EVEKEO ODT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EVEKEO ODT (EVEKEO ODT).
EVEKEO ODT (amphetamine) is a CNS stimulant that increases extracellular levels of dopamine and norepinephrine by blocking their reuptake into presynaptic neurons and inhibiting monoamine oxidase, leading to enhanced neurotransmission.
| Metabolism | Hepatic via CYP2D6 to active metabolites (e.g., 4-hydroxyamphetamine, norephedrine) and inactive metabolites. |
| Excretion | Renal: approximately 50% as unchanged drug and metabolites; fecal: minimal (<10%) |
| Half-life | 3-5 hours in healthy adults; prolonged in renal impairment (up to 20 hours in ESRD) |
| Protein binding | 70-80% bound to albumin |
| Volume of Distribution | 2.6 L/kg |
| Bioavailability | Oral (ODT): 75-85% |
| Onset of Action | Oral (ODT): within 1-1.5 hours |
| Duration of Action | 6-8 hours; may be longer in hepatic impairment |
| Molecular Weight | 327.41 |
0.25 mg orally as a single dose; may repeat once after 30 minutes if required.
| Dosage form | TABLET, ORALLY DISINTEGRATING |
| Renal impairment | No dose adjustment necessary for renal impairment; not studied in dialysis. |
| Liver impairment | Contraindicated in Child-Pugh Class C; use with caution in Class A/B with reduced dose. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dose adjustment; use with caution due to increased sensitivity to adverse effects. |
| 1st trimester | Insufficient data in pregnant women; animal studies show teratogenicity at high doses. Use only if potential benefit justifies risk. |
| 2nd trimester | Limited human data; may increase risk of preterm labor or low birth weight. Use cautiously. |
| 3rd trimester | Avoid near term due to potential neonatal adverse effects (e.g., irritability, poor feeding). |
Clinical note
Comprehensive clinical and safety monograph for EVEKEO ODT (EVEKEO ODT).
| Placental transfer | Crosses placenta; evidence from animal studies and human case reports. |
| Breastfeeding | Excreted into breast milk in low amounts; monitor infant for jitteriness, insomnia, and weight loss. |
| Lactation Rating |
■ FDA Black Box Warning
Amphetamines have a high potential for abuse. Administration for prolonged periods may lead to drug dependence. Misuse may cause sudden death or serious cardiovascular adverse events.
| Serious Effects |
Hypersensitivity to methylphenidate or any componentConcurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOIGlaucomaTics or Tourette's syndromeSevere hypertension or cardiovascular disease
| Precautions | Serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities or other serious heart problems., Blood pressure and heart rate increase; monitor., Psychiatric adverse events including exacerbation of pre-existing psychosis, mania, and aggressive behavior., Long-term suppression of growth; monitor weight and height in pediatric patients., Seizures; use with caution in patients with seizure disorders., Peripheral vasculopathy including Raynaud's phenomenon., Serotonin syndrome risk when used with other serotonergic drugs. |
| Food/Dietary | No significant food interactions reported. Caffeine may be present in breast milk; monitor infant for caffeine accumulation. |
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| L3 |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in pregnancy; causes fetal harm. First trimester: high risk of major malformations including craniofacial defects, cardiovascular abnormalities. Second/third trimesters: fetal growth restriction, oligohydramnios, neonatal renal impairment. |
| Fetal Monitoring | Avoid in pregnancy; if exposed, monitor fetal anatomy ultrasound, fetal growth, and amniotic fluid index. Maternal renal function and blood pressure monitoring. |
| Fertility Effects | May impair fertility in females; case reports of menstrual irregularities and anovulation. Reversible upon discontinuation. Males: not studied. |
| Clinical Pearls | EVEKEO ODT (caffeine citrate) is used for apnea of prematurity. Loading dose 20 mg/kg caffeine citrate IV/PO, maintenance 5-10 mg/kg/day. Monitor for tachycardia and jitteriness. Avoid in infants with seizure disorders. May need to adjust dosing in renal impairment. Consider therapeutic drug monitoring if toxicity suspected (target caffeine base 8-20 mg/L). |
| Patient Advice | This medication helps your baby breathe more regularly. · Give the orally disintegrating tablet exactly as prescribed, usually once daily. · Do not crush or chew the tablet; place on tongue and allow to dissolve. · Contact doctor if baby has fast heart rate, irritability, or difficulty feeding. · Store at room temperature away from moisture and heat. |