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

Hidroxizina Pentafarma

Active Ingredient:
Hydroxyzine Hydrochloride
Origin:
EU

Hidroxizina Pentafarma (Hydroxyzine Hydrochloride)

Hidroxizina Pentafarma is a prescription medication that contains hydroxyzine hydrochloride, a first‑generation H1‑receptor antagonist, supplied in oral dosage form. Marketed in the European Union, it is classified as an antihistamine with anxiolytic and sedative properties. The product is intended for use under medical supervision for allergic skin conditions, itching, anxiety relief, and procedural sedation, and should be taken only as directed by a healthcare professional.

Manufacturer / TM Owner

Pentafarma - Sociedade Tecnico-Medicinal S.A.

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Indications & Clinical Uses

Hidroxizina Pentafarma is prescribed for several clinical situations where its antihistamine and central nervous system effects are beneficial.

  • Relief of itching associated with allergic dermatoses such as urticaria or eczema.
  • Management of generalized anxiety or tension in adults.
  • Short‑term sedation before or after minor surgical or diagnostic procedures.
  • Adjunctive treatment of nausea or vomiting related to anxiety or medication side effects.
  • Control of pruritus in chronic liver disease or renal failure.

How It Works

  • Hydroxyzine hydrochloride acts as a selective antagonist of peripheral histamine H1 receptors, thereby preventing histamine‑mediated allergic responses. The drug readily crosses the blood‑brain barrier, where central H1 blockade contributes to its sedative and anxiolytic effects. Additional anticholinergic activity adds to its calming properties, while inhibition of serotonin release may further modulate mood and nausea.

Side Effects

Adverse reactions to Hidroxizina Pentafarma are generally related to its antihistaminic and anticholinergic activity.

Common

  • Drowsiness or sedation
  • Dry mouth
  • Blurred vision
  • Constipation
  • Headache
  • Dizziness

Serious

  • Severe allergic reaction (anaphylaxis)
  • Cardiac arrhythmias or QT interval prolongation
  • Seizures
  • Hepatic dysfunction
  • Acute angle‑closure glaucoma

Precautions & Warnings

When prescribing Hidroxizina Pentafarma, clinicians should consider several safety factors.

  • Do not use in patients with known hypersensitivity to hydroxyzine or related compounds.
  • Use caution in the elderly, who may be more susceptible to sedation and anticholinergic effects.
  • Avoid operating machinery or driving until the individual’s response to the drug is known.
  • Adjust dosing in patients with hepatic or renal impairment, as clearance may be reduced.
  • Pregnancy and lactation safety have not been established; use only if the potential benefit justifies the risk.
  • Concomitant use with alcohol or other central nervous system depressants may enhance sedation.
  • Monitor patients with glaucoma, urinary retention, or prostatic hypertrophy for worsening symptoms.

Avoid Interactions

Hydroxyzine can interact with several medication classes, requiring attention to avoid adverse outcomes.

Avoid

  • Other central nervous system depressants (e.g., benzodiazepines, opioids, alcohol).
  • Additional antihistamines or anticholinergic agents, which may increase anticholinergic burden.
  • Monoamine oxidase inhibitors (MAOIs) due to the risk of heightened serotonergic effects.
  • Drugs known to prolong the QT interval, increasing the risk of cardiac arrhythmias.
  • Strong CYP3A4 inhibitors that could raise hydroxyzine plasma concentrations.

Use with caution

  • CYP3A4 inducers (e.g., rifampin) that may reduce hydroxyzine effectiveness.
  • Certain antidepressants (e.g., tricyclics) that share anticholinergic properties.
  • Antihypertensive agents, as hydroxyzine may cause additive hypotensive effects.
  • Diabetic medications, because sedation could mask hypoglycemia symptoms.
  • Other medications metabolized by the liver, requiring monitoring for altered drug levels.

Frequently Asked Questions

It is used for allergic skin conditions with itching, for short‑term relief of anxiety or tension, and as a sedative before or after minor surgical or diagnostic procedures.

Hydroxyzine blocks peripheral H1 histamine receptors, preventing the actions of histamine that cause itching, redness, and swelling, while also crossing the brain to produce sedative and anxiolytic effects.

Alcohol can increase the sedative effect of hydroxyzine, so it is generally recommended to avoid or limit alcohol consumption while using this medication.

The most common adverse effects include drowsiness, dry mouth, blurred vision, constipation, headache, and dizziness.

Serious but rare risks include severe allergic reactions, cardiac arrhythmias or QT prolongation, seizures, hepatic dysfunction, and acute angle‑closure glaucoma.

Safety in pregnancy has not been established; it should only be used if the potential benefit outweighs any possible risk to the fetus.

Store at room temperature, away from excess heat and moisture, and keep the container tightly closed out of reach of children.

Take the missed dose as soon as you remember, unless it is close to the time of the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule.

Hydroxyzine is sometimes prescribed for pediatric patients, but dosing and safety must be determined by a qualified healthcare professional.

Avoid other central nervous system depressants, additional antihistamines, MAO inhibitors, drugs that prolong the QT interval, and strong CYP3A4 inhibitors unless directed by a physician.

The sedative effect typically begins within 30 minutes to an hour after oral administration and may last several hours, varying with individual metabolism and dose.

No, it is a prescription‑only medication in the European Union and must be prescribed by a licensed healthcare provider.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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