Cetirizine STELLA 10 mg

OTC

Indication

Cetirizine STELLA 10 mg is indicated in adults and paediatric patients 6 years and above:

• For the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• For the relief of symptoms of chronic idiopathic urticaria.

Dosage

• Adults and adolescents 12 years and above: 1 tablet once daily.
• Adults and adolescents above 12 years: 10 mg once daily.
• Children aged 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
• Renal impairment:
  Patients with mild renal impairment (creatinine clearance is 50 – 79 ml/min): 1 tablet once daily.
  Patients with moderate renal impairment (creatinine clearance is 30 – 49 ml/min): a half tablet once daily.
  Patients with severe renal impairment (creatinine clearance is less than 30 ml/min): a half tablet once every 02 days.
  Cetirizine is contraindicated in patients at end-stage renal disease or undergoing dialysis.
• Hepatic impairment:
  No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended.

Cetirizine STELLA 10 mg should not be used in children under 6 years of age as it does not allow the necessary dose adjustments. It is recommended to use suitable dosage form of cetirizine for this population.

Usage

• Cetirizine may be administered with or without food.

• Known hypersensitivity to any of the active substance or excipients.
• Patients with severe renal impairment with a creatinine clearance below 10 ml/min.

• Uncommon
  Agitation, paraesthesia, diarrhea, asthenia, malaise, pruritus, rash.
• Rare
  Aggression, confusion, depression, hallucination, insomnia, Convulsions, movement disorders, oedema.

• Precaution is recommended if alcohol is taken concomitantly.
• Patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.
• Epileptic patients and patients at risk of convulsions is precaution.
• Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
• Cetirizine STELLA 10 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should be resolved when the treatment is restarted.
• Caution should be exercised when prescribing cetirizine to lactating women.
• Patients should be aware of how they react to drug before driving or operating machinery.