Ellezin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Levocetirizine HCl

Indications/Uses

Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria in adults & childn ≥6 yr.

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Dosage/Direction for Use

Adult, adolescent ≥12 yr & childn 6-12 yr 1 tab daily. Patient w/ eGFR ≥90 mL/min & 60-<90 mL/min 1 tab once daily, 30-<60 mL/min 1 tab once every 2 days, 15-<30 mL/min (not requiring dialysis) 1 tab once every 3 days.

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Administration

May be taken with or without food: Swallow whole w/ liqd.

Contraindications

Hypersensitivity to levocetirizine HCl, cetirizine, hydroxyzine, or any other piperazine derivatives. Patients w/ ESRD w/ eGFR <15 mL/min (requiring dialysis treatment).

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Special Precautions

Increased risk of urinary retention. Caution in patients w/ predisposing factors for urinary retention (eg, spinal cord lesion, prostatic hyperplasia). Risk of seizure aggravation. Caution in patients w/ epilepsy & those at risk of convulsion. Response to allergy skin tests is inhibited, & wash-out period of 3 days is required before performing them. Pruritus may occur when treatment is stopped even if it was not present before treatment initiation. Caution w/ concurrent intake of alcohol. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption. Use may be considered during pregnancy, if necessary. Exercise caution when prescribing to lactating women.

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Use In Pregnancy & Lactation

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Adverse Reactions

Unknown frequency: Hypersensitivity including anaphylaxis; increased appetite; aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare; convulsion, paraesthesia, dizziness, syncope, tremor, dysgeusia; vertigo; visual disturbances, blurred vision, oculogyration; palpitations, tachycardia; dyspnoea; nausea, vomiting, diarrhoea; hepatitis; dysuria, urinary retention; angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria; myalgia, arthralgia; oedema; increased wt, abnormal LFTs.

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Storage

View Ellezin storage conditions for details to ensure optimal shelf-life.

Description

View Ellezin description for details of the chemical structure and excipients (inactive components).

MIMS Class

Antihistamines & Antiallergics

ATC Classification

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

Regulatory Classification

P₂

Presentation/Packing

Form

Ellezin FC tab 5 mg

Packing/Price

1 × 10's;50 × 10's

Ellezin

levocetirizine

Manufacturer:

Millimed

Distributor:

Mediline

Marketer:

Mediline