Levocetirizine dihydrochloride........................5 mg
Excipients q.s........................................... 1 tablet
Film coated tablet.
Box of 3 blisters x 10 tablets.
The drug does not affect the ability to drive and operate machinery.
Caution should be taken when concurrent use with alcohol. Patients with problems of galactose intolerance, lactase deficiency or galactose-galactase malabsorption should not take this medicine.
The drug should not be prescribed to pregnant women and nursing mothers.
No interaction studies have been performed with levocetirizine. The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased. In sensitive patients, simultaneous administration of levocetirizine and alcohol or other CNS depressants may cause adverse effects on central nervous system.
Mild to moderate adverse effects may include dry mouth, asthenia, fatigue, headache, rhinitis, insomnia, abdominal pain.
Inform your physician about any adverse effects occur during the treatment.
Symptoms of overdose may include drowsiness in adults and initially agitation, followed by drowsiness in children.
Treatment: There is no known specific antidote to levocetirizine. Symptomatic or supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion.
Store in dry places, not exceeding 300C, protect from light.
Levocetirizine, the active enantiomer of cetirizine, is a third-generation antihistamine; its principal effects are mediated via inhibition of H1 receptors. It is used to treat allergy. Levocetirizine rarely produces drowsiness.
Levocetirizine is rapidly absorbed following oral administration. The extent of metabolism of levocetirizine in human is less than 14% of the dose; therefore, no dose adjustment is needed in patients with hepatic impairment. The half-life in adult healthy subjects was about 8 to 9 hours. The major route of excretion of levocetirizine is via urine, a small amount is excreted via feces.
Treatment or prophylaxis of allergic symptoms: seasonal allergic rhinitis (including ocular symptoms), perennial allergic rhinitis, chronic allergic rhinitis, runny nose, itchy nose; allergic pinkeye; urticaria.
Hypersensitivity to any component of the drug or to piperazine derivatives. Patients with severe renal impairment at less than 10 ml/min creatinine clearance.
It is recommended to take the daily dose in 1 single intake; it may be taken with or without food.
Adults and children aged > 6 years: The recommended dose is 5 mg (1 tablet).
Patients with hepatic impairment: No dose adjustment is needed.
Patients with renal impairment:
- Mild renal impairment (creatinine clearance from 50 - 79 ml/min): 1 tablet once daily.
- Moderate renal impairment (creatinine clearance from 30 - 49 ml/min): 1 tablet every two days.
- Severe renal impairment (creatinine clearance 10 - 29 ml/min): 1 tablet every three days.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
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