Acitrin-L5 mg

Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as- perennial allergic rhinitis seasonal allergic rhinitis chronic idiopathic urticaria

Non-sedating antihistamines

Acitrin-L 5 mg is a preparation of Acitrin-L 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.

Adults and children 12 years of age and older: 5 mg once daily in the eveningChildren 6 to 11 years of age: 2.5 mg once daily in the eveningChildren 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily in the eveningRenal Impairment: Adjust the dose in patients 12 years of age and older with decreased renal function

Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.Children 6 to 11 years of age: The recommended dose is 2.5 mg (½ tablet or 1 teaspoon oral solution) once daily.Children 6 months to 5 years of age: The recommended dose is 1.25 mg (½ teaspoon oral solution) once daily.Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.Renal impairment: Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended. Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended. Severe renal impairment (creatinine clearance: 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 (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.

Levocetirizine is not known to have any interactions with other drugs.

Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.

Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.

Pregnancy: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the foetus.Lactation: 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 risk to the nursing infant.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.

Store at a temperature not exceeding 30°C in a dry place. Protect from light.

Paediatric use: Not recommended for use in children less than 6 years of age.

Non-sedating antihistamines

This preparation contains Acitrin-L 5 mg. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.

Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.