Stadeltine

Stadeltine

levocetirizine

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Concise Prescribing Info
Contents
Levocetirizine HCl
Indications/Uses
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria in adults & childn ≥6 yr.
Dosage/Direction for Use
Adult, adolescent ≥12 yr, childn 6-12 yr, patient w/ normal renal function (CrCl ≥80 mL/min), patient w/ mild renal impairment (CrCl 50-79 mL/min) 1 tab once daily. Patient w/ moderate renal impairment (CrCl 30-49 mL/min) 1 tab once every 2 days. Patient w/ severe renal impairment (CrCl <30 mL/min) 1 tab once every 3 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or any other piperazine derivatives. Severe renal impairment (CrCl <10 mL/min).
Special Precautions
Caution is recommended w/ concurrent alcohol intake. Caution in patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). May increase risk of urinary retention. Caution in patients w/ epilepsy & patients at risk of convulsion. May cause seizure aggravation. Wash-out period (3 days) is required before performing allergy skin tests. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption. Pruritus may occur upon discontinuation. May impair ability to drive or operate machinery. Pregnancy & lactation. Not recommended in childn <6 yr.
Adverse Reactions
Frequency unknown: 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 liver function tests.
Drug Interactions
Small decrease in cetirizine clearance w/ theophylline. Increased extent of exposure to cetirizine w/ ritonavir. Decreased rate of absorption w/ food. Co-administration w/ alcohol or other CNS depressants may cause additional reductions in alertness & impairment of performance in sensitive patients.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
Form
Stadeltine FC tab 5 mg
Packing/Price
5 × 10's
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