Serenace Capsules (Hard Gelatin)
Haloperidol
0.5mg
Searle Pharmaceuticals
| Pack size | 20's |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 9.50 AED |
Available as:
Indications
Serenace Capsules (Hard Gelatin) is used for:
Schizophrenia, Delirium, Hiccups, Acute psychosis, Hyperactivity, Aggression, Agitation and confusion, Tic disorders, Tourette syndrome, Chorea, Nausea and vomiting, Dementia.
Adult Dose
Oral
Psychoses
Adult: 0.5-5 mg bid/tid, may increase up to 100 mg daily in severe or resistant cases. Usual maintenance: 3-10 mg daily.
Tourette's syndrome; Severe tics
Adult: Initially, 0.5-1.5 mg tid. Up to 30 mg daily may be required in Tourette's syndrome; adjust dose carefully to obtain optimum response; usual maintenance: 4 mg daily.
Short-term adjunct in severe anxiety or behavioral disturbances
Adult: 0.5 mg bid.
Restlessness and confusion
Adult: 1-3 mg every 8 hr.
Intractable hiccup
Adult: 1.5 mg tid, adjust according to response.
Intramuscular
Acute psychosis
Adult: Doses range from 2-10 mg, may be given every hr or at intervals of 4-8 hr, until symptoms are controlled. Max: 18 mg/day. For emergency control of severely disturbed patients: Up to 18 mg may be given IV/IM.
Elderly:
PO: Lower initial doses and more gradual adjustments recommended; 0.25-0.5 mg PO q8-12hr initially
IM (prompt-acting): Lower adult doses and longer dosing intervals recommended compared with typical adult doses
Child Dose
<3 years: Safety and efficacy not established
Psychosis/Sedation
3-12 years (15-40 kg): 0.25-0.5 mg/day PO divided q8-12hr initially; may be increased by 0.5 mg/day every 5-7 days PRN; maintenance: 0.05-0.15 mg/kg/day PO divided q8-12hr
6-12 years: Lactate (prompt-acting): 1-3 mg IM q4-8hr PRN; not to exceed 0.15 mg/kg/day
>12 years: Moderate disease, 0.5-2 mg PO q8-12hr initially; severe disease, 3-5 mg PO q8-12hr; not to exceed 30 mg/day
Tourette Disorder
3-12 years: 0.5 mg/day PO initially; dose increased by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to lowest effective maintenance level of 0.05-0.075 mg/kg/day PO divided q8-12hr
>12 years: 0.5-2 mg PO q8-12hr initially; if severe symptoms necessitate increased dosage, titrate upward to 3-5 mg PO q8-12hr; if patient remains inadequately controlled, daily doses up to 100 mg have been used (safety not determined)
Behavioral Disorders
3-12 years: 0.5 mg/day PO initially; dose increased PRN by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to lowest effective maintenance level of 0.05-0.075 mg/kg/day PO divided q8-12hr
Acute Agitation
<12 years: Safety and efficacy not established
>12 years: 0.5-3 mg PO, repeated in 1 hour PRN; alternatively, 2-5 mg IM, repeated in 1 hr PRN
Renal Dose
Administration
May be taken with or without food. May be taken w/ meals to minimise GI irritation.
Contra Indications
Severe toxic CNS depression; preexisting coma; Parkinson's disease; lactation.
Precautions
Parkinsonism; epilepsy, allergy, angle-closure glaucoma, benign prostatic hyperplasia; severe cardiac or hepatic disease; extremes in temp (hot and cold weather); presence of acute infections or leucopenia; hyperthyroidism; pregnancy, elderly, children. Patients receiving anticoagulants. Discontinue upon signs of neurological toxicity in patients taking haloperidol and lithium.
Lactation: Drug enters breast milk; not recommended
Pregnancy-Lactation
Pregnancy
There are no well controlled studies in pregnant women; there are reports of cases of limb malformations observed following maternal use with drug along with other drugs which have suspected teratogenic potential during first trimester of pregnancy; causal relationships were not established in these cases; however, such experience does not exclude possibility of fetal damage due to therapy; drug should be used during pregnancy or in women likely to become pregnant only if benefit clearly justifies a potential risk to fetus; infants should not be nursed during drug treatment
Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; there have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates; these complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation
Drug is excreted in human breast milk; infants should not be nursed during drug treatment
Interactions
Carbamazepine and rifampicin reduce plasma concentrations. Symptoms of CNS depression may be enhanced by CNS depressants e.g. alcohol, hypnotics, general anaesthetics, anxiolytics and opioids. May reduce antihypertensive action of guanethidine. May increase risk of arrhythmia when used with drugs that prolong QT interval or diuretics that can cause electrolyte imbalance. May increase plasma levels of haloperidol when used with clozapine or chlorpromazine.
Potentially Fatal: Increases lithium blood levels and may predispose to neuroleptic malignant syndrome.
Adverse Effects
Side effects of Haloperidol :
Extrapyramidal symptoms
Akathisia, Dystonia, Muscle stiffness, Neuroleptic malignant syndrome (NMS; infrequent but serious), Parkinsonism, Tardive dyskinesia
Common
Anticholinergic effects, Sedation, Weight gain, Erectile dysfunction, Oligomenorrhea or amenorrhea
Less common
Orthostatic hypotension (after IM injection), tachycardia
Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness, confusion
Anorexia, constipation, dyspepsia, ileus, decreased gag reflex
Lens opacities (prolonged use)
Uncommon
ECG changes, Photosensitivity, Pruritus, Diarrhea, Blood dyscrasia, Ejaculatory disorder, Galactorrhea
Rare
Seizure, Cholestatic jaundice, Priapism
Potentially Fatal: Neuroleptic malignant syndrome
Mechanism of Action
Haloperidol blocks postsynaptic dopamine D1 and D2 receptors in the mesolimbic system and decreases the release of hypothalamic and hypophyseal hormones. It produces calmness and reduces aggressiveness with disappearance of hallucinations and delusions.
Note
Serenace 0.5mg Capsules (Hard Gelatin) manufactured by Searle Pharmaceuticals. Its generic name is Haloperidol. Serenace is availble in United Arab Emirates.
Farmaco UAE drug index information on Serenace Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.