CETIRIZINE MYLAN 10MG BOX OF 7 DRY TABLETS
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  • CETIRIZINE MYLAN 10MG BOX OF 7 DRY TABLETS

CETIRIZINE MYLAN Viatris 10MG BOX OF 7 DRY TABLETS

€2.16

Description : In adults and children 6 years and older:

- Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- Cetirizine is indicated for the treatment of symptoms of chronic idiopathic urticaria.

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In adults and children 6 years and older:

- Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- Cetirizine is indicated for the treatment of symptoms of chronic idiopathic urticaria.

Medical advice is recommended for chronic idiopathic urticaria.

Dosage

Children 6 to 12 years: 5 mg twice daily (half a tablet twice daily).

Adults and adolescents over 12 years of age: 10 mg once daily (one tablet).

The tablet should be swallowed with a drink.

Elderly: no dosage adjustment is necessary in elderly patients with normal renal function.

Moderate to severe renal insufficiency: the available data do not allow to document the benefit/risk ratio in case of renal insufficiency.

Given its essentially renal elimination (see Pharmacokinetics), and if no alternative treatment can be used, cetirizine should be administered in these situations by adjusting the dosage and the interval between doses according to renal clearance as shown in the table below.

Creatinine clearance (CLcr) can be estimated (in ml/min) from the measurement of serum creatinine (in mg/dl) using the following formula:

LCcr = [140- age (year)] x weight (kg) x (0.85 for women)

72 x serum creatinine (mg/dl)

Dosage adjustment in patients with renal impairment :

Group

Creatinine Clearance (mL/min)

Dose and frequency of administration

Normal renal function

Mild renal impairment

Moderate renal impairment

Severe renal impairment

End stage renal disease and dialysis patients

³ 80

50 - 79

30 - 49

< 30

< 10

10 mg once daily

10 mg once daily

5 mg once daily

5 mg once every 2 days

Contraindicated

In pediatric patients with renal impairment, dosage will be adjusted individually according to renal clearance, age and body weight.

Hepatic impairment: No dose adjustment is necessary in patients with isolated hepatic impairment.

In patients with hepatic impairment associated with renal impairment, dose adjustment is recommended (see "Moderate to Severe Renal Impairment" above).

CETIRIZINE MYLAN PHARMA: What it looks like and how it works

White, scored, oblong film-coated tablet.

CETIRIZINE MYLAN PHARMA: presentation

CETIRIZINE MYLAN PHARMA: how it works

Pharmacotherapeutic class: antihistamines for systemic use/piperazine derivatives, ATC code: R06AE07.

Cetirizine, a metabolite of hydroxyzine, is a potent and selective peripheral H1 receptor antagonist. In vitro receptor binding studies have not revealed any measurable affinity for receptors other than H1 receptors.

In combination with the anti-H1 effects, cetirizine at a dose of 10 mg once or twice daily inhibits the delayed phase of eosinophil recruitment in the skin and connective tissue of atopic subjects after allergen challenge.

Studies in healthy volunteers have shown that cetirizine, at doses of 5 and 10 mg, strongly inhibits erythematopapular reactions induced by high histamine concentrations in the skin. However, the correlation of efficacy with these findings is not established.

In a 35-day study in children aged 5 to 12 years, there was no decrease in the antihistamine effect (inhibition of erythema and papules) of cetirizine. Upon discontinuation of repeated-dose cetirizine therapy, skin reactivity to histamine was restored within 3 days.

In a six-week placebo-controlled study of 186 patients with allergic rhinitis and mild-to-moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms without affecting lung function. This study highlights the safety of cetirizine in allergic patients with mild to moderate asthma.

In a placebo-controlled study, cetirizine 60 mg for 7 days did not significantly prolong the QT interval.

At the recommended dosage, an improvement in quality of life was demonstrated in cetirizine-treated patients with perennial and seasonal allergic rhinitis.

Behavioural considerations for drivers of vehicles

Objective measures of driving ability, alertness and reaction time have not demonstrated a clinically significant effect at the recommended dose of 10 mg.

Patients who may drive or operate potentially dangerous tools or machinery should not exceed the recommended dose and should be assessed for response to treatment. Concomitant use of alcohol or other central nervous system (CNS) depressants may result in impaired alertness or performance in susceptible patients.

CETIRIZINE MYLAN PHARMA: Contraindications

- Known hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to piperazine derivatives.

- Severe renal insufficiency with a creatinine clearance of less than 10 ml/min.

CETIRIZINE MYLAN PHARMA: Precautions for use

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

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

The use of the tablet is not recommended in children under 6 years of age because this form does not allow for dosage adjustment in this age group.

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

CETIRIZINE MYLAN PHARMA: Interactions

Based on pharmacokinetic and pharmacodynamic data and the safety profile, no interaction with cetirizine is expected. To date, no significant pharmacodynamic or pharmacokinetic interactions have been reported in drug interaction studies with pseudoephedrine or theophylline (400 mg/day).

The rate of absorption of cetirizine is not decreased by food, although the rate of absorption is reduced.

CETIRIZINE MYLAN PHARMA: Incompatibilities

Not applicable.

In case of overdose

Symptoms

Symptoms observed after cetirizine overdosage are primarily associated with CNS effects or effects suggestive of anticholinergic action.

Adverse reactions reported after a dose at least five times the recommended daily dose include confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.

What to do in case of overdose

There is no known antidote to cetirizine.

In case of overdose: symptomatic treatment and clinical monitoring. Gastric lavage may be considered in case of recent ingestion.

Cetirizine is not effectively eliminated by hemodialysis.

Pregnancy - Lactation

Very few clinical data are available on pregnancies exposed to cetirizine. Animal studies have not revealed any direct or indirect adverse effect on gestation, embryonic and fetal development, parturition and postnatal development.

Caution is recommended when prescribing to pregnant or breast-feeding women because of the passage of cetirizine into breast milk.

CETIRIZINE MYLAN PHARMA: adverse reactions

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

Despite its selective antagonistic effect on peripheral H1 receptors and the relatively low anticholinergic activity, isolated cases of micturition difficulties, accommodation problems and dry mouth have been reported.

Liver function abnormalities with increased liver enzymes associated with increased bilirubin have been reported. Abnormalities have mostly resolved with discontinuation of cetirizine dihydrochloride therapy.

Clinical Trials

Over 3200 subjects exposed to cetirizine have been included in double-blind controlled clinical trials or pharmaco-clinical trials comparing cetirizine at the recommended dosage of 10 mg daily, placebo or other antihistamines, in which quantified safety data are available.

In this overall population, adverse events reported in placebo-controlled trials with an incidence of 1.0% or greater were as follows

Adverse Events

(WHO-ART)

Cetirizine 10 mg

(n = 3260)

Placebo

(n = 3061)

General health problems

Fatigue

1,63%

0,95%

Central and peripheral nervous system disorders

Vertigo

Headache

1,10%

7,42%

0,98%

8,07%

Gastrointestinal system disorders

Abdominal pain

Dry mouth

Nausea

0,98%

2,09%

1,07%

1,08%

0,82%

1,14%

Psychiatric disorders

Drowsiness

9,63%

5,00%

Respiratory disorders

Pharyngitis

1,29%

1,34%

Drowsiness was statistically more frequent than with placebo, but of mild to moderate intensity in the majority of cases. Objective tests, validated by other studies, have shown in young healthy volunteers that usual daily activities are not affected at the recommended daily dose.

Adverse reactions reported with an incidence of 1% or greater in children aged 6 months to 12 years included in placebo-controlled clinical trials or pharmaco-clinical studies are

Adverse Reactions

(WHO-ART)

Cetirizine 10 mg

(n = 1656)

Placebo

(n = 1294)

Gastrointestinal system disorders

Diarrhea

1,0%

0,6%

Psychiatric disorders

Drowsiness

1,8%

1,4%

Respiratory disorders

Rhinitis

1,4%

1,1%

Disorders of the general state

Fatigue

1,0%

0,3%

Post-Market Adverse Drug Reactions

In addition to the clinical trial adverse events listed above, isolated cases of adverse events have been reported since the product was marketed. For these less frequently reported adverse reactions, the frequency estimate (uncommon: ³ 1/1000 and < 1/100; rare: ³ 1/10000 and < 1/1000; very rare < 1/10000) is based on marketing data.

Hematologic and lymphatic system disorders:

Very rare: thrombocytopenia

Immune system disorders:

Rare: hypersensitivity

Very rare: anaphylactic shock

Psychiatric disorders:

Uncommon: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very Rare: tic

Nervous system disorders:

Uncommon: paresthesia

Rare: convulsions, abnormal movements

Very Rare: dysgeusia, syncope, tremor, dystonia, dyskinesia

Eye disorders:

Very rare: accommodation disorders, blurred vision, oculogyric seizures

Cardiac disorders:

Rare: tachycardia

Gastrointestinal disorders:

Uncommon: diarrhea

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Uncommon: pruritus, rash

Rare: urticaria

Very rare: angioedema, erythema pigmentum fixata

Kidney and urinary tract disorders

Very rare: dysuria, enuresis

General Disorders and Administration Site Conditions:

Uncommon: asthenia, malaise

Rare: edema

Investigations:

Rare: weight gain.

3400936699854

Specific References

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