OTAREX 25 MG

Israel - English - Ministry of Health

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Active ingredient:
HYDROXYZINE HYDROCHLORIDE 25 MG
Available from:
TEVA PHARMACEUTICAL INDUST.LTD
ATC code:
N05BB01
Pharmaceutical form:
TABLETS
Administration route:
PER OS
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD
Therapeutic group:
HYDROXYZINE
Therapeutic indications:
Anxiety and tension. Pruritus. Behavior disturbances in children. Preoperative sedation.
Authorization number:
025082075600
Authorization date:
2011-08-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

22-01-2021

Otarex27.7.2011,AH

® "# $

HydroxyzineHCl25mg

Lactosemonohydrate,microcrystallinecellulose,colloidalsilicondioxide,magnesiumstearate,

FD&CyellowNo.6aluminiumlake,D&CyellowNo.10aluminiumlake.

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" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : טסוגוא 2011 .

“This leaflet format has been determined by the Ministryof Healthand thecontent thereof has been

checked and approved.” Dateof approval:August2011.

OTAREX

TABLETS

Composition

Each scored tablet contains:

Active Ingredient

Hydroxyzine hydrochloride 25 mg

Other Ingredients

Lactosemonohydrate * , microcrystalline cellulose, colloidalsilicondioxide,

magnesiumstearate, FD&C yellow No.6 aluminium lake 15-18%, D&C yellow No.10

aluminium lake 18-24%.

* Lactose content: 135.2 mgper tablet.

Mechanism of Action

Otarex is a rapid-acting tranquilizer unrelated chemicallytothephenothiazines.It

inducesa calming effect in anxious, tense and psychoneurotic patients, usually

without impairing mental alertness.

Bronchodilatoractivity and antihistaminic and analgesic effects have been

demonstrated experimentallyand confirmed clinically.

Otarexisalsousedas an antiemetic, as an adjunct to pre- and post-operative

medication, and as a mild anticholinergic agent.

Otarex has a wide margin of safety and is well tolerated.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract.Clinicaleffectsare

usually noted within 15-30 minutes following oral administration.

Indications

Anxiety and tension.

Pruritus.

Behavioral disturbances in children.

Preoperative sedation.

Contraindications

Known hypersensitivity to cetirizine, to other piperazinederivatives,to

aminophylline, or to ethylenediamine, or toany other ingredient of the preparation.

Pregnancy and lactation.

Patients with porphyria.

Warnings

Otarex should be administered cautiously in patients with increased potential for

convulsions.

Dosage adjustments may be required if Otarex is used simultaneouslywithother

central nervous system depressant drugsor with drugs havinganticholinergic

properties .

The concomitant use with alcohol should be avoided .

Caution is needed in patients who have a knownpredisposingfactortocardiac

arrhythmia, or who are concomitantly treated with a potentially arrhythmogenic drug.

2

In patients with pre-existing prolonged QT intervals,useof alternative treatments is

to be considered.

Otarex contains lactose. Patients with rare hereditiary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactose mal-absorption should

not take this medicine.

Use in Pregnancy

(see Contraindications)

Hydroxyzine is contraindicated in pregnancy.

Animal studies have shown reproductive toxicity.

Hydroxyzinecrossestheplacental barrier leading to higher fetal than maternal

concentrations.

To date, no relevant epidemiological data are availablerelatingtoexposureto

hydroxyzine during pregnancy.

In neonates whose mothers received hydroxyzine during late pregnancy and/or

labour, the following events were observed immediately or only afewhoursafter

birth : hypotonia, movement disorders including extrapyramidaldisorders,clonic

movements, CNS depression, neonatal hypoxic conditions, or urinary retention.

Therefore, this product should not be used during pregnancy

Use in Breastfeeding

(see Contraindications)

Itisnotknown whether this drug isexcreted in human milk. Since many drugs are

so excreted, hydroxyzine should not be given to nursing mothers.

Use in Pediatrics

This product is not intended for use in children.

Use in Patients with Impaired Hepatic Function

Inpatientswithhepaticdysfunction,itis recommended to reduce the daily dose by

33%.

As hydroxyzine is metabolized in the liver,anincreaseinhydroxyzineblood

concentrations may be expected when hydroxyzine isco-administeredwithother

drugs known to be potent inhibitors of liver enzymes.

Use in Patients with Impaired Renal Function

Otarex should be used with caution in patients with impaired renalfunction.Itis

uncertainwhether the drug may accumulate or have other adverse effects in such

patients. Otarex is completely metabolized and one of the metabolitesistheactive

metabolitecetirizine.Cetirizineis renally excreted and clearance is reduced in

patients with moderate renal impairment and on dialysis compared to normal

volunteers.

Use in the Elderly

In the elderly, it is advised to start with half the recommended doseduetoa

prolonged action.

Precautions

Sincehydroxyzinepossessesantihistaminic effects (including an atropine-like

action), this drug should be used with caution in patients with a historyoforsuffering

from bronchial asthma, increased intraocularpressure,bladderoutflowobstruction,

decreased gastro-intestinal motility, myasthenia gravis, or dementia, hyperthyroidism,

cardiovascular disease or hypertension.

3

Inotherconditions,antihistamines are contraindicated. These include: narrow-

angleglaucoma,stenosingpeptic ulcer, symptomatic prostatic hypertrophy, bladder

neck obstruction, pyloroduodenal obstruction.

Patientswhoexperience drowsiness as a result of Otarex therapy should be

cautioned against engaging in potentially-hazardous activitiesrequiringmental

alertness, such as driving a car or operating machinery.

Adverse Reactions

Undesirable effects are mainly related to CNSdepressantorparadoxicalCNS

stimulation effects, to anticholinergic activity, or to hypersensitivity reactions.

A Clinical trials

The following table list the relevantundesirableeffectsreportedinplacebo-

controlledclinicaltrialsfor hydroxyzine and including 735 subjects exposed to

hydroxyzineupto50 mg daily. The frequency has been estimated using the following

definitions: very common (1/10); common (1/100 to < 1/10); uncommon (1/1000

to <1/100); rare (1/10000to<1/1000);very rare (<1/10000), not known (cannot be

estimated from the available data).

System Organ ClassAdverse event preferred term Frequency

SomnolenceVery common

HeadacheCommon

DizzinessUncommon

InsomniaUncommon Nervous system

disorders

Disturbance in attention Uncommon

Dry mouth Common

ConstipationUncommon Gastrointestinal

disorders

NauseaUncommon

FatigueCommon General disorders

and administration

site conditions AstheniaUncommon

B Post-marketing experience

Thefollowingtablelists,per body system, the additional undesirable adverse

reactionsreported during marketed use of the drug. No frequency can be estimated

from post-marketing reporting of events.

Immune systemdisorders :

Hypersensitivity, anaphylactic shock

Psychiatric disorders :

Agitation, confusion, disorientation, hallucination

Nervous systemdisorders :

Sedation, tremor, convulsions, dyskinesia

Eye disorders :

Accommodation disorder, vision blurred

Cardiac disorders :

Tachycardia

4

Vascular disorders :

Hypotension

Respiratory, thoracic and mediastinal disorders :

Bronchospasm

Gastrointestinal disorders :

Vomiting

Skin and subcutaneous tissue disorders :

Pruritus,erythematousrash,maculo-papular rash, urticaria, dermatitis, angioneurotic

oedema, sweating increased, fixed drug eruption

Renal and urinary disorders :

Urinary retention

General disorders and administration site conditions :

Malaise, pyrexia

Investigations :

Liver function tests abnormal

Drug Interactions

Since hydroxyzine possesses antihistaminic effects, the potentialofsharing

antihistamines drug interactions exists. Examples include:

Hydroxyzine/Alcohol/CNS Depressants/(including Tricyclic Antidepressants):

Antihistaminesmayhaveadditive effects when used concurrently with alcohol or

otherCNSdepressants,e.g. barbiturates, hypnotics, sedatives, tranquilizers,

antianxiety agents, narcotic analgesics.

Hydroxyzine/ Monoamine Oxidase (MAO)Inhibitors: Concurrent use of

antihistamines with monoamine oxidase (MAO) inhibitors may prolong and intensify

theanticholinergic(drying)effects of antihistamines. Therefore, concurrent use with

monoamine oxidase (MAO) inhibitor therapyor within 14 days of discontinuation of

such therapy should be avoided.

Hydroxyzine/AnticholinergicAgentsor Other Agents Possessing Anticholinergic

Activity: Concurrent use of antihistamines with theseagentsmayleadtoa

potentiation of the anticholinergic effects. Therefore, caution should be exercised and

patients should be advised to promptly report occurrence ofgastrointestinal

problems, since paralytic ileus may occur uponconcurrenttherapyofantihistamines

and anticholinergic agents.

Hydroxyzine/Betahistine/Anticholinesterase Drugs :Hydroxyzine antagonizes the

effects of betahistine, and of anticholinesterase drugs.

Hydroxyzine/Epinephrine : ounteracts the epinephrine pressor action.

Hydroxyzine/Phenytoin :Inrats,hydroxyzine antagonised the anticonvulsant action of

phenytoin.

Hydroxyzine/Cimetidine: Cimetidine 600 mg bid has been shown to increasetheserum

concentrationsofhydroxyzineby36% and to decrease peak concentrations of the

metabolite cetirizine by 20%.

Hydroxyzine is an inhibitor of cytochrome P450 2D6 and may cause athighdoses

drug-drug interactions with CYP2D6 substrates.

Hydroxyzinehasnoinhibitoryeffect at 100 µM on UDP-glucuronyl transferase

isoforms 1A1 and 1A6 in human liver microsomes.ItinhibitscytochromeP

2C9/C10, 2C19 and 3A4 isoforms at concentrations well above peakplasma

concentrations. The metabolite cetirizine at 100 µM has noinhibitoryeffectonhuman

liver cytochrome P

(1A2,2A6, 2C9/C10, 2C19, 2D6, 2E1 and 3A4) and UDP-

glucuronyltransferaseisoforms.Therefore, this product is unlikely to impair the

metabolism of drugs which are substrates for these enzymes.

5

Diagnostic Interference

Theadministrationof hydroxyzine may interfere with measurements of urinary 17-

hydroxycorticosteroids.

The treatment should be stopped at least 5daysbeforeallergytestingor

methacholine bronchial challenge, to avoid effects on the test results.

Dosage and Administration

1 tablet 3 times daily.

Overdosage

Manifestations

Symptomsobservedafteranimportant overdose are mainly associated with

excessiveanticholinergicload,CNS depression or CNS paradoxical stimulation.

They include nausea, vomiting, tachycardia, pyrexia, somnolence, impaired pupillary

reflex,tremor,confusion,or hallucination. This may be followed by depressed level of

consciousness,respiratory depression, convulsions, hypotension, or cardiac

arrhythmia. Deepening coma and cardiorespiratory collapse may ensue.

Treatment

Airway, breathing and circulatory status must becloselymonitoredwithcontinuous

ECG recording and an adequate oxygen supply should be available. Cardiac and

bloodpressuremonitoringshould be maintained until the patient is free of symptoms

for24 hours. Patients with altered mental status should be checked for simultaneous

intakeofotherdrugsoralcoholand should be given oxygen, naloxone, glucose, and

thiamine if deemed necessary.

Norepinephrineormetaraminol should be used if vasopressor is needed.

Epinephrine should not be used.

Syrup of ipecac should not be administered in symptomatic patients or thosewho

could rapidly become obtunded, comatose or convulsing, as thiscouldleadto

aspiration pneumonitis. Gastric lavage with prior endotracheal intubationmaybe

performed if a clinically significant ingestion has occurred. Activated charcoal maybe

left in the stomach but there are scant data to support its efficacy.

It is doubtful that hemodialysis or hemoperfusion would be of any value.

There is no specific antidote.

Literaturedataindicatethat, in the presence of severe, life-threatening, intractable

anticholinergiceffects unresponsive to other agents, a therapeutic trial dose of

physostigmine may be useful. Physostigmine should not be used just to keepthe

patientawake.Ifcyclic antidepressants have been coingested, use of physostigmine

may precipitate seizures and intractable cardiac arrest.Alsoavoidphysostigminein

patients with cardiac conduction defects.

Registration Numbers

025 08 20756 00

025 08 20756 01.

Storage

Store in a dry place below 25 C.

Manufacturer

Teva Pharmaceutical Industries Ltd

P.O.Box 3190, Petach Tikva

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