Haldol Decanoate - FDA prescribing information, side effects and uses

Haldol Decanoate 50 Ampul

haldol dec injection

Avoid hard work and exercise in hot weather. Last reviewed on RxList: Analyses of seventeen placebo-controlled trials modal duration of 10 weeks , largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1. These may be signs of a rare but serious condition known as neuroleptic malignant syndrome. Before using this medication, tell your doctor or pharmacist your medical history, especially of:

Side Effects

Precautions Before using haloperidol , tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. The risk of ECG changes associated with torsade de pointes should be considered. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. The management of NMS should include 1 immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2 intensive symptomatic treatment and medical monitoring, and 3 treatment of any concomitant serious medical problems for which specific treatments are available. Since there is no specific antidote, treatment is primarily supportive. Do not drink alcohol Dry mouth Try chewing sugar-free gum or sucking sugar-free sweets Stomach upset Stick to simple meals - avoid rich or spicy food Constipation Drink plenty of water and eat a well-balanced diet Headache Ask your pharmacist to recommend a suitable painkiller.

Haloperidol is used to treat schizophrenia. It is also used to control motor and speech tics in people with Tourette's syndrome. What are the possible side effects of haloperidol Haldol? Get emergency medical help if you have any of these signs of an allergic reaction: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the most important information I should know about haloperidol Haldol? Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to haloperidol, or have certain conditions.

Be sure your doctor knows if you have Parkinson's disease. Before taking haloperidol, tell your doctor if you have liver disease, kidney disease, heart disease, angina chest pain , a thyroid disorder, epilepsy or other seizure disorder, a personal or family history of "Long QT syndrome," or an electrolyte imbalance such as low potassium or magnesium levels in your blood. Haloperidol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Call your doctor at once if you have tremor uncontrolled shaking or restless muscle movements in your eyes, tongue, jaw, or neck. What should I discuss with my healthcare provider before taking haloperidol Haldol? To make sure you can safely take haloperidol, tell your doctor if you have any of these other conditions:.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn , such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles.

However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking haloperidol, do not stop taking it without your doctor's advice. Haloperidol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Taking too much of this medication can cause a serious heart rhythm disorder or sudden death.

Never take more than your prescribed dose. It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve. In male mice, no statistically significant differences in incidences of total tumors or specific tumor types were noted. Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro , a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients.

An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Rodents given up to 3 times the usual maximum human dose of haloperidol decanoate showed an increase in incidence of resorption, fetal mortality, and pup mortality. No fetal abnormalities were observed. Cleft palate has been observed in mice given oral haloperidol at 15 times the usual maximum human dose. Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents.

There are no adequate and well-controlled studies in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established with these cases. Since such experience does not exclude the possibility of fetal damage due to haloperidol, haloperidol decanoate should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus.

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.

Haloperidol decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Since haloperidol is excreted in human breast milk, infants should not be nursed during drug treatment with haloperidol decanoate. Safety and effectiveness of haloperidol decanoate in children have not been established. Clinical studies of haloperidol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not consistently identified differences in responses between the elderly and younger patients. Since vast experience has accumulated with haloperidol, the adverse reactions are reported for that compound as well as for haloperidol decanoate.

As with all injectable medications, local tissue reactions have been reported with haloperidol decanoate. Tachycardia, hypotension, and hypertension have been reported.

Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.

EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia including opisthotonos and oculogyric crisis.

While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl hydrochloride USP. It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases. Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.

While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal.

In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under " Tardive Dyskinesia " except for duration. Although the long-acting properties of haloperidol decanoate provide gradual withdrawal, it is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs.

As with all antipsychotic agents haloperidol has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy with haloperidol decanoate or may occur after drug therapy has been discontinued.

The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw e. Sometimes these may be accompanied by involuntary movements of extremities and the trunk. There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome.

It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked. It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the full syndrome may not develop. Tardive dystonia, not associated with the above syndrome, has also been reported.

Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible. Neuroleptic malignant syndrome NMS , hyperpyrexia and heat stroke have been reported with haloperidol. Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis.

Agranulocytosis has rarely been reported to have occurred with the use of haloperidol, and then only in association with other medication. Leukopenia, Neutropenia, and Agranulocytosis. Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair. Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

While overdosage is less likely to occur with a parenteral than with an oral medication, information pertaining to haloperidol is presented, modified only to reflect the extended duration of action of haloperidol decanoate.

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reactions would be manifested by muscular weakness or rigidity and a generalized or localized tremor, as demonstrated by the akinetic or agitans types, respectively. With accidental overdosage, hypertension rather than hypotension occurred in a two-year old child.

The risk of ECG changes associated with torsade de pointes should be considered. Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine.

Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered, and should be continued for several weeks, and then withdrawn gradually as extrapyramidal symptoms may emerge. ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate anti-arrhythmic measures.

Haloperidol Decanoate Injection, 50 mg per mL or Haloperidol Decanoate Injection, mg per mL should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Haloperidol Decanoate Injection, 50 mg per mL or Haloperidol Decanoate Injection, mg per mL are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy.

These patients should be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate. Furthermore, it is recommended that patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting haloperidol in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection.

During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate therapy can be supplemented with short-acting forms of haloperidol.

The dose of Haloperidol Decanoate Injection, 50 mg per mL or Haloperidol Decanoate Injection, mg per mL should be expressed in terms of its haloperidol content.

The starting dose of haloperidol decanoate should be based on the patient's age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed.

For patients previously maintained on low doses of antipsychotics e. Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents. In patients who are elderly, debilitated, or stable on low doses of oral haloperidol e. In patients previously maintained on higher doses of antipsychotics for whom a low dose approach risks recurrence of psychiatric decompensation and in patients whose long-term use of haloperidol has resulted in a tolerance to the drug, 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections.

The initial dose of haloperidol decanoate should not exceed mg regardless of previous antipsychotic dose requirements. If, therefore, conversion requires more than mg of haloperidol decanoate as an initial dose, that dose should be administered in two injections, i. The maintenance dosage of haloperidol decanoate must be individualized with titration upward or downward based on therapeutic response.

The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient. Close clinical supervision is required during initiation and stabilization of haloperidol decanoate therapy.

Haloperidol decanoate is usually administered monthly or every 4 weeks. Clinical experience with haloperidol decanoate at doses greater than mg per month has been limited. Haloperidol Decanoate Injection, 50 mg haloperidol as Haloperidol Decanoate Injection, mg haloperidol as Do not refrigerate or freeze.

Keep in carton until empty. The container closure is not made with natural rubber latex. Haldol , Haldol Decanoate.

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haldol dec injection

Inform your doctor if your symptoms do not improve or if they worsen. Ways to comfort your sick child.

haldol dec injection

Haloperidol is metabolized by several routes, including the glucuronidation and the cytochrome P enzyme system.

haldol dec injection

When prolonged treatment weeks haldol dec injection enzyme-inducing drugs such dex rifampin or carbamazepine is added to HALDOL therapy, this results in a significant reduction of haloperidol plasma levels. Sodium haldol dec injection, a drug known to inhibit glucuronidation, does not affect haloperidol plasma concentrations. Share Email Print Feedback Close. Some medicines are not suitable for people with certain conditions, and sometimes a medicine testosterone deficiency symptoms only be used if extra care is taken. Dizziness and lightheadedness can increase the risk of falling. Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents. Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newbornsuch as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and haldol dec injection or stiff muscles.