Haldol Depot (Haloperidol Krka depo) 50 mg/mL injection – haloperidol decanoate for maintenance treatment of schizophrenia

Haldol Depot is the former name of the Krka long-acting antipsychotic which in Serbia is now marketed as Haloperidol Krka depo. It contains haloperidol as haloperidol decanoate – 50 mg haloperidol in 1 mL of oily solution for injection.

The medicine is given as a deep injection into a muscle (gluteal), and the effect of one dose usually lasts 4 weeks. It is intended as maintenance treatment for adults with schizophrenia or schizoaffective disorder who have previously been stabilised on oral haloperidol. It is given only by a doctor or nurse in a healthcare institution.

What is Haldol Depot (Haloperidol Krka depo) used for and how is it given?

Key facts about the medicine

What is Haldol Depot used for?

According to the leaflet and the information for healthcare professionals, Haloperidol Krka depo is indicated as maintenance treatment of schizophrenia and schizoaffective disorder in adults who are currently stabilised on oral haloperidol.

These illnesses may cause confusion (delirium), hallucinations, delusions, paranoia, excessive excitement, impulsiveness or hyperactivity and aggressive or violent behaviour. The depot form provides an even effect with one injection every four weeks.

How is it given and dosed?

The dose is determined individually by the doctor under careful clinical supervision, based on the previous oral haloperidol dose, age, kidney and liver function and other medicines. Patients are maintained on the lowest effective dose.

• Adults: the usual starting dose is 25–150 mg; the dose may be adjusted by 50 mg every 4 weeks, most often to 50–200 mg every 4 weeks. Maximum 300 mg every 4 weeks.
• Elderly: usually start with 12.5–25 mg every 4 weeks, then most often 25–75 mg every 4 weeks; more than 75 mg only if the doctor considers it safe.
• Administration: deep intramuscular injection into the gluteal muscle, alternating between left and right; never into a vein. The medicine is not mixed with other solutions for injection.
• The doctor may also prescribe haloperidol tablets alongside the depot injection.

Special patient groups

• Children and adolescents: the medicine is not intended for under-18s.
• Elderly patients and patients with dementia: lower doses; in elderly people with dementia a small increase in deaths and stroke has been reported with antipsychotics.
• Kidney or liver impairment: the dose is adjusted; because of benzyl alcohol, special caution in liver or kidney disease (possible accumulation and metabolic acidosis).

Contraindications – when the medicine must not be used

Do not receive Haloperidol Krka depo:

• if you are allergic to haloperidol or any of the excipients (benzyl alcohol, sesame oil);
• if you are less aware of your surroundings or your reactions become unusually slow;
• if you have Parkinson's disease, dementia with Lewy bodies or progressive supranuclear palsy;
• if you have a prolonged QT interval or another heart rhythm problem, heart failure or a recent heart attack;
• if you have untreated low blood potassium;
• if you take medicines that prolong the QT interval – medicines for irregular heart rhythm (amiodarone, dofetilide, disopyramide, dronedarone, ibutilide, quinidine, sotalol), citalopram, escitalopram, certain antipsychotics (e.g. fluphenazine, pimozide, sertindole, ziprasidone), azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, telithromycin, pentamidine, halofantrine, dolasetron, toremifene or vandetanib.

Warnings and precautions

Talk to your doctor before use if you have a slow heart rate or heart disease (or sudden cardiac death in the family), low blood pressure or dizziness on standing, low potassium or magnesium, bleeding in the brain or an increased risk of stroke, epilepsy, kidney, liver or thyroid problems, high prolactin or a prolactin-dependent cancer, a personal or family history of blood clots, depression or bipolar disorder.

• The doctor may request an ECG and tests for potassium, magnesium and other electrolytes before and during treatment.
• Benzyl alcohol: 15 mg per 1 mL (0.2 mg/kg for a 75 kg person) – may cause allergic reactions; consult your doctor if you are pregnant, breast-feeding or have liver or kidney disease.
• Sesame oil: may rarely cause severe allergic reactions.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take. In addition to the medicines listed under contraindications:

• lithium: additional monitoring is needed; unexplained fever, uncontrollable movements, confusion, headache, balance problems and drowsiness require urgent assessment;
• medicines that alter the effect of haloperidol and increase the cardiac risk: alprazolam, buspirone, certain antidepressants (duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, venlafaxine, bupropion), St John's wort, carbamazepine, phenobarbital, phenytoin, rifampicin, azole antifungals, HIV medicines, chlorpromazine, promethazine, verapamil, blood pressure medicines and diuretics;
• medicines whose effect haloperidol alters: tranquillisers and sleeping medicines, strong painkillers, tricyclic antidepressants, guanethidine, methyldopa, adrenaline, stimulants, levodopa, phenindione.

Pregnancy and breast-feeding

• Pregnancy: consult your doctor. Newborns of mothers treated in the last trimester may show trembling, stiffness or weakness of muscles, sleepiness or agitation and breathing or feeding problems.
• Breast-feeding: haloperidol passes into breast milk in small amounts; the doctor decides.
• Fertility: raised prolactin may affect fertility.

Driving and using machines

According to the leaflet, the medicine has a strong effect on psychophysical abilities – driving a motor vehicle or working with machines is not permitted during treatment.

Possible side effects

Like all medicines, Haloperidol Krka depo can cause side effects, although not everybody gets them.

• Serious – see a doctor immediately: heart rhythm disorders, fast heartbeat and palpitations (uncommon; sudden deaths have also been reported); neuroleptic malignant syndrome; extrapyramidal disorders – tardive dyskinesia, restlessness, slowed movements, tremor, stiffness, mask-like face (very common); severe allergic reaction; blood clots in the leg veins.
• Common (up to 1 in 10): depression, insomnia or sleepiness, constipation, dry mouth or increased saliva, sexual dysfunction, irritation, pain or abscess at the injection site, weight gain.
• Uncommon (up to 1 in 100): abnormal muscle tension, headache, uncontrolled eye movements, blurred vision.
• Not known: delusions and hallucinations, agitation or confusion, seizures, dizziness and drop in blood pressure on standing, breathing problems, nausea, vomiting, reduced blood cell counts, raised prolactin, SIADH, low blood sugar, liver problems and jaundice, skin changes, sweating, rhabdomyolysis, muscle spasms, difficulty opening the mouth, urinary retention, priapism, impotence, reduced libido, menstrual disorders, milk secretion, breast enlargement in men, swelling, temperature disturbance, gait disturbance, weight loss.

Overdose, missed dose and stopping treatment

• Overdose: the medicine is given by a healthcare professional, so overdose is not expected; if you are concerned, talk to your doctor or nurse.
• Missed dose: if you miss a scheduled injection, contact your doctor as soon as possible.
• Stopping treatment: do not stop treatment without your doctor's advice, as symptoms of the illness may return.

Related information

For questions about the injection schedule, switching from tablets and ECG checks, contact the psychiatrist managing your treatment. Haloperidol tablets and the short-acting injection are described on the Haldol (Haloperidol Krka) page.

Composition, pack and manufacturer

• Active substance: haloperidol decanoate – 1 mL (1 ampoule) contains 50 mg haloperidol as haloperidol decanoate.
• Excipients: benzyl alcohol (E1519) – 15 mg/mL; refined sesame oil.
• Pack: glass ampoules with 1 mL of solution; carton with 1 blister of 5 ampoules.
• Marketing authorisation holder: Krka-Farma d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: Krka d.d., Novo mesto, Šmarješka cesta 6, Slovenia.

Storage

• Store below 25 °C in the original package.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

Is Haldol Depot the same as Haloperidol Krka depo?

Yes – it is the same long-acting Krka haloperidol decanoate (50 mg/mL, 5 ampoules), renewed on 09.11.2023 under the name Haloperidol Krka depo.

How often is the injection given?

Usually once every 4 weeks, deep into a muscle. The dose is adjusted individually – in adults most often 50–200 mg, at most 300 mg every 4 weeks.

Who can receive Haldol Depot?

Adults with schizophrenia or schizoaffective disorder who are already stabilised on haloperidol tablets. The medicine is not intended for under-18s.

What if I miss a scheduled injection?

Contact your doctor as soon as possible. Do not stop treatment on your own, as symptoms of the illness may return.

Sources

• ALIMS – Summary of Product Characteristics, Haloperidol Krka depo 50 mg/mL solution for injection (SmPC, Serbian)
• ALIMS – Patient leaflet, Haloperidol Krka depo 50 mg/mL solution for injection (PIL, Serbian)

Sources checked on: 25 October 2026.