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Donepezil crosses the blood-brain barrier and cerebrospinal fluid concentrations at the above doses have been measured at 15.7%.Donepezil is 96% protein-bound, with approximately 75% binding to albumin and approximately 21% binding to alpha-1-glycoprotein.Donepezil is metabolized by first pass metabolism in the liver, primarily by CYP3A4, in addition to CYP2D6. After this, O-dealkylation, hydroxylation, N-oxidation, hydrolysis, and O-glucuronidation occur, producing various metabolites with similar half-lives to the unchanged parent drug. Administered as monotherapy or as adjunct to lithium or divalproexEither immediate-release or extended-release tablets may be given; dosage titrated upward over 4 daysGenerally, in maintenance phase, patients continue to receive same dosage on which they were stabilizedExtended-release formulation administered as adjunct to antidepressants25-50 mg PO at bedtime; may be titrated; not to exceed 300 mgPreferably, take in evening without food or with light mealNot approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)Immediate release: 50-200 mg/day PO; may be increased by 25-50 mg/dayExtended release: 50 mg/day PO; may be increased by 50 mg/day12.5-50 mg/day PO initially; may be gradually increased as tolerated; not to exceed 200-300 mg/dayDrug reaction with eosinophilia and systemic symptoms (DRESS), falls, nocturnal enuresis, retrograde amnesia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), decreased platelet count, serious liver reactions (including hepatitis, liver necrosis, and hepatic failure), agranulocytosis, intestinal obstruction, ileus, colon ischemia, urinary retention, sleep apnea, and acute generalized exanthematous pustulosis (AGEP)Not approved for dementia-related psychosis; elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in natureIncreased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders; prescriptions should be written for smallest therapeutically effective quantity, and caregivers should monitor and report to healthcare professionals incidence of suicidality and associated behaviorsUse with caution in cardiovascular and cerebrovascular diseaseUse with caution in breast cancer and history of seizureIncreased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death; monitor blood glucose of high-risk patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness; monitor glucose regularly in patients with diabetes or at risk for diabetesIncreased incidence of cerebrovascular adverse effects, including stroke and TIAs, in elderly with dementia (not approved for the treatment of patients with dementia-related psychosis); see Black Box WarningsNeuroleptic malignant syndrome (NMS) reported with useClinical worsening of depression and suicide ideation may occur despite treatmentHyperlipidemia may occur; appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatmentWeight gain may occur; monitoring of weight recommendedIncreased blood pressure in children and adolescents reported; monitor blood pressure at the beginning of, and periodically during treatmentLeukopenia, neutropenia, and agranulocytosis may occur; perform a complete blood count (CBC) during first few months of therapy; in such patients, consider discontinuation of therapy at first sign of clinically significant decline in WBC in absence of other causative factorsCan elevate prolactin levels, and elevation can persist during chronic administration; hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion; this, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patientsOrthostatic vital signs should be monitored in patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medicationsMay cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapyPotential for withdrawal symptoms after abrupt discontinuanceFalse-positive urine drug screens reported when immunoassays for methadone or tricyclic antidepressants usedFDA warning regarding off-label use for dementia in elderly (see Black Box Warnings)There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, during pregnancy; healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at Neonates exposed during third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery; overall available data from published epidemiologic studies of pregnant women exposed to drug have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to drug during pregnancyThere is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide; schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth; it is not known if this is a direct result of the illness or other comorbid factorsExtrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates exposed to drug, during third trimester of pregnancy; symptoms varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalizationBased on pharmacologic action of drug, treatment may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potentialLimited data from published literature report the presence of drug in human breast milk at relative infant dose of <1% of maternal weight-adjusted dosage; there are no consistent adverse events reported in infants exposed to quetiapine through breast milk; there is no information on effects of quetiapine on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from mother’s underlying conditionA: Generally acceptable.