GENTAMICIN-POS EYE OINTMENT

País: Malàisia

Idioma: anglès

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

ingredients actius:

GENTAMICIN SULPHATE

Disponible des:

PHARMAFORTE (MALAYSIA) SDN. BHD.

Designació comuna internacional (DCI):

GENTAMICIN SULPHATE

Unidades en paquete:

2.5gm mcg/mL

Fabricat per:

Ursapharm Arzneimittel GmbH

Fitxa tècnica

Edition 12/2020
GENTAMICIN-POS® EYE OINTMENT
5.0 MG GENTAMICIN SULFATE (= 3.0 MG GENTAMICIN)
ANTIBIOTIC OPHTHALMIC DRUG
PRODUCT DESCRIPTION
Gentamicin-POS® eye ointment (5.0 mg/g gentamicin sulfate) is a
yellowish, translucent suspension
ointment filled in a 2.5 g aluminium tube.
PHARMACOLOGY
PHARMACODYNAMICS
The aminoglycoside antibiotic gentamicin belongs to the antibiotic
substances, which interfere both in
the resting stage and in the proliferation stage of the sensititve
germs with the protein synthesis on the
ribosomes.
Gentamicin binds to the 30S-subunit of the bacteria ribosome, which
leads to a misreading of the m-
RNA.
The misreading and the resulting proteins with wrong amino acid
sequences generate disorders of the
membrane function in the bacteria, which lead to a discharge of
cytoplasmic constituents. Furthermore,
wrong, functionally inefficient enzyme- and structure-proteins result.
PHARMACOKINETICS
After topical application to the affected eye gentamicin is absorbed
by cornea and conjunctiva. After 15
minutes gentamicin was found in the aqueous humor. Gentamicin,
however, does not diffuse through
the healthy cornea and measurements of the aqueous humor confirm that
no effective antibacterial
concentration of gentamicin can be achieved after application of eye
ointment to the undamaged
cornea.
INDICATIONS AND CLINICAL USE
Gentamicin-POS® is indicated in infections of the anterior eye
including conjunctivitis, keratitis,
blepharitis, and hordeolum, caused by gentamicin-sensitive pathogens.
Gentamicin-POS® eye
ointment is also used for post-operative antibacterial prophylaxis.
DOSAGE AND ADMINISTRATION
INSTRUCTIONS FOR PROPER USE
The following statements apply to Gentamicin-POS® unless otherwise
prescribed by your physician.
Please observe these instructions for use, otherwise you will not
fully benefit from Gentamicin-POS®.
Apply approximately a 1 cm strip of ointment (= 0.1 mg of gentamicin
sulfate) 2 – 3 times daily into
the conjunctival sac.
_ _
Gentamicin-POS® is applied into the conjun