Inhouse product
Alcet
® tablet is a presentation of 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.
Composition:
Each film-coated tablet contains Levocetirizine Dihydrochloride INN 5 mg.
Indications:
Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic
rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.
Dosage and Administration:
Adults & children over 6 years of age: One Alcet
® tablet once daily.
Patients with renal impairment: The recommended dose in patients with moderate renal impairment (Creatinine
Clearance 30-49 ml/min) is one Alcet
® tablet every two days. In those with severe renal impairment (Creatinine
clearance < 30 ml/min), the dose interval should be increased to every three days. Patients with end stage renal disease
(Creatinine clearance < 10 ml/min) should not be given levocetirizine. The tablet should be swallowed whole with liquid
and may be taken with or without meals.
Side Effects:
Generally levocetirizine is well tolerated. However a few side effects like headache, dry mouth, fatigue and skin rash have
been reported rarely.
Contraindications:
Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment
(< 10 ml/min creatinine clearance) should not be administered Alcet®
Pregnancy:
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 foetus.
Lactation:
Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.
Geriatric Use:
Some dose reduction may be required, if renal function is impaired
Hepatic Impairment: No dosage adjustment is required.
Paediatric Use: Not recommended for use in children less than 6 years of age.
Drug Interaction:
Levocetirizine is not known to have any interactions with other drugs.
Overdosage:
No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage,
symptomatic and supportive treatment is recommended.
Storage Requirement:
Store in a cool and dry place below 30ºC. Keep the product away from light.
How Supplied:
Alcet
® tablet: Box containing 10×10 tablets in blister pack.
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