Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
MEDISPEC (M) SDN.BHD
LORATADINE
10x10tablet Tablets; 5x10tablet Tablets; 3x10tablet Tablets; 1x10tablet Tablets
SQUARE PHARMACEUTICALS LTD
PRODUCT NAME Lorazin 10mg Orodispersible Tablet NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Each orally dispersible tablet contains Loratadine 10 mg. THERAPEUTIC CODE R06AX13 - Loratadine; Belongs to the class of other antihistamines for systemic use. PRODUCT DESCRIPTION A white oval flat tablet with a slight beveled edge having break line on one side and engraved “SPL” on another side PHARMACODYNAMICS Loratadine is a cyproheptadine, structurally related to azatadine. It exhibits potent, long- acting H1-antihistamine activity with no central sedative or anticholinergic effects. In man, nasal and other signs and symptoms of allergic rhinitis are relieved rapidly after oral administration. Loratadine is a tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. During studies of its effects on the CNS, loratadine has exhibited no depressant activity and no acute anticholinergic activity. Loratadine has exhibited a very low affinity for membrane receptors from the cerebral cortex and does not readily penetrate into the CNS. Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and in vivo radioligand studies in mice have shown that neither loratadine nor its metabolites readily cross the blood-brain barrier. Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors. The sedation profile of loratadine, 10 mg once daily, is comparable to that of placebo and, during long term treatment; there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms. Loratadine has no significant H2-receptor activity, does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity. PHARMACOKINETICS After oral administration of loratadine in the conventional tablet formulation, the drug i Baca dokumen lengkap