AERIUS TABLET SALUT SELAPUT 5 MG

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

DESLORATADINE

Available from:

MERCK SHARP & DOHME PHARMA - Indonesia

INN (International Name):

DESLORATADINE

Dosage:

5 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT

Manufactured by:

SCHERING PLOUGH LABO N.V. - Belgium

Authorization date:

2018-05-23

Summary of Product characteristics

Proposed PI ver.2 (Versus PI 07/08 LRN: 034117-DL-TB-PIPB
1
AERIUS
®
DESLORATADINE
FILM COATED TABLETS
DESCRIPTION: AERIUS (desloratadine) Film coated Tablets are light
blue,
round, film coated tablets containing 5 mg desloratadine, an
antihistamine, to
be
administered
orally.
It
also
contains
the
following
excipients:
dibasic
calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn
starch
NF, talc USP, carnauba wax NF, white wax NF, coating material
consisting of
lactose
monohydrate,
hydroxypropyl
methylcellulose,
titanium
dioxide,
polyethylene glycol, and FD&C Blue # 2 Aluminum Lake.
Desloratadine is a white to off-white powder that is slightly soluble
in water,
but very soluble in ethanol and propylene glycol. It has an empirical
formula:
C
19
H
19
ClN
2
and a molecular weight of 310.8. The chemical name is 8-chloro-
6,11-dihydro-11-(4-piperdinylidene)-5
H
-benzo[5,6]cyclohepta[1,2-
b
]pyridine
and has the following structure :
CLINICAL PHARMACOLOGY:
MECHANISM
OF
ACTION:
Desloratadine
is
a
longacting
tricyclic
histamine
antagonist with selective H1-receptor histamine antagonist activity.
Receptor
binding data indicates that at a concentration of 2 – 3 ng/mL (7
nanomolar),
DISETUJUI OLEH BPOM : 26/12/2021
EREG10037312100311
Proposed PI ver.2 (Versus PI 07/08 LRN: 034117-DL-TB-PIPB
2
desloratadine shows significant interaction with the human histamine H
1
-
receptor. Desloratadine inhibited histamine release from human mast
cells
in
vitro
.
Results of a radiolabeled tissue distribution study in rats and a
radioligand H
1
-
receptor binding study in guinea pigs showed that desloratadine did
not
readily cross the blood brain barrier. The clinical significance of
this finding is
unknown.
PHARMACOKINETICS: ABSORPTION: Following oral administration of
desloratadine
5 mg once daily for 10 days to normal healthy volunteers, the mean
time to
maximum plasma concentrations (T
max
) occurred at approximately 3 hours
post dose and mean steady state peak plasma concentrations (C
max
) and area
under the concen