Acitrin-L Oral Solution
Levocetirizine Dihydrochloride
Indications
Acitrin-L is indicated in the treatment of symptoms associated with allergic conditions such as-
- perennial allergic rhinitis
- seasonal allergic rhinitis
- chronic idiopathic urticaria
Pharmacology
This preparation contains Levocetirizine Dihydrochloride. 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.
Dosage & Administration
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.
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Interaction
Acitrin-L is not known to have any interactions with other drugs.
Contraindications
Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.
Side Effects
Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.
Pregnancy & Lactation
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.
Precautions & Warnings
Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.
Overdose Effects
No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.
Therapeutic Class
Non-sedating antihistamines
Storage Conditions
Store at a temperature not exceeding 30°C in a dry place. Protect from light.
