AERIUS TABLET SALUT SELAPUT 5 MG

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

DESLORATADINE

Tersedia dari:

MERCK SHARP & DOHME PHARMA - Indonesia

INN (Nama Internasional):

DESLORATADINE

Dosis:

5 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT

Diproduksi oleh:

SCHERING PLOUGH LABO N.V. - Belgium

Tanggal Otorisasi:

2018-05-23

Karakteristik produk

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 : 08/07/2021
ID : EREG100373VR12100205
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.
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 concentration-time curve (AUC) of 4 ng/mL and 56.9 ng·hr/mL
were
observed,
respectively.
Neither food nor grapefruit
juice had an effect
on the
bioavailability (C
max
and A