| Composition |
Each film coated tablet contains:
– Levocetirizine 2HCl 5 mg. |
| Properties |
| Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via inhibition of H1 receptors. |
| Therapeutic indications |
Levonda is a histamine H1-receptor antagonist indicated for:
– The relief of symptoms associated with seasonal and perennial allergic rhinitis.
– The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria. |
| Side effect |
| The most common adverse reactions are somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. |
| Contraindication |
– Patients with a known hypersensitivity to levocetirizine or any of the ingredients of Levonda or to cetirizine.
– Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis.
– Children 6 to 11 years of age with renal impairment. |
| Warnings & precautions |
– Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Levonda.
– Avoid concurrent use of alcohol or other central nervous system depressants with Levonda. |
| Pregnancy & lactation |
PREGNANCY:
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Levonda should be used during pregnancy only if clearly needed.
NURSING MOTHERS:
Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is also expected to be excreted in human milk, use of Levonda in nursing mothers is not recommended. |
| Drug interactions |
| In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes. No in vivo drug-drug interaction studies have been performed with levocetirizine. |
| Dosage & administration |
Adults and children 12 years of age and older: 5 mg (1 tablet) once daily in the evening.
Children 6 to 11 years of age: 2.5 mg (1/2 tablet) once daily in the evening. |
| Overdose |
| Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Levonda. |
| Package |
Carton box of 20 F.C.Tablets, blister packed.
Carton box of 10 F.C.Tablets, blister packed. |
| Storage |
| Store at (15–25)°C. Keep away from reach of children. |
