Full Prescribing Info
Gentamicin sulphate.
1 ml isotonic solution contains: 5.0 mg gentamicin sulfate (= 3.0 mg gentamicin).
Excipients/Inactive Ingredients: Benzalkonium chloride (preservative) 0.05 mg/ml sodium chloride, disodium edetate, monobasic sodium phosphate, dibasic sodium phosphate, water for injections.
Antibiotic ophthalmic drug.
Pharmacology: Gentamicin belongs to aminoglycoside class of antibiotics, which interfere both in the resting stage and in the proliferation stage of the sensitive 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.
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 drops to the undamaged cornea.
Gentamicin-POS is indicated in infections of the anterior eye including conjunctivitis, keratitis, blepharitis, and hordeolum, caused by gentamicin-sensitive pathogens.
Dosage/Direction for Use
The following statements apply to Gentamicin-POS unless otherwise prescribed by the physician. Observe these instructions for use, otherwise the patient will not fully benefit from Gentamicin-POS. Instill 1 drop 4-6 times daily into the affected eye.
No signs of systemic effects have been observed after topical ophthalmological application of Gentamicin-POS, due to its poor penetration. Pharmacological experiments with rabbits showed that topically applied gentamicin is well tolerated even in high dosages and long-term treatment.
In hypersensitivity to gentamicin or any of the ingredients.
Special Precautions
Contact lenses should not be worn during treatment with Gentamicin-POS.
Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceplible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of medication and consult a physician. If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue the use of this preparation and appropriate therapy should be instituted.
Safety and effectiveness for use of Gentamicin-POS eye drops in children less than six years of age have not been established.
Use in Pregnancy & Lactation: Even though no risk was observed in humans after ophthalmological use of Gentamicin-POS eye drops, a very careful benefit-risk analysis by the physician should justify the application of the drug, especially in the first three months of pregnancy.
Side Effects
If the patient notices any unwanted effects or if the patient is unsure about the effects of this product, please inform the doctor or pharmacist. Irritation, stinging, itching and dermatitis. Non-specific conjunctivitis, conjunctival epithelial defect and conjunctival hyperemia. In rare cases the sensation of temporary burning in the eyes has been reported.
If side effects occur, stop applying Gentamicin-POS and consult the ophthalmologist soon.
Drug Interactions
Not known.
Caution For Usage
Unscrew the cap covering the nozzle, with a finger retract the lower eye lid until the inner red, moist surface is exposed. Tilt the head back, invert the bottle and gently squeeze out the prescribed number of drops onto the exposed surface of the lower lid avoiding any contact of the bottle with eye or skin. Close the bottle carefully after use. Treatment with Gentamicin-POS should normally not extend beyond a period of 2 weeks, or maximally 3 weeks. The exact duration of Gentamicin-POS therapy should be based on the physician's judgement when all factors including efficacy, severity of symptoms, and potential side effects are considered.
Do not store above 25°C.
With proper care, Gentamicin-POS eye drops can be used up to 4 weeks after the bottle has been opened.
ATC Classification
S01AA11 - gentamicin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Eye drops 3 mg/mL (clear, colourless solution) x 5 mL x 1's.
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