COMPOSITION
Each
film coated tablet contains
Levocetrizine 5 mg
DESCRIPTION
Levocetirizine
is a third generation non-sedative antihistamine, developed from the second
generation antihistamine Cetirizine. Chemically, levocetirizine is the active
enantiomer of cetirizine. Levocetrizine is a selective, long acting peripheral
H1 receptor antagonist antihistamine.
PHARMACOLOGY
Pharmacodynamics:
Levocetirizine, the active enantiomer of
cetirizine, is an anti-histamine; its principal effects are mediated via
selective inhibition of H1 receptors. In vitro binding studies revealed that
levocetirizine has an affinity for the human H1-receptor 2-fold
higher than that of cetirizine (Ki = 3 nmol/L vs. 6 nmol/L,
respectively).
Pharmacokinetics:
Levocetirizine is rapidly and extensively absorbed
following oral administration. In adults, peak plasma concentrations are
achieved 0.9 hour after administration of the oral tablet. Food had no effect
on the extent of exposure (AUC) of the levocetirizine tablet, but Tmax was
delayed by about 1.25 hours and Cmax was decreased by about 36% after
administration with a high fat meal; therefore, levocetirizine can be
administered with or without food.
INDICATIONS
- Seasonal allergic rhinitis
- Perennial allergic rhinitis
- Chronic idiopathic urticaria
- Acute allergic reactions due to food, drugs, insect bite.
- Ocular symptoms (redness, lacrimation and itching)
- Urticaria Demographism
- Atopic eczema
- Contact dermatitis
DOSAGE
The daily dose in adults and adolescents 12 years
of age and older should not exceed 5 mg once daily in the evening. In children
6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening.
In children 6 months to 5 years of age, the recommended dose is 1.25 mg once
daily in the evening.
CONTRAINDICATIONS
·
Patients with known hypersensitivity
·
Patients
with end-stage renal disease
·
Pediatric
patients with impaired renal function
ADVERSE REACTIONS
Headache, Somnolence,
Dry mouth, Mild Drowsiness
Use the drug with caution during pregnancy and lactation, as the drug may pass into the breast milk.
DRUG INTERACTIONS
Rate
of absorption is reduced with food. Alcohol and CNS depressant may potentiate
CNS side effects in the patient.
Levocetirizine dihydrochloride can
potentially interact with a few other medications. Some of the medicines that
may lead to drug interactions with levocetirizine include:
Theophylline