Zenzedi

(dextroamphetamine sulfate) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

 Tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg  

 

 

 Dosing 

 

 Age: ≥ 3 y/o 

 Onset: ~ 30-60 minutes 

 Duration: 4-6 hours 

 Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours. Periodic drug holidays are recommended to assess the patient’s condition. 

 Initial Dose: 

 

 3-5 y/o: 2.5 mg daily 

 6+ y/o: 5 mg once or twice daily 

 

 

 Titration: 

 

 3-5 y/o: 2.5 mg weekly 

 6+ y/o: 5 mg weekly 

 

 

 Max Dose: 

 

 3-5 y/o:  20 mg/day 

 6+ y/o: 

 

 ≤50 kg: 40 mg/day 

 >50 kg: 60 mg/day   

 

 

 

 

 

 

 Quick Facts 

 

 Increases synaptic dopamine and norepinephrine by enhancing presynaptic release and inhibiting reuptake 

 Enhances focus, attention, and impulse control 

 Immediate-release formulation for rapid onset 

 Contains dextroamphetamine sulfate as the active ingredient 

 Common side effects: decreased appetite, insomnia, increased heart rate, headache, dry mouth   

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 Narcolepsy (ICD-10: G47.419) 

 

 

 Off-Label Uses 

 

  N/A 

 

 

 How to Take 

 

 Take once or multiple times daily , as directed. 

 Can be taken with or without food ; high-fat meals may delay absorption. 

 Swallow the tablet whole ; do not crush, chew, or split. 

 Avoid taking late in the day to prevent insomnia. 

 

 

 Side Effects 

 

 Common: Insomnia, decreased appetite, weight loss, dry mouth, headache 

 Serious: Cardiovascular events, psychiatric symptoms (e.g., psychosis, mania), growth suppression in children, peripheral vasculopathy (including Raynaud's phenomenon) 

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). 

 Uncontrolled movements, tics, or worsening anxiety. 

 Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). 

 Unexplained weight loss or delayed growth in pediatric patients . 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. 

 Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. 

 Avoid caffeine and other stimulants , which may amplify side effects. 

 Ensure adequate hydration and nutrition , as appetite suppression is common. 

 Tapering may be required if discontinuing after long-term use. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Encourage a nutrient-dense diet to counteract appetite suppression. 

 Administer in the morning before school for optimal effect. 

 Monitor school performance and behavioral changes . 

 Observe for sleep disturbances ; adjust timing if necessary. 

 Communicate regularly with teachers and caregivers about medication effects. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to dextroamphetamine or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . 

 History of substance use disorder , unless benefits outweigh risks. 

 

 

 

 Pregnancy: 

 

 Category C ; use only if benefits outweigh risks. 

 May cause neonatal withdrawal symptoms or low birth weight . 

 

 

 

 Lactation: 

 

 Excreted in breast milk ; not recommended due to potential infant exposure. 

 

 

 

 Drug Interactions: 

 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . 

 Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. 

 Alkalinizing agents (e.g., sodium bicarbonate) may increase dextroamphetamine levels. 

 May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists)