Lorazin 10mg Orodispersible Tablet

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

LORATADINE

可用日期:

MEDISPEC (M) SDN.BHD

INN（国际名称）:

LORATADINE

每包单位数:

10x10tablet Tablets; 5x10tablet Tablets; 3x10tablet Tablets; 1x10tablet Tablets

厂商:

SQUARE PHARMACEUTICALS LTD

产品特点

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