- 1 How long does it take 20 mg of Vyvanse to wear off?
- 2 What cancels out the effects of Vyvanse?
- 3 Does Vyvanse increase dopamine?
- 4 Does coffee make Vyvanse less effective?
- 5 Does vitamin C neutralize Vyvanse?
- 6 What happens if you take 100 mg of Vyvanse?
- 7 Can I go from 30 to 60 mg of Vyvanse?
- 8 What time is too late to take Vyvanse?
- 9 What happens if you accidentally take 2 Vyvanse 20 mg?
How long does it take 20 mg of Vyvanse to wear off?
Vyvanse Half-Life & Effect Duration – According to the book Workplace Drug Testing, the length of time that a drug remains in an individual’s system is often estimated or measured by the drug’s half-life (the time it takes normal metabolic processes to reduce the concentration of the drug by half ).
- Lisdexamfetamine, the active ingredient in Vyvanse, is naturally metabolized into the stimulant dextroamphetamine.
- Lisdexamfetamine would only be detectable for a very short period of time (only a few hours in most cases).
- Instead, dextroamphetamine, which has a half-life of about 12 hours, would be detectable for longer.
Dextroamphetamine is an amphetamine-like substance that would show up on most drug tests. For general purposes, it can be estimated that it takes about 5.5 half-lives of a particular drug for it to be eliminated from the body. However, numerous factors can affect the metabolism of any drug, including the person’s weight and gender, whether or not the drug was taken in conjunction with other drugs, and how much of the drug was taken.
Again, numerous factors could influence the detectability of the drug in the system. For instance, if an individual were to take several doses of Vyvanse several hours apart, the detectability window should be estimated from the person’s last use of the drug and not when they started taking the drug.
The duration of effects of Vyvanse range between 10-14 hours.
How long do the effects of 30mg Vyvanse last?
Vyvanse is taken once daily and is a long-acting medication, which means it is released in the body gradually. So the effects are similar 2 hours and 14 hours after it’s taken. Unlike other stimulants, like Adderall and Ritalin, Vyvanse needs to be broken down by your body into its active component, dextroamphetamine.
How long does the peak of Vyvanse last?
How does Vyvanse work? What’s its half-life and how long does it stay in your system? – Vyvanse is a type of stimulant drug called an amphetamine, How Vyvanse works to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED) isn’t known for sure.
- The level of Vyvanse in your body typically peaks about 3.5 hours after you take a Vyvanse capsule.
- It peaks about 4.4 hours after you take a chewable tablet.
- When Vyvanse levels peak can differ depending on whether you take the drug with food.
- For instance, it can take longer for Vyvanse levels in your body to peak if you take Vyvanse with food rather than without it.
The effects of Vyvanse usually last for about 14 hours after you take a dose. The half-life of Vyvanse describes how long it takes for half a dose of the drug to leave your body. Vyvanse’s half-life is about 12 hours. So, it takes about 12 hours for your body to get rid of half of a dose of Vyvanse.
What cancels out the effects of Vyvanse?
Acidic juices, like citrus juices (examples: orange juice, grapefruit juice) may decrease the absorption of this medication and are best avoided during the 1 hour before a dose, at the time of dosing, and for 1 hour after taking a dose.
Is 20 mg of Vyvanse high?
Dosage for attention deficit hyperactivity disorder (ADHD) – The starting dose of Vyvanse for ADHD is 30 mg once daily. Then your doctor may increase your dose by 10 mg to 20 mg weekly. They’ll do this until you reach the dosage that manages your ADHD symptoms. The dosage range for ADHD is between 30 mg to 70 mg once daily. The maximum dose for Vyvanse in 24 hours is 70 mg.
How long does 35 mg Vyvanse last?
Bottom Line –
In adults with ADHD, Vyvanse was shown in clinical studies to improve attention at 2 hours and up to 14 hours after taking a dose. In children with ADHD, aged 6-12, Vyvanse was shown to start working within 1.5 hours after taking the medication and up to 13 hours after the morning dose. Vyvanse is a maintenance (long-term) medication taken once a day in the morning, but your doctor may hold your treatment for a period of time to check your symptoms. Common side effects with Vyvanse often include decreased appetite, trouble sleeping, decreased weight and dry mouth. Let your doctor know if you have high blood pressure.
This is not all the information you need to know about Vyvanse for safe and effective use. Review the full product information here, and discuss with your health care provider. References
Vyvanse (lisdexamfetamine dimesylate), Revised Jan.2017. Shire US. Lexington, MA. Accessed June 3, 2020 at http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf Goodman DW. Lisdexamfetamine dimesylate (vyvanse), a prodrug stimulant for attention-deficit/hyperactivity disorder. P T.2010;35(5):273‐287. PMCID: PMC2873712
Is 30mg of Elvanse a lot?
My Account Area – 1. Name of the medicinal product Elvanse Adult 30 mg capsules, hard.2. Qualitative and quantitative composition 30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine. For the full list of excipients, see section 6.1.3. Pharmaceutical form Capsule, hard. Elvanse Adult 30 mg capsule: white opaque body and pink opaque cap, printed ‘S489′ and ’30 mg’ in black ink. Each capsule measures approximately 16 mm long and 6 mm wide.4. Clinical particulars 4.1 Therapeutic indications Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults. Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient’s symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD. Treatment must be under the supervision of a specialist in behavioural disorders. Diagnosis should be based on a complete history and evaluation of the patient according to current DSM criteria or ICD guidelines. Diagnosis cannot be made solely on the presence of one or more symptom. In adults, the presence of symptoms of ADHD that were pre-existing in childhood is required and should be confirmed retrospectively (according to the patient’s medical record or, if not available, through appropriate and structured instruments or interviews). Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in two or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life. The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources. A comprehensive treatment programme typically includes psychological, educational, behavioural, occupational and social measures as well as pharmacotherapy and is aimed at stabilising the adult patient with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, impulsivity and hyperactivity.4.2 Posology and method of administration Treatment must be initiated under the supervision of an appropriate specialist in behavioural disorders. Pre-treatment evaluation Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient’s cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate recording of pre-treatment weight (see section 4.4). Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse Adult should be considered prior to prescribing (see section 4.4). Ongoing monitoring Psychiatric, and cardiovascular status should be continually monitored (see also section 4.4). • Blood pressure and pulse should be recorded at each adjustment of dose and at least every six months. • Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every six months and at every visit. Patients should be monitored for the risk of diversion, misuse, and abuse of Elvanse Adult. Posology Dosage should be individualised according to the therapeutic needs and response of the patient. Careful dose titration is necessary at the start of treatment with Elvanse Adult, The starting dose is 30 mg taken once daily in the morning. The dose may be increased by 20 mg increments, at approximately weekly intervals. Elvanse Adult should be administered orally at the lowest effective dosage. The maximum recommended dose is 70 mg/day; higher doses have not been studied. In patients with severe renal insufficiency (GFR 15 to 2 or CrCl <30 mL/min) the maximum dose should not exceed 50 mg/day. Further dosage reduction should be considered in patients undergoing dialysis (see section 5.2). Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a 1-month period. If paradoxical aggravation of symptoms or other intolerable adverse events occur, the dosage should be reduced or discontinued. Method of administration Elvanse Adult may be taken with or without food. Elvanse Adult may be swallowed whole, or the capsule opened and the entire contents emptied and mixed with a soft food such as yogurt or in a glass of water or orange juice. If the contents include any compacted powder, a spoon may be used to break apart the powder in the soft food or liquid. The contents should be stirred until completely dispersed. The patient should consume the entire mixture of soft food or liquid 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. The patient should not take anything less than one capsule per day and a single capsule should not be divided. In the event of a missed dose, Elvanse Adult dosing can resume the next day. Afternoon doses should be avoided because of the potential for insomnia. Long-term use Pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use Elvanse Adult for extended periods (over 12 months) should re-evaluate the usefulness of Elvanse Adult at least yearly, and consider trial periods off medication to assess the patient's functioning without pharmacotherapy. Older people Dexamfetamine clearance is reduced in the elderly, therefore dose adjustment may be required (see section 5.2). Patients with renal impairment Due to reduced clearance in patients with severe renal insufficiency (GFR 15 to 2 or CrCl < 30 mL/min) the maximum dose should not exceed 50 mg/day. Further dosage reduction should be considered in patients undergoing dialysis. Lisdexamfetamine and dexamfetamine are not dialysable. Patients with hepatic impairment No studies have been conducted in patients with hepatic impairment. Paediatric population Elvanse Adult is indicated for adults. For children and adolescents aged 6 to 17 years, another product containing lisdexamfetamine dimesylate is available. Currently available data are described in sections 4.8, 5.1 and 5.2. Elvanse Adult should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.4.3 Contraindications Hypersensitivity to sympathomimetic amines or any of the excipients listed in section 6.1. Concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis may result; see section 4.5). Hyperthyroidism or thyrotoxicosis. Agitated states. Symptomatic cardiovascular disease. Advanced arteriosclerosis. Moderate to severe hypertension. Glaucoma.4.4 Special warnings and precautions for use Abuse and dependence Stimulants including lisdexamfetamine dimesylate have a potential for abuse, misuse, or diversion that physicians should consider when prescribing this product. The risk of misuse may be greater in adults (especially young adults) than in paediatric use. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence. Abuse of amfetamines can lead to tolerance, and psychological dependence with varying degrees of abnormal behaviour. Symptoms of amfetamine abuse may include dermatoses, insomnia, irritability, hyperactivity, emotional lability and psychosis. Withdrawal symptoms such as fatigue and depression have been reported. Cardiovascular adverse events Sudden death and pre-existing structural cardiac abnormalities or other serious heart problems Children and adolescents: Sudden death has been reported in children and adolescents taking CNS stimulants, including those with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents 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. 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 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. Hypertension and other cardiovascular conditions 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. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for 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.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia. Lisdexamfetamine has shown to prolong the QT c interval in some patients. It should be used with caution in patients with prolongation of the QT c interval, in patients treated with drugs affecting the QT c interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances. The use of lisdexamfetamine dimesylate is contraindicated in patients with symptomatic cardiovascular disease and also in those patients with moderate to severe hypertension (see section 4.3). Cardiomyopathy Cardiomyopathy has been reported with chronic amfetamine use. It has also been reported with lisdexamfetamine dimesylate, Assessing cardiovascular status in patients being treated with stimulant medications All patients 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.g., electrocardiogram or 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 adverse events Pre-existing psychosis Administration of stimulants may exacerbate symptoms of behaviour disturbance and thought disorder in patients with pre-existing psychotic disorders. 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.g., hallucinations, delusional thinking, or mania in children and adolescents without 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. Aggression Aggressive behaviour 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 including lisdexamfetamine dimesylate. Stimulants may cause aggressive behaviour or hostility. Patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behaviour or hostility. Tics Stimulants have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome should precede use of stimulant medications. Long-term effect on weight Stimulants have been associated with weight loss. Weight should be monitored during treatment with stimulants, and patients who are losing weight 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. Visual disturbance Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Prescribing and dispensing The least amount of lisdexamfetamine dimesylate feasible should be prescribed or dispensed in order to minimise the risk of possible overdose by the patient. Use with other sympathomimetic drugs Lisdexamfetamine dimesylate should be used with caution in patients who use other sympathomimetic drugs (see section 4.5). Excipients This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.4.5 Interaction with other medicinal products and other forms of interaction In vitro enzyme inhibition Lisdexamfetamine dimesylate was not an in vitro inhibitor of the major human CYP450 isoforms (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) in human hepatic microsomal suspensions, nor was it an in vitro inducer of CYP1A2, CYP2B6 or CYP3A4/5 in cultured fresh human hepatocytes. Lisdexamfetamine dimesylate was not an in vitro substrate for P-gp in MDCKII cells nor an in vitro inhibitor of P-gp in Caco-2 cells and is therefore unlikely to be involved in clinical interactions with drugs transported by the P-gp pump. An in vivo human study of lisdexamfetamine dimesylate did not result in any clinically meaningful effect on the pharmacokinetics of drugs metabolized by CYP1A2, CYP2D6, CYP2C19, or CYP3A. Agents whose blood levels may be impacted by lisdexamfetamine dimesylate Extended release guanfacine: In a drug interaction study, administration of an extended release guanfacine in combination with lisdexamfetamine dimesylate induced a 19% increase in guanfacine maximum plasma concentrations (C max ) whereas, exposure (area under the curve; AUC) was increased by 7%. These small changes are not expected to be clinically meaningful. In this study, no effect on dexamfetamine exposure was observed following co-administration of extended release guanfacine and lisdexamfetamine dimesylate. Extended release venlafaxine: In a drug interaction study, administration of 225 mg extended release venlafaxine, a CYP2D6 substrate, in combination with 70 mg lisdexamfetamine dimesylate induced a 9% decrease in the C max and 17% decrease in the AUC for the primary active metabolite o-desmethylvenlafaxine and a 10% increase in C max and 13% increase in AUC for venlafaxine. Dexamfetamine may be a weak inhibitor of CYP2D6. Lisdexamfetamine has no effect on the AUC and C max of the composite of venlafaxine and o-desmethylvenlafaxine. These small changes are not expected to be clinically meaningful. In this study, no effect on dexamfetamine exposure was observed following co-administration of extended release venlafaxine and lisdexamfetamine dimesylate, Agents and conditions that alter urinary pH and impact the urinary excretion and half-life of amfetamine Ascorbic acid and other agents and conditions (thiazide diuretics, diets high in animal protein, diabetes, respiratory acidosis) that acidify urine increase urinary excretion and decrease the half-life of amfetamine. Sodium bicarbonate and other agents and conditions (diets high in fruits and vegetables, urinary tract infections and vomiting) that alkalinise urine decrease urinary excretion and extend the half-life of amfetamine. Monoamine oxidase inhibitors Amfetamine should not be administered during or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) because it can increase the release of norepinephrine and other monoamines. This can cause severe headaches and other signs of hypertensive crisis. A variety of toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal outcomes (see section 4.3). Serotonergic drugs Serotonin syndrome has rarely occurred in association with the use of amfetamines such as lisdexamfetamine dimesylate, when given in conjunction with serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). It has also been reported in association with overdose of amfetamines, including lisdexamfetamine dimesylate (see section 4.9). Agents whose effects may be reduced by amfetamines Antihypertensives: Amfetamines may decrease the effectiveness of guanethidine or other antihypertensive medications. Agents whose effects may be potentiated by amfetamines Amfetamines potentiate the analgesic effect of narcotic analgesics. Agents that may reduce the effects of amfetamines Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amfetamines. Haloperidol: Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amfetamines. Lithium carbonate: The anorectic and stimulatory effects of amfetamines may be inhibited by lithium carbonate. Use with alcohol There are limited data on the possible interaction with alcohol. Drug/laboratory test interactions Amfetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amfetamine may interfere with urinary steroid determinations.4.6 Fertility, pregnancy, and lactation Pregnancy Dexamfetamine, the active metabolite of lisdexamfetamine, crosses the placenta. Data from a cohort study of in total approximately 5570 pregnancies exposed to amfetamine in the first trimester do not suggest an increased risk of congenital malformation. Data from another cohort study in approximately 3100 pregnancies exposed to amfetamine during the first 20 weeks of pregnancy, suggest an increased risk of preeclampsia, and preterm birth. Newborns exposed to amfetamine during pregnancy may experience withdrawal symptoms. In animal reproduction studies, lisdexamfetamine dimesylate had no effect on embryofoetal development or survival when administered orally to pregnant rats and rabbits (see section 5.3). Administration of lisdexamfetamine dimesylate to juvenile rats was associated with reductions in growth measurements at clinically relevant exposures. The physician should discuss lisdexamfetamine dimesylatetreatment in the context of potential pregnancy or lactation with female patients of child-bearing potential. lisdexamfetamine dimesylate should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus. Breast-feeding Amfetamines are excreted in human milk. lisdexamfetamine dimesylate should not be used during breast-feeding. Fertility The effects of lisdexamfetamine dimesylate on fertility and early embryonic development have not been investigated in animal reproductive studies. Amfetamine has shown no harmful effects on fertility in a rat study (see section 5.3). The effect of lisdexamfetamine dimesylate on human fertility has not been investigated.4.7 Effects on ability to drive and use machines Lisdexamfetamine dimesylate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, and blurred vision. These could have a moderate influence on the ability to drive and use machines. Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.4.8 Undesirable effects Summary of the safety profile Adverse reactions observed with lisdexamfetamine dimesylate treatment mainly reflect side effects commonly associated with stimulant use. Very common adverse reactions seen in adults include decreased appetite, insomnia, dry mouth and headache. Tabulated summary of adverse reactions The following table presents all adverse reactions based on clinical trials and spontaneous reporting. The following definitions apply to the frequency terminology used hereafter: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Frequency not known (cannot be estimated from the available data). An asterisk (*) indicates that additional information on the respective adverse reaction is provided below the table.
|System/Organ Class||Adverse Reaction||Children (6 to 12 years)||Adolescents (13 to 17 years)||Adults|
|Immune System Disorders||Anaphylactic reaction||Frequency not known||Frequency not known||Frequency not known|
|Metabolism and Nutrition Disorders||Decreased appetite||Very common||Very common||Very common|
|Psychiatric Disorders||*Insomnia||Very common||Very common||Very common|
|Libido decreased||Not applicable||Not reported||Common|
|Euphoria||Frequency not known||Uncommon||Uncommon|
|Psychotic episodes||Frequency not known||Frequency not known||Frequency not known|
|Hallucination||Uncommon||Uncommon||Frequency not known|
|Aggression||Common||Uncommon||Frequency not known|
|Nervous System Disorders||Headache||Very common||Very common||Very common|
|Seizure||Frequency not known||Frequency not known||Frequency not known|
|Eye Disorders||Vision blurred||Uncommon||Frequency not known||Uncommon|
|Mydriasis||Uncommon||Uncommon||Frequency not known|
|QTc prolongation||Frequency not known||Frequency not known||Frequency not known|
|Cardiomyopathy||Frequency not known||Uncommon||Frequency not known|
|Vascular disorders||Raynaud’s phenomenon||Uncommon||Frequency not known||Frequency not known|
|Respiratory, Thoracic and Mediastinal Disorders||Dyspnoea||Uncommon||Common||Common|
|Gastrointestinal Disorders||Dry mouth||Common||Common||Very common|
|Upper abdominal pain||Very common||Common||Common|
|Hepatobiliary Disorders||*Eosinophilic Hepatitis||Frequency not known||Frequency not known||Frequency not known|
|Skin and Subcutaneous Tissue Disorders||Hyperhidrosis||Uncommon||Uncommon||Common|
|*Angioedema||Frequency not known||Frequency not known||Frequency not known|
|*Stevens-Johnson Syndrome||Frequency not known||Frequency not known||Frequency not known|
|Reproductive System and Breast Disorders||Erectile dysfunction||Not applicable||Uncommon||Common|
|General Disorders and Administration Site Conditions||Chest Pain||Uncommon||Uncommon||Common|
|Investigations||Blood pressure increased||Uncommon||Uncommon||Common|
|*Weight decreased||Very Common||Very Common||Common|
Description of selected adverse reactions Insomnia Includes insomnia, initial insomnia, middle insomnia, and terminal insomnia. Weight decreased in Paediatric population In a 4-week controlled trial of lisdexamfetamine dimesylate in children aged 6 to 12 years, mean weight loss from baseline to endpoint was 0.4, 0.9, and 1.1 kg, for patients assigned to receive 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate respectively, compared to a 0.5 kg weight gain for patients receiving placebo.
Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful follow-up for weight in children aged 6 to 12 years who received lisdexamfetamine dimesylate over 12 months suggests that continuous treatment (i.e., treatment for 7 days per week throughout the year) slows growth rate measured by body weight as demonstrated by an age- and sex-normalised mean change from baseline in percentile of -13.4 over 1 year.
The average percentiles at baseline (n=271) and 12 months (n=146) were 60.9 and 47.2, respectively. In a 4-week controlled trial of lisdexamfetamine dimesylate in adolescents aged 13 to 17 years, mean weight loss from baseline to endpoint was 1.2, 1.9, and 2.3 kg for patients assigned to receive 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate respectively, compared to a 0.9 kg weight gain for patients receiving placebo.
Careful follow-up for weight in adolescents aged 13 to 17 years who received lisdexamfetamine dimesylate over 12 months suggests that continuous treatment (i.e., treatment for 7 days per week throughout the year) slows growth rate measured by body weight as demonstrated by an age- and sex-normalised mean change from baseline in percentile of -6.5 over 1 year.
The average percentiles at baseline (n=265) and 12 months (n=156) were 66.0 and 61.5, respectively. In children and adolescents (aged 6-17) who received lisdexamfetamine dimesylate over two years, careful monitoring of weight suggested that consistent medication (i.e., treatment for 7 days per week throughout the two years) resulted in a slowing of growth as measured by body weight.
- In children and adolescents, the average weight percentiles and standard deviations (SD) at baseline (n=314) and 24 months (week 104, n=189), were 65.4 (SD 27.11) and 48.2 (SD 29.94), respectively.
- The age- and sex-normalized mean change from baseline in percentile over 2 years was -16.9 (SD 17.33).
- In a controlled clinical trial of lisdexamfetamine dimesylate in children ages 4 to 5 years who received 5 – 30 mg of lisdexamfetamine dimesylate, there were no clinically meaningful changes in weight from baseline after 6 weeks of follow-up.
Careful follow-up for weight in children aged 4 to 5 years who received lisdexamfetamine dimesylate over 12 months in an open-label extension study suggests that continuous treatment (i.e., treatment for 7 days per week throughout the year) slows growth rate measured by body weight as demonstrated by an age- and sex-normalised mean change from baseline in percentile of -17.92 (SD=13.767) over 1 year.
- The average percentiles at baseline (n=113) and 12 months (n=69) were 66.51 (SD=25.173) and 47.45 (SD=26.144), respectively.
- Eosinophilic hepatitis No cases were reported in the clinical studies.
- Angioedema No cases were reported in the clinical studies.
- Stevens-Johnson syndrome No cases were reported in the clinical studies.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose The prolonged release of dexamfetamine after administration of lisdexamfetamine dimesylate should be considered when treating patients with overdose.
Manifestations of acute overdosage with amfetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggression, hallucinations, panic states, hyperpyrexia, and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma. There is no specific antidote to amfetamine overdose. Management of acute amfetamine intoxication is largely symptomatic and may include administration of activated charcoal, administration of a cathartic, and sedation.
Lisdexamfetamine and dexamfetamine are not dialysable. In case of amfetamine overdose, consult a poison control center for guidance or treat as clinically indicated. The prolonged duration of action of amfetamine should be considered when treating patients with overdose.5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Centrally Acting Sympathomimetics, ATC code: N06 BA12.
Mechanism of action Lisdexamfetamine dimesylate is a pharmacologically inactive prodrug. After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and hydrolysed primarily by red blood cells to dexamfetamine, which is responsible for the drug’s activity.
Amfetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action of amfetamine in ADHD is not fully established, however it is thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
The prodrug, lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and dopamine in vitro, Clinical efficacy and safety The efficacy of lisdexamfetamine dimesylate in the treatment of ADHD has been demonstrated in four controlled trials in adults, three controlled studies in adolescents aged 13-17 years, three controlled trials in children and adolescents (6 to 17 years) and three controlled studies in children aged 6 to 12 years.
- The patients in all these studies met DSM-IV-TR criteria for ADHD.
- In clinical studies conducted in children and adults, when lisdexamfetamine dimesylate was taken once daily in the morning efficacy was ongoing at 14 hours after dosing in adults and 13 hours in children.
- Adult population The efficacy of lisdexamfetamine dimesylate in the treatment of adults who met DSM-IV-TR criteria for ADHD has been demonstrated in four controlled trials in which 846 patients were enrolled.
Study 1 was a double-blind, randomised, placebo-controlled, parallel-group study conducted in adults (n=420). In this 4-week study, patients were randomised to fixed dose treatment groups receiving final doses of 30, 50, or 70 mg of lisdexamfetamine dimesylate or placebo.
All subjects receiving lisdexamfetamine dimesylate were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 and 70 mg dose groups were titrated by 20 mg per week until they achieved their assigned dose. Significant improvements in ADHD symptoms, based upon investigator ratings on the ADHD Rating Scale with adult prompts total score (ADHD-RS), were observed at endpoint for all lisdexamfetamine dimesylate doses compared to placebo (see Table 1).
Treatment with lisdexamfetamine dimesylate significantly reduced the degree of functional impairment as measured by improvement on the Clinical Global Impression-Improvement (CGI-I) rating scale compared to placebo.
|Table 1: Change from Baseline to Endpoint in ADHD-RS with Adult Prompts Total Score at Endpoint 1 (Full Analysis Set)|
|Placebo||30 mg||50 mg||70 mg|
|Baseline Total Score||N Mean (SD)||62 39.4 (6.42)||115 40.5 (6.21)||117 40.8 (7.30)||120 41.0 (6.02)|
|Change from baseline at Endpoint||N LS Mean (SE)||62 -8.2 (1.43)||115 -16.2 (1.06)||117 -17.4 (1.05)||120 -18.6 (1.03)|
|Placebo-adjusted difference||LS Mean (95% CI) p-value||NA||-8.04 (-12.14, -3.95) <0.0001||-9.16 (-13.25, -5.08) <0.0001||-10.41 (-14.49, -6.33) <0.0001|
|1 Endpoint is the last post-randomisation treatment week for which a valid ADHD-RS-IV Total Score is obtained. Note: Dunnett’s test was used for the construction of CIs and p-values; p-values are the adjusted p-values and should be compared to a critical alpha of 0.05. LS=least squares; SD= standard deviation; SE=standard error.|
Study 2 was a 10-week, double-blind, placebo-controlled study conducted to evaluate change in executive function behaviours, key quality of life outcomes, and ADHD symptoms in adults with ADHD and a clinically significant impairment in executive function. The study enrolled adults aged 18 to 55 years (n=161) who met DSM-IV criteria for ADHD as assessed by a total score of ≥ 65 on the Behaviour Rating Inventory of Executive Function – Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score by subject-report and a score of ≥ 28 using the Adult ADHD-RS with prompts at the Baseline visit. At Week 10 the mean subject-reported BRIEF-A GEC T-score was 68.3 for the placebo group and 57.2 for the SPD489 group, representing LS mean changes from baseline of -11.1 and -22.3, respectively. The effect size was 0.74 in favour of the SPD489 group. The difference in LS mean change from baseline to week 10 (-11.2) was significantly better in the lisdexamfetamine dimesylate group compared with placebo (p<0.0001). Secondary efficacy measures of Adult ADHD Impact Module (AIM-A), ADHD-RS with adult prompts, CGI-I and the ADHD Index T-score of the Conners' Adult ADHD Rating Scale – Observer: Short Version (CAARS-O:S) were all significantly better in the lisdexamfetamine dimesylate group compared with placebo. Study 3 was a multi-centre, randomised, double-blind, placebo-controlled, crossover study. This study of lisdexamfetamine dimesylate was designed to simulate a workplace environment and enrolled 142 adults. Following a 4-week open-label, dose optimisation phase with lisdexamfetamine dimesylate (30, 50, or 70 mg/day in the morning), subjects were randomised to one of two treatment sequences: 1) lisdexamfetamine dimesylate (optimised dose) followed by placebo, each for one week, or 2) placebo followed by lisdexamfetamine dimesylate each for one week. Efficacy assessments occurred at the end of each week, using the Permanent Product Measure of Performance (PERMP). The PERMP is a skill-adjusted maths test that measures attention in ADHD. lisdexamfetamine dimesylate treatment, compared to placebo, resulted in a statistically significant improvement in attention across all post-dose time points, as measured by average PERMP total scores over the course of one assessment day, as well as at each time point measured. The PERMP assessments were administered at pre-dose (-0.5 hours) and at 2, 4, 8, 10, 12, and 14 hours post-dose. Study 4 examined maintenance of efficacy. This study was a double-blind, placebo-controlled, randomised withdrawal design study was conducted in adults aged 18 to 55 (n=123) who met DSM-IV criteria for ADHD. At study entry, subjects must have had documentation of treatment with lisdexamfetamine dimesylate for a minimum of 6 months and had to demonstrate treatment response as defined by CGI-S ≤ 3 and Total Score on the ADHD-RS with adult prompts < 22. ADHD-RS with adult prompts Total Score is a measure of core symptoms of ADHD. Subjects that maintained treatment response at week 3 of open label treatment phase (n=116) were eligible to enter the double-blind randomised withdrawal phase, and received their entry dose of lisdexamfetamine dimesylate (n=56) or placebo (n=60). Maintenance of efficacy for subjects treated with lisdexamfetamine dimesylate was demonstrated by the significantly lower proportion of treatment failure (< 9%) compared to subjects receiving placebo (75%) in the double-blind randomized withdrawal phase. Treatment failure was defined as a ≥ 50% increase (worsening) in the ADHD-RS with adult prompts Total Score and ≥ 2-point increase in the CGI-S score compared to scores at entry into the double-blind randomized withdrawal phase. Paediatric population The effects of lisdexamfetamine dimesylate in the treatment of paediatric patients with ADHD have been demonstrated in three controlled trials in children aged 6 to 12 years, three controlled studies in adolescents aged 13 to 17 years, and three controlled studies in children and adolescents aged 6 to 17 years. In study SPD489-325, 336 patients aged 6 to17 years were evaluated in a 7-week randomised double-blind, dose-optimised, placebo controlled with an active reference arm study. The primary efficacy assessment was the ADHD-RS-IV Total Score. lisdexamfetamine dimesylate showed significantly greater efficacy than placebo. The difference at Endpoint in least square means reduction from baseline in the ADHD-RS-IV Total Score was 18.6 (p<0.001). At every on-treatment visit and at Endpoint the percentages of subjects who met pre-defined response criteria (a ≥ 30% reduction from Baseline in ADHD-RS-IV Total Score and a CGI-I value of 1 or 2) was significantly higher for lisdexamfetamine dimesylate when compared to placebo (p<0.001). In addition, mean scores for ADHD symptoms following treatment discontinuation did not exceed baseline scores prior to treatment, indicating there was no rebound effect. In addition to a reduction in symptoms, lisdexamfetamine dimesylate significantly improved functional outcomes. In this study, 75.0% of subjects receiving lisdexamfetamine dimesylate showed "improvement" (defined as "very much improved" or "much improved") on the CGI-I rating scale compared to 14.2% on placebo (p<0.001). Similar results for ADHD-RS Total Score and CGI-I have been shown in two placebo controlled studies, one in children (n=297) and the other in adolescents (n=314), both conducted in the United States. A double-blind, randomised, active-controlled, dose-optimisation study was conducted in children and adolescents aged 6 to 17 years (n=267) who met DSM-IV criteria for ADHD and also had an inadequate response to methylphenidate treatment. In this 9-week study, patients treated with lisdexamfetamine dimesylatehad a shorter time to first response compared to patients treated with atomoxetine (median 13.0 vs 21.0 days, respectively; p=0.003), where response was defined as having a CGI-I score of 1 (very much improved) or 2 (much improved) at any of the double-blind treatment visits. Two double-blind, parallel-group, active-controlled (OROS-MPH) studies have been conducted in adolescents aged 13-17 years with ADHD. Both studies also included a placebo reference arm. The 8-week dose-optimization study (SPD489-405) had a 5-week dose-optimization period and a 3-week dose-maintenance period. During the dose-optimization period, subjects were titrated once weekly based on treatment emergent adverse events TEAEs and clinical response to an optimal dose of 30, 50, or 70 mg/day (for SPD489 subjects) or 18, 36, 54, or 72 mg/day (for OROS-MPH subjects), which was maintained throughout a 3-week dose-maintenance period. The mean doses at endpoint were 57.9 mg and 55.8 mg for SPD489 and OROS-MPH, respectively. In this study, neither SPD489 nor OROS-MPH was found to be statistically superior to the other product at Week 8. The 6-week fixed-dose study (SPD489-406) had a 4-week forced-dose titration period and a 2-week dose-maintenance period. At the highest doses of SPD489 (70 mg) and OROS-MPH (72 mg), SPD489 treatment was found to be superior to OROS-MPH as measured by both the primary efficacy analysis (change from baseline at Week 6 on the ADHD-RS Total score) and the key secondary efficacy analysis (at last study visit on the CGI-I) (see Table 2). Table 2: Change from Baseline on ADHD-RS-IV Total Score and Endpoint on CGI-I (Full Analysis Set)
|SPD489-405||Primary at Week 8 ADHD-RS-IV||Placebo||SPD489||OROS-MPH|
|Baseline Total Score||N Mean (SE)||89 38.2 (0.73)||179 36.6 (0.48)||184 37.8 (0.45)|
|Change from baseline at Week 8||N LS Mean (SE)||67 -13.4 (1.19)||139 -25.6 (0.82)||152 -23.5 (0.80)|
|Lisdexamfetamine vs OROS-MPH difference||LS Mean (SE) (95% CI) Effect size p-value||NA||-2.1 (1.15) -4.3, 0.2 0.2 0.0717||NA|
|Active vs Placebo difference||LS Mean (SE) (95% CI) Effect size p-value||NA||-12.2 (1.45) -15.1, -9.4 1.16 <0.0001||-10.1 (1.43) -13.0, -7.3 0.97 <0.0001|
|Key Secondary Endpoint CGI-I|
|Subjects analysed (n)||89||178||184|
|Improved (%) Not improved (%)||31 (34.8) 58 (65.2)||148 (83.1) 30 (16.9)||149 (81.0) 35 (19.0)|
|Lisdexamfetamine vs OROS-MPH Active treatment vs Placebo||NA NA||0.6165 <0.0001||NA <0.0001|
|SPD489-406||Primary at Week 6 ADHD-RS-IV||Placebo||SPD489||OROS-MPH|
|Baseline Total Score||N Mean (SE)||106 36.1 (0.58)||210 37.3 (0.44)||216 37.0 (0.44)|
|Change from baseline at Week 6||N LS Mean (SE)||93 -17.0 (1.03)||175 -25.4 (0.74)||181 -22.1 (0.73)|
|Lisdexamfetamine vs OROS-MPH difference||LS Mean (SE) (95% CI) Effect size p-value||NA||-3.4 (1.04) -5.4, -1.3 0.33 0.0013||NA|
|Active vs Placebo difference||LS Mean (SE) (95% CI) Effect size p-value||NA||-8.5 (1.27) -11.0, -6.0 0.82 <0.0001||-5.1 (1.27) -7.6, -2.6 0.50 <0.0001|
|Key Secondary Endpoint CGI-I|
|Subjects analysed (n)||106||210||216|
|Improved (%) Not improved (%)||53 (50.0) 53 (50.0)||171 (81.4) 39 (18.6)||154 (71.3) 62 (28.7)|
|Lisdexamfetamine vs OROS-MPH Active treatment vs Placebo||NA NA||0.0188 <0.0001||NA 0.0002|
From a mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, interaction of the treatment group with the visit as factors, baseline ADHD-RS-IV total score as a covariate, and an adjustment for the interaction of the baseline ADHD-RS-IV total score with the visit. The model is based on a REML method of estimation and utilizes an unstructured covariance type. The effect size is the difference in LS mean divided by the estimated standard deviation from the unstructured covariance matrix. The ‘Improved’ category includes responses of ‘Very much improved’ and ‘Much improved’. The ‘Not improved’ category includes responses of ‘Minimally improved’, ‘No change’, ‘Minimally worse’, ‘Much worse’ and ‘Very much worse’. From a CMH test stratified by baseline CGI-S. Note: N = number of subjects in each treatment group, n = number of subjects analysed. A 2-year open label safety study conducted in children and adolescents (ages 6-17) with ADHD enrolled 314 patients. Of these, 191 patients completed the study. Maintenance of effect was demonstrated in a double-blind, placebo-controlled, randomised withdrawal study conducted in children and adolescents ages 6 to 17 (n=157) who met the diagnosis of ADHD (DSM-IV criteria). Patients were optimised to open-label lisdexamfetamine dimesylate for an extended period (at least 26 weeks) prior to entry into the 6-week randomised withdrawal period. Eligible patients were randomised to continue receiving their optimised dose of lisdexamfetamine dimesylate or to switch to placebo. Patients were observed for relapse (treatment failure) during the 6-week double-blind phase. Treatment failure was defined as a ≥ 50% increase (worsening) in the ADHD-RS Total Score and a ≥ 2-point increase in the CGI-S score compared to scores at entry into the double-blind randomised withdrawal phase. Treatment failure was significantly lower for the lisdexamfetamine dimesylate subjects (15.8%) compared to placebo (67.5%) (p<0.001). For the majority of subjects (70.3%) who were treatment failures regardless of treatment, ADHD symptoms worsened at or before the week 2 visit following randomisation. A fixed-dose safety and efficacy study was conducted in preschool children aged 4 to 5 years with ADHD. Subjects were randomized in a 5:5:5:5:6 ratio to lisdexamfetamine dimesylate (5, 10, 20, 30 mg dose strength) or placebo (see also section 5.2). The duration of the double-blind evaluation period was 6 weeks. In this study, the most commonly reported TEAEs for subjects receiving lisdexamfetamine dimesylate were decreased appetite (13.7% of subjects), irritability (9.6% of subjects), and affect lability and cough (4.8% subjects each). In a 52-week open-label study, the most commonly reported TEAEs were decreased appetite (15.9%) (see section 4.8). Abuse liability studies In a human abuse liability study, when equivalent oral doses of 100 mg lisdexamfetamine dimesylate and 40 mg immediate-release dexamfetamine sulphate were administered to individuals with a history of drug abuse, lisdexamfetamine dimesylate 100 mg produced subjective responses on a scale of "Drug Liking Effects" (primary endpoint) that were significantly less than dexamfetamine immediate-release 40 mg. However, oral administration of 150 mg lisdexamfetamine dimesylate produced increases in positive subjective responses on this scale that were comparable to the positive subjective responses produced by 40 mg of oral immediate-release dexamfetamine and 200 mg of diethylpropion. Intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of drug abuse produced positive subjective responses on scales measuring "Drug Liking", "Euphoria", "Amfetamine Effects", and "Benzedrine Effects" that were greater than placebo but less than those produced by an equivalent dose (20 mg) of intravenous dexamfetamine.5.2 Pharmacokinetic properties Absorption After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract of healthy adults and children (6 to 12 years) with ADHD, thought to be mediated by the high capacity PEPT1 transporter. Food does not affect the observed AUC and C max of dexamfetamine in healthy adults after single-dose oral administration of lisdexamfetamine dimesylate 70 mg capsules but prolongs T max by approximately 1 hour (from 3.8 hours at fasted state to 4.7 hours after a high fat meal). After an 8-hour fast, the AUCs for dexamfetamine following oral administration of lisdexamfetamine dimesylate in solution and as intact capsules were equivalent. Distribution In 18 children (6 to 12 years) with ADHD, the T max of dexamfetamine was approximately 3.5 hours following single-dose oral administration of lisdexamfetamine dimesylate either 30 mg, 50 mg, or 70 mg administered after an 8-hour overnight fast. The T max of lisdexamfetamine dimesylate was approximately 1 hour. Linear pharmacokinetics of dexamfetamine after single-dose oral administration of lisdexamfetamine dimesylate was established over the dose range of 30 mg to 70 mg in children aged 6 to 12 years. Weight/dose normalised AUC and C max were 22% and 12% lower, respectively, in adult females than in males on day 7 following a 70 mg/day dose of lisdexamfetamine for 7 days. Weight/dose normalised AUC and C max values were the same in girls and boys following single doses of 30-70 mg. There is no accumulation of dexamfetamine at steady state in healthy adults and no accumulation of lisdexamfetamine dimesylate after once-daily dosing for 7 consecutive days. Biotransformation Lisdexamfetamine dimesylate is converted to dexamfetamine and l-lysine, which occurs by metabolism in blood primarily due to the hydrolytic activity of red blood cells. Red blood cells have a high capacity for metabolism of lisdexamfetamine as in vitro data demonstrated substantial hydrolysis occurs even at low hematocrit levels. Lisdexamfetamine is not metabolised by cytochrome P450 enzymes. Amfetamine is oxidised at the 4 position of the benzene ring to form 4-hydroxyamfetamine, or on the side chain α or β carbons to form alpha-hydroxy-amfetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amfetamine are both active and each is subsequently oxidised to form 4-hydroxy-norephedrine. Alpha-hydroxy-amfetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amfetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amfetamine. Elimination Following the oral administration of a 70 mg dose of radiolabelled lisdexamfetamine dimesylate to 6 healthy subjects, approximately 96% of the oral dose radioactivity was recovered in the urine and only 0.3% recovered in the faeces over a period of 120 hours. Of the radioactivity recovered in the urine 42% of the dose was related to amfetamine, 25% to hippuric acid, and 2% intact lisdexamfetamine. Plasma concentrations of unconverted lisdexamfetamine are low and transient, generally becoming non-quantifiable by 8 hours after administration. The plasma elimination half-life of lisdexamfetamine typically averaged less than one hour in studies of lisdexamfetamine dimesylate in volunteers. The half-life of dexamfetamine is 11 hours. Special populations The pharmacokinetics of dexamfetamine, as evaluated by clearance, is similar in children (aged 6 to 12) and adolescents (aged 13 to 17) ADHD patients, and healthy adult volunteers after correcting for body weight. Systemic exposure to dexamfetamine is similar for men and women given the same mg/kg dose. Formal pharmacokinetic studies for race have not been conducted. There is no evidence of any impact of ethnicity on the pharmacokinetics of Elvanse Adult, In a pharmacokinetic study of 40 subjects ( 8 subjects in each of five renal functional groups: normal, mild impairment, moderate impairment, severe impairment, and end stage renal disease) dexamfetamine clearance was reduced from 0.7 L/hr/kg in normal subjects to 0.4 L/hr/kg in subjects with severe renal impairment (GFR 15 to < 30 mL/min1.73m 2 or CrCl < 30 mL/min). Mean steady state exposure of dexamfetamine was approximately 44% higher in paediatric patients ages 4 to 5 years compared to the paediatric population patients ages 6 to 11 years receiving the same dose (30 mg/day), based on a population pharmacokinetic analysis. In a study of 47 subjects aged 55 years of age or older dexamfetamine clearance was approximately 0.7 L/hr/kg for subjects 55 to 74 years of age and 0.55 L/hr/kg for subjects ≥ 75 years of age. This is slightly reduced compared to younger adults (approximately 1 L/hr/kg for subjects 18 to 45 years of age).5.3 Preclinical safety data Non-clinical abuse liability studies indicate that lisdexamfetamine dimesylate can produce subjective effects in rats and monkeys that are similar to those of the CNS stimulant dexamfetamine, but that are delayed in onset and transient while the rewarding effects as determined in self-administration studies are lower than those of methylphenidate or cocaine. In repeat dose toxicity studies, the major findings were changes in behaviour, such as increased activity typical of stimulant administration, with associated reductions in body weight gain, growth measurements and food intake, considered to be a consequence of an exaggerated pharmacological response. Lisdexamfetamine dimesylate was not genotoxic when tested in vitro in the Ames test and the mouse lymphoma assay or in vivo in the mouse bone marrow micronucleus test. Carcinogenicity studies of lisdexamfetamine dimesylate have not been performed. No evidence of carcinogenicity was found in studies in which d-, l- amfetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. Lisdexamfetamine dimesylate had no effect on embryofoetal development or survival when administered orally to pregnant rats at doses up to 40 mg/kg/day, and rabbits at doses up to 120 mg/kg/day. Acute administration of high doses of amfetamine (d- or d,l-) has been shown to produce long lasting neurotoxic effects in rodents, including irreversible nerve fibre damage. However, in definitive juvenile toxicity studies with lisdexamfetamine dimesylate in rats and dogs, adverse central nervous system changes were not apparent. The significance of these findings to humans is unknown. Amfetamine ( d- to l- enantiomer ratio of 3:1) did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day. A number of studies in rodents indicate that prenatal or early postnatal exposure to amfetamine ( d - or d,l- ) at doses similar to those used clinically can result in long-term neurochemical and behavioural alterations. Reported behavioural effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. Similar studies have not been conducted for lisdexamfetamine dimesylate, However, an assessment of fertility following cessation of treatment with lisdexamfetamine dimesylate was included in a juvenile rat toxicity study, with no adverse effects on fertility observed.6. Pharmaceutical particulars 6.1 List of excipients Capsule content: Microcrystalline cellulose. Croscarmellose sodium. Magnesium stearate. Capsule shells Gelatin.30 mg: titanium dioxide (E171) and erythrosine (E127). Printing ink : Shellac Potassium hydroxide Black iron oxide (E172) Propylene glycol 6.2 Incompatibilities Not applicable.6.3 Shelf life 3 years 6.4 Special precautions for storage Do not store above 25 °C.6.5 Nature and contents of container High density polyethylene bottle and a polypropylene child resistant cap with a foil inner seal. Pack sizes: 28 or 30. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.7. Marketing authorisation holder Takeda UK Limited 1 Kingdom Street London W2 6BD UNITED KINGDOM 8. Marketing authorisation number(s) 30 mg: PL 16189/0134 9. Date of first authorisation/renewal of the authorisation Date of first authorisation: 03 February 2015 Date of latest renewal: 20 January 2020 10. Date of revision of the text 01-11-2022
Is Vyvanse 30 mg strong?
Children’s dosage – Vyvanse is approved to treat ADHD in children ages 6 years and older. For this purpose, the starting dose of Vyvanse is 30 mg. You’ll take this once per day. Your doctor will likely increase your dose over time to find the best dose for you.
Does Vyvanse increase dopamine?
Vyvanse and Adderall are used by many people to treat attention deficit hyperactivity disorder (ADHD). Both are stimulants called amphetamines, They work by raising levels of chemicals in your brain called dopamine and norepinephrine that help you focus, control your impulses, and pay attention at school or work.
About 80% of people notice that their symptoms are better when they take stimulants. Vyvanse and Adderall aren’t exactly the same, though. They do different things in your body and can cause different side effects. You’ll work with your doctor to find an ADHD treatment that’s best for you. It might take some time to find the right medicine and dose.
If the first one your doctor prescribes doesn’t work, you can try a different one. Adderall is the brand name for a mix of two stimulants called amphetamine – dextroamphetamine, It comes in a capsule full of beads that hold these medicines. A dose of the original form lasts about 4 hours in your body.
- The longer-acting form, called Adderall XR, can last 8 to 12 hours.
- This is because half the beads are fast-acting, and the others are slow-acting.
- Vyvanse is the brand name for lisdexamfetamine dimesylate.
- It comes in both capsules and chewable tablets.
- It also has the stimulant amphetamine, but adds a compound called lysine.
Your body has to absorb the lysine to get to the stimulant, so your dose may last up to 14 hours. Any stimulant can cause side effects like:
Headaches Dizziness Dry mouth Higher blood pressure Stomach upset or pain
Anyone who has a heart problem shouldn’t take stimulants. And if you have psychosis, bipolar disorder, aggression, or seizures, these medications can make your symptoms worse. They also can cause blurred vision, Vyvanse may be more likely to affect your sleep because it sticks around a little longer in your body. Other possible side effects of both Adderall and Vyvanse include:
Anxiety or the jitters Insomnia Stomach pain Loss of appetite Weight loss Irritability Vomiting Mood swings Skin rash RestlessnessTremors Tics Diarrhea Constipation Weight lossCrankiness Hives Skin rash
More rarely, you might have a faster heart rate, heart palpitations, or tremors. With Adderall, men may have changes in their sex drives, impotence, frequent erections, or erections that last longer than normal. Some people who take it might have hair loss or rhabdomyolysis, when muscle breaks down and gets weaker.
- These can vary widely, based on the form and dosage.
- And pharmacies can have different prices for the drugs, too.
- Check with your insurance plan to see what’s covered.
- In general, generics can cost much less than brand names.
- Vyvanse is only available as a name-brand prescription drug right now.
- Adderall, which is older, is available as the generic drug amphetamine-dextroamphetamine.
That can cut down on cost. While it’s possible to abuse or start to depend on any stimulant, that may be less likely with Adderall XR and Vyvanse because they’re designed to release their active chemicals slowly. That’s especially true for Vyvanse because your body has to process the lysine before it gets to the stimulant part of the drug.
What happens if I take Vyvanse and I don’t have ADHD?
Many studies in the lab don’t show that people without ADHD get any boost to their cognition when they take ADHD drugs, but real-life situations like exams and writing papers haven’t fully been tested. But many studies do show that these kinds of meds make you think you did better than you actually did.
Can you drink caffeine while on Vyvanse?
Does Vyvanse interact with food? – Vyvanse can interact with caffeine, This is because both caffeine and Vyvanse are central nervous system (CNS) stimulants, Caffeine and Vyvanse can cause similar side effects, and the combination can worsen these side effects.
- Note that certain medications, such as migraine treatments, contain caffeine.
- An example is Excedrin Migraine, which contains acetaminophen, aspirin, and caffeine.
- Depending on the amount of caffeine you consume, your doctor may recommend reducing how much caffeine you take during Vyvanse treatment.
- They may also recommend you avoid caffeine completely if you continue to have side effects while taking Vyvanse.
These side effects may include nervousness, trouble sleeping, or tremor. Though many drugs can interact with grapefruit, Vyvanse does not. If you have questions about eating certain foods during your treatment with Vyvanse, talk with your doctor.
Does coffee make Vyvanse less effective?
Should I avoid caffeine on Vyvanse? – It is a good idea to limit or avoid caffeine while on Vyvanse. Caffeine, which is found in colas, coffees, and teas, can cause increased irritability, insomnia, rapid heartbeat, and other side effects. In some people, consuming caffeine while using Vyvanse can worsen these side effects.
Does vitamin C neutralize Vyvanse?
Best practices for taking Vyvanse – Caffeine isn’t the only substance to be mindful about when you’re taking Vyvanse. Here are a few other substances to be mindful of if you’re on this particular medication: Vitamin C: “If patients are taking vitamin C supplements, they should separate the time they take the vitamin by at least one hour before and one hour after taking Vyvanse,” Dr.
Gray says. Vitamin C, or ascorbic acid, may decrease the blood levels and effectiveness of Vyvanse. Acidic foods: Watch out for acidic foods like tomatoes, citrus fruits, grapes, and plums. Wait an hour before or after consuming those foods for taking your Vyvanse, says Dr. Gray. Like vitamin C, acidic foods can affect how your body absorbs the medication and may decrease the effectiveness of Vyvanse.
Alkalinizing agents: Certain drugs and substances act as alkalinizing agents, which cause the opposite effect of acidic agents when combined with Vyvanse. Urinary alkalinizing agents, such as acetazolamide and methazolamide, can increase blood levels and potential side effects of Vyvanse.
- Antacids, such as sodium bicarbonate, are also alkalinizing agents.
- Vyvanse may have interactions with some medications that are used for depression,” cautions Dr. Gray.
- You shouldn’t take Vyvanse if you’re also taking an antidepressant in the category of monoamine oxidase inhibitors (MAOIs), and you may want to be careful about selective serotonin reuptake inhibitors (SSRIs).
Taking Vyvanse with drugs that increase serotonin levels may increase the risk of serotonin syndrome. Ultimately, your best bet is to take any medication, including Vyvanse, exactly as prescribed–and to ask your provider if you’re uncertain about anything.
Does Vyvanse speed up metabolism?
Side Effects & Weight Loss Risks from Prolonged Adderall or Vyvanse Use – Using Adderall or Vyvanse for weight loss isn’t an approved use. It’s considered a possible side effect, although Vyvanse can be used to treat symptoms of binge eating disorder.
Amphetamines like Adderall can lead to weight loss, Vyvanse acts similarly to an amphetamine. These drugs release certain brain chemicals that can increase energy and suppress appetite. In some cases, they can also increase metabolism levels. Both tend to have similar weight loss results, but with Adderall people may experience rebound hunger after the effects of the drug wear off.
Regardless of whether you consider Adderall or Vyvanse for weight loss, they’re not healthy or sustainable options. When the effects of either medicine wear off, so does the appetite suppression. Your body also quickly adjusts to the medicine’s effects, so you may no longer experience appetite suppression after a short period of taking them.
- This makes the weight loss effects both short-lived and unsustainable for most people.
- With either medication, your body usually adjusts to the effects, making them ineffective and impractical for a weight loss goal.
- What’s more, when you’re withdrawing from amphetamines, the result is an increased appetite.
If you use either of these drugs as a way to lose weight and you stop, you will have more problems controlling your appetite than you did before.
Does Vyvanse affect serotonin?
Page 2 – See also How to Use section. may change how your work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and,
Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug include: /appetite suppressants (such as ), drugs for (such as, ),,,,,, deutetrabenazine,,,, certain (such as tryptophan, tyramine),, certain “triptans” used to treat (such as,, ), valbenazine.
The risk of /toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort,, certain medications (such as,,, tapentadol), certain (including,, SSRIs such as /paroxetine, SNRIs such as /, tricyclics such as /), among others.
The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Some products can interact with if you take them together, or even if you take them weeks before or after taking rasagiline. Tell your doctor or pharmacist if you take anything in the list of products that may interact with this drug, or any of the products that increase serotonin, within 2 weeks before or after taking rasagiline.
Also tell them if you have taken fluoxetine within 5 weeks before starting rasagiline. Ask your doctor how much time to wait between starting or stopping any of these drugs and starting rasagiline. Taking other MAO inhibitors with this may cause a serious (possibly fatal),
- Do not take any other MAO inhibitors (,,, methylene blue, moclobemide,,, safinamide, selegiline, ) during treatment with this medication.
- Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication.
- Ask your doctor when to start or stop taking this medication.
Before using rasagiline, report the use of drugs that may increase the risk of extremely (hypertensive crisis) when combined with rasagiline, including herbal products (such as ephedra/ma Huang), and -and-cold products (including dextromethorphan, such as /), and stimulants (such as,,, ).
Is it OK to take 100mg of Vyvanse?
While Vyvanse offers dosing options from 10 mg to 70 mg, the recommended starting dose is 30 mg. Your doctor may periodically increase or decrease your dosage to help control ADHD symptoms and manage side effects. The maximum daily dose of Vyvanse is 70 mg.
Can you take 80 mg of Vyvanse in a day?
Summary Diagnosis: Mental health/Attention deficit hyperactivity disorder (ADHD) Treatment: Pharmacy prescription drugs. The insurer denied Vyvanse 40 mg 2 tablets (60 tablets a month). The denial is overturned in whole. This case involves a patient diagnosed with attention deficit hyperactivity disorder (ADHD) with a co-morbid diagnosis of bulimia (binge eating).
- The patient has demonstrated a response to Vyvanse 80 milligrams (mg) daily with noted benefit from this medication.
- Yes, the requested health service/treatment of Vyvanse 40 mg (lisdexamfetamine) with quantities of 60 pills at 40 mg is medically necessary for this patient.
- The requested benefit of Vyvanse at a daily dose of 80 mg with two 40 mg caps per day is medically necessary for this patient and clinically appropriate with regard to the indications for use.
Vyvanse is being prescribed by a mental health practitioner. Additionally, psychological testing affirmed the diagnosis of ADHD. The Vyvanse is prescribed for a patient who benefits with regard to improved symptoms and functioning, and who has been effectively treated at the current dose of 80 mg daily for over 4 years.
The dose of medication is individualized and was titrated as clinically appropriate. Treatment with a lower dose would be detrimental to the patient with a reasonable degree of medical certainty. The requested Vyvanse is backed by scientific evidence that means the results of controlled clinical trials or other studies are published in peer-reviewed, medical literature; the requested medication for the diagnosis of attention deficit hyperactivity disorder is generally recognized by the relevant medical specialty community; and is consistent with prevailing medical standards and clinical guidelines including national consensus statements, nationally recognized clinical guidelines, and national specialty society guidelines, as referenced below.
Vyvanse at a daily dosage of 80 mg daily for the treatment of attention deficit hyperactivity disorder (ADHD) is reasonable, in the patient’s best interest, and consistent with prevailing standards of medical practice, as well as the Food and Drug Administration (FDA) indicated use for the treatment of ADHD at a dose that has been prescribed for over 4 years with coverage from other health plans.
Specifically, in this case, the patient has demonstrated a clinical response to the requested treatment with Vyvanse 80 mg daily (two 40 mg pills); thus, it is in the patient’s best interest to remain on this medication that provides clear therapeutic benefit, especially with respect to daily functioning.
The requested benefit with Vyvanse 80 mg daily is provided for the purpose of treating ADHD, as clinically appropriate and indicated; and is entirely consistent with nationally recognized scientific evidence as available, and prevailing medical standards and clinical guidelines, referenced below.
- References 1) Frampton JE.
- Lisdexamfetamine: A Review of ADHD in Adults.
- CNS Drugs.2016 Apr;30(4):343-54.2) Zimovetz EA, Joseph A, Ayyagari R, Mauskopf JA.
- A cost-effectiveness analysis of lisdexamfetamine dimesylate in the treatment of adults with attention-deficit/hyperactivity disorder in the UK.
- Eur J Health Econ.2018 Jan;19(1):21-35.3) Burcu M, Zito JM, Metcalfe L, Underwood H, Safer DJ.
Trends in Stimulant Medication Use in Commercially Insured Youths and Adults, 2010-2014. JAMA Psychiatry.2016 Sep 1;73(9):992-3.4) Stark JG, Engelking D, McMahen R, Sikes C. A randomized crossover study to assess the pharmacokinetics of a novel amphetamine extended release orally disintegrating tablet in healthy adults.
- Postgrad Med.2016 Sep;128(7):648-55.5) Walker DJ, Mason O, Clemow DB, Day KA.
- Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder.
- Postgrad Med.2015;127(7):686-701.6) Kocher J, Adams P.
- Immediate-release methylphenidate for the treatment of ADHD in adults.
- Am Fam Physician.2015 Apr 1;91(7):445-6.7) Ermer JC, Pennick M, Frick G.
Lisdexamfetamine Dimesylate: Prodrug Delivery, Amphetamine Exposure and Duration of Efficacy. Clin Drug Investig.2016 May;36(5):341-56.8) Newcorn JH, Nagy P, Childress AC, Frick G, Yan B, Pliszka S. Randomized, Double-Blind, Placebo-Controlled Acute Comparator Trials of Lisdexamfetamine and Extended-Release Methylphenidate in Adolescents with Attention-Deficit/Hyperactivity Disorder.
CNS Drugs.2017 Nov;31(11):999-1014.9) Cortese S, Adamo N, Mohr-Jensen C, Hayes AJ, Bhatti S, Carucci S, Del Giovane C, Atkinson LZ, Banaschewski T, Simonoff E, Zuddas A, Barbui C, Purgato M, Steinhausen HC, Shokraneh F, Xia J, Cipriani A, Coghill D; European ADHD Guidelines Group (EAGG). Comparative efficacy and tolerability of pharmacological interventions for attention-deficit/hyperactivity disorder in children, adolescents, and adults: protocol for a systematic review and network meta-analysis.
BMJ Open.2017 Jan 10;7(1): e013967.10) De Crescenzo F, Cortese S, Adamo N, Janiri L. Pharmacological and non-pharmacological treatment of adults with ADHD: a meta-review. Evid Based Ment Health.2017 Feb;20(1):4-11.11) Hansen MV, Darling L, Holst H. Safety and Tolerability of Lisdexamfetamine: A Retrospective Cohort Study.
- CNS Drugs.2015 May;29(5):415-23.12) Adler LA, Lynch LR, Shaw DM, Wallace SP, O’Donnell KE, Ciranni MA, Briggie AM, Faraone SV.
- Effectiveness and Duration of Effect of Open-Label Lisdexamfetamine Dimesylate in Adults With ADHD.
- J Atten Disord.2017 Jan;21(2):149-157.
- Doi: 10.1177/1087054713485421.
- Epub 2016 Jul 28.
PubMed PMID: 23657761.13) Rostain A, Jensen PS, Connor DF, Miesle LM, Faraone SV. Toward quality care in ADHD: defining the goals of treatment. J Atten Disord.2015 Feb;19(2):99-117.
What happens if you take 100 mg of Vyvanse?
Vyvanse Overdose Symptoms – Overdosing on Vyvanse can be harmful and potentially even life-threatening.1 Complications from an overdose on Vyvanse may include high body temperature, muscle breakdown that results in the release of a protein into the blood that damages the kidneys (rhabdomyolysis), liver damage, cognitive difficulties, and death.8
Does Vyvanse make you talk a lot?
Social Effects – The effects of Vyvanse Use Disorder can be off-putting in social settings. Hyperactivity, distractibility, and excessive talkativeness, for example, are difficult for others to accommodate.
Can I go from 30 to 60 mg of Vyvanse?
Dosage for Treatment of Moderate to Severe BED in Adults – The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily. The maximum recommended dosage is 70 mg once daily, Discontinue VYVANSE if binge eating does not improve.
What time is too late to take Vyvanse?
If you forget to take a dose of lisdexamfetamine, take the missed dose as soon as you remember. However, if it is more than 4 hours after your scheduled dose, skip the missed dose and continue with your regular schedule.
What happens if you accidentally take 2 Vyvanse 20 mg?
If you take more than the recommended amount of Vyvanse – Call your doctor right away if you believe you’ve taken too much Vyvanse. Another option is to call America’s Poison Centers at 800-222-1222 or use its online tool, If you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.
The dosages in this article are typical dosages provided by the drug manufacturer. If your doctor recommends Vyvanse for you, they will prescribe the dosage that’s right for you. Always follow the dosage that your doctor prescribes for you. As with any drug, never change your dosage of Vyvanse without your doctor’s recommendation.
If you have questions about the dosage of Vyvanse that’s right for you, talk with your doctor. Besides learning about dosage, you may want other information about Vyvanse. These additional articles might be helpful to you:
More about Vyvanse. For information about other aspects of Vyvanse, refer to this article, Side effects. To learn about side effects of Vyvanse, see this article, You can also look at the Vyvanse prescribing information, Drug comparison. Find out how Vyvanse compares with Straterra, Adderall, and Concerta, Cost. If you’d like to learn about Vyvanse and cost, see this article, Interactions. For details about what Vyvanse interacts with, see this article, Details about your condition. For details about binge eating disorder, see our mental health hub and these articles, To learn more about attention deficit hyperactivity disorder (ADHD), you can refer to our ADHD hub as well as this list of articles,
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional.
You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
What will 20mg of Vyvanse do?
Vyvanse 20mg capsule, – Medication guide – Familiprix This medication stimulates the central nervous system. Typically, it is used for Attention Deficit Hyperactivity Disorder. It may also be used for the treatment of binge eating disorder, as well as for other uses.
Its effects can be felt within 1 hour. This pharmacologic treatment should be an integral part of a global treatment program that could include supportive psychological, educational or other measures. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you.
Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Chronic abusive use can lead to dependence. If you are unable to swallow the capsule whole, open and mix the content with yogurt or in a glass of water or orange juice and take it immediately.
If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may be taken with or without food. As with most medications, this product should be stored at room temperature. Store it in a secure location where it will not be exposed to excessive heat, moisture or direct sunlight.
Make sure that any leftover portion is disposed of safely. This drug is occasionally sought out by some people for non-medical purposes. Please store in a safe place. This medication may interact with other medications or supplements, sometimes significantly.
- Many interactions, however, may be dealt with by a dosage adjustment or a change in medication schedule.
- Check with your pharmacist before using this medication in combination with any other medications (including non-prescription products), vitamins or natural products.
- Rarely, this product causes potentially severe reactions, mostly if taken at high doses or with some other drugs.
If you experience agitation, confusion, diarrhea, fever, tremor and muscular rigidity or contractions, you should contact your doctor. When meeting with any health professional, it is important for you to share the following information:
Your medical history and allergies (medication, food, or other); If you’re pregnant or want to become pregnant, or if you’re breastfeeding; If you use tobacco or cannabis or its derivatives, or if you use recreational drugs; The names of all the medications you take, whether you take them regularly or once in a while, including over-the-counter medications, vitamins, and natural health products.
It is also strongly recommended that you keep an up-to-date list of all the medications you take and carry it with you at all times. This could be useful if you have to see a health professional or need emergency care. Keep all your medications out of the reach of children and pets and return any unused or expired medications to the pharmacy for proper disposal.
- The information contained on the familiprix.com site is for informational purposes only and does not in any way replace the advice and advice of your pharmacist or any other health professional.
- Always consult a health professional before taking or discontinuing medication or making any other decision.
Familiprix inc. and proprietary pharmacists affiliated with Familiprix do not engage in any way by making this information available on this website. : Vyvanse 20mg capsule, – Medication guide – Familiprix
Is 25 mg of Vyvanse a lot?
While Vyvanse offers dosing options from 10 mg to 70 mg, the recommended starting dose is 30 mg. Your doctor may periodically increase or decrease your dosage to help control ADHD symptoms and manage side effects. The maximum daily dose of Vyvanse is 70 mg.
Can you lose weight on 20 mg of Vyvanse?
VYVANSE ® ( Vi’- vans ) – (lisdexamfetamine dimesylate) Capsules and Chewable Tablets, CII What is the most important information I should know about VYVANSE? VYVANSE may cause serious side effects, including:
Abuse and dependence. VYVANSE, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and may cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with VYVANSE.
Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Heart-related problems including:
sudden death, stroke, and heart attack in adults sudden death in children who have heart problems or heart defects increased blood pressure and heart rate
Your healthcare provider should check you or your child carefully for heart problems before starting treatment with VYVANSE. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Mental (psychiatric) problems, including:
new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with VYVANSE, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. VYVANSE may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. Moderate to severe binge eating disorder (BED) in adults. VYVANSE may help reduce the number of binge eating days in people with BED.
VYVANSE is not for use in children under 6 years of age with ADHD. VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of obesity. It is not known if VYVANSE is safe and effective for use in children with BED.
- VYVANSE is a federally controlled substance (CII) because it contains lisdexamfetamine dimesylate that can be a target for people who abuse prescription medicines or street drugs.
- Eep VYVANSE in a safe place to protect it from theft.
- Never give your VYVANSE to anyone else because it may cause death or harm them.
Selling or giving away VYVANSE may harm others and is against the law. Do not take VYVANSE if you or your child are:
allergic to amphetamine products or any of the ingredients in VYVANSE. See the end of this Medication Guide for a complete list of ingredients in VYVANSE. taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI). being treated with the antibiotic linezolid or intravenous methylene blue.
Before taking VYVANSE, tell your healthcare provider about all medical conditions, including if you or your child:
have heart problems, heart defects, or high blood pressure have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression have circulation problems in fingers and toes are pregnant or plan to become pregnant. VYVANSE may harm the unborn baby.
There is a pregnancy registry for females who are exposed to VYVANSE during pregnancy. The purpose of the registry is to collect information about the health of females exposed to VYVANSE and their baby. If you or your child becomes pregnant during treatment with VYVANSE, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at
are breastfeeding or plan to breastfeed. VYVANSE passes into breast milk. You should not breastfeed during treatment with VYVANSE. Talk to your healthcare provider about the best way to feed the baby during treatment with VYVANSE.
Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VYVANSE can affect the way other medicines work and other medicines may affect how VYVANSE works.
|selective serotonin reuptake inhibitors (SSRIs)||serotonin norepinephrine reuptake inhibitors (SNRIs)|
|medicines used to treat migraine headaches called triptans||tricyclic antidepressants|
|buspirone||St. John’s Wort|
Keep a list of all medicines to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if VYVANSE can be taken with other medicines. Do not start any new medicine during treatment with VYVANSE without talking to your healthcare provider first. How should VYVANSE be taken?
Take VYVANSE exactly as prescribed by your healthcare provider. Your healthcare provider may change the dose if needed. Take VYVANSE 1 time each day in the morning with or without food. Your healthcare provider may sometimes stop VYVANSE treatment for a while to check ADHD or BED symptoms. VYVANSE comes in capsules or chewable tablets.
Taking VYVANSE Capsules:
VYVANSE capsules may be swallowed whole. If VYVANSE capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto yogurt, or poured into water or orange juice.
Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE powder and yogurt, water, or orange juice until they are completely mixed together. Swallow all the yogurt, water, or orange juice mixture right away. Do not store the yogurt, water, or orange juice mixture. It is normal to see a filmy coating on the inside of your glass or container after you eat or drink all the VYVANSE mixture.
Taking VYVANSE Chewable Tablets:
Chew VYVANSE tablets completely before swallowing.
If you or your child take too much VYVANSE, call your healthcare provider or poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away. What should I avoid while taking VYVANSE? Do not drive, operate machinery, or do other dangerous activities until you know how VYVANSE affects you.
See “What is the most important information I should know about VYVANSE?” Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with VYVANSE. VYVANSE treatment may be stopped if your child is not growing or gaining weight. Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
Fingers or toes may feel numb, cool, painful Fingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with VYVANSE.
Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when VYVANSE is taken with certain other medicines. Stop taking VYVANSE and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:
|loss of coordination||confusion|
|dizziness||tremors, stiff muscles, or muscle twitching|
|seeing or hearing things that are not real (hallucination)||changes in blood pressure|
|high body temperature (hyperthermia)||nausea, vomiting, diarrhea|
The most common side effects of VYVANSE in children 6 to 17 years old and adults with ADHD include:
|loss of appetite (anorexia)||anxiety|
|decreased appetite||weight loss|
The most common side effects of VYVANSE in adults with BED include:
|dry mouth||trouble sleeping|
|decreased appetite||increased heart rate|
These are not all the possible side effects of VYVANSE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store VYVANSE?
Store VYVANSE in a safe place (like a locked cabinet) and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). Protect VYVANSE from light. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix VYVANSE with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) VYVANSE in the household trash.
Keep VYVANSE and all medicines out of the reach of children. General information about the safe and effective use of VYVANSE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VYVANSE for a condition for which it was not prescribed.
- Do not give VYVANSE to other people, even if they have the same symptoms that you have.
- It may harm them and it is against the law.
- You can ask your pharmacist or healthcare provider for information about VYVANSE that is written for health professionals.
- What are the ingredients in VYVANSE? Active Ingredient: lisdexamfetamine dimesylate Capsule Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide. Chewable Tablet Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.
- Distributed by: Takeda Pharmaceuticals America, Inc., Lexington, MA 02421.
- VYVANSE ® and the VYVANSE Logo ® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.
- ©2022 Takeda Pharmaceuticals U.S.A., Inc.
- All rights reserved.
- For more information, go to www.vyvanse.com or call 1-877-TAKEDA-7 (1-877-825-3327).
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2021 SPI-0340 Reformatted for US-LIS-1284 : Vyvanse® (lisdexamfetamine dimesylate)