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Antihistamines & Antiallergics

Stadeltine

 

Pack size:

Box of 5 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains levocetirizine dihydrochloride 5 mg.

 

Shelf-life:  

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
  • The relief of symptoms of chronic idiopathic urticaria.
  • Taken orally regardless to food.
     
  • Adults and children aged 12 years and over: 5 mg once daily.
  • Children aged 6 to 12 years: 5 mg daily.
  • Levocetirizine is not recommended for use in children below age 6 due to insufficient data on safety and efficacy.
  • Adult patients with renal impairment:
    Normal (CLCr  ≥ 80 ml/min): 5 mg once daily.
    Mild (CLCr  50 - 79 ml/min): 5 mg once daily.
    Moderate (CLCr 30 - 49 ml/min): 5 mg every 2 days.
    Severe (CLCr < 30 ml/min): 5 mg every 3 days.
    Contra-indicated with end-stage renal disease (CLCr < 10 ml/min) and patients undergoing dialysis.
  • Elderly:
    There is no data to suggest that the dose needs to be reduced in elderly patients provided that the renal function is normal.
  • In pediatric patients suffering from renal impairment:
    The dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.
  • Patients with hepatic impairment:
    No dose adjustment is needed in patients with solely hepatic impairment.
  • Patients with hepatic impairment and renal impairment:
    Dosage adjustment recommended.


Or as advised by physicians.

 

  • Hypersensitivity to levocetirizine, to hydroxyzine, any piperazine derivatives or to any ingredient of the drug.
  • 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.

     

Common:

  • Somnolence.
  • Dizziness, Headache.
  • Pharyngitis, rhinitis in children.
  • Abdominal pain, dry mouth, nausea.
  • Fatigue.

Uncommon:

  • Agitation.
  • Paraesthesia.
  • Diarrhoea.
  • Pruritus, rash.
  • Asthenia, malaise.

Rare:

  • Hypersensitivity.
  • Aggression, confusion.
  • Convulsions, movement disorders.
  • Tachycardia.
  • Hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin).
  • Urticaria.
  • Oedema.
  • Weight increased.

Very rare:

  • Thrombocytopenia.
  • ImmAnaphylactic shock.
  • Tic.
  • Dysgeusia, syncope, tremor, dystonia, dyskinesia.
  • Accomodation disorder, blurred vision, oculogyration.
  • Angioneurotic oedema, fixed drug eruption.
  • Dysuria, enuresis.

     

  • The use of levocetirizine dihydrochloride is not recommended in children aged less than 6 years since the currently available film-coated tablets do not yet allow dose adaptation.
  • Caution in epileptic patients and patients at risk of convulsions is 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 levocetirizine.
  • 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.
  • Stadeltine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed.
  • Because levocetirizine is also expected to be excreted in human milk, use of  levocetirizine in nursing mothers is not recommended.
  • Effects on ability to drive and use machines: Comparative clinical trials have revealed no evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity or the ability to drive. Nevertheless, some patients could experience somnolence, fatigue and asthenia under therapy with levocetirizine. Therefore, patients intending to drive, engage in potentially hazardous activities or operate machinery should take their response to the medicinal product into account.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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