COMPOSITION :

Each f/c tablet contains : Levocetirizine dihydrochloride 5 mg.

DESCRIPTION :

Xyex (levocetirizine dihydrochloride) is antihistamine, non sedating and long acting with antiallergic properties which is the (R)-enantiomer

of cetirizine with high affinity for H1-receptor and it is a potent selective antagonist of peripheral H1-receptors and has almost no

anticholinergic or antiserotonergic properties. Levocetirizine is rapidly and extensively absorbed after oral administration . Peak plasma

concentrations are achieved 0.9 h after dosing and steady state is achieved after two days. The extent of absorption is dose independent and

is not altered by food, but the peak concentration is reduced and delayed. Levocetirizine is 90% bound to plasma proteins and does not pass

through brain in significant amount, and is therefore unlikely to cause drowsiness . The palsma half life is 7.9 ± 1.9 hrs. The major route of

excretion of levocetirizine and metabolism is via urine, accounting for 85.4% of the dose and only 12.9% through faeces.

INDICATIONS :

Xyex is indicated for following cases :

- The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- The relief of symptoms of chronic urticaria

DOSAGE & ADMINISTRATION :

Adults and Adolescents 12 years and above : The recommended dose is 5 mg once daily (1 film coated tablet).

Children between 6 - 12 years : The recommended dose is 5 mg daily divided to two doses in the morning and in the evening.

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 to the patient’s creatinine clearance (CLcr) in ml / min is needed and it may

be estimated from serum creatinine (mg /dl) determination using the following formula :

CLcr = (x 0.85 for women)

Dosing adjustments for adult patients with impaired renal function :-

Patients with hepatic impairment : No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic and

renal impairment , dose adjustment is recommeneded .(see the chart above) .

RESTRICTIONS ON USE :

Contraindications

Hypersensitivety to levocetirizine dihydrochloride or any piperazine derivatives.

Patients with the terminal kidney failure (Creatinine clearance 10 ml / min.) .

Precautions

Precaution is recommended when Xyex taken in concomitantly with alcohol. Caution in epileptic patients and patients at risk of convulsions

is recommended . The use of Xyex is not recommended in children aged less than 6 years.

Effects on the capacity to drive vehicles or use machines

Special care is recommended in patients driving cars, having high risk work or operating machines.

Use in Pregnancy & Lactation

No controlled studies in pregnant women are available , levocetirizine like other drugs should not be used during pregnancy. Levocetirizine

should not be used in lactating women since it passes into breast milk.

ADVERSE EFFECTS :

Adverse effects are somnolence , headache, dry mouth and fatigue .

Very rare adverse effects are hypersensitivity , photosensitivity , anaphylactic reaction, oedema, convulsions, sinus thrombosis, tachycardia ,

rhinitis, pruritus, urticaria, nausea and increase liver enzymes.

OVERDOSAGE :

Symptoms : Confusion, diarrhoea, dizziness, fatigue, headache, malaise , mydriasis, pruritus, restlessness, somnolence, tachycardia, stapor,

tremor and urinary retenion can be symptoms of levcetirizine overdosage.

Management of overdoses : There is no known specific antidote to levocetirizine, symptomatic or supportive treatment is recommended.

Gastric lavage should be considered following ingestion of a short occurence. Levocetirizine is not effectively removed by haemodialysis.

STORAGE INSTRUCTIONS :

Store below 30oC, in a dry place.

PRESENTATION :

Xyex 5 mg Tablet : Pack of 20 tablets and hospital pack of different sizes