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    / Medison


    Active Ingredient
    Lisdexamfetamine (Dismesylate) 30, 50, 70 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    30 X 30 mg

    not in the basket chart 32833 22405

    Capsules

    30 X 50 mg

    not in the basket chart 32834 22406

    Capsules

    30 X 70 mg

    not in the basket chart 32835 22407

    Capsules

    100 X 30 mg

    not in the basket chart 29369 22400

    Capsules

    100 X 50 mg

    not in the basket chart 29405 22401

    Capsules

    100 X 70 mg

    not in the basket chart 29407 22402

    Related information


    Dosage

    General Instructions for Use: Take Lisdexamfetamine by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Lisdexamfetamine may be administered in one of the following ways: Swallow Lisdexamfetamine capsules whole, or open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed. Do not take anything less than one capsule per day, and a single capsule should not be divided.
    Dosing Information: The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above. Dosage may be adjusted in increments of 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day. Patients may be maintained on their optimal doseIn patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2) the maximum dose should not exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m2), the maximum recommended dose is 30 mg/day.
    Important Information Prior to Dosing: Prior to treating children, adolescents, and adults with CNS stimulants, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)To reduce the abuse of CNS stimulants including Lisdexamfetamine, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Lisdexamfetamine use.


    Indications

    Lisdexamfetamine is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years and above.


    Contra-Indications

    – Known hypersensitivity to amphetamine products or other ingredients of Lisdexamfetamine. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in post marketing reports.
    – 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.


    Special Precautions

    Potential for Abuse and Dependence: CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
    Serious Cardiovascular Reactions: Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Lisdexamfetamine treatment.
    Blood Pressure and Heart Rate Increases: CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension.
    Psychiatric Adverse Reactions: Exacerbation of Pre-existing Psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
    Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode.
    Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode.
    New Psychotic or Manic Symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g. hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania.
    See prescribing information for full details.


    Side Effects

    Anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
    See prescribing information for full details.


    Drug interactions

    Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Lisdexamfetamine dosage accordinglyConcomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Concomitant use of MAOIs -Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate and well-controlled studies with this drug in pregnant women.
    Lactation: Amphetamines are excreted into human milk. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown.
    See prescribing information for full details.


    Overdose

    Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
    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 system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
    Lisdexamfetamine and d-amphetamine are not dialyzable. 


    Important notes

    Storage: Do not store above 25ºC.


    Manufacturer
    Shire Pharmaceuticals Ltd., UK
    Licence holder
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