Haloperidol Lactate (haloperidol lactate)

Dosage of haloperidol lactate and the decanoate is expressed in terms of haloperidol.

There is considerable interindividual variation in optimal dosage requirements of haloperidol, and dosage must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and concomitant medication(s) or disease state(s). Children, debilitated or geriatric patients, and patients with a history of adverse reactions to antipsychotic drugs may require less haloperidol. In such patients, the optimal response is usually obtained with more gradual dosage adjustments and at lower dosage levels.

Haloperidol is administered orally, haloperidol lactate is administered orally or by IM injection, and haloperidol decanoate is administered by IM injection.

Haloperidol lactate has also been administered IV+. Haloperidol decanoate injection should not be administered IV.

Haloperidol decanoate should be administered by deep IM injection into the gluteal region using a 21-gauge needle, usually at monthly intervals. The maximum volume of haloperidol decanoate should not exceed 3 mL per IM injection site.

Haloperidol lactate injection should be administered at intervals based on patient response; the injection may be administered as often as every hour, although 4- to 8-hour intervals may be satisfactory.

Haloperidol lactate and decanoate injections should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Administration of IM haloperidol decanoate or lactate in pediatric patients is not recommended.

Store haloperidol decanoate injection at controlled room temperature (15--30degreesC); do not refrigerate or freeze, and protect from light.

Store haloperidol tablets at controlled room temperature (20--25degreesC); protect from light. Dispense in a tight, light-resistant container.

Store haloperidol lactate oral solution and injection at controlled room temperature (20--25degreesC); do not freeze, and protect from light. Dispense oral solution in a tight, light-resistant container.

No dosing information is available for this tab.

No dosing information is available for this tab.

Haloperidol is metabolized by cytochrome P-450 (CYP) isoenzymes, mainly CYP3A4 and, to a lesser extent, CYP2D6. Haloperidol is an inhibitor of CYP2D6.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Severe toxic CNS depression or comatose states from any cause.

*Hypersensitivity to haloperidol.

*Parkinson's disease.

*Dementia with Lewy bodies (IM haloperidol).

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most frequent adverse effects of haloperidol involve the CNS and include extrapyramidal reactions (e.g., Parkinson-like symptoms, akathisia, dystonia).

Based on the pooled safety data, the most common adverse effects in patients treated with IM haloperidol lactate (>=5%) were extrapyramidal disorder, hyperkinesia, tremor, hypertonia, dystonia, and somnolence.

The most common adverse reactions (>=5%) in haloperidol decanoate-treated patients in a double-blind, active comparator-controlled clinical trial were parkinsonism and oculogyric crisis.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of IM haloperidol decanoate or lactate injection in children have not been established; safety and efficacy of oral haloperidol preparations in children younger than 3 years of age have not been established.

Although there are no adequate and controlled studies to date in humans, cases of limb malformations have occurred in offspring of women who were given haloperidol concurrently with other potentially teratogenic drugs during the first trimester of pregnancy; these teratogenic effects have not been directly attributed to haloperidol. Haloperidol has been shown to be teratogenic and fetotoxic in animals administered oral or parenteral haloperidol.

Neonates exposed to antipsychotic agents, including haloperidol, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Symptoms reported in these neonates to date include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. Symptoms were self-limiting in some neonates, but varied in severity; some infants required intensive care unit support and prolonged hospitalization.

Haloperidol should be used during pregnancy or in women likely to become pregnant only when the potential benefits justify the possible risks to the fetus.

Haloperidol is distributed into human milk. The manufacturers warn that nursing should not be undertaken by women receiving haloperidol.

Geriatric patients may require less haloperidol; in such patients, the optimal response is usually obtained with more gradual dosage adjustments and at lower dosage levels as recommended above.

Clinical studies of haloperidol did not include sufficient numbers of geriatric patients 65 years of age and older to determine whether this age group responds differently from younger adults. Other reported clinical experience has not consistently identified differences in responses between geriatric and younger patients. However, the prevalence of tardive dyskinesia appears to be highest among geriatric patients, particularly elderly women. In addition, the pharmacokinetics of haloperidol generally warrant the use of reduced dosages in geriatric patients.

Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.