CELESTAMINE

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, DEXCHLORPHENIRAMINE MALEATE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

BETAMETHASONE, DEXCHLORPHENIRAMINE MALEATE

Dosis:

0,250 MG /2,000 MG

Bentuk farmasi:

SIRUP

Unit dalam paket:

DUS, 1 BOTOL @ 30 ML

Diproduksi oleh:

ORGANON PHARMA INDONESIA TBK - Indonesia

Tanggal Otorisasi:

2021-06-23

Karakteristik produk

                                CELESTAMINE

Tablets and Syrup
Betamethasone
Dexchlorpeniramine maleate
DESCRIPTION :
Each Celestamine

Tablet contains 0.25 mg betamethasone, a synthetic
derivative of prednisolone, and 2 mg dexchlorpheniramine maleate. One
teaspoonful (5 ml) of Celestamine

Syrup is equivalent to one Celestamine

Tablet.
ACTIONS :
Celestamine

Tablet and Syrup combine the anti-inflammatory and antiallergic
effects of the corticosteroid betamethasone with the antihistaminic
activity of
dexchlorpheniramine maleate.
INDICATIONS AND USAGE :
Celestamine

Tablets and Syrup are recommended in the treatment of difficult
cases of respiratory, dermatologic and ocular allergies, as well as
ocular
inflammatory disorders, where adjunctive systemic corticosteroid
therapy is
indicated.
DOSAGE AND ADMINISTRATION:
DOSAGE SHOULD BE INDIVIDUALIZED AND ADJUSTED ACCORDING TO
THE SPECIFIC DISEASE BEING TREATED, ITS SEVERITY AND THE
RESPONSE OF THE PATIENT.
The recommended initial dosage of Celestamine

Tablets and Syrup adults and
children over 12 years is 1 to 2 tablets (or 1 to 2 teaspoonfuls) four
times daily,
after meals and at bedtime. The dose is not to exceed 8 tablets (or 8
DISETUJUI OLEH BPOM: 05/08/2021
EREG100373VR12100217
EREG100373VR12100218
teaspoonfuls)
per
day.
In
younger
children
dosage
should
be
adjusted
according to the severity of the condition, and the response of the
patient, rather
than by age or body weight.
Children 6 to 12 years – The recommended dosage is ½ teaspoonful
three times
a day. If an additional daily dose is required, it should be taken
preferable at
bedtime. The dose is not to exceed 4 teaspoonful a day.
Children 2 to 6 years – The initial dosage of Celestamine

Syrup is ¼ to ½
teaspoonful three times a day with adjustment of dosage according to
patient
response. Daily dose is not to exceed 2 teaspoonfuls.
DRUG INTERACTIONS:
Betamethasone – Corticosteroids (including betamethasone) are
metabolized
by CYP3A4.
Concurrent
use
of
Phenobarbital,
phenytoin,
rifampin
or
ephedrine
may
en
                                
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