Stadeltine

Stadeltine

levocetirizine

Manufacturer:

Stellapharm

Distributor:

Sage Healthcare
Concise Prescribing Info
Contents
Levocetirizine diHCl
Indications/Uses
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & chronic idiopathic urticaria.
Dosage/Direction for Use
Adult & adolescent ≥12 yr & childn 6-12 yr 1 tab once daily. Renal impairment CrCl 50 to ≥80 mL/min 1 tab once daily, >30-49 mL/min 1 tab once every 2 days, <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 piperazine derivatives. Severe renal impairment (CrCl <10 mL/min).
Special Precautions
Concurrent alcohol intake. May increase risk of urinary retention in patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). May cause seizure aggravation in patients w/ epilepsy & in those at risk of convulsion. Wash-out period of 3 days is required before performing allergy skin tests. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Pruritus may occur upon discontinuation. Patient may experience somnolence, fatigue & asthenia during therapy; may affect ability to drive, engage in potentially hazardous activities or operate machinery. Pregnancy & lactation. Not recommended in childn <6 yr.
Adverse Reactions
Headache, somnolence; dry mouth; fatigue.
Drug Interactions
Small decrease in cetirizine clearance w/ theophylline. Increased extent of exposure to cetirizine w/ ritonavir. Decreased rate of absorption w/ food. Concurrent 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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