ADDERALL 7.5
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADDERALL 7.5 (ADDERALL 7.5).
ADDERALL 7.5 is a combination of amphetamine and dextroamphetamine, which are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mechanism of action involves blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, as well as increasing their release into the extraneuronal space. This leads to increased levels of these neurotransmitters in the synaptic cleft, enhancing stimulation of postsynaptic receptors.
| Metabolism | Amphetamine and dextroamphetamine are metabolized primarily in the liver via oxidative deamination and aromatic hydroxylation. The major metabolic pathway involves the enzyme CYP2D6, which converts amphetamine to 4-hydroxyamphetamine and norephedrine. Other minor pathways include N-dealkylation and deamination. |
| Excretion | Renal: approximately 90% of a dose is excreted in urine, with about 30% as unchanged amphetamine and the remainder as metabolites (including deaminated and hydroxylated products). Fecal excretion is negligible (<5%). |
| Half-life | The terminal elimination half-life of amphetamine is approximately 10-13 hours in adults, but can vary based on urinary pH (alkaline urine prolongs half-life up to 20 hours; acidic urine reduces it to 7-8 hours). In children, half-life is slightly shorter (6-8 hours). Clinical context: Steady-state is achieved within 2-3 days. |
| Protein binding | Approximately 20-25% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Apparent volume of distribution is approximately 3-4 L/kg, indicating extensive tissue distribution, with high concentrations in the brain and cerebrospinal fluid. |
| Bioavailability | Oral bioavailability is approximately 75-80% for immediate-release formulations, with no significant food effect. Extended-release capsules have similar bioavailability when taken intact. |
| Onset of Action | Immediate-release (IR) oral: Onset of CNS effects within 30-60 minutes. Extended-release (XR) oral: Onset within 1-2 hours. Peak plasma concentrations occur at 3 hours for IR and 7 hours for XR. |
| Duration of Action | Immediate-release: Duration of clinical effect is 4-6 hours. Extended-release: Duration is 8-12 hours. Clinical note: XR formulation provides a biphasic release pattern with an initial immediate release and a delayed second peak. |
| Molecular Weight | 238.28 |
5-20 mg orally 1-3 times daily; immediate-release tablets administered upon awakening and at 4-6 hour intervals as needed; extended-release capsules administered once daily upon awakening; maximum total daily dose 40 mg.
| Dosage form | TABLET |
| Renal impairment | eGFR 30-89 mL/min: Administer 50% of usual dose; eGFR <30 mL/min: Not recommended due to accumulation; Hemodialysis: Not recommended. |
| Liver impairment | Child-Pugh Class A: No adjustment necessary; Child-Pugh Class B: Reduce dose by 50%; Child-Pugh Class C: Not recommended. |
| Pediatric use | Children ≥3 years (ADHD): Immediate-release: Starting dose 2.5 mg once or twice daily, increase by 2.5-5 mg/day weekly to max 40 mg/day in divided doses; Extended-release: ≥6 years: Starting 10 mg once daily, increase by 5-10 mg weekly to max 30 mg/day. Weight <30 kg: Use lower end of dosing range. |
| Geriatric use | Initiate at 2.5 mg once or twice daily; increase by 2.5-5 mg at weekly intervals; maximum 40 mg/day; monitor for cardiovascular effects, insomnia, and appetite suppression. |
| 1st trimester | Contraindicated due to risk of teratogenicity; case reports of cardiovascular malformations and oral clefts. Use only if benefit outweighs risk. |
| 2nd trimester | Avoid; may cause fetal growth restriction, preterm delivery, and neonatal withdrawal syndrome. |
| 3rd trimester | Avoid; risk of preterm delivery, low birth weight, and neonatal withdrawal (irritability, poor feeding). |
Clinical note
Comprehensive clinical and safety monograph for ADDERALL 7.5 (ADDERALL 7.5).
| Placental transfer | Extensive placental transfer; amphetamine crosses blood-placenta barrier, with fetal blood levels approximately 50-100% of maternal concentrations. |
| Breastfeeding | Excreted into breast milk; infant plasma concentrations may reach 6.6% of maternal dose, potentially causing irritability and poor weight gain. Not recommended during breastfeeding. |
■ FDA Black Box Warning
WARNING: ABUSE AND DEPENDENCE. CNS stimulants, including ADDERALL, 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 |
Hypersensitivity to amphetamines or sympathomimetic aminesConcurrent use of MAOIs or within 14 days of MAOI therapyGlaucomaAgitated statesHistory of drug abuse (amphetamine misuse)Moderate to severe hypertensionHyperthyroidismParkinson's-like syndromeCardiovascular disease (symptomatic CAD, cardiomyopathy, arrhythmias)
| Precautions | Serious Cardiovascular Events: Sudden death, stroke, and myocardial infarction have been reported in patients with pre-existing structural cardiac abnormalities., Blood Pressure and Heart Rate Increases: Monitor heart rate and blood pressure; use caution in patients with hypertension or tachycardia., Psychiatric Adverse Events: May exacerbate pre-existing psychosis, mania, or cause new psychotic/manic symptoms., Seizures: May lower seizure threshold; use with caution in patients with a history of seizures., Peripheral Vasculopathy: Including Raynaud's phenomenon; monitor for digital changes., Serotonin Syndrome: Risk when co-administered with serotonergic drugs., Growth Suppression: Monitor growth in pediatric patients during treatment., Abuse and Dependence: High potential; prescribe cautiously and monitor for misuse. |
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| Lactation Rating | L5 (Avoid) |
| Teratogenic Risk | Pregnancy Category C. First trimester: Possible increased risk of congenital malformations (e.g., cardiac, oral clefts) based on amphetamine class; insufficient human data. Second/third trimester: Risk of preterm delivery, low birth weight, and neonatal withdrawal (e.g., irritability, poor feeding). |
| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and signs of stimulant toxicity. Fetal growth and development via ultrasound; assess for preterm labor. Neonatal monitoring for withdrawal symptoms after delivery. |
| Fertility Effects | May impair fertility in females via altered ovulation (dopaminergic effects) and in males via ejaculatory dysfunction or reduced sperm parameters; reversible upon discontinuation. |
| Food/Dietary | Take with or without food, but consistency is recommended to avoid fluctuating absorption. Avoid acidic foods or large amounts of vitamin C (e.g., citrus fruits, juices) within 1 hour of dosing, as they can decrease absorption. Avoid high-fat meals which can delay absorption. Grapefruit and grapefruit juice may increase amphetamine levels; limit or avoid. |
| Clinical Pearls | Adderall 7.5 mg is a combination of amphetamine salts (dextroamphetamine and levoamphetamine) in a 3:1 ratio. It is a CNS stimulant indicated for ADHD and narcolepsy. Monitor for cardiovascular effects (BP, HR) prior to and during therapy. Use with caution in patients with hypertension, tachyarrhythmias, or history of substance abuse. Avoid concomitant use with MAOIs or within 14 days of discontinuation. May cause growth suppression in children; monitor height and weight. Abuse potential is high; prescribe the smallest effective dose and use tamper-resistant formulations when possible. |
| Patient Advice | Take exactly as prescribed; do not take more or more often than directed. · Swallow tablets whole; do not crush, chew, or break them. · Avoid taking late in the day to prevent insomnia. · Do not stop abruptly; sudden discontinuation can cause severe fatigue and depression. · Notify your doctor of any history of heart problems, high blood pressure, seizures, or mental health conditions. · Report any chest pain, shortness of breath, fainting, or seizures immediately. · Avoid alcohol and marijuana; they can increase side effects. · Store at room temperature away from moisture and heat. · Keep out of reach of children; this medication has a high risk of overdose. |