Haldol Decanoate - FDA prescribing information, side effects and uses

DESCRIPTION

haldol 50 mg injection

If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist. It has a markedly extended duration of effect. Show More Show Less. Since there is no specific antidote , treatment is primarily supportive. There are reports, however, of cases of limb malformations observed following maternal use of HALDOL along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy.

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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. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The ECG measures the electrical activity of your heart. Skin and Subcutaneous Tissue Disorders: In 5 other schizophrenic patients treated with oral haloperidol and rifampin, discontinuation of rifampin produced a mean 3. 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. It is recommended to alternate between the two gluteal muscles.

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.

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 HALDOL, and then only in association with other medication. 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. Anorexia , constipation, diarrhea , hypersalivation, dyspepsia , nausea and vomiting. Dry mouth , blurred vision , urinary retention, diaphoresis and priapism. An encephalopathic syndrome characterized by weakness, lethargy, fever , tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS followed by irreversible brain damage has occurred in a few patients treated with lithium plus HALDOL.

A causal relationship between these events and the concomitant administration of lithium and HALDOL has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

In 5 other schizophrenic patients treated with oral haloperidol and rifampin, discontinuation of rifampin produced a mean 3. Thus, careful monitoring of clinical status is warranted when rifampin is administered or discontinued in haloperidol-treated patients. Cases of sudden death, QT-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol.

Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism , and familial long QT-syndrome.

A syndrome consisting of potentially irreversible, involuntary , dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.

Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.

However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Antipsychotic treatment, itself, however, may suppress or partially suppress the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that 1 is known to respond to antipsychotic drugs, and 2 for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.

In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered.

However, some patients may require treatment despite the presence of the syndrome. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome NMS has been reported in association with antipsychotic drugs.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including catatonic signs and evidence of autonomic instability irregular pulse or blood pressure , tachycardia , diaphoresis, and cardiac dysrhythmias. Additional signs may include elevated creatine phosphokinase, myoglobinuria rhabdomyolysis and acute renal failure. The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis , it is important to identify cases where the clinical presentation includes both serious medical illness e.

Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system CNS pathology.

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. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered.

The patient should be carefully monitored, since recurrences of NMS have been reported. A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including HALDOL haloperidol.

It has been postulated that lethargy and decreased sensation of thirst due to central inhibition may lead to dehydration , hemoconcentration and reduced pulmonary ventilation. Therefore, if the above signs and symptoms appear, especially in the elderly, the physician should institute remedial therapy promptly. Should hypotension occur and a vasopressor be required, epinephrine should not be used since HALDOL haloperidol may block its vasopressor activity, and paradoxical further lowering of the blood pressure may occur.

Instead, metaraminol, phenylephrine or norepinephrine should be used. If indicated, adequate anticonvulsant therapy should be concomitantly maintained. If both drugs are discontinued simultaneously, extrapyramidal symptoms may occur. The physician should keep in mind the possible increase in intraocular pressure when anticholinergic drugs, including antiparkinson agents, are administered concomitantly with haloperidol decanoate. In patients with thyrotoxicosis who are also receiving antipsychotic medication, including haloperidol decanoate, severe neurotoxicity rigidity, inability to walk or talk may occur.

No mutagenic potential of haloperidol decanoate was found in the Ames Salmonella microsomal activation assay.

Negative or inconsistent positive findings have been obtained in in vitro and in vivo studies of effects of short-acting haloperidol on chromosome structure and number.

The available cytogenetic evidence is considered too inconsistent to be conclusive at this time. In the rat study survival was less than optimal in all dose groups, reducing the number of rats at risk for developing tumors. You may need urgent medical treatment. Hives also known as nettle rash or urticaria , severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction.

The signs may include: An arrhythmia can cause your heart to stop beating cardiac arrest. In elderly people with dementia, a small increase in the number of deaths have been reported for patients taking neuroleptics compared with those not receiving neuroleptics.

The precise frequency of how often this occurs is not known. More saliva than normal, twitching or unusual movements of the tongue, face, mouth, jaw or throat, or rolling of the eyes.

If you get any of these effects, you may be given an additional medicine Tell your doctor or nurse if you notice or suspect any of the following side effects: This medicine should not be refrigerated or frozen.

Haldol decanoate should not be used after the expiry date which is stated on the label. The expiry date refers to the last day of that month. If stored for long periods in the cold, solid particles may form in Haldol decanoate. These may disappear when stored at room temperature. If these particles do not disappear, the ampoule should be thrown away. Haldol decanoate comes in two strengths: What Haldol decanoate looks like and contents of the pack Haldol decanoate is a solution for injection.

It is supplied in glass ampoules containing 1 ml of solution. The ampoules are supplied in packs of 5. The product licence is held by: Strada Provinciale Asolana N. This leaflet was last revised in December Latest Drug Information Updates. Ilumya Ilumya tildrakizumab-asmn is an anti-ILp19 monoclonal antibody for the treatment of moderate-to-severe Cimduo Cimduo lamivudine and tenofovir disoproxil fumarate is a combination of two nucleo t side reverse Symfi Lo Symfi Lo efavirenz, lamivudine and tenofovir disoproxil fumarate is a three-drug combination of a Apadaz Apadaz acetaminophen and benzhydrocodone hydrochloride is an immediate release combination of acetaminophen Erleada Erleada apalutamide is an oral androgen receptor inhibitor for the treatment of men with non-metastatic This medication should not be used if you have certain medical conditions.

Before using this medicine, consult your doctor or pharmacist if you have: Before using this medication, tell your doctor or pharmacist your medical history, especially of: Haloperidol decanoate may cause a condition that affects the heart rhythm QT prolongation. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using haloperidol decanoate, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation.

Talk to your doctor about using haloperidol decanoate safely. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. This medication can reduce sweating , making you more likely to get heatstroke. Avoid hard work and exercise in hot weather. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness , difficulty urinating, and heart effects such as QT prolongation see above.

Drowsiness, dizziness, and lightheadedness can increase the risk of falling. During pregnancy , this medication should be used only when clearly needed. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away. If you are planning pregnancy, become pregnant , or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast -feeding. What should I know regarding pregnancy, nursing and administering Haldol Decanoate 50 Ampul to children or the elderly?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: Many drugs besides haloperidol decanoate may affect the heart rhythm QT prolongation , including amiodarone , dofetilide , pimozide , quinidine , sotalol , procainamide , and macrolide antibiotics such as erythromycin , among others.

Therefore, before using haloperidol, report all medications you are currently using to your doctor or pharmacist. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine.

Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Does Haldol Decanoate 50 Ampul interact with other medications?

If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away.

Iamges: haldol 50 mg injection

haldol 50 mg injection

Close clinical supervision is required during initiation and stabilization of haloperidol decanoate therapy. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. Enzyme induction may be observed after a few days of treatment.

haldol 50 mg injection

It is supplied in glass ampoules containing 1 ml of solution.

haldol 50 mg injection

In patients who are elderly, debilitated, or stable on low doses of oral haloperidol e. Torticollis, Trismus, Muscle twitching. For patients previously maintained on low doses of antipsychotics e. Rodents given up to 3 lexi debol hockey the usual maximum human dose of haloperidol decanoate showed an increase in incidence of resorption, fetal mortality, and pup mortality. Epinephrine mb not be used. Side Effects Dizzinesslightheadednessdrowsiness, difficulty urinating, trouble sleepingheadacheanxietyand pain at the haldol 50 mg injection site may occur.