Halodem

Rapid control of severe acute psychomotor agitation associated w/ psychotic disorder or manic episodes of bipolar I disorder in adults when oral therapy is not appropriate. Acute treatment of delirium in adults when non-pharmacological treatments have failed. Treatment of mild to moderate chorea in Huntington's disease in adults, when other medicinal products are ineffective or not tolerated, & oral therapy is not appropriate. Single or combination prophylaxis in adult patients at moderate to high risk of post-op nausea & vomiting, when other medicinal products are ineffective or not tolerated. Combination treatment of post-op nausea & vomiting in adults when other medicinal products are ineffective or not tolerated.

IM Adult ≥18 yr Rapid control of severe acute psychomotor agitation associated w/ psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate 5 mg, may be repeated hrly until sufficient symptom control is achieved. Max: 20 mg/day. Acute treatment of delirium when non-pharmacological treatments have failed 1-10 mg. Start treatment at lowest possible dose, & adjust dose in increments at 2- to 4-hr intervals if agitation continues, up to max 10 mg/day. Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, & oral therapy is not appropriate 2-5 mg, may be repeated hrly until sufficient symptom control is achieved or up to max 10 mg/day. Single or combination prophylaxis in patients at moderate to high risk of post-op nausea & vomiting, when other medicinal products are ineffective or not tolerated 1-2 mg, at induction or 30 min before end of anaesth. Combination treatment of post-op nausea & vomiting when other medicinal products are ineffective or not tolerated 1-2 mg. Elderly Initial dose: ½ lowest adult dose. Max: 5 mg/day. Patient w/ hepatic impairment ½ of initial dose.

Hypersensitivity. Comatose state. CNS depression. Parkinson's disease. Dementia w/ Lewy bodies. Progressive supranuclear palsy. Known QTc interval prolongation or congenital long QT syndrome. Renal acute MI. Uncompensated heart failure. History of ventricular arrythmia or torsades de pointes. Uncorrected hypokalemia. Concomitant treatment w/ medicinal products that prolong the QT interval.

Not indicated for treatment of dementia-related behavioural disturbances. Reports of QTc prolongation &/or ventricular arrhythmias, in addition to sudden death; tachycardia & hypotension (including orthostatic hypotension); hypoglycemia & SIADH. Caution in patients w/ bradycardia, cardiac disease, family history of QTc prolongation or history of heavy alcohol exposure; w/ potentially high plasma conc; manifesting hypotension or orthostatic hypotension; w/ risk factors for stroke; patients suffering from epilepsy & in conditions predisposing to seizures (eg, alcohol w/drawal & brain damage); w/ relevant medical history of breast tumors; w/ pre-existing hyperprolactinaemia & possible prolactin-dependent tumors; who are known poor CYP2D6 metabolisers & who are co-administered w/ CYP3A4 inhibitor. Baseline ECG is recommended before IM dosing. Assess need for ECG monitoring for QTc interval prolongation & ventricular arrhythmias during therapy but continuous ECG monitoring is recommended for repeated IM doses. Correct electrolyte disturbances (eg, hypokalaemia & hypomagnesaemia) before starting treatment; baseline & periodic electrolyte monitoring is recommended. Increased risk of cerebrovascular adverse events. W/draw treatment immediately & institute appropriate supportive therapy & careful monitoring if NMS occurs. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. Extrapyramidal symptoms may occur. Possible increase in IOP in concomitant administration w/ anticholinergic agents. Caution in patients w/ hyperthyroidism & always accompany treatment w/ therapy to achieve a euthyroid state. Identify all possible risk factors for VTE before & during treatment, & undertake preventive measures. Gradual w/drawal is advised. Do not use alone in patients in whom depression is predominant. Risk of patients switching from mania to depression in treatment of manic episodes of bipolar disorder. Caution in renal & hepatic impairment. Preferable to avoid use during pregnancy. Discontinue breastfeeding or discontinue therapy taking into account the benefit of breastfeeding to the child or of therapy to the woman. Carefully monitor newborn infants exposed during 3rd trimester of pregnancy. Safety & efficacy in childn & adolescents <18 yr have not been established. Increased mortality in elderly w/ dementia.

Agitation, insomnia; extrapyramidal disorder, hyperkinesia, headache. Depression, psychotic disorder; tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypokinesia, hypertonia, somnolence, tremor, dizziness; oculogyric crisis, visual disturbance; orthostatic hypotension, hypotension; constipation, dry mouth, salivary hypersecretion, nausea, vomiting; abnormal LFT; rash; urinary retention; erectile dysfunction; increased/decreased wt.

CV effects w/ medicinal products known to prolong QTc interval eg, class IA (eg, disopyramide, quinidine) & class III (eg, amiodarone, dofetilide, dronedarone, ibutilide, sotalol) antiarrhythmics, certain antidepressants (eg, citalopram, escitalopram), certain antibiotics (eg, azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, telithromycin), other antipsychotics (eg, phenothiazine derivatives, sertindole, pimozide, ziprasidone), certain antifungals (eg, pentamidine), certain antimalarials (eg, halofantrine), certain GI medicinal products (eg, dolasetron), certain medicinal products used in cancer (eg, toremifene, vandetanib), certain other medicinal products (eg, bepridil, methadone). Caution w/ medicinal products known to cause electrolyte imbalance. Plasma conc may be increased w/ CYP3A4 inhibitors (eg, alprazolam, fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone, posaconazole, saquinavir, verapamil, voriconazole); CYP2D6 inhibitors (eg, bupropion, chlorpromazine, duloxetine, paroxetine, promethazine, sertraline, venlafaxine); combined CYP3A4 & CYP2D6 inhibitors (eg, fluoxetine, ritonavir); buspirone. Plasma conc may be gradually decreased to such extent that efficacy may be reduced w/ potent CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifampicin, St. John's wort). Increased CNS depression produced by alcohol or CNS-depressants including hypnotics, sedatives or strong analgesics. Enhanced CNS effect w/ methyldopa. May antagonise action of adrenaline & other sympathomimetics (eg, stimulants like amphetamines) & reverse BP-lowering effects of adrenergic-blockers (eg, guanethidine). May antagonise effect of levodopa & other dopamine agonists. Increased plasma conc of TCAs (eg, imipramine, desipramine). Rare cases of encephalopathy, extrapyramidal symptoms, tardive dyskinesia, NMS, acute brain syndrome & coma w/ lithium. Reports of antagonised effect of anticoagulant phenindione.

Antipsychotics / Antivertigo Drugs

N05AD01 - haloperidol ; Belongs to the class of butyrophenone derivatives antipsychotics.

Rx