1. Name Of The Medicinal Product
Piriteze Allergy Syrup
2. Qualitative And Quantitative Composition
Each 1 ml of solution contains 1 mg of cetirizine hydrochloride.
For excipients, see 6.1.
3. Pharmaceutical Form
Oral solution.
Clear colourless solution with a banana odour.
4. Clinical Particulars
4.1 Therapeutic Indications
Adults and children 6 years and over:
Symptomatic treatment of allergic rhinitis (seasonal and perennial), and chronic idiopathic urticaria.
4.2 Posology And Method Of Administration
Adults and children aged 6 years and over: 2 x 5 ml once daily or 5ml taken twice daily (morning and evening).
If drowsiness occurs, the solution can be administered in the evening.
Children under 6 years:
Not recommended.
Cetirizine is contraindicated in patients with severe renal impairment. In patients with moderate renal impairment the dose should be adjusted to 5 ml. Caution should be exercised in patients with mild to moderate renal impairment or impaired liver function (see 4.4 Special warnings and precautions for use).
There is no evidence that the dose needs to be modified for healthy elderly patients. The duration of the treatment may vary depending on the symptoms.
4.3 Contraindications
Hypersensitivity to cetirizine hydrochloride and other piperazine-derivatives or to any of the excipients.
Patients with severe renal impairment (CLcr: <10 ml/min).
4.4 Special Warnings And Precautions For Use
In some patients, long term treatment with Cetirizine Solution may lead to an increased risk of caries due to mouth dryness. The patients should therefore be informed about the importance of oral hygiene.
In cases of impaired hepatic function and renal function, the elimination of cetirizine may be impaired. Caution should be exercised when administering cetirizine to these patients. (see section 4.2 posology and section 4.3 contraindications).
Cetirizine may potentiate the effects of alcohol. Therefore caution is recommended during concomitant use of alcohol.
Caution is recommended with concomitant use of CNS depressants.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Allergy testing: Use of cetirizine must be discontinued three days before allergy tests. Cetirizine may potentiate the effects of alcohol. Therefore caution is recommended during concomitant use of alcohol. Caution is recommended during concomitant use of CNS depressants.
4.6 Pregnancy And Lactation
Data on a limited number of exposed pregnancies indicate no adverse effects of cetirizine on pregnancy or on the health of the foetus/new born child. To date no other relevant epidemiological data are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post natal development (see 5.3). Caution should be exercised when prescribing to pregnant women.
Breast feeding
No data concerning the excretion of cetirizine into human milk are available. Cetirizine should be avoided during lactation.
4.7 Effects On Ability To Drive And Use Machines
Cetirizine may have minor or moderate influence on the patient's ability to react. This should be considered when extra alertness is required e.g. when driving. Cetirizine may potentiate the effects of alcohol and CNS depressants.
4.8 Undesirable Effects
In objective tests of psychomotor function the incidence of sedation with cetirizine was similar to placebo. There have been occasional reports of mild and transient side effects such as drowsiness, fatigue, headache, dizziness, agitation, dry mouth and gastrointestinal discomfort. If desired the dose might be taken as 5 mg in the morning and 5 mg in the evening.
Undesirable effects reported from the post-marketing experience are listed below. The frequency is defined as: very common (>10%); common (
Blood and lymphatic disorders: Very rare: thrombocytopenia
Cardiac disorders: Rare: tachycardia, palpitations
Eye disorders: Very rare: accommodation disorder, blurred vision, oculogyric crisis
Gastrointestinal disorders: Uncommon: diarrhoea
General disorders and administration site conditions: Uncommon: asthenia, malaise; Rare: oedema
Immune system disorders: Rare: hypersensitivity; Very rare: anaphylactic shock
Hepatobiliary disorders: Rare: abnormal hepatic function (increased transaminases, alkaline phosphatase, γ-GT and bilirubin); Very rare: hepatitis
Investigations: Rare: weight increase
Nervous system disorders: Uncommon: paraesthesia; Rare: convulsions, movement disorders; Very rare: dysgeusia, syncope
Psychiatric disorders: Uncommon: agitation; Rare: aggression, confusion, depression, hallucinations, insomnia
Renal and urinary disorders: Very rare: dysuria, enuresis, micturition difficulties
Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash; Rare: urticaria; Very rare: angioneurotic oedema, erythema multiforme.
4.9 Overdose
Toxicity: Limited experience of overdosing. 20 mg to a 2 year old, 30 mg to a 3 year old and 40 mg to an 11 year old did not give any symptoms. 60 mg to a 4 year old gave mild intoxication, 400 mg to a 14 year old gave mild symptoms while 400-500 mg to an adult gave no symptoms at all.
Symptoms of overdosage reported with antihistamine substances: Somnolence, unconsciousness and/or excitation (principally in children). Ataxia, tremor, headache, hallucinations, seizures, dry mouth, flush, hyperthermia, mydriasis, urine retention tachycardia and in the case of massive doses, possible fall in blood pressure and arrhythmias. Nausea and vomiting. Also extrapyramidal symptoms are possible. Cetirizine has a low sedative and anticholinergic effect. Sedation can be a symptom of overdose, it can occur after a single dose of less than 50 mg.
Treatment: At the present time there is no specific antidote. Experience of overdosing is limited and no severe intoxication has been reported to date. Primary treatment should be gastric lavage, if justified and charcoal. Symptomatic treatment should be instituted in the case of acute intoxication, such as diazepam for seizures or acute dystonias.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: RO6AEO7
Pharmacotherapeutic group: Antihistamine piperazine derivatives.
Cetirizine hydrochloride is a racemate and an anti-allergic with specific histamine H1 -receptor blocking characteristics.
Cetirizine inhibits cutaneous reactions in allergic individuals through VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides that are considered to be involved in the allergic reaction. Effect is reached within 2 hours with a maximum effect after 4 hours, and remains for at least 24 hours. In allergic individuals, cetirizine inhibits the recruitment of eosinophils after stimulation with allergens and non selective histamine liberators, by a mechanism that is not primarily explained by the H1-receptor blocking characteristics of the pharmaceutical.
5.2 Pharmacokinetic Properties
Cetirizine is absorbed with small inter-individual variations. Cetirizine has not been given intravenously, therefore the bioavailability, clearance and volume of distribution (Vd) are unknown. Maximum plasma concentration is achieved within 1 hour and the terminal half-life is about 10 hours in adults and 6 hours in children between the age of 6-12 years. The grade of protein binding in plasma is about 93%. Cetrizine is metabolised to a small extent with a known inactive main metabolite. 60% of a dose of cetirizine is eliminated in unchanged form via the kidneys within 96 hours. Repeated administration does not lead to any accumulation, nor is the absorption or elimination affected. In cases of impaired kidney function, the elimination is slower and the half-life is prolonged. Elimination will also be decreased in cases of hepatic impairment.
There is no evidence that the pharmacokinetics of cetirizine is altered in elderly patients unless renal or hepatic function is reduced.
5.3 Preclinical Safety Data
Preclinical information has not been included because the safety profile of Cetirizine Hydrochloride 1mg/ml Oral Solution has been established after many years of clinical use. Please refer to section 4.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerol
Propylene glycol
Sorbitol 70% solution
Methylparaben
Propylparaben
Sodium acetate
Acetic acid glacial
Saccharin sodium
Banana flavour
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
No special precautions for storage.
6.5 Nature And Contents Of Container
70 ml fill bottles.
Amber glass bottle, with child-resistant polypropylene screw cap incorporating a tamper evident seal (yellow polyethylene).
Measuring device: 5 ml plastic PP measuring spoon graduated at 2.5 ml
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex BN22 9AG
8. Marketing Authorisation Number(S)
PL 00289/0595
9. Date Of First Authorisation/Renewal Of The Authorisation
27 January 2004
10. Date Of Revision Of The Text
08/01/2009
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