Gentisone Hc Ear Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentisone HC Ear Drops.
Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
This medicine is a sterile aqueous suspension in 10 ml dropper bottles containing gentamicin sulphate, equivalent to 0.3% w/v gentamicin base and 1.0% w/v hydrocortisone acetate.
Excipients with known effect:
Benzalkonium chloride 50% w/v solution (0.02% w/v per 10ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sterile, isotonic solution in dropper bottles.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicine is indicated in adults and children:
1. For the treatment of eczema and infection of the outer ear (otitis externa).
2. For prophylaxis against otitis externa following trauma.
3. For post-operative local use in surgery to infected mastoid cavities.
4.2 Posology and method of administration
Posology
Adults, the elderly and the paediatric population
The area should be cleaned and 2 - 4 drops instilled in the affected ear three to four times a day and at night. Alternatively, wicks medicated with this medicine may be placed in the external ear or mastoid cavity.
Method of administration Auricular use only.
4.3
Contraindications
Hypersensitivity to gentamicin or to any of the excipients listed in section 6.1.
Myasthenia gravis.
Known or suspected perforation of the ear drum.
4.4 Special warnings and precautions for use
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 this medicine should be supplemented with appropriate systemic antibiotic treatment.
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.
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.
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.
In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.
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.
This medicine contains benzalkonium chloride Irritant, may cause skin reactions.
4.5 Interaction with other medicinal products and other forms of interaction
None relevant to topical use.
4.6 Fertility, pregnancy and lactation
Pregnancy
Safety for use in pregnancy has not been established. Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. This medicine should only be used in pregnancy when considered essential by the physician, after careful assessment of the potential risks and benefits.
Breast-feeding
Safety for use in lactation has not been established. This medicine should only be used in lactation when considered essential by the physician, after careful assessment of the potential risks and benefits.
4.7 Effects on ability to drive and use machines Not applicable.
4.8 Undesirable effects
In the event of irritation, sensitisation or super-infection, treatment with Gentisone HC Ear drops should be discontinued and appropriate therapy instituted.
|
Ear and labyrinth disorders |
-Local sensitivity -Ototoxicity -Vestibular disorder: -Hearing loss |
|
Skin and subcutaneous tissue disorders |
-Burning sensation - Stinging -Itching (pruritus): -Dermatitis. |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard.
4.9 Overdose Not applicable.
5.1 Pharmacodynamic properties
ATC code: S03AA
Pharmacotherapeutic group: Antibiotic
Mechanism of action:
Gentamicin is mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is a bactericidal antibiotic which acts by inhibiting protein synthesis. It has greater antibacterial activity than streptomycin, neomycin or kanamycin.
Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but it's most important effect is inhibition of protein synthesis at the level of the 30s ribosomal subunit.
Corticosteroids, such as hydrocortisone acetate, are used in pharmacological doses for their anti-inflammatory and immuno-suppressant glucocorticoid properties which suppress the clinical manifestation of disease in a wide range of disorders.
5.2 Pharmacokinetic properties
Absorption:
Topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1pg/ml.
Gentamicin is 70-85% bound to plasma albumin following administration.
Effective plasma concentration is 4 - 8ug/ml The volume of distribution (VD) is 0.3 1/kg
Hydrocortisone acetate is not absorbed through the skin as rapidly as hydrocortisone and therefore has a prolonged action. Some is absorbed systemically, where greater than 90% is protein bound.
Elimination:
> 90% Gentamicin is excreted unchanged in the urine by glomerular filtration.
Ti/2 = 2 - 3 hours in individuals with normal kidney function, but can be increased in cases of renal insufficiency.
The elimination rate constant is;
0.02 Hr-1 for anuric patients*
0.30 Hr-1 normal
*Therefore in those with anuria care must be exercised.
> 70% hydrocortisone acetate is metabolised by the liver. The metabolites are excreted in the urine.
Plasma T/ = 1/ hours.
5.3 Preclinical safety data
See section 4.6
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium chloride (preservative), povidone, polyethylene glycol 4000, sodium chloride, borax, disodium edetate and purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years. Discard contents 4 weeks after opening.
6.4 Special precautions for storage
Store below 25°C. Do not freeze or mix with other liquids.
6.5 Nature and contents of container 10ml dropper bottles.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20072/0058
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
10
26/02/2015