Alti-Haloperidol

In the U.S.

• Haldol

In Canada

• Alti-Haloperidol
• Apo-Haloperidol
• Novo-Peridol
• Peridol
• Pms-Haloperidol
• Ratio-Haloperidol

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antipsychotic

Pharmacologic Class: Dopamine Antagonist

Chemical Class: Butyrophenone

Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
-Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Maintenance dose: After achieving a satisfactory response, the dose should be adjusted as practical to achieve optimum control

Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
-The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Maximum dose: 20 mg/day

Comments:
-Oral formulations should be used as soon as practical.
-The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
-The safety of prolonged oral doses of 100 mg/day or greater has not been studied.

Haloperidol Decanoate for Injection:
Initial dose of-Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
Maintenance dose: 10 to 15 times the previous daily oral dose IM once a month, titrated to response
r patients stabilized on low daily oral doses (up to 10 mg/day): 10 to 15 times the daily oral dose IM once a month
Initial dose for patients stabilized on higher daily oral doses, tolerant to oral treatment, or at risk of relapse: 20 times the daily oral dose IM once a month
-Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
Maintenance dose: 10 to 15 times the previous daily oral dose IM once a month, titrated to response
-Maximum monthly dose: 450 mg

Comments:
-Patients should be stabilized on antipsychotic medication before starting prolonged parenteral therapy.
-Monitor closely during initiation and stabilization to minimize the risk of overdosage or reappearance of psychotic symptoms; short acting formulations may be used during this period of adjustment.
-Extended-release injections are generally administered once a month or every 4 weeks, however, the dosing interval as well as dose may be adjusted to best suit the patient.
-Clinical experience with doses greater than 450 mg per months is limited.

Uses:
-Treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
-Management of manifestations of psychotic disorders

• May be used in the treatment of schizophrenia.
• May help control tics and vocal utterances of Tourettes syndrome. Some studies have reported a 78-91% reduction in tics.

• Take as directed by your doctor. Haloperidol is usually dosed two to three times daily.
• Avoid alcohol while taking haloperidol as it may contribute to the side effects of haloperidol including low blood pressure.
• Haloperidol may affect your judgment and impair your ability to drive or operate machinery.
• A 'one-dose fits all' dosage schedule does not apply for haloperidol. Your doctor may have to adjust your haloperidol frequently on initiation to find the right dose for you.
• Tell your doctor if you experience any unexplained fever, muscle rigidity or unusual muscle movements, agitation, irritability, anxiety, or other uncharacteristic mental disturbances while taking haloperidol.
• Do not take any other medications either on prescription or over-the-counter without talking with a doctor or pharmacist to check that they don't interact with haloperidol.
• Do not abruptly stop haloperidol. If you need to discontinue haloperidol, your doctor will tell you how to taper it down.

This drug should be used during pregnancy only if the benefit clearly outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -The duration of treatment in pregnant patients should be as short as possible. -Some experts recommend avoiding use during the first trimester. -Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization. -Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

Animal data have revealed evidence of an increased incidence of resorption, decreased fertility, embryolethality, delayed delivery, decreased brain and body weights, behavioral effects, and pup mortality. Gross malformations (e.g., cleft palate, neural tube defects) occurred in one animal model; these malformations may be the result of concomitant drug exposure, non-specific stress responses, and/or nutritional imbalances. There are reports of limb malformations in infants whose mothers received concomitant drugs with suspected teratogenic potential during the first trimester. Oral formulations given to male animal models before mating resulted in increased preimplantation loss, decreased fertility, and induced changes in reproductive organs. There are no controlled data in human males. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

LactMed Record Number

132

Last Revision Date

20161207

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