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Logo ZYRTEC® TABLET 10 mg
ZYRTEC® ORAL DROPS 10 mg/mL
ZYRTEC® ORAL SOLUTION 1 mg/mL
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ZYRTEC® TABLET 10 mg
ZYRTEC® ORAL DROPS 10 mg/mL
ZYRTEC® ORAL SOLUTION 1 mg/mL

COMPOSITION:
Each film-coated TABLET contains 10 mg Cetirizine dihydrochloride
Each 1 mL ORAL DROPS contains 10 mg Cetirizine dihydrochloride
Each 1 mL ORAL SOLUTION contains 1 mg Cetirizine dihydrochloride
The ORAL DROPS and ORAL SOLUTION contain methylparahydroxybenzoate 0,135% m/v and propylparahydroxybenzoate 0,015% m/v as preservatives.
The ORAL DROPS and ORAL SOLUTION do not contain sucrose or alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
ZYRTEC®, a metabolite of hydroxyzine, is an anti-allergic agent with a histamine H1 receptor antagonism devoid of any significant anticholinergic and antiserotonin effects as demonstrated in experimental and clinical pharmacology.
At the present stage of research into the mode of action of cetirizine, the anti-allergic activity seems to be exerted mainly via its effects on the release of certain mediators, such as histamine, together with a selective action on the H1 receptors. Cetirizine reduces eosinophil recruitment induced by an antigen-antibody reaction.
PHARMACOKINETIC PROPERTIES:
Peak blood levels of 300 ng/mL are reached within one hour after oral administration of cetirizine. Cetirizine does not undergo extensive first pass metabolism. The terminal half life is approximately 10 hours in adults, 6 hours in children aged 6 to 12 years and 5 hours in children aged 2 to 6 years.
These data are consistent with the urinary excretion half-life of the drug. The cumulative urinary excretion represents about two thirds of the dose given in both adults and children. The apparent plasma clearance in children is higher than that measured in adults. Plasma levels are linearly related to the dosage given. A high proportion of cetirizine is bound to human plasma proteins. In patients with impaired renal clearance (less than 40 mL/min) and hepatic insufficiency, an increase in half-life and decrease in total creatinine clearance occurs.

INDICATIONS:
Allergic processes responding to a histamine H1 receptor antagonist.
– Respiratory: Allergic rhinitis, hay fever.
– Cutaneous: Allergic skin conditions associated with pruritus e.g. urticaria.

CONTRA-INDICATIONS:
History of hypersensitivity to any of the constituents of the formulations.
Hypersensitivity to hydroxyzine.
ZYRTEC® is contra-indicated in lactating women since the active ingredient is excreted in breast milk.
ZYRTEC® is contra-indicated in pregnancy as the safety has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Tablets:
– Adults, or children 12 years of age or older: one 10 mg tablet daily.
– Children 6 to 12 years old: 10 mg (1 tablet) once daily or 5 mg (half a tablet) twice daily.
Oral drops:
– Adults, or children 12 years of age or older: 10 mg (20 drops) once daily.
– Children 6 to 12 years old: 10 mg (20 drops) daily, either as a single dose or as divided doses of 10 drops in the morning and 10 drops in the evening.
– Children 2 to 6 years old: 5 mg (10 drops) daily, either as a single dose or as divided doses of 5 drops in the morning and 5 drops in the evening.
Oral solution:
– Adults, or children 12 years of age or older: 10 mg (10 mL) once daily.
– Children 6 to 12 years old: 10 mg (10 mL) daily, either as a single dose or as divided doses of 5 mL in the morning and 5 mL in the evening.
– Children 2 to 6 years old: 5 mg (5 mL) daily, either as a single dose or as divided doses of 2,5 mL in the morning and 2,5 mL in the evening.
At present there are no data to suggest that the dose needs to be reduced in elderly patients with normal renal function. In patients with renal insufficiency (creatinine clearance less than 40 mL/min), the dosage should be reduced to half the usual recommended dose. Half the recommended daily dose should be used in patients with moderate to severe hepatic impairment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
ZYRTEC® lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. There have been occasional reports of mild and transient subjective side-effects such as headache, dizziness, drowsiness, agitation, dry mouth, increased appetite, nervousness, fatigue, asthenia, malaise, nausea and gastro-intestinal discomfort. In some individuals, hypersensitivity reactions including skin reactions, urticaria, pruritus and angioedema may develop.
Interactions: To date there are no known interactions with other drugs. Studies with diazepam, glipizide, pseudoephedrine, ketoconazole, azithromycin, erythromycin and cimetidine have revealed no evidence of pharmacokinetic interactions. As with other antihistamines it is advisable to avoid excessive alcohol consumption.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Drowsiness can be a symptom of overdosage. Overdosage in children may produce agitation, somnolence, pruritus, rash, urinary retention, fatigue, tremor, and tachycardia. In the case of massive overdosage, gastric lavage should be performed together with the usual supportive measures. To date there is no specific antidote. Cetirizine is not effectively removed by dialysis.

IDENTIFICATION:
ZYRTEC® TABLET 10 mg. White, oblong, film-coated tablet, scored on one side and marked Y/Y.
ZYRTEC® ORAL DROPS 10 mg/mL. Clear and colourless solution.
ZYRTEC® ORAL SOLUTION 1 mg/mL. Clear and colourless solution with a banana flavour.

PRESENTATION:
ZYRTEC® TABLET 10 mg is available in packs of 10's and 30's.
ZYRTEC® ORAL DROPS 10 mg/mL is available in 15 mL bottles.
ZYRTEC® ORAL SOLUTION 1 mg/mL is available in 50 mL and 150 mL bottles.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep tablets in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
ZYRTEC® TABLET 10 mg.         W/5.7.1/148
ZYRTEC® ORAL DROPS 10 mg/mL.         28/5.7.1/0477
ZYRTEC® ORAL SOLUTION 1 mg/mL.         28/5.7.1/0478

Zimbabwe only:
Zyrtec Tablet 10 mg:        PP10        Reg. No. 91/5/2542
Zyrtec Oral Solution 1 mg/mL        PP        Reg. No: 2000/5/3795

NAME AND BUSINESS ADDRESS OF APPLICANT:
UCB (S.A.) (PTY) LTD
3rd Floor, Park Terras,
33 Princess of Wales Terrace,
Parktown,
Johannesburg
Postal Address:
P.O. Box 31036, Braamfontein, 2017

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5/94

        A&S PRINTERS
        D756

Updated on this site: March 2003
Source: Community Pharmacy

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