RiteMED Levocetirizine Dosage & Drug Information

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

Concise Prescribing Info

Contents

Levocetirizine diHCl

Indications/Uses

Relief of symptoms associated w/ seasonal & perennial allergic rhinitis. Uncomplicated skin manifestations of chronic idiopathic urticaria.

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Dosage/Direction for Use

Adult & childn ≥12 yr 1 tab once daily at bedtime. Mild renal impairment (CrCl 50-79 mL/min) 1 tab once daily. Moderate renal impairment (CrCl 30-49 mL/min) 1 tab once every 2 days. Severe renal impairment (CrCl <30 mL/min) 1 tab once every 3 days.

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Overdosage

View RiteMED Levocetirizine overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity to levocetirizine, cetirizine & other piperazine derivatives. ESRD (CrCl <10 mL/min) or undergoing hemodialysis. Lactation. Childn 6 mth-11 yr w/ renal impairment.

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Special Precautions

Predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). Epileptic patients & those at risk of convulsion. Avoid concomitant use w/ alcohol or other CNS depressants. May impair ability to drive or operate machinery. Pregnancy. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, constipation, otitis media, vomiting, cough, pyrexia, epistaxis, asthenia, dry mouth, fatigue, headache, nasopharyngitis, pharyngitis, somnolence. Hypersensitivity (anaphylaxis); edema, increased appetite, wt gain; aggression, agitation, depression, hallucination, suicidal ideation; convulsion, dizziness, dysgeusia, extrapyramidal symptoms, febrile seizure, insomnia, movement disorders (including dystonia & oculogyric crisis), myoclonus, orofacial dyskinesia, paresthesia, seizure, syncope, tic, tremor; blurred vision, visual disturbances; vertigo; palpitations, tachycardia; severe hypotension; dyspnea; nausea; cholestasis, hepatitis; acute generalized exanthematous pustulosis, angioedema, fixed drug eruption, pruritus, rash, urticaria; arthralgia, myalgia; dysuria, glomerulonephritis, urinary retention; stillbirth; abnormal LFTs, increased blood bilirubin & transaminases.

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Drug Interactions

Possible additive effect w/ CNS depressants (eg, alcohol). Increased AUC & t_½ w/ ritonavir. Decreased clearance w/ theophylline & ritonavir.

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Storage

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Description

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

Action

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MIMS Class

Antihistamines & Antiallergics

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

RiteMED Levocetirizine FC tab 5 mg

Packing/Price

50's (P18/film-coated tab, P900/box)

RiteMED Levocetirizine

levocetirizine

Manufacturer:

RiteMED

Distributor:

United Lab