Zyrtec online in Australia

Use

Therapeutic indications

Cetirizine dihydrochloride 10 mg / ml, the oral solution in drops is indicated in adults and children from 2 years:

• in the treatment of nasal and eye symptoms of seasonal and perennial allergic rhinitis;
• in the treatment of symptoms of chronic idiopathic urticaria.

Dosage and method of administration

Dose

10 mg once a day (20 drops).

Special populations

Elderly

No dosage adjustment is necessary in the elderly with normal renal function.

Patients with moderate to severe kidney failure.

The available data do not allow documenting the benefit / risk ratio in case of renal failure. In view of the essentially renal elimination of cetirizine (see section Pharmacokinetic properties), and if an alternative treatment cannot be used, the interval between doses should be adjusted according to renal function. The dose should be adjusted as indicated in the table below. To use this table, it is necessary to estimate the patient's creatinine clearance (Clcr) in ml / min. The Clcr (ml / min) can be estimated from the serum creatinine value (in mg / dl) according to the following formula:

CrCr = ((140 - age (years)) x weight (kg)) / (72 x serum creatinine (mg / dl) (x 0.85 for women)

Dose adjustment in patients with renal failure:

Group

Creatinine clearance (ml / min)

Dosage and frequency of administration

Normal kidney function

≥ 80

10 mg once a day

Mild kidney failure

50-79

10 mg once a day

Moderate kidney failure

30-49

5 mg once a day

Severe kidney failure

minus 30

5 mg once every 2 days

Patients with end-stage renal failure and dialysis.

minus 10

Contraindicated

Patients with liver failure.

No dosage adjustment is necessary in patients with isolated hepatic impairment. In patients with hepatic impairment associated with renal impairment, a dose adjustment is recommended (see section "Patients with moderate to severe renal impairment" above).

Pediatric population

Children from 2 to 6 years old: 2.5 mg twice a day (5 drops twice a day).

Children from 6 to 12 years old: 5 mg twice a day (10 drops twice a day).

Adolescents over 12 years: 10 mg once a day (20 drops).

In children with renal impairment, the dose will be adjusted individually according to the renal clearance, age and body weight of the patient.

Administration form

The drops should be poured into a spoon or diluted in water and then swallowed.

The volume of water added for dilution should be tailored to the amount that the patient, especially when administered to the child, can swallow. The diluted solution should be ingested immediately.

Prescription and delivery conditions

List II

Duration and special precautions for conservation

Shelf life: 5 years.

After opening: 3 months.

Special storage precautions: This medicine does not require any special storage precautions.

Preclinical safety data

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive and developmental functions have revealed no particular risk to humans.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section, to hydroxyzine or to piperazine derivatives.

Patients with severe renal impairment with a creatinine clearance of less than 10 ml / min.

Pregnancy and lactation

Pregnancy

The prospective data collected on the outcome of pregnancies exposed to cetirizine does not suggest a greater maternal or embryo-fetal toxic potential than that of the general population.

Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonic and fetal development, delivery, and postnatal development.

Caution is recommended when prescribing in pregnant women.

Breastfeeding

Zyrtec is excreted in human breast milk in concentrations in the range of 25% to 90% of plasma measurements, depending on the time of collection compared to administration. Therefore, caution is recommended when prescribing cetirizine in nursing mothers.

Fertility

Data on human fertility are limited, but no risks have been identified.

Animal data do not show safety concerns for human reproduction.

Warnings and precautions for use

At therapeutic doses, no clinically significant interaction with alcohol consumption has been demonstrated (for blood alcohol concentrations up to 0.5 g / l). However, caution is advised when drinking alcohol concomitantly.

Caution should be exercised in patients with factors predisposing to urinary retention (eg, spinal cord injury, prostatic hyperplasia) since cetirizine may increase the risk of urinary retention.

Cetirizine should be used with caution in patients with epilepsy or at risk of seizures.

The response to allergic skin tests is inhibited by antihistamines and a period of 3 days without treatment is necessary before performing them.

Propyl and methyl parahydroxybenzoates can cause allergic reactions (the onset of which may be delayed compared to when taken).

Pruritus and / or hives may occur when cetirizine is discontinued, even if symptoms were not present before treatment was started. In some cases, symptoms can be severe and require resumption of treatment. Symptoms should disappear when treatment is resumed.

Pediatric population

The use of this medicine is not recommended in children under 2 years of age.

Interaction with other medicinal products and other forms of interaction

Given the pharmacokinetics, pharmacodynamics, and tolerance profile of cetirizine, no interaction with this antihistamine is expected. To date, no significant pharmacodynamic or pharmacokinetic interactions have been reported in drug interaction studies, in particular with pseudoephedrine or theophylline (400 mg / day).

Diet does not reduce the absorption rate of cetirizine, although the absorption rate is reduced.

Concomitant use of alcohol or other central nervous system (CNS) depressants may affect alertness or performance in sensitive patients, although cetirizine does not potentiate the effects of alcohol (at a concentration of 0.5 g / l).

Caution

Undesirable effects

Clinical trials

Synthesis

Non-serious side effects to the central nervous system, including drowsiness, fatigue, dizziness and headache, have been observed in clinical trials with cetirizine at the recommended dose. In some cases, a paradoxical effect of stimulation of the central nervous system has been observed.

Despite the selective antagonistic effect of peripheral H1 receptors and relatively weak anticholinergic activity, isolated cases of voiding difficulty, accommodation problems and dry mouth have been reported.

There have been reports of abnormal liver function with increased liver enzymes associated with increased bilirubin. Abnormalities returned in most cases with discontinuation of cetirizine dihydrochloride.

List of side effects.

More than 3,200 subjects exposed to cetirizine have been included in double-blind controlled clinical trials comparing cetirizine at the recommended dose of 10 mg per day, placebo or other antihistamines, for which quantified safety data are available. available.

Side effects reported with cetirizine 10 mg for the entire population in placebo-controlled trials, with an incidence of 1.0% or more, were as follows:

Adverse effect

(OMS-ART)

Zyrtec 10 mg

(n = 3260)

Placebo

(n = 3061)

General disorders and administration site conditions.

Tired

1.63%

0.95%

Nervous system disorders

Dizzying sensations

1.10%

0.98%

Headache

7.42%

8.07%

Gastrointestinal disorders.

Abdominal pain

0.98%

1.08%

Dry mouth

2.09%

0.82%

Sickness

1.07%

1.14%

Psychiatric disorders

Drowsiness

9.63%

5.00%

Respiratory, thoracic and mediastinal disorders.

Pharyngitis

1.29%

1.34%

Sleepiness was statistically more common than placebo, but mild to moderate in most cases. Objective tests, validated by other studies, have shown, in healthy young volunteers, that normal daily activities are not affected at the recommended daily dose.

Pediatric population

The reported side effects with an incidence of 1% or more in children aged 6 months to 12 years included in placebo-controlled clinical trials are as follows:

Adverse effect

(OMS-ART)

Zyrtec 10 mg

(n = 1656)

Placebo

(n = 1294)

Gastrointestinal disorders.

Diarrhea

1.0%

0.6%

Psychiatric disorders

Drowsiness

1.8%

1.4%

Respiratory, thoracic and mediastinal disorders.

Rhinitis

1.4%

1.1%

General disorders and administration site conditions.

Tired

1.0%

0.3%

Post-marketing adverse reactions

In addition to the side effects reported in clinical trials and listed above, the following side effects have been reported from the market.

Adverse effects are described according to the MedDRA convention for organ system classes and by estimating their market frequency.

Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100, minus 1/10); uncommon (≥ 1/1000, minus 1/100); rare (≥ 1 / 10,000, minus 1 / 1,000); very rare (less than 1 / 10,000); frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders.

Very rare: thrombocytopenia.

Immune system disorders.

Rare: hypersensitivity.

Very rare: anaphylactic shock.

Metabolism and nutrition disorders.

Frequency not known: increased appetite.

Psychiatric disorders

Uncommon: agitation

Rare: aggression, confusion, depression, hallucinations, insomnia.

Very rare: tics

Frequency not known: suicidal thoughts.

Nervous system disorders

Uncommon: paresthesia

Rare: seizures.

Very rare: dysgeusia, syncope, tremors, dystonia, dyskinesia.

Frequency not known: amnesia, memory impairment.

Eye conditions

Very rare: accommodation disorders, blurred vision, oculogyric crisis.

Ear and labyrinth disorders.

Frequency not known: dizziness.

Heart conditions

Rare: tachycardia

Gastrointestinal disorders.

Uncommon: diarrhea

Hepatobiliary disorders.

Rare: abnormal liver function test (increased liver enzymes: transaminases, alkaline phosphatases, gamma-GT, and bilirubin)

Skin and subcutaneous tissue disorders.

Uncommon: itching, skin rash.

Rare: urticaria

Very rare: angioneurotic edema, fixed pigmented erythema.

Kidney and urinary tract disorders.

Very rare: dysuria, enuresis.

Frequency not known: urinary retention

General disorders and administration site conditions.

Uncommon: asthenia, general malaise.

Rare: edema.

Frequency not known: withdrawal syndrome, which includes itching and itching.

Research

Rare: weight gain.

Description of some side effects.

Pruritus (severe itching) and / or urticaria have been reported after discontinuation of cetirizine therapy.

Overdose

symptom

Symptoms observed after a cetirizine overdose are primarily associated with effects on the central nervous system (CNS) or effects suggesting anticholinergic action.

The unwanted effects reported after taking a dose at least 5 times greater than the recommended daily dose are: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, agitation, sedation, drowsiness, stupor, tachycardia, tremors and urinary retention.

What to do

There is no known specific antidote for cetirizine.

In case of overdose, symptomatic treatments or support measures are recommended. Gastric lavage can be considered in case of recent ingestion.

Zyrtec is not effectively removed by hemodialysis.

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