NEOXIZIN 2 mq /ml syrup
NEOXIZIN
International non-patented name: Hydroxyzine hydrochloride
Composition:
Active substance: 1 ml of syrup contains 2 mg of hydroxyzine hydrochloride.
Excipients: sodium benzoate (E 211), sucrose, orange flavoring, purified water.
Description
It is a light yellow orange flavored syrup.
Pharmacotherapeutic group
Anxiolytic.
ATC: N05BB01.
Pharmacological properties
Pharmacodynamics
It is a derivative of diphenylmethane, it has certain anxiolytic activity. It has a sedative, antiemetic, antihistamine, M-cholinoblocking effect. It blocks central H1-histamine receptors and weakens the activity of certain subcortical areas. Improves cognitive skills, memory, attention. It does not create mental dependence and habituation. It is possible to get a clinical effect 15-20 minutes after taking the drug. It relaxes skeletal and thigh muscles. It has bronchodilator, muscle relaxant, spasmolytic and analgesic properties. Hydroxyzin prevents the itching that occurs in diseases such as urticaria, eczema, and dermatitis. No withdrawal syndrome occurs during long-term use.
Pharmacokinetics
It has a very high absorption capacity. Cmax is reached 2 hours after oral administration. The elimination half-life (T 1/2) is 12-20 hours in adults and 7 hours in children. Its main metabolite is cetirizine.
Instructions for use
- – The drug is prescribed for the treatment of anxiety in adults.
- – Atopic and contact dermatitis and acute and chronic urticaria in adults and children, including cholinergic and physical types.
Contraindications
- Porphyria, pregnancy and lactation period. Hypersensitivity to hydroxyzine, cetirizine and other piperazine derivatives, aminophylline and ethylenediamine or excipients.
- Congenital or acquired prolongation of the QT interval, patients at risk of prolongation of the QT interval.
Special instructions and precautions
- Liver failure.
- Kidney failure.
- Myasthenia.
- Glaucoma.
- Ulcer disease.
- Patients with breathing difficulties, for example, emphysema, chronic bronchitis.
- Hyperthyroidism.
- Hypertension, cardiovascular diseases.
- Difficult urination.
- Constipation.
- Dementia.
- Tendency to convulsions.
- Patients with arrhythmia or taking antiarrhythmic drugs should take this drug with caution and under medical supervision.
- It is not recommended to use the drug in the elderly (the risk of side effects is higher).
- The drug contains ethanol
Interaction with other drugs
When Hydroxyzine is prescribed at the same time as antidepressants and anticholinergic drugs, the possibility of strengthening the properties of Hydroxyzine should be taken into account.
The dose should be adjusted individually. Alcohol also increases the effect of hydroxy.
Hydroxyzine weakens the vasopressor effect of adrenaline.
Hydroxyzine has an opposite effect on betahistine and cholinesterase inhibitors. In order to get the results of allergy tests correctly, allergy treatment should be stopped at least 5 days before.
Simultaneous administration of hydroxyzine with monoamine oxidase inhibitors (MAOIs) should be avoided. Hydroxyzine antagonizes the anticonvulsant effect of phenytoin in rats.
After prescribing 600 mg of cimetidine twice a day, it increases serum hydroxyzine concentrations by 36% and reduces the peak concentrations of cetirizine metabolites by 20%.
As a CYP2D6 inhibitor, hydroxyzine may cause drug interactions with CYP2D6 substrates at high doses. Hydroxyzine has no adverse effect on UDP-glucuronyltransferase isoforms 1A1 and 1A6 in human liver microsomes.
It inhibits cytochrome P450 isoenzymes 2C9,2C19 and 3A4 (IC50: from 103 to 140 μM; from 46 to 52 μg / ml) at concentrations above the peak plasma concentrations. Therefore, hydroxyzine is unlikely to interfere with the metabolism of drugs that are substrates for these enzymes.
Concomitant use of hydroxyzine with drugs that can cause cardiac arrhythmias may increase the risk of QT prolongation and torsades de pointes.
Because hydroxyzine prolongs the QT interval, simultaneous use with these drugs is contraindicated, for example, class IA antiarrhythmic drugs (eg, quinidine, disopyramide) and class III antiarrhythmic drugs (eg, amiodarone, sotalol);
some antihistamines,
some antipsychotics (e.g. haloperidol),
some antidepressants (eg citalopram, escitalopram),
some antimalarials (eg mefloxine),
certain antibiotics (eg, erythromycin, levofloxacin, moxifloxacin)
some antifungals (pentamidine),
some preparations for the gastrointestinal tract (for example, prucalopride),
some oncology drugs (for example, toremifene, vandetanib),
methadone.
It is used with caution in combination with drugs that cause bradycardia and hypokalemia.
Hydroxyzine is metabolized by alkodehydrogenase and CYP3A4 / 5, and when simultaneously prescribed with inhibitors of these enzymes, an increase in the concentration of hydroxyzine in the blood can be expected.
Use during pregnancy and lactation
If treatment with the drug is necessary during pregnancy, then the treatment should be carried out under strict medical supervision.
The drug should not be taken during lactation.
Effects on the ability to drive vehicles and other potentially dangerous mechanisms
When taking Neoxyzin, they should be warned about the potential risk in the ability to drive vehicles and dangerous mechanisms. Every psychoactive drug of Neoxyzin can lead to impaired thinking skills or abilities.
Method of use and dosage
It is necessary to use the drug in the minimum effective dose and for a very short time.
The maximum daily dose for adults and children weighing more than 40 kg is 100 mg.
Anxiety: adults-50-100 mg/day divided into several doses.
To prevent itching during allergic diseases and dermatoses:
Adults can be prescribed 25 mg 1 time in the evening, 3-4 times a day if necessary.
For children older than 12 months, the daily dose is 1 mg/kg (average dose 5-15 mg) divided into several doses. In children with body weight up to 40 kg, the maximum daily dose is 2 ml/kg/day.
The daily dose should be divided into several doses. It is not recommended to use in children younger than 12 months.
The elderly
The maximum daily dose for the elderly is 50 mg/day.
In case of liver failure, the daily dose should be reduced by 33%. The use of the drug should be avoided in case of severe liver failure. The dose should be reduced by 50% in patients with moderate and severe renal impairment.
Side effects
Blood and lymphatic system disorders: agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, anaphylaxis.
Immune system disorders: hypersensitivity, anaphylactic shock
Metabolism and nutritional disorders: anorexia, porphyria.
Psychiatric disorders: agitation, confusion, disorientation, hallucinations, depression, nightmares, anxiety, sedation, weakness, headache, psychomotor disturbances, paresthesia, extrapyramidal effect, coma, impaired attention, involuntary motor activity, ataxia, bitter taste in the mouth, fainting, slurred speech.
Nervous system diseases: drowsiness, dizziness, insomnia, tremor, convulsions, dyskinesia
Eye diseases: disturbance of accommodation, blurred vision.
Hearing disorders: tinnitus, vertigo.
Heart diseases: tachycardia, prolongation of the QT interval in ECG monitoring, heart rhythm disturbances – torsade de pointes, prolongation of the QT interval.
Vascular diseases: hypotension.
Respiratory, chest and mediastinal diseases: bronchospasm, wheezing, stuffy nose, dry throat.
Gastrointestinal diseases: nausea, constipation, vomiting, increase in MBT peristalsis, dry mouth.
Disturbances in the hepatobiliary system: liver dysfunction.
Skin and subcutaneous tissue diseases: itching, papular rash, alopecia, eczema, urticaria, dermatitis, angioneurotic edema, excessive sweating, drug rash, acute widespread exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal disorders: myalgia.
Kidney and urinary diseases: delayed urination, dysuria.
Disorders in the reproductive system: priapism, impotence, early menstruation.
Common disorders and scope of application: fatigue, malaise, fever, asthenia, irritation, tremors, tightness in the chest, dryness of the mucous membrane of the respiratory tract.
Diagnostic tests: abnormal liver function tests
Side effects are usually mild and transient.
Overdose
In case of overdose, a high sedative effect is observed. There is no specific antidote. Supportive measures such as gastric lavage and symptomatic treatment measures are used. Hemodialysis is not appropriate.
Packing form
200 ml syrup, colored glass bottle with white aluminum cap, self-adhesive label. Packed in a cardboard box with 1 vial, measuring cup and leaflet.
Store condition
It should be stored at a temperature below 30°C, in a dry, dark place and out of the reach of children.
Shelf life
2 years.
By prescription
Manufacturer:
Polfarmex S.A.
Ul. Jozefow 9, 99-300 Kutno, Poland.