FDA prescribing information, side effects and uses. 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. EACH TABLET CONTAINS5 mg. Dextroamphetamine. Saccharate. 1. 2. Amphetamine Aspartate Monohydrate Equivalent. 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. Pharmacokinetics. Adderall. Following administration of a single dose 1. Indications and Usage for Adderall. Adderall ® (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed. Most drugs of abuse can alter a person’s thinking and judgment, leading to health risks, including addiction, drugged driving and infectious disease. How To Beat Post-Adderall Weight Gain July 27th, 2010 by Lilah. Aside from keeping up at work, it seems that weight gain is one of the biggest hurdles many Adderall. Methylphenidate, sold under various trade names, Ritalin being one of the most commonly known, is a central nervous system (CNS) stimulant of the phenethylamine and. Adderall. The mean elimination half- life (t. The PK parameters (Cmax, AUC0- inf) of d- and l- amphetamine increased approximately three- fold from 1. The effect of food on the bioavailability of Adderall. Norephedrine and 4- hydroxy- amphetamine are both active and each is subsequently oxidized to form 4- hydroxy- norephedrine. Alpha- hydroxy- amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2. D6 is known to be involved with formation of 4- hydroxy- amphetamine. ![]() Since CYP2. D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P4. For the former, it’s therapy. For the latter, it’s. In vitro experiments with human microsomes indicate minor inhibition of CYP2. D6 by amphetamine and minor inhibition of CYP1. A2, 2. D6, and 3. A4 by one or more metabolites. However, due to the probability of auto- inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made. With normal urine p. Hs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha- hydroxy- amphetamine and approximately another 3. Since amphetamine has a p. Ka of 9. 9, urinary recovery of amphetamine is highly dependent on p. H and urine flow rates. Alkaline urine p. Hs result in less ionization and reduced renal elimination, and acidic p. Hs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 7. H, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary p. H are known to alter the elimination of amphetamine, and any decrease in amphetamine’s metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased (see PRECAUTIONS). Indications and Usage for Adderall. Adderall. The symptoms must cause clinically significant impairment, e. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive- Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go; ” excessive talking; blurting answers; can't wait turn; 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. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM- IV. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Long- Term Use. The effectiveness of Adderall. Therefore, the physician who elects to use Adderall. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS). Hypertension and Other Cardiovascular Conditions. Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mm. Hg) and average heart rate (about 3 to 6 bpm) . 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. CONTRAINDICATIONS). Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications. 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. 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. Preexisting Psychosis. Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder. Bipolar Illness. 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. Emergence of New Psychotic or Manic Symptoms. Treatment emergent psychotic or manic symptoms, e. 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. Aggression. 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 1. 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. Peripheral Vasculopathy, Including Raynaud’s Phenomenon. Stimulants, including Adderall. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e. Serotonin Syndrome. ADHD Drug Uses, Side Effects & Interactions. Adderall vs. Concerta comparison. What are Adderall and Concerta? Amphetamines like those in Adderall stimulate the brain by increasing the level of neurotransmitters like dopamine and norepinephrine in the brain. Nerves produce neurotransmitter chemicals, which then release and attach to other nearby nerves as a means of communication among nerves. The exact way Adderall works to alleviate ADHD symptoms is unknown. Methylphenidate, the active ingredient in Concerta and Ritalin, is a medication that stimulates the central nervous system (CNS or brain) with effects similar to the amphetamines in Adderall; however, its effect is milder than those of the amphetamines. An additional difference is that methylphenidate produces more noticeable effects on mental activities of those with ADHD than on motor activities. Medically Reviewed by a Doctor on 2/7/2. Report Problems to the Food and Drug Administration. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA Med. Watch website or call 1- 8.
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