Gentacare Ophthalmic/Otic Solution

Gentacare Ophthalmic/Otic Solution

gentamicin

Manufacturer:

EBE Pharma

Distributor:

AGlobal Care
Full Prescribing Info
Contents
Gentamicin sulfate.
Description
Each mL contains: Gentamicin (as sulfate) 3 mg.
Action
Pharmacology: Pharmacodynamics: Gentamicin is a bactericidal antibiotic which acts by inhibiting protein synthesis.
Pharmacokinetics: Topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1μg/mL.
>90% Gentamicin is excreted in the urine by glomerular filtration.
<10% is bound to plasma protein.
T½=2-3 hours in individuals with normal kidney function, but can be increased in cases of renal insufficiency.
Indications/Uses
Gentamicin eye/ear drops are indicated: For the treatment of superficial eye and ear infections caused by organisms sensitive to gentamicin.
For prophylaxis against infection in trauma of the eye or ear.
Dosage/Direction for Use
Adults, including the elderly and children: Eyes: 1 or 2 drops should be instilled in the affected eye up to six times a day, or more frequently if required. (Severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ears: The area should be cleaned and 2-3 drops instilled in the affected ear three to four times a day and at night, or more frequently if required.
Overdosage
The oral ingestion of the contents of one bottle is unlikely to cause any significant adverse effect.
Contraindications
Hypersensitivity to gentamicin or to any of the ingredients. Known or suspected perforation of the ear drum is a contraindication to use in otitis externa only.
Special Precautions
Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur. In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment.
Gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.
The condition of the ear drum must always be checked before this medicinal product is prescribed. The medicinal product must not be used if the integrity of the ear drum cannot be guaranteed. Irreversible toxic effects may result from direct contact of gentamicin with the middle and inner ear. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss. Contact lenses should be removed during the period of treatment of ocular infections.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical otic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.
Effects on ability to drive and use machines: Patients should be advised that the use of Gentamicin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.
Use In Pregnancy & Lactation
Safety for use in pregnancy and lactation has not been established. Gentamicin should only be used in pregnancy or lactation when considered essential by the physician, after careful of the potential risks and benefits.
Adverse Reactions
Irritation, burning, stinging, itching and dermatitis may occur. In the event of irritation, sensitization or super-infection, treatment should be discontinued and appropriate therapy instituted.
Gentamicin may cause nephrotoxicity when given systematically. However, it is likely that systemic absorption following topical administration does not constitute a comparable risk.
Drug Interactions
Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician.
Storage
Store at temperatures not exceeding 30°C.
Special Precautions for Storage: Discard contents 4 weeks after opening.
ATC Classification
S01AA11 - gentamicin ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Presentation/Packing
Ophth/otic soln 3 mg/mL (clear, colorless) x 8 mL x 1's.
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