Product image of Histexil (Hydroxyzine Hydrochloride) supplied by GNH India

Histexil

Active Ingredient:
Hydroxyzine Hydrochloride
Origin:
EU

Histexil (Hydroxyzine Hydrochloride)

Histexil is a prescription medication that contains the active ingredient hydroxyzine hydrochloride, supplied as an oral tablet. It belongs to the first‑generation antihistamine class and is marketed in the European Union. Hydroxyzine hydrochloride works by blocking peripheral H1 histamine receptors and also has central sedative and anxiolytic properties. Histexil is used under medical supervision for allergic skin reactions, anxiety, sedation, and nausea, and related symptoms.

Manufacturer / TM Owner

Pharma Bavaria Internacional (Pbi) Portugal Unipessoal Lda

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Indications & Clinical Uses

Histexil is indicated for several clinical situations where its antihistamine, anxiolytic, and sedative actions are beneficial.

  • Relief of itching, hives, and other symptoms of urticaria or allergic skin reactions.
  • Short‑term management of anxiety or tension when non‑sedating agents are unsuitable.
  • Pre‑operative or post‑operative sedation and anxiolysis to facilitate surgical procedures.
  • Prevention or treatment of nausea and vomiting associated with allergic reactions or anesthesia.
  • Adjunctive therapy for motion sickness when other options are ineffective.
  • Control of pruritus in dermatologic conditions such as atopic dermatitis.

How It Works

  • Hydroxyzine hydrochloride acts as a selective antagonist of peripheral H1 histamine receptors, reducing the actions of histamine that cause itching, swelling, and vasodilation. It also exhibits anticholinergic activity and penetrates the central nervous system, where it produces sedative and anxiolytic effects by depressing neuronal activity, contributing to its utility in allergy, anxiety, and pre‑operative settings.

Side Effects

Histexil may cause a range of adverse reactions, from mild and transient effects that may resolve without intervention to rare but potentially serious events that require prompt medical attention.

Common

  • Drowsiness or sedation, which may impair alertness.
  • Dry mouth, leading to a feeling of thirst.
  • Blurred vision, especially at higher doses.
  • Constipation or reduced bowel movements.
  • Headache, ranging from mild to moderate.
  • Dizziness or light‑headedness.

Serious

  • Severe allergic reaction (anaphylaxis, angioedema) requiring emergency care.
  • Cardiac arrhythmias or QT interval prolongation, especially with pre‑existing heart disease.
  • Seizures, particularly in patients with a seizure disorder.
  • Significant liver injury, indicated by jaundice or abnormal tests.
  • Acute urinary retention in individuals with prostate enlargement or bladder outlet obstruction.

Precautions & Warnings

When prescribing Histexil, clinicians consider several precautionary factors to minimize risk and ensure safe use.

  • Known hypersensitivity to hydroxyzine or other antihistamines.
  • Elderly patients, who may be more sensitive to sedative effects.
  • Patients with glaucoma, urinary retention, or prostatic hypertrophy.
  • Individuals with hepatic impairment, as metabolism may be reduced.
  • Pregnancy and breastfeeding, because safety data are limited.
  • Activities requiring mental alertness, such as driving, should be avoided until individual response is known.
  • Concomitant use of other central nervous system depressants may increase sedation.

Avoid Interactions

Histexil can interact with other medicines, potentially altering its effects or increasing the risk of adverse reactions.

Avoid

  • Alcohol and other CNS depressants (e.g., benzodiazepines, opioids) because combined sedation may be excessive.
  • Other antihistamines, which can increase anticholinergic burden.
  • Monoamine oxidase inhibitors (MAOIs), due to possible additive central effects.
  • Drugs that prolong the QT interval, increasing risk of cardiac arrhythmias.
  • Strong anticholinergic agents, which may exacerbate dry mouth and urinary retention.

Use with caution

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) that may raise hydroxyzine levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine) that may lower hydroxyzine concentrations.
  • Antidepressants (e.g., SSRIs, tricyclics) that may enhance sedation.
  • Antihypertensive agents, as additive hypotensive effects may occur.
  • Anticholinergic medications, requiring monitoring for excessive side effects.

Frequently Asked Questions

The active ingredient in Histexil is hydroxyzine hydrochloride.

Histexil blocks peripheral H1 histamine receptors, reducing the effects of histamine that cause itching, swelling, and vasodilation.

Histexil may be prescribed for urticaria, pruritus, and other itchy skin reactions associated with allergies.

Yes, hydroxyzine has anxiolytic properties and may be used for short‑term anxiety relief under medical supervision.

No, Histexil is a prescription‑only medication in the European Union.

Common side effects include drowsiness, dry mouth, blurred vision, constipation, headache, and dizziness.

Signs of a severe allergic reaction, cardiac arrhythmias, seizures, significant liver injury, or acute urinary retention should prompt urgent medical care.

Alcohol can increase sedation and should be avoided or used with caution when taking Histexil.

Histexil should be kept at room temperature, protected from moisture, and stored out of reach of children.

The pregnancy safety category for Histexil is unknown, so it should only be used if the potential benefit justifies any potential risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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