to drive and/or operate heavy machinery Alkaline urine will significantly increase half-life Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications High abuse potential; use caution Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections Consistently methylphenidate medicated children (ie, treatment for 7 days per week throughout the year) have a temporary slowing in growth rate; published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, it is anticipated that they likely have this effect; monitor growth during treatment with stimulants; patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted Serotonin syndrome Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems Symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) Discontinue treatment if above symptoms occur, and initiate supportive symptomatic treatment; if concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome Peripheral vasculopathy Stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon; 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, observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment Signs and symptoms generally improve after reduction in dose or discontinuation of drug; careful observation for digital changes is necessary during treatment with ADHD stimulants; further clinical evaluation (eg, rheumatology referral) may be appropriate for certain patients Cardiovascular events 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 Sudden death has been reported in association with CNS stimulant treatment at usual doses in patients with structural cardiac abnormalities or other serious heart problems Not for use in children, adolescents or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases 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, eg, those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia 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 (eg, 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 effects Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder Particular care should be taken in using stimulants to treat ADHD 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, eg, hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses; if such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate 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 appearance of or worsening of aggressive behavior or hostility Drug interaction overview Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort Amphetamines are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with coadministration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines; in these situations, consider alternative non-serotonergic drug or alternative drug that does not inhibit CYP2D6 If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome Pregnancy Category: C Lactation: do not nursePregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Amphetamine anorexigenic agent; sympathomimetic amine related to ephedrine and amphetamine with CNS stimulant activity; causes release of dopamine and other catechoamines from their storage in the presynaptic nerve terminals; inhibits monoamine transporters and oxidase, causing reuptake and metabolism of catecholamines Pharmacokinetics Half-Life: 4-5 hr Absorption: Rapid Metabolism: Liver Excretion: Urine, varies with pH BRAND FORM. UNIT PRICE PILL IMAGE methamphetamine oral- 5 mg tabletmethamphetamine oral- 5 mg tabletDesoxyn oral- 5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationmethamphetamine oral METHAMPHETAMINE - ORAL (meth-am-FET-a-meen HYE-droe-KLOR-ide) COMMON BRAND NAME(S): Desoxyn WARNING: Misuse or abuse of amphetamines may result in serious (possibly fatal) heart and blood pressure problems. Amphetamine-type medications can be habit-forming. Use only as directed. If you use this drug for a long time, you may become dependent on it and may have withdrawal symptoms after stopping the drug. Consult your doctor or pharmacist for more details. USES: This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Methamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.This medication should not be used to treat tiredness or to hold off sleep in people who do not have a sleep disorder. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using methamphetamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. During treatment, your doctor may occasionally recommend stopping the medication for a short time to see if there are any changes in your behavior and whether the medication is still needed.Do not take this medication late in the day because it may cause you to have trouble sleeping.If you suddenly stop using this medication, you may have withdrawal symptoms (such as severe tiredness, sleep problems, mental/mood changes such as depression). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used methamphetamine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if you do not get better or if you get worse. SIDE EFFECTS: Dry mouth, nausea, upset stomach, diarrhea, constipation, dizziness, weight loss, trouble sleeping, or headache may occur. If any of these effects last or get worse, notify your doctor promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, thoughts of suicide, hallucinations, abnormal thoughts/behavior), uncontrolled muscle movements (such as twitching, shaking), outbursts of words/sounds, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss, change in sexual ability/interest, frequent/prolonged erections (in males), vision changes (such as blurred vision).Get medical help right away if you have any very serious side effects, including: fainting, severe headache, fast/pounding irregular heartbeat, seizures, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking methamphetamine, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic amines (such as dextroamphetamine); or if you have any other allergies. This