TAJ PHARMA Haloperidol tablets
Pronunciation
Generic Name: TAJ PHARMA Haloperidol (HAL-oh-PER-i-dol)
Brand Name: Generic only. No brands available.
TAJ PHARMA Haloperidol tablets are used for:
Treating certain mental disorders (eg, schizophrenia) and controlling symptoms associated with Tourette disorder. It also may be used to treat severe behavior problems in children and for short-term treatment in hyperactive children. It also may be used for other conditions as determined by your doctor.
TAJ PHARMA Haloperidol tablets are an antipsychotic agent. Exactly how it works is not known, but it may work by blocking certain chemicals in the brain.
Do NOT use TAJ PHARMA Haloperidol tablets if:
• you are allergic to any ingredient in TAJ PHARMA Haloperidol tablets
• you are in a coma, have Parkinson disease, or have severe central nervous system depression (eg, severe drowsiness, slow or shallow breathing)
• you have severely low levels of certain white blood cells (neutrophils)
• you are taking astemizole, dofetilide, dronedarone, nilotinib, propafenone, sodium oxybate (GHB), terfenadine, or tetrabenazine
Contact your doctor or health care provider right away if any of these apply to you.
SLIDESHOW
View Frightful (But Dead Serious) Drug Side Effects
Before using TAJ PHARMA Haloperidol tablets:
Some medical conditions may interact with TAJ PHARMA Haloperidol tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have the blood disease porphyria, low white blood cell levels, electrolyte problems (eg, low blood magnesium, low blood potassium), or high or low blood pressure
• if you have a history of dementia, Alzheimer disease, seizures, an abnormal electroencephalogram (EEG), thyroid problems, neuroleptic malignant syndrome (NMS), or low white blood cell levels caused by a medicine
• if you have heart problems or irregular heartbeat (eg, QT prolongation, long QT syndrome), or if a member of your family has a history of these conditions
• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer
• if you are dehydrated, drink alcohol, or if you are regularly exposed to extreme heat
• if you are taking medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation) or the risk of electrolyte problems (eg, low blood potassium). Check with your doctor if you are unsure if any of your medicines may increase these risks
Some MEDICINES MAY INTERACT with TAJ PHARMA Haloperidol tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
• Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, propafenone, sotalol), antipsychotics (eg, iloperidone, paliperidone, ziprasidone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, ketolides (eg, telithromycin), kinase inhibitors (eg, lapatinib, nilotinib), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin, moxifloxacin), terfenadine, or tetrabenazine because the risk of serious heart-related side effects may be increased
• Lithium because unexpected toxic effects, including weakness, severe tiredness, confusion, unusual muscle movements, and brain damage, have occurred in a few patients taking this combination. It is not known whether the combination of TAJ PHARMA Haloperidol and lithium may have caused this reaction. Discuss any questions or concerns with your doctor
• Tramadol because the risk of seizures may be increased
• Azole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of TAJ PHARMA Haloperidol tablets's side effects
• Rifampin because it may decrease TAJ PHARMA Haloperidol tablets's effectiveness
• Anticholinergics (eg, benztropine) or carbamazepine because it may increase the risk of TAJ PHARMA Haloperidol tablets's side-effects or decrease TAJ PHARMA Haloperidol tablets's effectiveness
• Anticoagulants (eg, warfarin), narcotic pain medicines (eg, oxycodone), or sodium oxybate (GHB) because the risk of their side effects may be increased by TAJ PHARMA Haloperidol tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if TAJ PHARMA Haloperidol tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use TAJ PHARMA Haloperidol tablets:
Use TAJ PHARMA Haloperidol tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
• Take TAJ PHARMA Haloperidol tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of TAJ PHARMA Haloperidol tablets, take it as soon as possible. Take the remaining doses for the day at evenly spaced intervals. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use TAJ PHARMA Haloperidol tablets.
Important safety information:
• TAJ PHARMA Haloperidol tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use TAJ PHARMA Haloperidol tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT drink alcohol while you are using TAJ PHARMA Haloperidol tablets.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using TAJ PHARMA Haloperidol tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or suddenly stop taking TAJ PHARMA Haloperidol tablets without checking with your doctor.
• TAJ PHARMA Haloperidol tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to TAJ PHARMA Haloperidol tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Tell your doctor or dentist that you take TAJ PHARMA Haloperidol tablets before you receive any medical or dental care, emergency care, or surgery.
• NMS is a possibly fatal syndrome that can be caused by TAJ PHARMA Haloperidol tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take TAJ PHARMA Haloperidol tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take TAJ PHARMA Haloperidol tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking TAJ PHARMA Haloperidol tablets.
• Diabetes patients - TAJ PHARMA Haloperidol tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• TAJ PHARMA Haloperidol tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• TAJ PHARMA Haloperidol tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• TAJ PHARMA Haloperidol tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Lab tests, including complete blood cell counts, may be performed while you use TAJ PHARMA Haloperidol tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use TAJ PHARMA Haloperidol tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
• TAJ PHARMA Haloperidol tablets should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking TAJ PHARMA Haloperidol tablets while you are pregnant. Using TAJ PHARMA Haloperidol tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. TAJ PHARMA Haloperidol tablets are found in breast milk. Do not breast-feed while taking TAJ PHARMA Haloperidol tablets.
Possible side effects of TAJ PHARMA Haloperidol tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; stomach upset; trouble sleeping.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; dark urine; decreased or difficult urination; decreased sexual ability; dehydration; difficulty speaking or swallowing; drooling; enlarged breasts; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); missed menstrual period or other menstrual changes; nipple discharge; prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shortness of breath or unusual cough; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; muscle rigidity, tremor, or weakness; rapid or irregular pulse; slow or shallow breathing; unusual drowsiness or deep sleep; very dry mouth.
Proper storage of TAJ PHARMA Haloperidol tablets:
Store TAJ PHARMA Haloperidol tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep TAJ PHARMA Haloperidol tablets out of the reach of children and away from pets.
General information:
• If you have any questions about TAJ PHARMA Haloperidol tablets, please talk with your doctor, pharmacist, or other health care provider.
• TAJ PHARMA Haloperidol tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take TAJ PHARMA Haloperidol tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about TAJ PHARMA Haloperidol tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to TAJ PHARMA Haloperidol tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using TAJ PHARMA Haloperidol tablets.
In Summary
More frequently reported side effects include: akathisia, blurred vision, constipation, lactation, menstrual disease, myasthenia, weight gain, dysphagia, dysphasia, mask-like face, shuffling gait, mastalgia, restlessness, and xerostomia. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to TAJ PHARMA Haloperidol: oral solution, oral tablet
Other dosage forms:
• intramuscular oil, intramuscular solution, intramuscular suspension
In addition to its needed effects, some unwanted effects may be caused by TAJ PHARMA Haloperidol. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking TAJ PHARMA Haloperidol:
More common:
• Difficulty with speaking or swallowing
• inability to move the eyes
• loss of balance control
• mask-like face
• muscle spasms, especially of the neck and back
• restlessness or need to keep moving (severe)
• shuffling walk
• stiffness of the arms and legs
• trembling and shaking of the fingers and hands
• twisting movements of the body
• weakness of the arms and legs
Less common:
• Decreased thirst
• difficulty in urination
• dizziness, lightheadedness, or fainting
• hallucinations (seeing or hearing things that are not there)
• lip smacking or puckering
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• skin rash
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
Rare
• Confusion
• convulsions (seizures)
• difficult or fast breathing
• fast heartbeat or irregular pulse
• fever (high)
• high or low blood pressure
• hot, dry skin, or lack of sweating
• increased blinking or spasms of the eyelid
• increased sweating
• loss of bladder control
• muscle stiffness (severe)
• muscle weakness
• sore throat and fever
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions
• unusual tiredness or weakness
• unusually pale skin
• yellow eyes or skin
Incidence not known:
• Continuing nausea or vomiting
• increase in the frequency of seizures
• loss of appetite
• swelling of the face
• tiredness and weakness
If any of the following symptoms of overdose occur while taking TAJ PHARMA Haloperidol, get emergency help immediately:
Symptoms of overdose:
• Difficulty with breathing (severe)
• dizziness (severe)
• drowsiness (severe)
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• unusual tiredness or weakness (severe)
Minor Side Effects
Some of the side effects that can occur with TAJ PHARMA Haloperidol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:
• Blurred vision
• changes in menstrual period
• constipation
• dryness of the mouth
• swelling or pain in the breasts (in females)
• unusual secretion of milk
• weight gain
Less common:
• Decreased sexual ability
• drowsiness
• increased sensitivity of the skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn)
• nausea or vomiting
For Healthcare Professionals
Applies to TAJ PHARMA Haloperidol: compounding powder, injectable solution, intramuscular solution, oral concentrate, oral tablet
General
The most common side effects include extrapyramidal disorder, insomnia, and agitation.[Ref]
Nervous system
Acute dystonia usually occurred early in treatment.
Sedation may occur more frequently in elderly patients.
Akathisia usually occurred within 6 hours of administration and may be indistinguishable from psychotic agitation.[Ref]
Very common (10% or more): Extrapyramidal disorder (up to 34%), hyperkinesia (up to 13%), headache (up to 12%)
Common (1% to 10%): Tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypertonia, somnolence, masked facies, tremor, dizziness, parkinsonism/parkinsonian effects
Uncommon (0.1% to 1%): Convulsion, akinesia, cogwheel rigidity, sedation, involuntary muscle contractions, gait disturbance, persistent tardive dyskinesia
Rare (0.01% to 0.1%): Motor dysfunction, neuroleptic malignant syndrome, nystagmus
Frequency not reported: Drowsiness, epileptic/grand mal seizure, vertigo, lethargy
Postmarketing reports: Opisthotonos[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 19%), agitation (up to 15%)
Common (1% to 10%): Depression, psychotic disorder
Uncommon (0.1% to 1%): Confusion, increased/decreased libido, restlessness, hallucinations
Frequency not reported: Apparent exacerbation of psychotic symptoms, anxiety, euphoria, agitation, apprehension, toxic psychosis, catatonic-like behavioral states[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, dry mouth, salivary hypersecretion/hypersalivation, nausea, vomiting
Frequency not reported: Dyspepsia, diarrhea, heartburn, excessive salivation[Ref]
Genitourinary
Common (1% to 10%): Urinary retention, erectile dysfunction, sexual dysfunction
Uncommon (0.1% to 1%): Amenorrhea, dysmenorrhea, galactorrhea, breast discomfort/pain
Rare (0.01% to 0.1%): Menorrhagia, menstrual disorder
Frequency not reported: Priapism, oligomenorrhea, mastalgia, breast engorgement, lactation[Ref]
Cardiovascular
Common (1% to 10%): Orthostatic hypotension, hypotension
Uncommon (0.1% to 1%): Tachycardia, edema
Rare (0.01% to 0.1%): QT prolongation (on ECG)
Frequency not reported: Ventricular fibrillation, Torsade de pointes/polymorphous configuration of Torsade de pointes, ventricular tachycardia, extrasystoles, peripheral edema, venous thromboembolism, deep vein thrombosis, unusual bleeding, heat stroke
Postmarketing reports: Ventricular arrhythmia, cardiac arrest, hypertension[Ref]
QT prolongation, Torsade de pointes, ventricular arrhythmias/fibrillation/tachycardia and cardiac arrest occurred more frequently at high doses and/or in patients at risk for cardiovascular side effects.
Tachycardia and hypotension may occur more frequently in elderly patients. Hypotension occurred as a dose-related event.
Heat stroke included hot, dry skin, the inability to sweat, muscle weakness, and/or confusion.[Ref]
Metabolic
Hyperammonemia occurred in a pediatric patient with citrullinemia (inherited disorder of ammonia excretion).[Ref]
Common (1% to 10%): Weight increased/decreased
Frequency not reported: Hypoglycemia, hyperglycemia, loss of appetite, anorexia, hyponatremia
Postmarketing reports: Hyperammonemia[Ref]
Ocular
Common (1% to 10%): Oculogyric crisis, visual disturbance
Uncommon (0.1% to 1%): Blurred vision
Frequency not reported: Cataracts, retinopathy[Ref]
Dermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Photosensitivity reaction, urticaria, pruritus, hyperhidrosis
Frequency not reported: Exfoliative dermatitis, leukocytoclastic vasculitis, Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular/acneiform skin reactions, alopecia[Ref]
Musculoskeletal
Common (1% to 10%): Muscle rigidity
Uncommon (0.1% to 1%): Torticollis, muscle spasms, musculoskeletal stiffness
Rare (0.01% to 0.1%): Trismus, muscle twitching
Postmarketing reports: Rhabdomyolysis[Ref]
Other
Common (1% to 10%): Hyperthermia
Uncommon (0.1% to 1%): Unusual tiredness/weakness
Frequency not reported: Neonatal drug withdrawal syndrome, sudden/unexpected death, face edema, hypothermia[Ref]
Hepatic
Common (1% to 10%): Abnormal liver function test
Uncommon (0.1% to 1%): Hepatitis, jaundice
Frequency not reported: Acute hepatic failure, cholestasis, impaired liver function[Ref]
Local
Common (1% to 10%): Injection site reaction
Frequency not reported: Injection site abscesses, localized erythema/swelling/tender lumps[Ref]
Respiratory
Uncommon (0.1% to 1%): Dyspnea
Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Laryngeal edema, laryngospasm, pulmonary embolism, increased respiratory rate/depth, sore throat, bronchopneumonia/lethal bronchopneumonia[Ref]
Hematologic
Agranulocytosis included sore throat/fever and unusual bleeding/bruising, and typically occurred with concurrent use of other drugs.
Leukopenia and leukocytosis were usually mild and transient.[Ref]
Uncommon (0.1% to 1%): Leukopenia
Frequency not reported: Agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, unusual bruising, decreased red blood cell counts, anemia, lymphocytosis, monocytosis, lymphomonocytosis[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reaction[Ref]
Endocrine
Inappropriate antidiuretic hormone secretion occurred with hyponatremia[Ref]
Rare (0.01% to 0.1%): Hyperprolactinemia
Frequency not reported: Inappropriate antidiuretic hormone secretion, gynecomastia[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Haldol (TAJ PHARMA Haloperidol)." McNeil Pharmaceutical, Raritan, NJ.
Not all side effects for TAJ PHARMA Haloperidol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to the following strength(s): 0.5 mg ; 1 mg ; 2 mg ; 5 mg ; 10 mg ; 20 mg ; 2 mg/mL ; decanoate 50 mg/mL ; decanoate 100 mg/mL ; 5 mg/mL ; 1 mg/mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
• Schizophrenia
• Agitated State
• Psychosis
• Agitation
• Tourette's Syndrome
Usual Geriatric Dose for:
• Schizophrenia
Usual Pediatric Dose for:
• Psychosis
• Tourette's Syndrome
• Agitated State
• Aggressive Behavior
Additional dosage information:
• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments
Usual Adult Dose for Schizophrenia
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Adult Dose for Agitated State
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Adult Dose for Psychosis
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
TAJ PHARMA Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.
Usual Adult Dose for Agitation
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
TAJ PHARMA Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.
Usual Adult Dose for Tourette's Syndrome
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases.
Usual Geriatric Dose for Schizophrenia
Oral:
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. The lowest possible effective dose should be used since geriatric patients are more sensitive to the adverse effects of TAJ PHARMA Haloperidol (e.g., tardive dyskinesia).
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Pediatric Dose for Psychosis
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
5 years younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
TAJ PHARMA Haloperidol decanoate:
17 year or younger: Safety and efficacy have not been established.
Usual Pediatric Dose for Tourette's Syndrome
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg: 1 to 2 mg orally 2 to 3 times a day.
Usual Pediatric Dose for Agitated State
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.
Intramuscular:
TAJ PHARMA Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
Usual Pediatric Dose for Aggressive Behavior
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.
Intramuscular:
TAJ PHARMA Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
Renal Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with renal dysfunction.
Liver Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with liver dysfunction.
Dose Adjustments
TAJ PHARMA Haloperidol has been associated with dose-dependent QT interval prolongation.
Precautions
TAJ PHARMA Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who have Parkinson's disease.
Sudden death has been reported in psychiatric patients treated with TAJ PHARMA Haloperidol. In addition, QT interval prolongation and Torsades de Pointes have been observed in patients treated with TAJ PHARMA Haloperidol. The risk of QT interval prolongation and Torsades de Pointes appears to be increased when larger than recommended dosages are used, and with intravenous administration. Patients with conditions that prolong the QT interval (e.g., cardiac abnormalities, hypothyroidism, long QT syndromes, hypokalemia, hypomagnesemia, electrolyte imbalances, drugs known to prolong QT, etc.) should be treated with caution. TAJ PHARMA Haloperidol decanoate must never be given intravenously. TAJ PHARMA Haloperidol lactate is not approved for intravenous use; however, if intravenous administration is given, the ECG should be monitored for QT prolongation and arrhythmias.
Dialysis
A supplemental dose is not necessary with dialysis.
Other Comments
Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.
A total of 1072 drugs (6052 brand and generic names) are known to interact with TAJ PHARMA Haloperidol.
• 186 major drug interactions (616 brand and generic names)
• 865 moderate drug interactions (5356 brand and generic names)
• 21 minor drug interactions (80 brand and generic names)
Show all medications in the database that may interact with TAJ PHARMA Haloperidol.
Check for interactions with TAJ PHARMA Haloperidol
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 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 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. TAJ PHARMA Haloperidol Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
TAJ PHARMA Haloperidol Description
TAJ PHARMA Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula:
TAJ PHARMA Haloperidol is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg TAJ PHARMA Haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 – 3.6.
ACTIONS
The precise mechanism of action has not been clearly established.
Review Date: January 6, 2017
Pronunciation
Generic Name: TAJ PHARMA Haloperidol (HAL-oh-PER-i-dol)
Brand Name: Generic only. No brands available.
TAJ PHARMA Haloperidol tablets are used for:
Treating certain mental disorders (eg, schizophrenia) and controlling symptoms associated with Tourette disorder. It also may be used to treat severe behavior problems in children and for short-term treatment in hyperactive children. It also may be used for other conditions as determined by your doctor.
TAJ PHARMA Haloperidol tablets are an antipsychotic agent. Exactly how it works is not known, but it may work by blocking certain chemicals in the brain.
Do NOT use TAJ PHARMA Haloperidol tablets if:
• you are allergic to any ingredient in TAJ PHARMA Haloperidol tablets
• you are in a coma, have Parkinson disease, or have severe central nervous system depression (eg, severe drowsiness, slow or shallow breathing)
• you have severely low levels of certain white blood cells (neutrophils)
• you are taking astemizole, dofetilide, dronedarone, nilotinib, propafenone, sodium oxybate (GHB), terfenadine, or tetrabenazine
Contact your doctor or health care provider right away if any of these apply to you.
SLIDESHOW
View Frightful (But Dead Serious) Drug Side Effects
Before using TAJ PHARMA Haloperidol tablets:
Some medical conditions may interact with TAJ PHARMA Haloperidol tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have the blood disease porphyria, low white blood cell levels, electrolyte problems (eg, low blood magnesium, low blood potassium), or high or low blood pressure
• if you have a history of dementia, Alzheimer disease, seizures, an abnormal electroencephalogram (EEG), thyroid problems, neuroleptic malignant syndrome (NMS), or low white blood cell levels caused by a medicine
• if you have heart problems or irregular heartbeat (eg, QT prolongation, long QT syndrome), or if a member of your family has a history of these conditions
• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer
• if you are dehydrated, drink alcohol, or if you are regularly exposed to extreme heat
• if you are taking medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation) or the risk of electrolyte problems (eg, low blood potassium). Check with your doctor if you are unsure if any of your medicines may increase these risks
Some MEDICINES MAY INTERACT with TAJ PHARMA Haloperidol tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
• Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, propafenone, sotalol), antipsychotics (eg, iloperidone, paliperidone, ziprasidone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, ketolides (eg, telithromycin), kinase inhibitors (eg, lapatinib, nilotinib), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin, moxifloxacin), terfenadine, or tetrabenazine because the risk of serious heart-related side effects may be increased
• Lithium because unexpected toxic effects, including weakness, severe tiredness, confusion, unusual muscle movements, and brain damage, have occurred in a few patients taking this combination. It is not known whether the combination of TAJ PHARMA Haloperidol and lithium may have caused this reaction. Discuss any questions or concerns with your doctor
• Tramadol because the risk of seizures may be increased
• Azole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of TAJ PHARMA Haloperidol tablets's side effects
• Rifampin because it may decrease TAJ PHARMA Haloperidol tablets's effectiveness
• Anticholinergics (eg, benztropine) or carbamazepine because it may increase the risk of TAJ PHARMA Haloperidol tablets's side-effects or decrease TAJ PHARMA Haloperidol tablets's effectiveness
• Anticoagulants (eg, warfarin), narcotic pain medicines (eg, oxycodone), or sodium oxybate (GHB) because the risk of their side effects may be increased by TAJ PHARMA Haloperidol tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if TAJ PHARMA Haloperidol tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use TAJ PHARMA Haloperidol tablets:
Use TAJ PHARMA Haloperidol tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
• Take TAJ PHARMA Haloperidol tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of TAJ PHARMA Haloperidol tablets, take it as soon as possible. Take the remaining doses for the day at evenly spaced intervals. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use TAJ PHARMA Haloperidol tablets.
Important safety information:
• TAJ PHARMA Haloperidol tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use TAJ PHARMA Haloperidol tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT drink alcohol while you are using TAJ PHARMA Haloperidol tablets.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using TAJ PHARMA Haloperidol tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or suddenly stop taking TAJ PHARMA Haloperidol tablets without checking with your doctor.
• TAJ PHARMA Haloperidol tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to TAJ PHARMA Haloperidol tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Tell your doctor or dentist that you take TAJ PHARMA Haloperidol tablets before you receive any medical or dental care, emergency care, or surgery.
• NMS is a possibly fatal syndrome that can be caused by TAJ PHARMA Haloperidol tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take TAJ PHARMA Haloperidol tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take TAJ PHARMA Haloperidol tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking TAJ PHARMA Haloperidol tablets.
• Diabetes patients - TAJ PHARMA Haloperidol tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• TAJ PHARMA Haloperidol tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• TAJ PHARMA Haloperidol tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• TAJ PHARMA Haloperidol tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Lab tests, including complete blood cell counts, may be performed while you use TAJ PHARMA Haloperidol tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use TAJ PHARMA Haloperidol tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
• TAJ PHARMA Haloperidol tablets should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking TAJ PHARMA Haloperidol tablets while you are pregnant. Using TAJ PHARMA Haloperidol tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. TAJ PHARMA Haloperidol tablets are found in breast milk. Do not breast-feed while taking TAJ PHARMA Haloperidol tablets.
Possible side effects of TAJ PHARMA Haloperidol tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; stomach upset; trouble sleeping.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; dark urine; decreased or difficult urination; decreased sexual ability; dehydration; difficulty speaking or swallowing; drooling; enlarged breasts; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); missed menstrual period or other menstrual changes; nipple discharge; prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shortness of breath or unusual cough; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; muscle rigidity, tremor, or weakness; rapid or irregular pulse; slow or shallow breathing; unusual drowsiness or deep sleep; very dry mouth.
Proper storage of TAJ PHARMA Haloperidol tablets:
Store TAJ PHARMA Haloperidol tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep TAJ PHARMA Haloperidol tablets out of the reach of children and away from pets.
General information:
• If you have any questions about TAJ PHARMA Haloperidol tablets, please talk with your doctor, pharmacist, or other health care provider.
• TAJ PHARMA Haloperidol tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take TAJ PHARMA Haloperidol tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about TAJ PHARMA Haloperidol tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to TAJ PHARMA Haloperidol tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using TAJ PHARMA Haloperidol tablets.
In Summary
More frequently reported side effects include: akathisia, blurred vision, constipation, lactation, menstrual disease, myasthenia, weight gain, dysphagia, dysphasia, mask-like face, shuffling gait, mastalgia, restlessness, and xerostomia. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to TAJ PHARMA Haloperidol: oral solution, oral tablet
Other dosage forms:
• intramuscular oil, intramuscular solution, intramuscular suspension
In addition to its needed effects, some unwanted effects may be caused by TAJ PHARMA Haloperidol. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking TAJ PHARMA Haloperidol:
More common:
• Difficulty with speaking or swallowing
• inability to move the eyes
• loss of balance control
• mask-like face
• muscle spasms, especially of the neck and back
• restlessness or need to keep moving (severe)
• shuffling walk
• stiffness of the arms and legs
• trembling and shaking of the fingers and hands
• twisting movements of the body
• weakness of the arms and legs
Less common:
• Decreased thirst
• difficulty in urination
• dizziness, lightheadedness, or fainting
• hallucinations (seeing or hearing things that are not there)
• lip smacking or puckering
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• skin rash
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
Rare
• Confusion
• convulsions (seizures)
• difficult or fast breathing
• fast heartbeat or irregular pulse
• fever (high)
• high or low blood pressure
• hot, dry skin, or lack of sweating
• increased blinking or spasms of the eyelid
• increased sweating
• loss of bladder control
• muscle stiffness (severe)
• muscle weakness
• sore throat and fever
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions
• unusual tiredness or weakness
• unusually pale skin
• yellow eyes or skin
Incidence not known:
• Continuing nausea or vomiting
• increase in the frequency of seizures
• loss of appetite
• swelling of the face
• tiredness and weakness
If any of the following symptoms of overdose occur while taking TAJ PHARMA Haloperidol, get emergency help immediately:
Symptoms of overdose:
• Difficulty with breathing (severe)
• dizziness (severe)
• drowsiness (severe)
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• unusual tiredness or weakness (severe)
Minor Side Effects
Some of the side effects that can occur with TAJ PHARMA Haloperidol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:
• Blurred vision
• changes in menstrual period
• constipation
• dryness of the mouth
• swelling or pain in the breasts (in females)
• unusual secretion of milk
• weight gain
Less common:
• Decreased sexual ability
• drowsiness
• increased sensitivity of the skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn)
• nausea or vomiting
For Healthcare Professionals
Applies to TAJ PHARMA Haloperidol: compounding powder, injectable solution, intramuscular solution, oral concentrate, oral tablet
General
The most common side effects include extrapyramidal disorder, insomnia, and agitation.[Ref]
Nervous system
Acute dystonia usually occurred early in treatment.
Sedation may occur more frequently in elderly patients.
Akathisia usually occurred within 6 hours of administration and may be indistinguishable from psychotic agitation.[Ref]
Very common (10% or more): Extrapyramidal disorder (up to 34%), hyperkinesia (up to 13%), headache (up to 12%)
Common (1% to 10%): Tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypertonia, somnolence, masked facies, tremor, dizziness, parkinsonism/parkinsonian effects
Uncommon (0.1% to 1%): Convulsion, akinesia, cogwheel rigidity, sedation, involuntary muscle contractions, gait disturbance, persistent tardive dyskinesia
Rare (0.01% to 0.1%): Motor dysfunction, neuroleptic malignant syndrome, nystagmus
Frequency not reported: Drowsiness, epileptic/grand mal seizure, vertigo, lethargy
Postmarketing reports: Opisthotonos[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 19%), agitation (up to 15%)
Common (1% to 10%): Depression, psychotic disorder
Uncommon (0.1% to 1%): Confusion, increased/decreased libido, restlessness, hallucinations
Frequency not reported: Apparent exacerbation of psychotic symptoms, anxiety, euphoria, agitation, apprehension, toxic psychosis, catatonic-like behavioral states[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, dry mouth, salivary hypersecretion/hypersalivation, nausea, vomiting
Frequency not reported: Dyspepsia, diarrhea, heartburn, excessive salivation[Ref]
Genitourinary
Common (1% to 10%): Urinary retention, erectile dysfunction, sexual dysfunction
Uncommon (0.1% to 1%): Amenorrhea, dysmenorrhea, galactorrhea, breast discomfort/pain
Rare (0.01% to 0.1%): Menorrhagia, menstrual disorder
Frequency not reported: Priapism, oligomenorrhea, mastalgia, breast engorgement, lactation[Ref]
Cardiovascular
Common (1% to 10%): Orthostatic hypotension, hypotension
Uncommon (0.1% to 1%): Tachycardia, edema
Rare (0.01% to 0.1%): QT prolongation (on ECG)
Frequency not reported: Ventricular fibrillation, Torsade de pointes/polymorphous configuration of Torsade de pointes, ventricular tachycardia, extrasystoles, peripheral edema, venous thromboembolism, deep vein thrombosis, unusual bleeding, heat stroke
Postmarketing reports: Ventricular arrhythmia, cardiac arrest, hypertension[Ref]
QT prolongation, Torsade de pointes, ventricular arrhythmias/fibrillation/tachycardia and cardiac arrest occurred more frequently at high doses and/or in patients at risk for cardiovascular side effects.
Tachycardia and hypotension may occur more frequently in elderly patients. Hypotension occurred as a dose-related event.
Heat stroke included hot, dry skin, the inability to sweat, muscle weakness, and/or confusion.[Ref]
Metabolic
Hyperammonemia occurred in a pediatric patient with citrullinemia (inherited disorder of ammonia excretion).[Ref]
Common (1% to 10%): Weight increased/decreased
Frequency not reported: Hypoglycemia, hyperglycemia, loss of appetite, anorexia, hyponatremia
Postmarketing reports: Hyperammonemia[Ref]
Ocular
Common (1% to 10%): Oculogyric crisis, visual disturbance
Uncommon (0.1% to 1%): Blurred vision
Frequency not reported: Cataracts, retinopathy[Ref]
Dermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Photosensitivity reaction, urticaria, pruritus, hyperhidrosis
Frequency not reported: Exfoliative dermatitis, leukocytoclastic vasculitis, Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular/acneiform skin reactions, alopecia[Ref]
Musculoskeletal
Common (1% to 10%): Muscle rigidity
Uncommon (0.1% to 1%): Torticollis, muscle spasms, musculoskeletal stiffness
Rare (0.01% to 0.1%): Trismus, muscle twitching
Postmarketing reports: Rhabdomyolysis[Ref]
Other
Common (1% to 10%): Hyperthermia
Uncommon (0.1% to 1%): Unusual tiredness/weakness
Frequency not reported: Neonatal drug withdrawal syndrome, sudden/unexpected death, face edema, hypothermia[Ref]
Hepatic
Common (1% to 10%): Abnormal liver function test
Uncommon (0.1% to 1%): Hepatitis, jaundice
Frequency not reported: Acute hepatic failure, cholestasis, impaired liver function[Ref]
Local
Common (1% to 10%): Injection site reaction
Frequency not reported: Injection site abscesses, localized erythema/swelling/tender lumps[Ref]
Respiratory
Uncommon (0.1% to 1%): Dyspnea
Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Laryngeal edema, laryngospasm, pulmonary embolism, increased respiratory rate/depth, sore throat, bronchopneumonia/lethal bronchopneumonia[Ref]
Hematologic
Agranulocytosis included sore throat/fever and unusual bleeding/bruising, and typically occurred with concurrent use of other drugs.
Leukopenia and leukocytosis were usually mild and transient.[Ref]
Uncommon (0.1% to 1%): Leukopenia
Frequency not reported: Agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, unusual bruising, decreased red blood cell counts, anemia, lymphocytosis, monocytosis, lymphomonocytosis[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reaction[Ref]
Endocrine
Inappropriate antidiuretic hormone secretion occurred with hyponatremia[Ref]
Rare (0.01% to 0.1%): Hyperprolactinemia
Frequency not reported: Inappropriate antidiuretic hormone secretion, gynecomastia[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Haldol (TAJ PHARMA Haloperidol)." McNeil Pharmaceutical, Raritan, NJ.
Not all side effects for TAJ PHARMA Haloperidol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to the following strength(s): 0.5 mg ; 1 mg ; 2 mg ; 5 mg ; 10 mg ; 20 mg ; 2 mg/mL ; decanoate 50 mg/mL ; decanoate 100 mg/mL ; 5 mg/mL ; 1 mg/mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
• Schizophrenia
• Agitated State
• Psychosis
• Agitation
• Tourette's Syndrome
Usual Geriatric Dose for:
• Schizophrenia
Usual Pediatric Dose for:
• Psychosis
• Tourette's Syndrome
• Agitated State
• Aggressive Behavior
Additional dosage information:
• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments
Usual Adult Dose for Schizophrenia
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Adult Dose for Agitated State
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Adult Dose for Psychosis
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
TAJ PHARMA Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.
Usual Adult Dose for Agitation
Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
TAJ PHARMA Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.
Usual Adult Dose for Tourette's Syndrome
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases.
Usual Geriatric Dose for Schizophrenia
Oral:
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. The lowest possible effective dose should be used since geriatric patients are more sensitive to the adverse effects of TAJ PHARMA Haloperidol (e.g., tardive dyskinesia).
Parenteral:
TAJ PHARMA Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.
Usual Pediatric Dose for Psychosis
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, TAJ PHARMA Haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.
Parenteral:
TAJ PHARMA Haloperidol lactate:
5 years younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
TAJ PHARMA Haloperidol decanoate:
17 year or younger: Safety and efficacy have not been established.
Usual Pediatric Dose for Tourette's Syndrome
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg: 1 to 2 mg orally 2 to 3 times a day.
Usual Pediatric Dose for Agitated State
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.
Intramuscular:
TAJ PHARMA Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
Usual Pediatric Dose for Aggressive Behavior
Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.
Intramuscular:
TAJ PHARMA Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.
Renal Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with renal dysfunction.
Liver Dose Adjustments
The manufacturer recommends caution when administering this drug to patients with liver dysfunction.
Dose Adjustments
TAJ PHARMA Haloperidol has been associated with dose-dependent QT interval prolongation.
Precautions
TAJ PHARMA Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who have Parkinson's disease.
Sudden death has been reported in psychiatric patients treated with TAJ PHARMA Haloperidol. In addition, QT interval prolongation and Torsades de Pointes have been observed in patients treated with TAJ PHARMA Haloperidol. The risk of QT interval prolongation and Torsades de Pointes appears to be increased when larger than recommended dosages are used, and with intravenous administration. Patients with conditions that prolong the QT interval (e.g., cardiac abnormalities, hypothyroidism, long QT syndromes, hypokalemia, hypomagnesemia, electrolyte imbalances, drugs known to prolong QT, etc.) should be treated with caution. TAJ PHARMA Haloperidol decanoate must never be given intravenously. TAJ PHARMA Haloperidol lactate is not approved for intravenous use; however, if intravenous administration is given, the ECG should be monitored for QT prolongation and arrhythmias.
Dialysis
A supplemental dose is not necessary with dialysis.
Other Comments
Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.
A total of 1072 drugs (6052 brand and generic names) are known to interact with TAJ PHARMA Haloperidol.
• 186 major drug interactions (616 brand and generic names)
• 865 moderate drug interactions (5356 brand and generic names)
• 21 minor drug interactions (80 brand and generic names)
Show all medications in the database that may interact with TAJ PHARMA Haloperidol.
Check for interactions with TAJ PHARMA Haloperidol
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 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 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. TAJ PHARMA Haloperidol Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
TAJ PHARMA Haloperidol Description
TAJ PHARMA Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula:
TAJ PHARMA Haloperidol is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg TAJ PHARMA Haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 – 3.6.
ACTIONS
The precise mechanism of action has not been clearly established.
Review Date: January 6, 2017
