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| Drug class description : | Antihistamine for Systemic Use, Piperazine Derivative |
| Generic Name : | Levocetirizine Dihydrochloride. |
| Drug description : | 5 mg Film-coated tablet. White to off-white, oval, film-coated tablet with a Y logo on one side. |
| Presentation : | Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients: 63.50 mg lactose monohydrate / tablet |
| Indications : | Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. |
| Adult Dosage : | The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake. Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet). E Patients with renal impairment: The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: Dosing Adjustments for Patients with Impaired Renal Function: Dosage and frequency: Normal: 80 - 1 tablet once daily Mild: 50 – 79 - 1 tablet once daily Moderate: 30 – 49 - 1 tablet once every 2 days Severe: < 30 - 1 tablet once every 3 days End-stage renal disease - Patients undergoing dialysis < 10 - Contra-indicated Patients with 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 (see Patients with renal impairment above). Duration of use: The duration of use depends on the type, duration and course of the complaints. For hay fever 3-6 weeks, and in case of short-term pollen exposure as little as one week, is generally sufficient. Clinical experience with 5 mg levocetirizine as a film-coated tablet formulation is currently available for a 6-month treatment period. For chronic urticaria and chronic allergic rhinitis, up to one year's clinical experience is available for the racemate, and up to 18 months in patients with pruritus associated with atopic dermatitis. |
| Child Dosage : | Children aged 6 to 12 years: The daily recommended dose is 5 mg (1 film-coated tablet). For children aged less than 6 years no adjusted dosage is yet possible. |
| Elderly Dosage : | Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment in the Adult Dosage section). |
| Contra Indications : | Hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients. Patients with severe renal impairment at less than 10 ml/min creatinine clearance. |
| Special Precautions : | The use of Xyzal is not recommended in children aged less than 6 years since the currently available film-coated tablets do not yet allow dose adaptation. Precaution is recommended with intake of alcohol (see Interactions). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. |
| Interactions : | No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration. The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased. In sensitive patients the simultaneous administration of cetirizine or levocetirizine and alcohol 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. Pregnancy and lactation For levocetirizine no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant or lactating women. |
| Adverse Reactions : | Incidences of adverse reactions (uncommon>1/1000, <1/100) like asthenia or abdominal pain were observed. The incidence of sedating adverse drug reactions such as somnolence, fatigue, and asthenia was altogether more common (8.1 %) under levocetirizine 5 mg than under placebo (3.1%). 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. • Cardiac disorders: palpitations • Eyes disorders: visual disturbances • Hepatobiliary disorders: hepatitis • Immune system disorders: hypersensitivity including anaphylaxis • Respiratory, thoracic, and mediastinal disorders: dyspnoea • Gastrointestinal disorders: nausea • Skin and subcutaneous tissue disorders: angioneurotic oedema, pruritus, rash, urticaria • Investigations: weight increased, abnormal liver function tests |
| Manufacturer : | UCB Pharma |
| Drug Availability : | (POM) |
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