems. prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in la, and anal atresia (VATER association) in a baby born to a woman who took place of talking to your doctor about your or your child’s treatment THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR deformity, tracheoesophageal fistu patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dextroamphetamine sulfate ® of) ever abused or been dependent on alcohol, prescription DISPENSED SPARINGLY. with ProCentra . Other serious side effects include: drug should be discontinued. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR medicines or street drugs. Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Stimulants, including ProCentra®, used to treat ADVERSE EVENTS. Nonteratogenetic Effects: Infants born to mothers dependent on amphetamines have an increased risk of • Slowing of growth (height and weight) in children ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as What is the most important information I should know about ® DESCRIPTION usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. demonstrated by dysphoria, including agitation, and significant lassitude. ® Who should not take ProCentra ? • Seizures, mainly in patients with a history of seizures Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports ProCentra ? Dextroamphetamine sulfate is the dextro isomer of the compound d,l-amphetamine sulfate, a Nursing Mothers: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised ® at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and ® ProCentra should not be taken if you or your child: • Eyesight changes or blurred vision sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha- to refrain from nursing. The following have been reported with use of ProCentra and methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology Pediatric Use: Long-term effects of amphetamines in pediatric patients have not been well established. • Have heart disease or hardening of the arteries • Serotonin syndrome. A potentially life-threatening problem called Structural Formula: other stimulant medicines. referral) may be appropriate for certain patients. Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE. • Have moderate to severe high blood pressure serotonin syndrome can happen when medicines such as Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines 1. Heart-related problems: ® are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate • Have hyperthyroidism ProCentra are taken with certain other medicines. Symptoms monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine symptoms of behavior disturbance and thought disorder. • Sudden death in patients who have heart problems or of serotonin syndrome may include: reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. heart defects • Have an eye problem called glaucoma and St. John’s Wort [see Drug Interactions]. Amphetamines and amphetamine derivatives are known to be Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede • agitation, hallucinations, coma or other changes in mental status ® metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 use of stimulant medications. • Are very anxious, tense, or agitated ProCentra (dextroamphetamine sulfate) is a colorless, bubblegum flavored oral solution. Each teaspoonful metabolism [see CLINICAL PHARMACOLOGY]. The potential for a pharmacokinetic interaction exists with the • Stroke and heart attack in adults ® Data are inadequate to determine whether chronic administration of amphetamines may be associated • problems controlling your movements or muscle twitching (5 mL) of ProCentra (dextroamphetamine sulfate) Oral Solution contains 5 mg of dextroamphetamine ® • Have a history of drug abuse coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to ProCentra .In with growth inhibition; therefore, growth should be monitored during treatment. • Increased blood pressure and heart rate sulfate. Inactive ingredients consist of benzoic acid, citric acid anhydrous, purified water, sodium citrate these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 • fast heartbeat hydrous, sodium saccharin, sorbitol solution, and artificial bubble gum flavor. [see Drug Interactions]. Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered • Are taking or have taken within the past 14 days an antidepression only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should Tell your doctor if you or your child have any heart problems, heart CLINICAL PHARMACOLOGY Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, medicine called a monoamine oxidase inhibitor or MAOI. • high or low blood pressure Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their

and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, appropriateness for his or her age. Prescription should not depend solely on the presence of one or more of the defects, high blood pressure, or a family history of these problems. • sweating or fever

Rev. 02/17 Rev. actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and

hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), behavioral characteristics. • Is sensitive to, allergic to, or had a reaction to other stimulant Code 983E00 983E00 Code FPO respiratory stimulant action. seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually Your doctor should check you or your child carefully for heart medicines • nausea or vomiting

There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce Concomitant use of ProCentra® with MAOI drugs is contraindicated [see CONTRAINDICATIONS]. ® ߑ only not indicated. mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to ® problems before starting ProCentra . ® • diarrhea Discontinue treatment with ProCentra and any concomitant serotonergic agents immediately if the above ADVERSE REACTIONS ProCentra is not recommended for use in children younger

the condition of the central nervous system. ®

5 mg/5 mL mg/5 5 symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ProCentra with other To report SUSPECTED ADVERSE REACTIONS, contact Independence Pharmaceuticals, LLC at 1-855-325-1928,

Pharmacokinetics ® Your doctor should check your or your child’s blood pressure and • muscle stiffness or tightness rlSolution Oral than 3 years old. serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ProCentra with lower doses, monitor or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ®

Ingestion of 10 mg of dextroamphetamine sulfate in oral solution form by healthy volunteers produced patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the dxrapeaiesulfate) (dextroamphetamine Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports heart rate regularly during treatment with ProCentra . ® Common side effects include:

an average peak dextroamphetamine blood level of 33.2 ng/mL. The half-life was 11.75 hours. The average increased risk for serotonin syndrome. ProCentra may not be right for you or your child. Before ProCentra ® of cardiomyopathy associated with chronic amphetamine use. urinary recovery was 38% in 48 hours. Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with Call your doctor right away if you or your child has any signs of ® • Fast heart beat • Dizziness Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, starting ProCentra tell your or your child’s doctor about all In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following stimulant treatment. dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics administration of the sustained release capsule formulation in the fed (58 to 75 gm fat) and fasted state. heart problems such as chest pain, shortness of breath, or • Decreased appetite • Stomach upset PRECAUTIONS: and Tourette’s syndrome. health conditions (or a family history of) including: INDICATIONS AND USAGE ® General: The least amount feasible should be prescribed or dispensed at one time in order to minimize Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal fainting while taking ProCentra . • Tremors • Weight loss ProCentra® (dextroamphetamine sulfate) Oral Solution is indicated in: • Heart problems, heart defects, • Seizures or have had an the possibility of overdosage. disturbances. Anorexia and weight loss may occur as undesirable effects. Narcolepsy • Headache • Dry mouth Information for Patients: Amphetamines may impair the ability of the patient to engage in potentially hazardous Allergic: Urticaria. 2. Mental (Psychiatric) problems: high blood pressure abnormal brain wave test Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly. Endocrine: Impotence, changes in libido. (EEG) • Trouble sleeping includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits All Patients • Mental problems including patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A Musculoskeletal: Rhabdomyolysis. • new or worse behavior and thought problems psychosis, mania, bipolar • Circulation problems in ® may affect your or your child’s ability to drive or do developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, patient Medication Guide is available for ProCentra®. The prescriber or health professional should instruct patients, DRUG ABUSE AND DEPENDENCE ProCentra hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Dextroamphetamine sulfate is a Schedule II controlled substance. • new or worse bipolar illness illness, or depression fingers and toes other dangerous activities. finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. disability have occurred. There are reports of patients who have increased the dosage to many times that • new or worse aggressive behavior or hostility • Tics or Tourette’s syndrome Talk to your doctor if you or your child have side effects that are system dysfunction may or may not be warranted. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon] recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue • Thyroid problems CONTRAINDICATIONS • Instruct patients beginning treatment with ProCentra® about the risk of peripheral vasculopathy, including and mental depression; changes are also noted on the sleep EEG. Children and Teenagers bothersome or do not go away. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. and/or may change color from pale, to blue, to red. irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication • new psychotic symptoms (such as hearing voices, believing Tell your doctor if you or your child is pregnant, planning to become This is not a complete list of possible side effects. Ask your Agitated states. • Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines. things that are not true, are suspicious) or new manic pregnant, or breastfeeding. doctor or pharmacist for more information. Call your doctor for Patients with a history of drug abuse. to temperature in fingers or toes. OVERDOSAGE Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an symptoms ® medical advice about side effects. You may report side effects During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive • Instruct patients to call their physician immediately with any signs of unexplained wounds appearing Can ProCentra be taken with other medicines? on fingers or toes while taking ProCentra®. idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe to FDA at 1-800-FDA-1088. crisis may result). reactions, yet doses of 400 to 500 mg are not necessarily fatal. Tell your doctor about any mental problems you or your child have, Tell your doctor about all of the medicines that you or your child WARNINGS • Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. ® In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg. How should I store ProCentra ? Serious Cardiovascular Events Drug Interactions: or about a family history of suicide, bipolar illness, or depression. take including prescription and nonprescription medicines, Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems: Acidifying Agents - Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ® ® rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states. • Store ProCentra in a safe place at room temperature, 68° to 77°F Children and Adolescents: Sudden death has been reported in association with CNS stimulant treatment at fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium Call your doctor right away if you or your child have any new vitamins, and herbal supplements. ProCentra and some medicines acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby Fatigue and depression usually follow the central stimulation. (20° to 25°C). Protect from light. usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. or worsening mental symptoms or problems while taking may interact with each other and cause serious side effects. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal • Keep ProCentra® and all medicines out of the reach of children. generally should not be used in children or adolescents with known serious structural cardiac abnormalities, Adrenergic Blockers - Adrenergic blockers are inhibited by amphetamines. symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually proceeded by ProCentra®, especially seeing or hearing things that are not Sometimes the doses of other medicines will need to be adjusted cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them Alkalinizing Agents - Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of convulsions and coma. while taking ProCentra®. General information about ProCentra® at increased vulnerability to the sympathomimetic effects of a stimulant drug. amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the Treatment real, believing things that are not real, or are suspicious. Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute Your doctor will decide whether ProCentra® can be taken with Medicines are sometimes prescribed for purposes other than at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a increase blood levels and therefore potentiate the actions of amphetamines. amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, 3. Circulation problems in fingers and toes [Peripheral ® administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious Antidepressants, Tricyclic - Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; other medicines. those listed in a Medication Guide. Do not use ProCentra for a permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed vasculopathy, including Raynaud’s phenomenon]: heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained ® to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates condition for which it was not prescribed. Do not give ProCentra abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS). increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Especially tell your doctor if you or your child take: amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. • fingers or toes may feel numb, cool, painful ® to other people, even if they have the same condition. It may harm Hypertension and Other Cardiovascular Conditions: Stimulant medications cause a modest increase in average CYP2D6 Inhibitors - The concomitant use of ProCentra and CYP2D6 inhibitors may increase the exposure of However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved. • Anti-depression medicines • Antacids blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger ProCentra® compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with • fingers or toes may change color from pale, to blue, to red Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat them and it is against the law. increases. While the mean changes alone would not be expected to have short term consequences, all patients lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during amphetamine intoxication. including MAOIs • Seizure medicines should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating ProCentra® initiation and after a dosage increase. If serotonin syndrome occurs, discontinue ProCentra® and Tell your doctor if you have or your child has numbness, pain, skin DOSAGE AND ADMINISTRATION This Medication Guide summarizes the most important patients whose underlying medical conditions might be compromised by increases in blood pressure or heart the CYP2D6 inhibitor [see WARNINGS, OVERDOSAGE]. Examples of CYP2D6 Inhibitors include paroxetine • Blood pressure medicines ® rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Amphetamines should be administered at the lowest effective dosage and dosage should be individually color change, or sensitivity to temperature in your fingers or toes. information about ProCentra . If you would like more information, adjusted. Late evening doses should be avoided because of the resulting insomnia. arrhythmia (see CONTRAINDICATIONS). Serotonergic Drugs - The concomitant use of ProCentra® and serotonergic drugs increases the risk of serotonin Call your doctor right away if you have or your child has any Know the medicines that you or your child take. Keep a list of your talk with your doctor. You can ask your doctor or pharmacist for Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications: Children, adolescents, syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, Narcolepsy: Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response. ® ® or adults who are being considered for treatment with stimulant medications should have a careful history particularly during ProCentra® initiation or dosage increase. If serotonin syndrome occurs, discontinue ProCentra® Narcolepsy seldom occurs in children under 12 years of age; however, when it does, ProCentra may be used. signs of unexplained wounds appearing on fingers or toes medicines with you to show your doctor and pharmacist. information about ProCentra that was written for healthcare (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to and the concomitant serotonergic drug(s) [see WARNINGS, PRECAUTIONS]. Examples of serotonergic drugs The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg ® ® ® assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; while taking ProCentra . Do not start any new medicine while taking ProCentra without professionals. For more information about ProCentra , please disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort. daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on talking to your doctor first. contact Independence Pharmaceuticals, LLC at 1-855-325-1928. pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should MAO Inhibitors - MAOI antidepressants, as wellas a metabolite of furazolidone, slow amphetamine metabolism. awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. ® ® ® undergo a prompt cardiac evaluation. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other What is ProCentra ? How should ProCentra be taken? What are the ingredients in ProCentra ? Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of age. Psychiatric Adverse Events monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. ProCentra® is a central nervous system stimulant prescription ® Pre-Existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results. In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments • Take ProCentra exactly as prescribed. Your doctor may adjust Active Ingredient: dextroamphetamine sulfate and thought disorder in patients with pre-existing psychotic disorder. Antihistamines - Amphetamines may counteract the sedative effect of antihistamines. of 2.5 mg at weekly intervals until optimal response is obtained. medicine. It is used for the treatment of Attention-Deficit the dose until it is right for you or your child. Inactive Ingredients: benzoic acid, citric acid anhydrous, purified Bipolar Illness: Particular care should be taken in using stimulants to treat ADHD in patients with comorbid Antihypertensives - Amphetamines may antagonize the hypotensive effects of antihypertensives. In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be Hyperactivity Disorder (ADHD). ® bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to Chlorpromazine - Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central • ProCentra is usually taken two or three times a day. The first dose water, sodium citrate hydrous, sodium saccharin, sorbitol solution, necessary to exceed a total of 40 mg per day. initiating treatment with stimulant, patients with comorbid depressive symptoms should be adequately screened stimulant effects of amphetamines, and can be used to treat amphetamine poisoning. ® to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. ProCentra may help increase attention and decrease impulsiveness is usually taken in the morning. One or two more doses may be and artificial bubble gum flavor. Ethosuximide - Amphetamines may delay intestinal absorption of ethosuximide. ® including a family history of suicide, bipolar disorder, and depression. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of Haloperidol - Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant and hyperactivity in patients with ADHD. ProCentra should be taken during the day, 4 to 6 hours apart. This Medication Guide has been approved by the U.S. Food and Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms, behavioral symptoms sufficient to require continued therapy. effects of amphetamines. e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of HOW SUPPLIED used as a part of a total treatment program for ADHD that may include • From time to time, your doctor may stop treatment with Drug Administration. psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration Lithium Carbonate - The stimulatory effects of amphetamines may be inhibited by lithium carbonate. ProCentra® (dextroamphetamine sulfate) Oral Solution, 5 mg/5 mL is a colorless, bubblegum flavored counseling or other therapies. ProCentra® is also used in the treatment ® should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. Meperidine - Amphetamines potentiate the analgesic effect of meperidine. oral solution, available in containers of 16 fluid ounces, NDC 21724-701-05. ProCentra for a while to check ADHD symptoms. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about Methenamine Therapy - Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Dispense in a tight, light of a sleep disorder called narcolepsy. • Your doctor may do regular checks of the blood, heart, and Distrubuted by: 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at agents used in methenamine therapy. resistant container. usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients. ® Independence Pharmaceuticals, LLC Norepinephrine - Amphetamines enhance the adrenergic effect of norepinephrine. Distrubuted By: blood pressure while taking ProCentra . Children should Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and Phenobarbital - Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital Newport, KY 41071 USA has been reported in clinical trials and the postmarketing experience of some medications indicated for the have their height and weight checked often while taking may produce a synergistic anticonvulsant action. treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or ProCentra®. Treatment with ProCentra® may be stopped if a www.independencepharma.com hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening Phenytoin - Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action. of, aggressive behavior or hostility. Independence Pharmaceuticals, LLC problem is found during these check-ups. Propoxyphene - In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and Revised February 2017 Newport, KY 41071 USA fatal convulsions can occur. www.independencepharma.com Veratrum Alkaloids - Amphetamines inhibit the hypotensive effect of veratrum alkaloids. Code 983E00 Rev. 02/17