资料单张
AP LORATADINE SYRUP
SCHEDULING STATUS:
S2
PROPRIETARY NAME
(and dosage form):
AP LORATADINE SYRUP
COMPOSITION
Each 5 mL of AP LORATADINE SYRUP contains:
5 mg of
Loratadine
as active
0,1% m/v Sodium Benzoate as preservative
PHARMACOLOGICAL CLASSIFICATION
A.5.7.1 Antihistaminics
PHARMACOLOGICAL ACTION
Loratadine is a second generation histamine (H1)-receptor antagonist. Loratadine exerts its action by competing with
histamine for H1-receptor sites on effector cells.
It prevents, but does not reverse responses mediated by histamine. Loratadine does not cross the blood-brain barrier to
any extent.
Pharmacokinetics:
After oral administration, loratadine is well absorbed from the gastrointestinal tract and peak plasma concentrations are
reached within 1,5 hours. Ingestion of food may enhance the absorption of loratadine. Loratadine undergoes extensive
first pass metabolism via the cytochrome P-450 system.
The major metabolite, desloratadine, is active. Loratadine is 97% protein bound, while desloratadine is less extensively
protein bound (73% to 77%). The mean elimination half-lives for loratadine and desloratadine are 8,4 and 28 hours
respectively.
INDICATIONS
AP LORATADINE SYRUP is indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic
urticaria.
CONTRA-INDICATIONS
Hypersensitivity to AP LORATADINE SYRUP or to any ingredients of this preparation.
Cross sensitivity to other antihistamines.
Porphyria.
WARNINGS
Safety of AP LORATADINE SYRUP in the elderly has not been established.
Safety of AP LORATADINE SYRUP in children under two years of age has not been established.
AP LORATADINE SYRUP should be used with caution in patients with:
• Severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed (See
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