XYZAL Oral drops

ក្រុមហ៊ុនផលិតឱសថ:

 

GlaxoSmithKline, France

  • សារធាតុសកម្ម
  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់
  • ហាមប្រើ
  • ផលរំខាន
  • អន្តរប្រតិកម្ម
  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន
  • ការប្រុងប្រយ័ត្នជាពិសេស
  • សកម្មភាពឱសថ
  • បរិយាយប័ណ្ណឱសថ 
  • សារធាតុសកម្ម

    Levocetrizine 5mg/mL

  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់

  • ហាមប្រើ

    ・hypersensitivity to levocetirizine, to any piperazine derivatives or any of the excitients

    ・severe renal impairment at less from 10 ml/min creatinine clearance

  • ផលរំខាន

    Clinical Trial Data

    In therapeutic studies in women and man aged 12 to 71 years, 15.1% of the patients in the levocetirizine 5mg group had at least on adverse drug reaction compared to 11.3% in the placebo group. 91.6% of these adverse drug reactions were mild to moderate.

    In therapeutic included 935 subjects exposed to the drug at the recommended dose of 5mg daily.

    Adverse reactions are ranked under headings of frequency using the following convention:

    Very common ≥ 1/10

    Common   ≥ 1/100 to < 1/10

    Uncommon  ≥ 1/1000 to < 1/100

    Rare     ≥ 1/10000 to < 1/1000

    Very rare   < 1/10000

    Not known (cannot be estimated from the available data).

    Nervous system disorders

    Common: headache, somnolence

    Gastrointestinal disorders

    Common: dry mouth

    Uncommon: abdominal pain

    General disorders and administration site conditions

    Common: fatigue

    Uncommon: asthenia

    The incidence of sedating adverse drug reactions such as somnolence, fatigue and asthenia was altogether more common (8.1%) under levocetirizine 5mg than under placebo (3.1%).

    Oral drops, Oral solution

    Paediatric Patients

    In two placebo-controlled studies aged 6-11 months and aged 1 year to less than 6 years, 159 subjects were exposed to levocetirizine at the dose of 1.25mg daily for 2 weeks and 1.25mg twice daily respectively. The following incidence of adverse drug reactions was reported under levocetirizine.

    Psychiatric disorders

    Common: sleep disorders

    Nervous system disorders:

    Common: somnolence

    Gastrointestinal disorders

    Common: diarrhea, constipation

    Uncommon: vomiting

    In children aged 6-12 years double blind placebo controlled studies were performed where 243 children were exposed to 5mg levocetirizine daily for variable periods ranging from less than 1 week to 13 weeks. The following incidence of adverse drug reactions was reported.

    Nervous system disorders

    Common: somnolence

    Uncommon: headache

    Please not that even if clinical data presented in this section are available in children aged 6 months to 12 years, we do not have sufficient data to support the administration of the product to infants and toddlers less than 2 years.

    Post Marketing Data

    In addition to the adverse reactions reported during clinical studies and listed above, very rare cases of the following adverse drug reactions have been reported in post-marketing experience.

    Immune system disorders

    Not known: hypersensitivity including anaphylaxis

    Metabolism and nutrition disorders

    Not known: increased weight, increased appetite

    Psychiatric disorders

    Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation

    Nervous system disorders

    Not known: convulsions, paraesthesia, dizziness, syncope, tremor, dysgeusia

    Eye disorders

    Not known: Visual disturbances, blurred vision

    Ear and labyrinth disorders

    Not known: vertigo

    Cardiac disorders

    Not known: palpitations, tachycardia

    Respiratory, thoracic and mediastinal disorders

    Not known: dyspnea

    Gastrointestinal disorders

    Not known: nausea, vomiting

    Hepatobiliary disorders

    Not known: hepatitis, abnormal liver function test

    Skin and subcutaneous tissue disorders

    Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria

    Musculoskeletal and connective tissue disorders

    Not known: myalgia

    Renal and urinary disorders

    Not known: dysuria, urinary retention

    General disorders and administration site conditions

    Not known: oedema

  • អន្តរប្រតិកម្ម

    No interaction studies have been performed with levocertirizine (including no studies with CYP34 inducers); studies with the racemate compound certirizine demonstrated that there were no clinically relevant adverse interactions(with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam).

    Theophyline

    A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophyline (400mg once a day); while the disposition of theophyline was not altered by concomitant cetirizine administration.

    Ritonavir

    In a multiple dose study of ritonavir (600mg twice a day) and cetirizine (10mg daily), the extent to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.

    Food

    The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased.

    Alcohol

    In sensitive patients the simultanous administration of cetirizine of levocetirizine and aldohol or other CNS depressants may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.

  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន

    Fertility

    There are no relevant data available.

    Pregnancy

    Caution should be exercised when prescribing to pregnant women.

    For levocetirizine no clinical data on exposed pregnancies are avalable.

    Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturitaion or postnatal development.

    Lactation

    Caution should be exercised when prescribing to lactating women. Cetirizine is excreted inn human milk.

  • ការប្រុងប្រយ័ត្នជាពិសេស

    Alcohol

    Precaution is recommended with intake of alcohol (see Section Interactions).

    Risk of urinary retention

    Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.

    Infants and children under 2 years

    Even if some clinical data are available in children aged 6 months to 12 years, these data are not sufficient to support the administration of levocetirizine to infants and toddlers aged less than 2 years.

    Therefore the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended.

    Oral drops

    Methyl parahydroxybenzoate, propyl parahydroxybenzoate

    The presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

  • សកម្មភាពឱសថ

    Antihistamine for systemic use, piperazine derivative.

    levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.

*ព័ត៌មានឱសថត្រូវបានរៀបរៀងដោយ អ៊ីម៉ាតុគឹ មេឌីក (ខេមបូឌា) ដោយផ្អែកលើប្រភពព័ត៌មានខាងក្រោម។ សម្រាប់ព័ត៌មានលម្អិត សូមស្វែងរកនៅក្នុងក្រដាសព័ត៌មាននៃឱសថនីមួយៗ ឬ សាកសួរទៅកាន់ក្រុមហ៊ុនឱសថឬតំណាងចែកចាយនៃឱសថនីមួយៗ។

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