Europe — EMA
Oxomémazine Sans Sucre Édulcorée À L’acésulfame Potassique Benta (Oxomemazine)
GNH USA supplies Oxomémazine Sans Sucre Édulcorée (Oxomemazine), an antihistamine for allergic rhinitis, urticaria and pre‑operative sedation.
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What is Oxomemazine?
Oxomemazine, the active ingredient in Oxomémazine Sans Sucre Édulcorée À L’acésulfame Potassique Benta, is a antihistamine presented as a sugar‑free oral formulation for oral use. It is employed to relieve allergic symptoms and to provide sedation in pediatric and adult patients when indicated.
GNH USA supplies Oxomémazine Sans Sucre Édulcorée À L’acésulfame Potassique Benta as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
What is Oxomemazine used for?
Oxomemazine is a first‑generation H1‑receptor antagonist that acts on allergic and central nervous system pathways. It is commonly used for: - Allergic rhinitis: reduces nasal congestion, itching and sneezing. - Acute urticaria: alleviates hives and associated itching. - Pre‑operative sedation: provides mild sedation and anxiolysis before minor procedures. - Cough associated with upper respiratory infections: suppresses the cough reflex. - Motion sickness prophylaxis: helps prevent nausea and vomiting related to travel.
What are the side effects of Oxomemazine?
Oxomemazine may cause a range of adverse reactions, most of which are dose‑dependent and reversible.
Common Side Effects: - Drowsiness: feeling unusually sleepy or fatigued. - Dry mouth: reduced salivation leading to a sticky sensation. - Dizziness: light‑headed feeling, especially when standing quickly. - Blurred vision: temporary difficulty focusing. - Constipation: reduced bowel movements. - Nausea: mild stomach upset.
Serious or Rare Side Effects: - Cardiac arrhythmias: irregular heart rhythm, particularly in patients with pre‑existing heart disease. - Extrapyramidal symptoms: involuntary muscle movements or tremor. - Severe allergic reaction: rash, swelling, or difficulty breathing. - Hepatotoxicity: signs of liver injury such as jaundice. - Hematologic abnormalities: unexplained bruising or bleeding. - Seizures: rare occurrence of convulsive episodes.
What precautions apply to Oxomemazine?
When prescribing oxomemazine, clinicians should consider several safety aspects: - Pregnancy: avoid use unless clearly needed, as safety data are limited. - Breastfeeding: monitor infant for sedation; consider alternative therapy. - Elderly patients: start with lower doses due to increased sensitivity to sedation. - Concomitant CNS depressants: risk of enhanced drowsiness and respiratory depression. - Driving and machinery: advise patients not to operate vehicles or heavy equipment until they know how the drug affects them. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Oxomemazine interact with?
Oxomemazine can interact with several drug classes, requiring attention to dosing and monitoring.
Major Interactions (Avoid): - Monoamine oxidase inhibitors (MAOIs): risk of severe hypotension and sedation. - Other antihistamines: additive sedative effects and anticholinergic burden. - CNS depressants (e.g., benzodiazepines, opioids): heightened risk of respiratory depression.
Moderate Interactions (Monitor Closely): - Anticholinergic drugs (e.g., atropine, ipratropium): may increase dry‑mouth and urinary retention. - CYP450 inhibitors (e.g., erythromycin, fluconazole): can raise oxomemazine plasma levels. - Alcohol: enhances drowsiness and impairment of coordination.



