Dafinace 5mg

Haloperidol 5mg

Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk for death, as shown in short-term controlled trials; deaths in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
Not approved for treatment of patients with dementia-related psychosis

Documented hypersensitivity
Severe CNS depression (including coma), NMS, poorly controlled seizure disorder, Parkinson disease

Risk of sudden death, torsades de pointes, and prolonged QT interval from off-label IV administration of higher than recommended dose: monitor ECG if administering IV
Conditions or drugs that prolong QT interval, congenital long QT syndrome
Safety of prolonged administration of 100 mg/day PO not established
Avoid use in narrow angle glaucoma, bone marrow suppression, and severe hypotension
FDA warning regarding off-label use for dementia in elderly
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
If patient has history of clinically significant presence of either risk factor, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery
Severe neurotoxicity manifesting as rigidity or inability to walk or talk may occur in patients with thyrotoxicosis also receiving antipsychotics
If administering IV or IM, watch for hypotension; use with caution in diagnosed CNS depression, subcortical brain damage, or cardiac disease; if history of seizures, benefits must outweigh risks; significant increase in body temperature may indicate intolerance to antipsychotics (discontinue if this occurs)
Use caution in patients at risk of pneumonia (eg, Alzheimer's patients); antipsychotic use reported to be associated with esophageal dysmotility and aspiration
Extrapyramidal symptoms may occur including acute dystonic reactions, akathisia, tardive dyskinesia, and pseudoparkinsonism; some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal; in certain cases dyskinetic movements are indistinguishable from tardive dyskinesia except for duration; not known whether gradual withdrawal will reduce rate of occurrence of withdrawal emergent neurological signs but until further evidence becomes available, gradually withdraw therapy
Hyperprolactinemia may occur
Monitor for mental status changes, muscle rigidity, fever, and/or autonomic instability; neuroleptic malignant syndrome may occur
Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects
Association with increased risk of pigmentary retinopathy reported
Impairment of core body temperature regulation reported; use caution with activities that may increase body temperature including strenuous exercise, heat exposure, dehydration, and concomitant medications with anticholinergic effects
Caution in patients receiving anticoagulants; isolated instance of interference occurred with effects of one anticoagulant (phenindione)
When used to control mania in cyclic disorders, there may be rapid mood swing to depression
May cause anticholinergic effects; use caution in patients with xerostomia, urinary retention, BPH, decreased gastrointestinal motility, paralytic ileus, or visual problems
May cause CNS depression; may impair ability to operate heavy machinery or driving
Decreased sensation of thirst due to central inhibition may lead to dehydration, hemoconcentration and reduced pulmonary ventilation; a number of cases of bronchopneumonia, some fatal, reported; if signs and symptoms appear, especially in the elderly, institute remedial therapy promptly
Use caution in patients with severe cardiovascular disorders, because of possibility of transient hypotension and/or precipitation of anginal pain; should hypotension occur and a vasopressor be required, epinephrine should not be used since haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur; use metaraminol, phenylephrine or norepinephrine instead
Use caution in patients receiving anticonvulsant medications, with a history of seizures, or with EEG abnormalities; haloperidol may lower convulsive threshold; if indicated, adequate anticonvulsant therapy should be concomitantly maintained

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Dafinace 5mg only for the indication prescribed.