- 1 Important to know about Atarax Hydroxyzine ?
- 2 Atarax Hydroxyzine indication and Uses
- 3 Atarax Hydroxyzine Dosage
- 4 How it works Atarax Hydroxyzine
- 5 Atarax Hydroxyzine Side Effects
- 6 Atarax Hydroxyzine Interactions
- 7 Atarax Hydroxyzine Warnings and Precautions
- 8 Drive and use machines
- 9 Atarax Hydroxyzine and PREGNANCY / BREAST FEEDING / FERTILITY
- 10 What happens if I overdose from Atarax Hydroxyzine ?
- 11 What is Forms and Composition Atarax Hydroxyzine?
Important to know about Atarax Hydroxyzine ?
This medicine is recommended in minor manifestations of anxiety, in premedication before general anesthesia, in urticaria, as well as in the treatment of certain insomnia in children over 6 years.
Atarax Hydroxyzine indication and Uses
- Minor manifestations of anxiety in adults.
- Premedication to general anesthesia.
- Symptomatic treatment of urticaria.
- In children over 3 years (syrup) or 6 years (tablet), second-line treatment of sleep insomnia related to a state of hyper-arousal (increased vigilance related to anxiety at bedtime), after failure of behavioral measures alone.
Atarax Hydroxyzine Dosage
The tablet is not a form suitable for children under 6 years (risk of mis-driving).
– Adult :
- Minor manifestations of anxiety : the average dose is 50 to 100 mg per day, up to 300 mg per day.
- Urticaria : the average dose is 50 to 100 mg daily.
- Premedication to general anesthesia : 100 to 200 mg in adults.
– Child :
- In sleep insomnia in children over 6 years , the suggested dosage is 1 mg / kg / day, and treatment will be short-term (up to 2 weeks).
In other indications in children from 6 years to 15 years :
- The maximum dose is 1 mg per kg and per day.
- These doses can be reduced by half when only a momentary effect is desired.
- Elderly, severe hepatic or renal insufficiency : it is recommended to reduce the dosage by half.
- The treatment will be short-lived.
How it works Atarax Hydroxyzine
Pharmacotherapeutic group: ANXIOLYTICS, ATC code: NO5BB01, (N: Central nervous system).
Hydroxyzine is a piperazine derivative not chemically related to phenothiazines and benzodiazepines.
- Hydroxyzine is an antihistamine antagonist of central and peripheral H 1 receptors with anticholinergic properties.
Efficacy and clinical safety
- Hydroxyzine has been shown to be effective in humans in urticaria.
- Hydroxyzine has a sedative effect evidenced by EEG recordings in healthy volunteers.
- Hydroxyzine exhibits activity on minor symptoms of anxiety.
Atarax Hydroxyzine Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
They are related to the action of the drug on the central nervous system, the dose ingested and the individual sensitivity of each.
- Drowsiness, headache, fatigue, confusion, excitement, hallucinations, disorientation, insomnia,
- Convulsions, tremors,unconsciousness, abnormal movements, vertigo,
- Rash with or without itching, rash and redness spreading throughout the body with pustules and accompanied by fever (generalized acute exanthematous pustulosis), severe skin manifestations such as blisters or burns on the body (Stevens syndrome) Johnson /Toxic Epidermal Necrolysis or Lyell Syndrome) and Polymorphic Erythema (a severe skin disease),
- Allergic manifestations, sometimes with respiratory embarrassment, even abrupt swelling of the face and neck of allergic origin (Quincke’s edema), or allergic reaction sometimes generalized (anaphylactoid reaction),
- Visual disturbances (accommodation disturbances),
- Pulse acceleration, drop in blood pressure, severe cardiac rhythm disturbance (prolongation of the QT interval at the electrocardiogram and torsade de pointes), with an undetermined frequency of onset,
Stop taking the medicine and see a doctor immediately if heart problems such as palpitations, breathing difficulties, or loss of consciousness occur.
- Nausea, vomiting,constipation, urine retention, hepatitis, increased liver enzymes
- Malaise, fever
Atarax Hydroxyzine Interactions
Co-administration of hydroxyzine with medicinal products known to prolong the QT interval and / or induce torsades de pointes, eg class IA (eg quinidine disopyramide) and class III (eg amiodarone) anti-arrhythmic drugs sotalol), some antihistamines, some antipsychotics (eg haloperidol), some antidepressants (eg citalopram and escitalopram), some antimalarials (eg mefloquine), some antibiotics (eg, erythromycin, levofloxacin, moxifloxacin), some antifungals (eg pentamidine), some gastrointestinal drugs (eg prucalopride), some anti-cancer drugs (eg, toremifene, vandetanib) and methadone increase the risk of cardiac arrhythmias. Therefore, these combinations are contraindicated (see sectionContraindications ).
Associations advised against
Alcohol enhancement of the sedative effect of H1 antihistamines. Impairment of alertness can make driving and using machines dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.
Associations subject to precautions for use
Drugs that may induce bradycardia and hypokalemia.
Hydroxyzine is metabolised by alcohol dehydrogenase and CYP3A4 / 5 and an increase in blood hydroxyzine concentration can be expected when hydroxyzine is co-administered with drugs known to be potent inhibitors of these enzymes.
Associations to consider
Other central nervous system depressants
Morphine derivatives (analgesics, antitussives and substitution treatments), benzodiazepines; anxiolytics other than benzodiazepines; barbiturates; hypnotics; neuroleptics; sedative antidepressants; central antihypertensives; baclofen; Thalidomide.
Increase of the central depression. Altered alertness can make driving and using machines more dangerous.
Atropine and other atropine substances
Imipraminic antidepressants, antiparkinsonian anticholinergics, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics.
Addition of atropine adverse effects such as urinary retention, constipation, dry mouth ..
Atarax Hydroxyzine Warnings and Precautions
Elongation of QT space
Hydroxyzine is associated with QT prolongation on the electrocardiogram. During post-marketing surveillance, cases of QT interval prolongation and torsade de pointes have been reported in patients taking hydroxyzine. Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have contributed.
Hydroxyzine should be used at the lowest effective dose and for the shortest duration of treatment.
Hydroxyzine treatment should be discontinued if signs or symptoms that may be associated with cardiac arrhythmia occur and patients should seek immediate medical attention.
Patients should be informed of the need to promptly report any cardiac symptoms.
Hydroxyzine is not recommended in elderly patients because of the decreased elimination of hydroxyzine in this population compared to the adult population and the increased risk of adverse effects (eg, anticholinergic effects) (see sections 4.2 and 4.8).
Patients should be advised against the absorption of alcoholic beverages during treatment.
In the treatment of sleep insomnia in children:
- Hydroxyzine is not a suitable treatment for insomnia of neurological cause, some insomnia of organic origin (obstructive sleep apnea syndrome – OSA – of the child, gastroesophageal reflux – GERD -, ENT infection, ), and insomnia of psychiatric origin.
- In case of vigilance disorders the morning after taking, treatment with hydroxyzine should be discontinued.
- In the absence of a therapeutic response to well conducted drug treatment, a specialized opinion is recommended.
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Precautions for use:
Hydroxyzine is not a suitable treatment for insomnia of neurological cause, some insomnia of organic origin (see Warnings), and insomnia of psychiatric origin. The following main clinical signs, suggestive of an organic cause, will therefore be sought before any prescription of hydroxyzine in a child with sleep disorders:
- Sound snoring, eating disorders, abnormal regurgitation,
- Prolonged nocturnal awakenings (greater than 15 minutes), or awakenings appearing from the first part of the night, restless sleep between awakenings, inconsolable crying,
- Daytime fatigue, unannounced naps, excessive activity, or behavioral disturbances,
- Failure to thrive or break the weight curve, or abnormal neurological or psychomotor examination.
This medicine should be used with caution:
- In young children, who are particularly sensitive to effects on the central nervous system (including convulsions),
- In cases of severe hepatic and / or renal impairment, due to the risk of accumulation (see section 4.2),
In addition, the administration of Atarax Hydroxyzine is not recommended in patients with cognitive or confounding disorders, because of the risk of aggravation related to the pharmacodynamic properties of the product.
Because of its potential anticholinergic effects, hydroxyzine should be used with caution in patients with glaucoma, urinary retention, decreased gastrointestinal motility, myasthenia gravis, or dementia.
Treatment should be discontinued for at least 5 days (7 days in the elderly) before an allergic test or bronchial provocation test with methacholine is performed to avoid an effect on the test result.
Drive and use machines
Atarax Hydroxyzine may cause drowsiness. This should be taken into account by vehicle drivers and machine users, who are also advised against the use of other sedative drugs. If sleep time is insufficient, the risk of impaired alertness is further increased.
Atarax Hydroxyzine and PREGNANCY / BREAST FEEDING / FERTILITY
Studies in animals have shown a teratogenic effect.In clinical studies, the analysis of a high number of exposed pregnancies apparently did not reveal any particular malformative effect of hydroxyzine. However, only epidemiological studies would verify the absence of risk.
Therefore, the use of hydroxyzine should be considered during the first trimester of pregnancy only if necessary. In the case of administration at the end of pregnancy, take into account the possible repercussions for the newborn of the atropine and sedative properties of this molecule.
What happens if I overdose from Atarax Hydroxyzine ?
Symptoms observed in case of significant overdose include: nausea, vomiting, tachycardia, somnolence, accommodation disturbances, tremors, confusion, hallucinations and sometimes, disturbances of consciousness or even coma, respiratory depression, convulsions, hypotension, disturbances of rhythm cardiac arrest or cardiopulmonary arrest.
Always think of drug poly-intoxication.
Monitoring of vital functions, including cardiac function with ECG recording, and, if necessary, symptomatic treatment should be implemented in a specialized environment.
Vomiting will be caused if it does not occur spontaneously. Immediate gastric lavage is also advised.
There is no specific antidote.
What is Forms and Composition Atarax Hydroxyzine?
|FORMS and PRESENTATIONS|
25 mg film-coated tablet (white): Box of 30, in blister packs. Syrup: 200 ml vial, with 0.25 ml 0.25 ml graduated oral syringe.
|Compressed :||p cp|
|Hydroxyzine (DCI) dihydrochloride||25mg|
Excipients: Core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Film coating : Opadry Y-1-7000 white (hypromellose 2910, macrogol 400, titanium dioxide E171).
Excipient with known effect: lactose.
|Hydroxyzine (DCI) dihydrochloride||2 mg|
Excipients: 95 ° ethanol, sucrose, sodium benzoate, levomenthol, purified water. Aroma: nutty.
Excipients with known effect: ethanol (less than 100 mg for 60 ml [maximum daily dose]), sucrose (700 mg / ml).
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
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