- Levocetirizine is enantiomer of cetirizine which is H1-receptor
antagonist indicated 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, and it is excreted
mainly in urine.
LEVOZIN® is indicated for adults and children , for the
treatment of symptoms associated with allergic conditions such
as:
- Seasonal allergic rhinitis (including ocular symptoms).
- Perennial allergic rhinitis.
- Chronic urticaria.
LEVOZIN® may be taken with or without food. It is
recommended to take the daily dose in one single intake.
• Adults and Children above 6 years of age:
5 mg (one F.C Tablets 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 renal impairment (in adults and children
above 12 years of age and older)::
The dosing intervals must be individualized according
to renal function:-
- Normal (Creatinine clearance ≥80ml/min): 5mg (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 hepatic impairment:
No dose adjustment is needed.
- Each Film coated Tablet of LEVOZIN® contains:
Levocetirizine Dihydrochloride 5 mg.
- Each 5ml of LEVOZIN® solution contains:
Levocetirizine Dihydrochloride 2.5 mg.
- LEVOZIN® is contraindicated in patients with known
hypersensitivity to Levocetirizine or to any 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 is not reduced with food, although
the rate of absorption is decreased.
LEVOZIN® 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:
concentration disorder, vertigo, agitation and
gastrointestinal disorders.
- In some cases, hypersensitivity reaction accompanied 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.
Over dosage:
- There is no known specific antidote to Levocetirizine . When
overdose occur, symptomatic or supportive treatment is
recommended. Gastric lavage should be considered following
short-term ingestion.
- Levocetirizine is not effectively removed by haemodialysis.
- Levocetirizine may increase somnolence, in a way that special
care is recommended in patients driving cars, or operating
machines.
- LEVOZIN® tablet : blister of 10 tablets, pack of three blisters.
- LEVOZIN® solution: bottle of 100ml
- Store in a dry place a temperature below 25oC.
