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Stadeltine
OTC

Stadeltine contains levocetirizine dihydrochloride that is an antihistamine; its principal effects are mediated via selective inhibition of H1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models.

Pack size Box of 10 tablets, 50 tablets. Bottle of 100 tablets.
Shelf-life 24 months
Composition Levocetirizine Dihydrochloride
Dosage forms and strengths Film-coated tablet: 5 mg
Product code :

PRESCRIBING INFORMATION

Indications:

The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Dosage:

Adults and children aged 12 years and over: 5 mg once daily.

Children aged 6 to 12 years: 5 mg daily.

Adult patients with renal impairment:

  • CLCr 50 – 79 ml/min: 5 mg once daily;
  • CLCr 30 – 49 ml/min: 5 mg every 2 days;
  • CLCr < 30 ml/min: 5 mg every 3 days;
  • Clcr < 10 ml/min and undergoing dialysis: Not use.

Usage:

Stadeltine is orally administered, taken with or without food.

Patients with end-stage renal disease (CLcr < 10 ml/min) and patients undergoing hemodialysis.

Pediatric patients 6 to 10 years of age with impaired renal function.

Hypersensitivity to levocetirizine, to any of the excipients, to hydroxyzine or to any piperazine derivatives.

Common: Somnolence; dizziness, headache; pharyngitis, rhinitis in children; abdominal pain, dry mouth, nausea; fatigue.

Uncommon: Agitation; paraesthesia; diarrhoea; pruritus, rash; asthenia, malaise.

The use of Stadeltine not recommended in children aged less than 6 years.

Caution is recommended when use Stadeltine in epileptic patients and patients at risk of convulsions.

Concurrent use of with alcohol or other central nervous system depressants levocetirizine should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Stadeltine.

Stadeltine should be used during pregnancy only if clearly needed. Use of Stadeltine in nursing mothers is not recommended.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of Stadeltine. Patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the medicinal product into account.