ADZENYS ER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADZENYS ER (ADZENYS ER).
ADZENYS ER is a central nervous system (CNS) stimulant that blocks the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their concentrations in the synaptic cleft.
| Metabolism | Metabolized primarily by hepatic esterases and cytochrome P450 (CYP) enzymes, including CYP2D6. |
| Excretion | 70% renal (30% unchanged, 40% as metabolites), 30% fecal/biliary |
| Half-life | 6-8 hours in adults; in children 3-6 hours, requiring twice-daily dosing for sustained effect |
| Protein binding | 97% bound to albumin and α1-acid glycoprotein |
| Volume of Distribution | 4.6-6.8 L/kg, indicating extensive tissue distribution, particularly in brain and adipose tissue |
| Bioavailability | Oral: 95% ± 10%; rectal: 80% ± 15% |
| Onset of Action | 2-4 hours following oral administration of extended-release formulation |
| Duration of Action | 12-14 hours for extended-release formulation; clinical efficacy wanes after 12 hours, necessitating twice-daily dosing in some patients |
Adults: Initial 5-10 mg orally once daily; titrate in 5-10 mg increments weekly to optimal response; max 60 mg/day.
| Dosage form | SUSPENSION, EXTENDED RELEASE |
| Renal impairment | GFR 30-89 mL/min: No adjustment. GFR <30 mL/min: Not recommended. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50%. Child-Pugh C: Not recommended. |
| Pediatric use | Children ≥6 years: Initial 5-10 mg orally once daily; titrate weekly by 5-10 mg; max 1 mg/kg/day or 60 mg/day, whichever is lower. |
| Geriatric use | Initiate at 5 mg once daily; titrate cautiously; monitor for cardiovascular effects and insomnia. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ADZENYS ER (ADZENYS ER).
| Breastfeeding | Excreted in breast milk; M/P ratio approximately 2.6. Irritability and weight loss reported in nursing infants. Not recommended unless benefit outweighs risk. |
| Teratogenic Risk | First trimester: Inadequate human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Second and third trimesters: Chronic use may lead to neonatal withdrawal syndrome (hyperactivity, irritability, poor feeding) and reduced fetal growth. Avoid in first trimester unless benefit outweighs risk; use lowest effective dose in later trimesters. |
■ FDA Black Box Warning
WARNING: ABUSE AND DEPENDENCE. CNS stimulants, including ADZENYS ER, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
| Serious Effects |
["Known hypersensitivity to amphetamines or other components of ADZENYS ER","Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI","Agitated states","History of drug abuse","Cardiovascular disease including hypertension, arteriosclerosis, hyperthyroidism, glaucoma"]
| Precautions | ["Serious cardiovascular events: Sudden death, stroke, and myocardial infarction have been reported in patients with pre-existing cardiac abnormalities.","Blood pressure and heart rate increase: Monitor regularly.","Psychiatric adverse reactions: May precipitate or exacerbate psychosis or mania.","Long-term suppression of growth in pediatric patients: Monitor height and weight.","Seizures: May lower seizure threshold in patients with history of seizures.","Peripheral vasculopathy: Including Raynaud's phenomenon."] |
| Food/Dietary |
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| Fetal Monitoring |
| Monitor maternal blood pressure and heart rate. Fetal: Growth ultrasound (weight, head circumference) at 28-32 weeks if used beyond first trimester. Neonatal: Observe for withdrawal signs for 48 hours postpartum. |
| Fertility Effects | May impair fertility in males (reversible oligospermia) and possibly females (menstrual irregularities). Discontinue if fertility is desired. |
| High-fat meals can significantly delay and reduce the absorption of Adzenys ER; the time to peak concentration (Tmax) may be prolonged by approximately 1 hour and peak concentration (Cmax) reduced by about 38%. It is recommended to take Adzenys ER on an empty stomach (at least 1 hour before or 2 hours after a meal) to ensure consistent effect. Avoid alcohol while taking this medication, as it may increase the risk of cardiovascular side effects and impair judgment. No other specific food interactions are known, but patients should maintain a balanced diet to manage potential appetite suppression common with amphetamines. |
| Clinical Pearls | Adzenys ER is an extended-release oral suspension of amphetamine (mixed salts) for ADHD. It provides a rapid onset (within 1 hour) and sustained effect over 10-12 hours. The suspension must be shaken vigorously for at least 10 seconds before each use. Dose titration should be guided by efficacy and tolerability, starting at 6.3 mg once daily in the morning for children 6-12 years. Avoid administration with high-fat meals as they may delay absorption (Cmax reduced by ~38%). Monitor for cardiovascular effects: heart rate, blood pressure, and potential for sudden death in patients with structural cardiac abnormalities. Use cautiously in patients with pyschosis, bipolar disorder, hypertension, hyperthyroidism, glaucoma, or history of drug abuse. Discontinue if agitation, aggression, or manic symptoms emerge. Drug holidays (weekend or holiday breaks) may be considered to assess need and reduce tolerance. |
| Patient Advice | Take Adzenys ER exactly as prescribed, once daily in the morning; do not take in the afternoon or evening to avoid insomnia. · Shake the bottle vigorously for at least 10 seconds before each use; use the provided oral syringe to measure the correct dose. · Do not mix the medication with food or liquids; take it directly from the syringe. · Avoid taking with high-fat meals, as they may delay and reduce the drug's effect; take on an empty stomach if possible. · Store at room temperature (20-25°C); protect from light and moisture. Discard any unused portion after 30 days of opening. · Notify your doctor immediately if you experience chest pain, shortness of breath, fainting, or palpitations. · This medication has a high potential for abuse; do not share it with others and keep in a safe place. · Inform your doctor about all other medications, including OTC drugs and supplements, especially MAOIs (avoid within 14 days), antihypertensives, and SSRIs. |