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Adezio

Film-Coated Tablet

 

COMPOSITION
Each tablet contains Cetirizine Hydrochloride 10 mg.

PHARMACODYNAMICS/ PHARMACOKINETICS
The principle effects of Cetirizine are mediated via selective inhibition of peripheral H1 receptors. It is reported to have negligible anticholinergic and antiserotonergic activity. Cetirizine is an antihistamine reported to be long acting and with some mast cell stabilizing activity. It inhibits the histamine-induced early phase of allergic reaction. It also inhibits the late phase recruitment of eosinophils, neutrophils and basophils associated with the allergic inflammatory response.


Cetirizine is rapidly absorbed from the gastro-intestinal tract after oral administration, with peak plasma concentration being attained in approximately 1 hour in adults. Food had no effect on the extent of cetirizine absorption but time to maximum concentration (Tmax) was delayed by 1.7 hours and maximum concentration (Cmax) was decreased by 23% in the presence of food. Cetirizine is highly bound to plasma proteins and has an elimination half-life of about 11 hours. The first-pass metabolism is reported to be low, and excretion is primarily through renal as unchanged drug.

INDICATION
Adezio is indicated for the relief of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children over 2 years of age such as sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, tearing and redness of the eyes.


Adezio is also indicated for the treatment of the uncomplicated skin manifestations of chronic urticaria in adults and children over 2 years of age. It significantly reduces the occurrence, severity and duration of hives and significantly reduces pruritus.

DOSAGE AND ADMINISTRATION
Adezio is given as a single daily dose, with or without food. The time of administration may be varied to suit individual patient needs. To be administered orally.

 

Adults and Children over 12 Years:

5 or 10 mg depending on symptom severity.

1/2 or 1 tablet once daily

Children 6 to 11 Years:

5 or 10 mg depending on symptom severity.

1/2 or 1 tablet once daily

Children 2 to 5 Years:

2.5 mg; can be increased to a maximum

dose of 5 mg per day depending on

symptom severity and patient esponse.

Recommended for Adezio Oral Solution


Dose Adjustment for Renal and Hepatic Impairment:
In patients 12 years old and older with decreased renal function (creatinine clearance 11-31 ml/min), patients on hemodialysis (creatinine clearance less than 7 ml/min), and in hepatically impaired patients, a dose of 5 mg once daily is recommended.


Similarly, pediatric patients aged 6 to 11 years with impaired renal or hepatic function should use the lower recommended dose. Because of the absence of pharmacokinetic and safety information for cetirizine in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.

CONTRAINDICATIONS
Adezio is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. It is also contraindicated during lactation.

PRECAUTIONS
Central sedation or antimuscarinic effects do not generally occur with usual doses of cetirizine. However, the occurrence of somnolence has been reported in some patients taking cetirizine in clinical trials. Caution should therefore be exercised when driving a car or operating potentially dangerous machinery.
 

Use in Pregnancy and Lactation
Teratogenic studies in animals have not demonstrated any special malformations. However as a precaution, Adezio should not be administered during the first trimester of pregnancy.


Cetirizine has been reported to be excreted in human breast milk. Because many drugs are excreted in human milk, use of cetirizine in nursing mothers is not recommended.

Use in Paediatric
The safety and effectiveness of cetirizine in pediatric patients under the age of 2 years have not yet been established.

DRUG INTERACTIONS
No clinically significant drug interactions have been reported with other drugs. However, caution should be exercised when other CNS depressants or alcohol is taken concurrently.

SIDE EFFECTS/ ADVERSE REACTIONS
Most adverse reactions reported during therapy with cetirizine were mild or moderate. There have been occasional reports on headache, dizziness, drowsiness, agitation, dry mouth, gastrointestinal discomfort and hypersensitivity.

SYMPTOMS AND TREATMENT FOR OVERDOSAGE
Overdosage has been reported with cetirizine. Symptoms reported include somnolence, restlessness, irritability and drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine. Cetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

SHELF-LIFE
The expiry date is indicated on the packaging.

STORAGE
Store in a cool place below 30C.

DESCRIPTION
White colour, oblong shape, normal convex film-coated tablet, with break line and "XS" logo.

PACKING / PACK SIZES
10's and 100's in blister packs of 10's.

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