Product image of Hidroxizina Generis (Hydroxyzine Hydrochloride) supplied by GNH India

Hidroxizina Generis

Active Ingredient:
Hydroxyzine Hydrochloride
Origin:
EU

Hidroxizina Generis (Hydroxyzine Hydrochloride)

Hidroxizina Generis is a prescription medication that contains the active ingredient hydroxyzine hydrochloride, supplied in an oral dosage form. It is marketed in the European Union and classified as an antihistamine with antipruritic and anxiolytic properties. The product, currently available, is intended for use through medical supervision for conditions such as allergic skin reactions, itching, anxiety, and pre‑operative sedation, and it follows EU regulatory standards.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Hidroxizina Generis is prescribed for several therapeutic purposes related to its antihistamine and central nervous system effects.

  • Relief of itching (pruritus) associated with allergic skin conditions such as urticaria or atopic dermatitis.
  • Management of anxiety or tension in short‑term clinical situations.
  • Adjunctive treatment for sedation before minor surgical or diagnostic procedures.
  • Control of histamine‑mediated symptoms in allergic reactions, including rash or hives.
  • Supportive therapy for patients with anxiety‑related insomnia when other options are unsuitable.

How It Works

  • Hydroxyzine hydrochloride acts primarily as a selective antagonist of peripheral H1 histamine receptors, preventing histamine‑induced vasodilation, increased vascular permeability, and sensory nerve activation that cause itching and allergic symptoms. The drug also penetrates the central nervous system, where it exerts anticholinergic activity and modulates neurotransmitter release, contributing to its sedative and anxiolytic effects. These combined actions underlie its clinical utility in pruritus and anxiety management.

Side Effects

Like other antihistamines, Hidroxizina Generis may cause a range of adverse reactions, most of which are mild and transient.

Common

  • Drowsiness or mild sedation.
  • Dry mouth, throat, or nasal passages.
  • Blurred vision or difficulty focusing.
  • Constipation or reduced gastrointestinal motility.
  • Headache or light‑headedness.

Serious

  • Significant hypotension or cardiovascular collapse.
  • Severe allergic reactions such as anaphylaxis.
  • Cardiac arrhythmias, especially in patients with pre‑existing heart disease.
  • Marked confusion or delirium, particularly in the elderly.

Precautions & Warnings

Healthcare providers should evaluate individual risk factors before prescribing Hidroxizina Generis and advise patients on safe use.

  • Avoid operating machinery or driving until the sedative effect is known.
  • Use cautiously in patients with glaucoma, urinary retention, or enlarged prostate due to anticholinergic activity.
  • Assess liver or kidney impairment, as reduced clearance may increase drug exposure.
  • Monitor elderly patients closely because they are more susceptible to sedation and confusion.
  • Discontinue use if signs of severe hypotension or allergic reaction appear.
  • Consider alternative therapy during pregnancy or breastfeeding, as safety data are limited.

Avoid Interactions

Hidroxizina Generis can interact with other medications, altering its efficacy or increasing the risk of adverse effects.

Avoid

  • Concurrent use with other central nervous system depressants (e.g., benzodiazepines, opioids, alcohol) that may intensify sedation.
  • Combination with monoamine oxidase inhibitors (MAOIs) or other antihistamines that can increase anticholinergic burden.

Use with caution

  • Co‑administration with drugs that prolong the QT interval (e.g., certain antiarrhythmics, antipsychotics).
  • Concurrent use of CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) which may raise hydroxyzine plasma levels.
  • Combining with anticholinergic agents (e.g., diphenhydramine, tricyclic antidepressants) may exacerbate dry mouth and constipation.

Frequently Asked Questions

Hidroxizina Generis is commonly used to treat allergic skin conditions, relieve itching (pruritus), manage short‑term anxiety, and provide pre‑operative sedation.

Hydroxyzine hydrochloride not only blocks peripheral H1 receptors but also crosses the blood‑brain barrier, providing sedative and anxiolytic effects that many first‑generation antihistamines lack.

Patients with liver impairment should use Hidroxizina Generis with caution, as reduced hepatic metabolism may increase drug levels; dose adjustment may be required under medical supervision.

Combining Hidroxizina Generis with alcohol can intensify drowsiness and impair coordination, so it is generally advised to avoid alcohol while taking the medication.

Severe dizziness may indicate hypotension or excessive sedation; you should stop the medication and contact your healthcare provider promptly.

Elderly individuals are more prone to sedation, confusion, and anticholinergic side effects, so lower starting doses and close monitoring are recommended.

Safety data for use during pregnancy are limited; the medication should only be used if the potential benefit justifies the potential risk, after consulting a physician.

Signs of an allergic reaction include rash, itching, swelling of the face or throat, difficulty breathing, and should be treated as an emergency.

The sedative effect typically begins within 30 minutes of oral intake and may last 4 to 6 hours, varying with individual metabolism.

Yes, Hidroxizina Generis is classified as a prescription‑only medication throughout the European Union.

Avoid other CNS depressants, MAO inhibitors, other antihistamines, and be cautious with QT‑prolonging drugs or strong CYP3A4 inhibitors.

Concurrent use with other antihistamines can increase anticholinergic side effects and is generally not recommended without medical guidance.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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