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HYDROXYZINE HYDROCHLORIDE is a brand name for Hydroxyzine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptomatic treatment of anxiety in adults. Symptomatic treatment of pruritus in adults and children ≥ 6 years of age.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Hydroxyzine Hydrochloride should be used at the lowest effective dose and for the shortest possible duration. 5 mg, 25 mg, where the larger dose can be taken in the evening. In more severe cases, doses up to 100 mg/day can be used The maximum daily dose is 100 mg per day.
Medicinal treatment of anxiety should always be used as adjuvant therapy. As far as possible, treatment should be initiated, supervised and discontinued by the same physician.
Symptomatic treatment of pruritus:
The starting dose is 25 mg in the evening (about an hour before bedtime), then if necessary up to 25 mg in total 3-4 times per day. The maximum daily dose is 100 mg per day. 2). In children <40 kg, the maximum daily dose is 2 mg/kg/day.
In children ≥40 kg, the maximum daily dose is 100 mg per day. Dose adjustment Dose should be adjusted within the given dose range in accordance with the treatment response in the patient.
Special populations Elderly:
In the elderly, it is advised to start with half the recommended dose due to the prolonged action. The lowest possible dose should be selected in the treatment of elderly patients. 4). The results and need for treatment should be continuously assessed.
Patients with renal impairment:
Caution is recommended in patients with impaired renal function. Dose should be reduced in patients with moderate or severe renal impairment due to decreased excretion of its metabolite cetirizine. See the following table and adjust the dose as directed.
The anxiolytic effect mediated by hydroxyzine may be affected by dose reduction and this should be evaluated on an individual basis. Dose adjustment for adult patients with impaired renal function. Group eGFR (ml/min) Percentage of recommended dose Mild renal impairment 60 - < 90 100% Moderately impaired renal function 30 - < 60 50% Severe renal impairment 15 - < 30 25% End stage renal failure (ESRD) < 15 25% 3 times a week Patients with hepatic impairment: Caution is required in patients with hepatic impairment, and a reduction of the dose should be considered.
Paediatric population:
The most common undesirable effect of the sedating antihistamines is CNS depression. Effects vary from slight drowsiness to deep sleep, and include lassitude, dizziness, and incoordination. Paradoxical stimulation may occasionally occur, especially at high doses and in children and the elderly.
If sedative effects occur, they may diminish after a few days of treatment. Other common adverse effects include anti-cholinergic activity, hypersensitivity reactions, headache, psychomotor impairment and antimuscarinic effects.
A Clinical trials Oral administration of hydroxyzine:
The following table lists the undesirable effects reported in placebo-controlled clinical trials at a rate of at least 1% for hydroxyzine. The trials included 735 patients who received hydroxyzine up to 50 mg daily and 630 patients who received placebo.
63 B Post-marketing experience The table below lists, per system organ class and frequency, the undesirable effects reported during post-marketing use of the drug. The frequency has been estimated using the following definitions: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
g. 4).
Vascular disorders:
Rare: hypotension Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm Gastrointestinal disorders: Uncommon: nausea Rare: constipation, vomiting Not known: diarrhoea Hepatobiliary disorders: Rare: liver function tests abnormal Not known: hepatitis Skin and subcutaneous tissue disorders: Rare: pruritis, erythema, papular rash, urticaria, dermatitis Very rare: angioedema, increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis (AGEP), erythema multiforme, Stevens-Johnson syndrome Renal and urinary disorders: Rare: urinary retention Not known: dysuria, enuresis General disorders and administration site conditions: Uncommon: malaise, pyrexia Not known: asthenia, oedema Investigations: Not known: weight increased Treatment with neuroleptics may cause prolongation of the QT interval and cardiac arrhythmias.
Cardiovascular effects Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been cases of QT interval prolongation and torsade de pointes in patients taking hydroxyzine.
8). Hydroxyzine should be used at the lowest effective dose and for the shortest possible duration. Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.
Patients should be advised to promptly report any cardiac symptoms. 2). In patients with hepatic impairment who receive hydroxyzine regularly, liver function should be monitored. 2). g. 8). 2). Other warnings and precautions for use Because of its potential anticholinergic effects, Hydroxyzine should be used with caution in in patients suffering from glaucoma, urinary tract obstruction, decreased gastro-intestinal motility, myasthenia gravis, or dementia.
Hydroxyzine should be administered cautiously in patients with increased risk of convulsions. 8). In children, convulsions have been more frequently reported than in adults. 5). 5). 5). Dry mouth may occur with high doses and patients should therefore be informed about this risk and observe good mouth and tooth hygiene.
The prescriber should discuss the anticipated duration of treatment with the patient and inform about the initial adverse reactions. Cerebrovascular effects An about 3-fold risk of cerebrovascular events has been observed in randomised, placebo-controlled clinical studies with certain atypical neuroleptics in patients with dementia.
Background mechanism for this increased risk is not known. An increased risk with other neuroleptics and in other patient populations cannot be excluded. Therefore, hydroxyzine should be used with caution in patients with risk factors for stroke.
1. - Patients with porphyria. 6). - Patients with a known acquired or congenital QT interval prolongation. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hydroxyzine Bluefish film-coated tablets are not recommended in paediatric patients under the age of 6 years as they may have difficulty swallowing tablets. The safety and efficacy of hydroxyzine in children under 12 months of age have not yet been established.
No data are available.
Method of administration:
The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or without food.
4) have been reported during treatment with these drugs. Paediatric population and elderly Children and elderly are more susceptible to side effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
1). Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Hydroxyzine film-coated tablets contain sodium This medicine contains less than 1 mmol sodium (23 mg) per 10 mg tablet, that is to say essentially ‘sodium-free’.