Netis® 5 mg Tablet: Each Film-coated Tablet Contains Levocetirizine Dihydrochloride USP 5 mg.
Netis® Oral Solution: Each 5 ml oral solution contains Levocetirizine Dihydrochloride USP 2.5 mg.
Levocetirizine is the active (levo) isomer of Cetirizine. It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H₁-receptors than Cetirizine. Levocetirizine has a rapid and long-lasting action, allowing once-a-day administration.
Mode of action:
Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H₁ receptors.
Levocetirizine is indicated for the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.
Adult and children 12 years of age and older: 5 mg once daily in the evening.
Children 6 to 11 years of age: 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily in the evening.
Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) (2.5 ml) once daily in the evening.
Patients with Renal Impairment: Mild Renal Impairment (Creastrine Clearance [CLra = 50-80 ml/min), a dose of 2.5 mg once daily is recommended. Moderate Renal Impairment [CLra = 30-50 ml/min], a dose of 2.5 mg twice every other day is recommended. Severe Renal Impairment [CLra = 10-30 ml/min], a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended. End-stage Renal Disease Patients [CLra < 10 ml/min] and patients undergoing hemodialysis should not receive Netis®.
No clinically important drug interactions have been reported.
Overdose:
No clinically relevant adverse events have been reported in case of overdose. However, in the event of overdose, symptomatic and supportive treatment is recommended.
The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the benefits to the mother outweigh any risks to the fetus.
Levocetirizine passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the possible risk to the nursing infant.
Not recommended for use in children less than 6 months of age.
Patients should be cautioned against engaging in hazardous occupations requiring Complete mental alertness after ingestion of Levocetirizine. Concurrent use of Levocetirizine with alcohol or other central nervous system depressants should be avoided. Levocetirizine should be used with caution in patients with predisposing factors of urinary retention.
Keep out of reach of children. Store in a dry place, below 25° C temperature and protected from light.