The daily recommended dose is 5 mg (one tablet)

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
Levocetirizine (Setzine), the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.
Pharmacokinetic properties
Absorption:
Levocetirizine (Setzine) is rapidly and extensively absorbed following oral administration. Peak plasma concentrations are achieved 0.9 h after dosing. Steady state is achieved after two days. Peak concentrations are typically 270 ng/ml and 308 ng/ml following a single and a repeated 5 mg o.d. dose, respectively. The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed.
Distribution:
Levocetirizine (Setzine) is 90% bound to plasma proteins. The distribution of levocetirizine is restrictive, as the volume of distribution is 0.4 l/kg.
Metabolism:
Metabolic pathways include aromatic oxidation, N- and O- dealkylation and taurine conjugation. Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involved multiple and/or unidentified CYP isoforms. Levocetirizine (Setzine) had no effect on the activities of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 at concentrations well above peak concentrations achieved following a 5 mg oral dose.
Due to its low metabolism and absence of metabolic inhibition potential, the interaction of levocetirizine with other substances, or vice-versa, is unlikely.
Elimination:
The plasma half-life in adults is 7.9 ± 1.9 hours. The mean apparent total body clearance is 0.63 ml/min/kg. The major route of excretion of levocetirizine (Setzine) and metabolites is via urine, accounting for a mean of 85.4% of the dose. Excretion via feces accounts for only 12.9% of the dose.

CONTRAINDICATIONS
History of hypersensitivity to levocetirizine (Setzine) or any of the other constituents of the formulation or to any piperazine derivates. Patients with severe renal impairment at less than 10ml/min creatinine clearance.

ADVERSE EFFECTS
From clinical trials, mainly mild to moderate side effects such as dry mouth, headache, fatigue, somnolence, have been reported commonly (above 1%). Further uncommon incidences of adverse reactions like asthenia or abdominal pain were observed.
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 edema, pruritus, rash, urticaria

WARNINGS AND SPECIAL PRECAUTIONS
The use of levocetirizine (Setzine) is not recommended in children aged less than 6 years.
Pregnancy & Lactation
No clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant or lactating women.

Hepatic impairment
No adjustment is needed in patients with solely hepatic impairment.

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:

OVERDOSAGE
Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children.
There is no known specific antidote to levocetirizine (Setzine).
In case of overdosage, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion. Levocetirizine (Setzine) is not effectively removed by haemodialysis

STORAGE
Store at room temperature. Protect from heat, light and moisture. Keep all medicines out of the reach of children.

PRESENTATION
(Setzine) 5 mg tablets blister of 10’s.
[140 - age(years)] x weight (kg)
72 x serum creatinine (mg / dl)
(x 0.85 for women)