Acitrin-L^®

Acitrin-L ® is a preparation of Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of Cetirizine. It has an affinity for the human H 1 -receptor 2-fold higher than that of Cetirizine. It is a new highly effective and well tolerated non-sedating antihistamine with potent antiallergic properties.

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Acitrin-L ® is indicated for the relief of symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children.

Adult & children over 6 years of age: One Acitrin-L ® tablet (5 mg) once daily
Paediatric use: Acitrin-L ® tablet is not recommended for use in children less than 6years of age
Acitrin-L ® Oral solution
Adult & children above 12 years of age: 10 ml (2 teaspoonfuls) once daily
Children 6 - 11 years of age: 5 ml (1 teaspoonful) once daily
Children 6 months - 5 years of age: 2.5 ml (1/2 teaspoonful) once daily

Note: Children below 6 months of age Levocetirizine is not recommended

Patients with renal and hepatic impairment
In patients with severe renal impairment, the dose should be 5 mg on alternate days if eGFR 30–50 mL/minute/1.73 m 2 ; 5 mg every 3 days if eGFR 10–30 mL/minute/1.73 m 2 and should be avoided if eGFR less than 10 mL/minute/1.73 m 2 . No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose 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 potential benefits to the mother outweigh any risks to the foetus. 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.

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Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of Levocetirizine. Concurrent use of Levocetirizine with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur.

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

The use of Levocetirizine is contraindicated in patients with known hypersensitivity to Levocetirizine or any of its ingredients, or to Cetirizine. Observed reactions range from urticaria to anaphylaxis. It is also contraindicated in patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis and children with impaired renal function.

Levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes and no drug-drug interaction have been reported with Levocetirizine.

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 Levocetirizine. In case of overdose occurrence, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

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Store in a cool and dry place. Protect from light. It should be kept out of the reach of children.