DIPROGENTA

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Karakteristik produk Karakteristik produk (SPC)
01-01-2021

Bahan aktif:

BETAMETHASONE DIPROPIONATE, GENTAMICIN SULFATE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

BETAMETHASONE DIPROPIONATE, GENTAMICIN SULFATE

Dosis:

0.64 MG /1.70 MG

Bentuk farmasi:

SALEP

Unit dalam paket:

DUS, TUBE @ 5 G

Diproduksi oleh:

ORGANON PHARMA INDONESIA TBK - Indonesia

Tanggal Otorisasi:

2021-08-24

Karakteristik produk

                                DIPROGENTA

CREAM AND OINTMENT
COMPOSITION
Each
gram
contains
0,64
mg
betamethasone
dipropionate
equivalent
to
0,5
mg
betamethasone and 1,7 mg gentamicin sulfate equivalent to 1 mg
gentamicin base.
DESCRIPTION
A combination of the corticosteroid betamethasone dipropionate and the
antibiotic gentamicin
sulfate
with
anti-inflammatory,
antipruritic,
vasoconstrictive
and
bactericidal
properties,
particularly against staphylococcal species.
INDICATIONS
For the reduce of inflammatory manifestations of
corticosteroid-responsive dermatoses when
complicated by secondary infection, caused by organisms susceptible to
gentamicin, or
when such infection is suspected.
DOSAGE AND ADMINISTRATION
A thin film should be applied to cover completely the affected area
twice daily, in the morning
and evening. Some patients may be maintained with less frequent
application.
PRECAUTIONS
Discontinue treatment if irritation or sensitization develops.
Any side effect reported following use of systemic corticosteroids may
occur, especially in
infants and children.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of corticosteroids will increase if occlusive
dressing is used or extensive
areas are treated.
Overgrowth
of
nonsusceptible
organisms
may
occur;
should
superinfection
develop,
discontinue treatment and initiate appropriate therapy.
Systemic absorption of topically applied gentamicin may be increased
if extensive body
surface areas are treated, especially over prolonged time periods or
in the presence of dermal
disruption. In these cases, the undesirable effects which occur
following systemic use of
gentamicin may potentially occur. Cautious use is recommended under
these conditions,
particularly in infants and children.
Not for ophthalmic use.
DISETUJUI OLEH BPOM: 25/06/2021
EREG100373VR12100265
EREG100373VR12100267
Visual disturbance may be reported with systemic and topical
(including, intranasal, inhaled
and intraocular) corticosteroid use. If a patient presents with
symptoms such as blurred v
                                
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