Indication
Lezin® is indicated for adults and children for the treatment of symptoms associated with allergic conditions such as:
- Seasonal allergic rhinitis (including ocular symptoms).
- Persistent allergic rhinitis.
- Chronic urticaria.
Composition
Each Film coated Tablet of Lezin® contains:
- Levocetirizine Dihydrochloride 5 mg.
Each 5ml of Lezin® solution contains:
- Levocetirizine Dihydrochloride 2.5 mg.
Dosage
¤ Lezin® may be taken with or without food.
Adults and Children above 6 years of age:
- 5 mg (one F.C tablet or two teaspoonfuls (10 ml) oral solution) daily.
Children 2 - 6 years of age:
- 1.25 mg (1 /2 teaspoonful ( 2.5 ml) oral solution) twice daily.
Patients with impaired renal function (in adults and children above 12 years of age and older):
The dosing intervals must be individualized according to renal function:
Normal (Creatinine clearance ≥ 80 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once daily.
Mild (Creatinine clearance 50 - 79 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once daily.
Moderate (Creatinine clearance 30 - 49 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml)) once every 2 days.
Severe (Creatinine clearance < 30ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once every 3 days.
Patients undergoing dialysis:
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once every 3 - 4 days.
Patients with impaired liver function:
- No dose adjustment is needed.
- Levocetirizine is enantiomer of cetrizine which is a H1-receptor antagonistindicated for symptoms associated with allergic conditions.
- Levocetirizine is rapidly absorbed following oral administration.
- Peak plasma concentration is achieved 0.9 hour after dosing .
- Levocetirizine half life is about 8 hours,
- it is excreted mainly in urine.
Each Film coated Tablet of Lezin® contains:
- Levocetirizine Dihydrochloride 5 mg.
Each 5ml of Lezin® solution contains:
- Levocetirizine Dihydrochloride 2.5 mg.
Lezin® is indicated for adults and children for the treatment of symptoms associated with allergic conditions such as:
- Seasonal allergic rhinitis (including ocular symptoms).
- Persistent allergic rhinitis.
- Chronic urticaria.
- Lezin® is contra-indicated in patients with known hyperrsensitivity to Levocetirizine or any other piperazine derivatives.
- No interaction studies have been performed with Levocetirizine.
- Studies with cetirizine demonstrated that there were no clinically relevant adverse reactions with: Pseudoephedrine, Cimetidine, Ketoconazole, Erythromycin, Azithromycin, Glipizide and Diazepam.
- The extent of Levocetirizine absorption is not reduced with food, although the rate of absorption is decreased.
- Lezin® should not be used during pregnancy and lactation periods.
Common side effects:
- somnolence, dry mouth, headache, fatigue and asthenia.
The following side effects have been noticed with cetirizine:
- vertigo, agitation and gastro-intestinal disorders.
- In some cases, hypersensitivity reaction accompanie by skin reactions and angioedema.
Rare side effects:
- convulsions, photosensitivity reactions, hepatic lesions, anaphylactic shock, blood circulation decompensation, deafness, malaise, pruritus, angitis and visual disorders.
¤ Lezin® may be taken with or without food.
Adults and Children above 6 years of age:
- 5 mg (one F.C tablet or two teaspoonfuls (10 ml) oral solution) daily.
Children 2 - 6 years of age:
- 1.25 mg (1 /2 teaspoonful ( 2.5 ml) oral solution) twice daily.
Patients with impaired renal function (in adults and children above 12 years of age and older):
The dosing intervals must be individualized according to renal function:
Normal (Creatinine clearance ≥ 80 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once daily.
Mild (Creatinine clearance 50 - 79 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once daily.
Moderate (Creatinine clearance 30 - 49 ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml)) once every 2 days.
Severe (Creatinine clearance < 30ml/min):
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once every 3 days.
Patients undergoing dialysis:
- 5 mg (one tablet or two teaspoonfuls (10 ml) oral solution) once every 3 - 4 days.
Patients with impaired liver function:
- No dose adjustment is needed.
- Levocetirizine may increase somnolence, in a way that special care is recommended in patients driving cars, or operating machines.
Lezin® tablets:
- Blister of 10 tablets, pack of one blister.
Lezin® solution:
- Bottle of 100 ml.
- Lezin® tablets:Store in a dry place at temperature below 25°C.
- Lezin® solution: store at a temperature not exceeding 25°C.