Halofar Pharmedic Treatment Treatment of mental disorders (10 blisters x 20 tablets)

Dosage form Box of 10 blisters x 20 tablets
Specifications Haloperidol

Ingredient

Composition information	Content
Haloperidol	2mg

Uses

indications

Halofar drugs are indicated in the following cases:

Treat the manifestations of mental disorders.

Control motor jerking and pronunciation in tourette syndrome in children and adults.

Treatment of serious behavioral issues in children such as quarrels, attacks, agitation (although there is no provocation).

Treatment of short -term children with excessive hyperactive children accompanied by behavioral disorders including the following symptoms: obsession, difficulty concentration, aggression, unstable mood and inadequate tolerance.

Haloperidol for children when not responding to psychotherapy or other anti -psychotic drugs. Haloperidol is a dopamine receptor antagonist 2 (D2), at the recommended dose with low Adrigernic alpha-1 and no antihistamine or cholinergic activity.

Haloperidol pharmacological effect inhibits paranoia and hallucinations by closing the dopaminergic signal in the masolimbic path.

The central dopamine blockage effect works on the background lymph nodes.

Dynamic pharmacokinetics

absorption

After drinking, Haloperidol is absorbed from 60 to 70% of the digestive tract. The peak concentration is reached after about 26 hours.

distribution

Haloperidol is quickly distributed to different tissues and agencies.

Average plasma haloperidol concentration in adults ranges from 80 to 92%. Haloperidol passes through blood and brain barriers; It also goes through the placenta and is excreted into breast milk.

transformation

Haloperidol is metabolized mainly in the liver.

Haloperidol's main metabolic lines include glucuronids, reducing kinema, oxidation of n-dealkylation and the formation of pyridinium metabolites. Cytochrome P450 - CYP3A4 and CYP2D6 enzymes are related to Haloperidol metabolism, inhibit or stimulate CYP3A4, or inhibit CYP2D6, which can affect Haloperidol metabolism.

The reduction of the activity of CYP2D6 may increase the concentration of Haloperidol. Elimination: Haloperidol's exhaust time is about 24 hours (about 15 to 37 hours) after drinking. After Haloperidol intravenous injection, 21% of the dose was eliminated in feces and 33% in urine.

Before taking Halofar Pharmedic Treatment Treatment of mental disorders (10 blisters x 20 tablets)

How to use

Halofar tablets for oral tablets.

Dosage

Dosage to be treated has a significant change among patients.

As with all other anti -psychotic drugs, dosage should be according to the needs and response of each patient.

The dose adjustment must be done as quickly as possible to achieve optimal treatment control. To determine the initial dosage, it is necessary to consider the age, the extent of the patient's disease, the previous response to other anti -psychotic drugs and any accompanying drugs or the disease.

Children, depression patients or geriatric as well as people with a history of side effects on anti -psychotic drugs, may need less dose Haloperidol. Optimal response in these patients is often achieved when the dose adjusts gradually and with low doses, as suggested below.

Starting dose:

Adults

Average symptoms: 0.5 mg-2 mg, 2-3 times/day.

Severe symptoms: 3 mg-5 mg, 2-3 times/day. To achieve fast control, higher doses may be needed in some cases.

Elderly or physical weakness: 0.5 mg-2 mg, 2-3 times/ day.

Chronic or drug resistance: 3 mg - 5 mg, 2-3 times/day. The patient is still uncomfortable or controlled badly, may need to adjust the dose.

In some cases, daily dose of up to 100 mg may be necessary to achieve optimal response. Sometimes Haloperidol can be used over 100 mg for patients with severe drug resistance. However, clinical data did not prove the safety of the use of this dose extended.

Children

Haloperidol is not for children under 3 years old.

Children from 3-12 years old (weighing from 15 kg to 40 kg): The treatment should start with the lowest possible doses (0.5 mg/day). If necessary, the dose will increase by 0.5 mg, in about 5-7 days until the desired treatment results are achieved. The total dose can be divided into 2-3 times/day.

Mental disorders: 0.05 -0.15 mg/kg/day.

Disorders of mental behavior and tourette syndrome: 0.05 - 0.075 mg/kg/day.

Among children with severe mental disorders or hyperactive children with over -behavioral disorders that do not respond to psychotherapy or other anti -psychotic drugs, short -term Haloperidol may be enough to respond. There is no evidence that the maximum dosage will be effective. There is very little evidence that improving the behavior achieved in the dosage exceeds 6 mg/ day.

Maintenance dose: When achieved treatment, dosage should gradually decrease to the point of efficiency.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms:

The reaction of severe pagoda, hypotension and sedation. In severe cases, the patient will appear coma with respiratory inhibition and lower blood pressure to create a state of shock. It is necessary to monitor the risk of ventricular arrhythmia that extends the QT range.

How to handle:

There is no specific antidote. Support treatment. The pathway must be used for trachea or intubation in a coma.

Need artificial respiration in respiratory inhibitors. Track ECG and important signs and continue tracking until normal ECG.

recommendations to treat severe arrhythmia with appropriate anti -arrhythmic measures. Hypotension and circulating stroke can be resolved by plasma intravenous or concentrated albumin and vasodilators, such as dopamine or noradrenalin.

In case of serious non -pagoda reactions should be injected with anti -Parkinson.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Halofar, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache, dizziness, depression and sedation. Symptoms of the pagoda with acute tone disorders, Parkinson's syndrome, standing still, late dysfunction occurs when long -term treatment.

Uncommon, 1/1000

Increase salivation and sweat, appetite, insomnia and weight change.

Heart beat fast and lower blood pressure, secretion of milk, big breasts, less menstruation or menstruation, vomiting, constipation, indigestion, dry mouth.

Symptoms of foreign tower with movement, weakness, muscle weakness.

Great seizures, mental stimulation, confusion, pee and blurred vision.

rare, ADR

Hypersensitivity reaction, such as skin reaction, urticaria, anaphylaxis.

Malignant sutta syndrome, leukopenia, granulocytosis, thrombocytopenia.

ventricular arrhythmia, hypoglycemia, hepatitis and biliary obstruction in the liver.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Halofar drugs contraindicated in the following cases:

allergies to any component of the drug.

Parkinson's coma.

Innocence.

Progressive paralysis.

Prolonged QT interval or prolonged congenital QT syndrome. Recent myocardial infarction.

Damage heart failure.

History of ventricular or ventricular arrhythmia.

Hypotension has not been adjusted.

Concomitant treatment with drug products that extend QT

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Increases the death rate in the elderly with dementia: an elderly person with mental illness accompanied by intellectual dementia treated with anti -psychotic drugs is at high risk of death.

Extended QT interval and/ or ventricular arrhythmia, have been reported to Haloperidol.

electrolyte disorders such as hypotension and hypoglycemia increases the risk of ventricular arrhyths and must be treated before treatment with Haloperidol.

tachycardia and hypotension (including vertical hypotension) have been reported.

Caution in patients with risk factors for stroke.

Malignant neuroleptic syndrome: Rare reactions are characterized by increased body temperature, muscle contraction, consciousness changes and increases blood clearance of blood phosphokinase. Increasing body temperature is usually an early sign of this syndrome.

Slow movement disorders:

Slow movement may appear in several patients when long -term treatment or after stopping the drug.

Symptoms can occur (tremor, spasticity, salivation, slow movement, stop movement, acute disorder).

seizures/convulsions: There are reports of convulsions that can be caused by Haloperidol.

Haloperidol is metabolized in the liver, so the dose should be adjusted and cautious in patients with liver failure. Abnormal liver function or hepatitis, often the cholestock stasis has been reported.

Regarding the endocrine system:

thyroxin increases the toxicity of Haloperidol. Haloperidol.

Cases of venous thrombosis (VTE) have been reported to anti -psychotic drugs.

Response treatment and quitting:

In schizophrenia, responding to anti -psychotic treatment may be slow. There are very few reports on the symptoms of quitting (including nausea, vomiting and insomnia) after stopping the high doses of anti -psychotic drugs.

Patients with depression: Haloperidol should not be used alone in depression patients. Can be combined with antidepressants to treat depression and psychosis coexist.

Switching from hunger to depression: There is a risk in the treatment of rectification of bipolar disorders for patients to switch from the state of manic to depression. The monitoring of patients switches to depression at the accompanying risks such as suicide behavior is very important to prevent.

Poor metabolism CYP2D6: Haloperidol should be used carefully in patients with poor metabolic Cytochrom P450 (CYP) 2D6 and those who are taking CYP3A4 inhibitors.

The ability to drive and operate machinery

Persons who often drive or operate machinery should use drugs?

Haloperidol has a moderate influence on driving and using machinery.

Pregnancy

Women during pregnancy should take medicine?

Should avoid using Haloperidol during pregnancy.

Breastfeeding period

Women who are breastfeeding should take medicine?

Haloperidol is excreted in breast milk.

The decision to stop breastfeeding or stop treatment with Haloperidol should consider the benefits of breastfeeding and the benefits of drug treatment in the mother.

Drug interaction

drug interactions may affect the activity of the drug or cause side effects. Should notify the doctor or pharmacist a list of drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Cardiovascular effect: Halofar is contraindicated when combined with the drug that lasts the QT.

Be careful when using Haloperidol in combination with drug products that cause electrolyte imbalance.

Medications may increase blood haloperidol levels including: CYP3A4 inhibitors: Alprazolam, Fluvoxamine, Indinavir, Itraconazole, Ketoconazole, Nefazodon, Posaconazol, Saquinavir, Verapamil, Voriconazole. CYP2D6 inhibitors: Bupropion, Chlorpromazin, Duloxetin, Paroxetin, Promethazin, Sertralin, Venlafaxin. CYP3A4 inhibitors combine CYP2D6: Fluoxetin, Ritonavir.

Medications can reduce blood haloperidol levels: The drug that causes strong enzyme induction CYP3A4: carbamazepin, phenobarbital, phenytoin, rifampicin.

Inhibiting the central nerve inhibitor increases when combined with methyldopa.

Haloperidol may fight against adrenalin and other sympathetic drug products (for example, stimulants such as amphetamines) and reverse the lowering blood pressure of adrenergic closing medicines like guanethidin.

Haloperidol can fight against levodopa and other dopamine owners.

Haloperidol is CYP2D6 inhibitor. Haloperidol inhibits the metabolism of three -round antidepressants (such as imipramin, desipramin), thus increasing the blood concentration of these drugs.

Storage

At a temperature not exceeding 30 ° C, avoiding light.

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