Neosporin Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neosporin Eye Drops.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Polymyxin B Sulphate E.P. 5,000 IU
Neomycin Sulphate E.P. 1,700 IU
(IU = International units)
Excipients with known effect:
Contains benzalkonium chloride
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM Topical Antibacterial Agent.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the prophylaxis and treatment of external bacterial infections of the eye.
Prophylactically, it is useful following removal of foreign bodies, and before and after ophthalmic surgery, to help provide and maintain a sterile field.
4.2. Posology and method of administration
Dosage in Adults (over 18 years of age)
1 or 2 drops in the affected eye, two to four times daily or more frequently as required. In severe infections therapy should he started with 1 or 2 drops
every 15 to 30 minutes, reducing the frequency of instillation gradually as the infection is controlled.
Treatment should be continued for at least 2 days after the condition has resolved, but treatment should not be continued for more than 7 days without medical supervision, and therefore patients should be advised to return to their doctor if their condition has not improved after 7 days.
Dosage in Children (over 2 years to 18 years of age)
As for adults.
Dosage in Infants under 2 years of age
Contra-indicated
Dosage in Elderly
As for adults. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulphate may occur (see 4.4 Special Warnings and Special Precautions for Use).
Dosage in renal impairment
Dosage should be reduced in patients with reduced renal function (see 4.4 Special warnings and special precautions for use).
4.3. Contra-indications
The use of Neosporin Eye Drops is contra-indicated in patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitising substances such as framycetin, kanamycin, gentamicin and other related antibiotics.
The use of Neosporin Eye Drops is contra-indicated in circumstances where the product could gain access to intra-ocular fluids (see 4.4 Special warnings and special precautions for use).
Due to the known ototoxic and nephrotoxic potential of neomycin sulphate, the use of Neosporin in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant absorption may occur.
A possibility of increased absorption exists in very young children; thus, Neosporin Eye Drops are contra-indicated for use in neonates and infants (up to 2 years of age).
In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Due to the risk of adsorption of the preservative (benzalkonium chloride), contact lenses should not be worn when using Neosporin Eye Drops.
4.4 Special warnings and precautions for use
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied neomycin/polymyxin B/gramicidin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; neomycin and polymyxin B sulphate have nephrotoxic potential and polymyxin B sulphate has neurotoxic potential.
Neomycin eye drops should not be used during surgical procedures nor before surgery in circumstances where access of the product to intra-ocular fluids could occur (see 4.3 Contra-Indications).
In renal impairment the plasma clearance of neomycin is reduced (see 4.2 Dosage in Renal Impairment).
4.5. Interaction with other medicinal products and other forms of interaction
Following significant systemic absorption, both neomycin sulphate and polymyxin B sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
4.6. Pregnancy and lactation
There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. No information is available regarding the excretion of the active ingredients or their metabolites in human breast milk. However, neomycin present in maternal blood can cross the placenta and may give rise to a small potential risk of foetal toxicity; thus, the use of Neosporin Eye Drops is not recommended in pregnancy or lactation.
4.7.
Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Allergic reactions following the topical application of Neomycin have been reported in the literature, but such reactions following the application of Polymyxin B and Gramicidin are rare events.
As with all antibacterial preparations prolonged use may result in the overgrowth of non-susceptible organisms including fungi.
Reporting of suspected adverse reactions
Reporting of 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 at: www.mhra.gov.uk/yellowcard
4.9. Overdose
Symptoms and signs:
No specific symptoms or signs have been associated with excessive use of Neosporin Eye Drops. However, consideration should be given to significant systemic absorption (see 4.4 Special Warnings and Special Precautions for Use).
Following accidental ingestion, minimal absorption is expected.
Management:
Use of the product should be stopped and the patient’s general status, hearing acuity, renal and neuromuscular functions should be monitored. Plasma levels of neomycin may be reduced by haemodialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Neomycin is an aminoglycoside antibiotic isolated from cultures of Streptomyces fradiae and is active against many Gram-negative bacteria. It diffuses through the channels formed by porin-proteins in the outer membrane of the bacteria. Transport across the inner membrane is energy-dependant and is blocked by the presence of calcium ions or in acidic conditions.
Neomycin inhibits protein synthesis by binding to subunits of the bacterial ribosome thus disrupting the normal cycle of ribosomal function. It leads to a misreading of the genetic code of messenger RNA template resulting in the incorporation of incorrect amino acids. Neomycin may inhibit the bacterial DNA polymerase.
Polymyxin B is one of a family of polypeptide antibiotics produced by various Bacilluspolymyxa strains. It is bactericidal for a variety of Gram-negative bacteria.
Polymixin B sulphate is a cationic cyclic decapeptide that is surface active. It intercalates into the bacterial cell membrane binding to the lipid A region of lipopolysaccharides, in particular to phosphatidylethanolamine, and renders the osmotic barrier ineffective. This leads to loss of cell contents and bacterial cell death.
Gramicidin is a polypeptide antibiotic produced by the growth of Bacillus brevis. It is effective against many Gram-positive organisms.
Gramicidin increases the permeability of cell membranes and uncouples oxidative phosphorylation in the bacterial cell wall with a temporary stimulation of oxygen consumption.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
A. Mutagenicity
There is insufficient information available to determine whether the active ingredients have mutagenic potential.
B. Carcinogenicity
There is insufficient information available to determine whether the active ingredients have carcinogenic potential.
C. Teratogenicity
There is insufficient information available to determine whether the active ingredients have teratogenic potential.
Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal ototoxicity.
D. Fertility
There is insufficient information available to determine whether any of the active ingredients can affect fertility.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol (96%)
Propylene Glycol Poloxamer 188 Benzalkonium Chloride Sodium Chloride Sulphuric acid 0.1M Sodium Hydroxide 1M Water for Injections.
6.2 Incompatibilities
None known
6.3. Shelf-life
2 years.
Use within one month of first opening.
6.4. Special precautions for storage
Do not store above 25°C.
Keep the bottle tightly closed. Keep the bottle in the outer carton.
6.5. Nature and content of container
Polypropylene bottle with integral nozzle and pilfer proof cap containing 5ml.
6.6. Instructions for use, handling and disposal
No special instructions.
MARKETING AUTHORISATION HOLDER
7
The Wellcome Foundation Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as
GlaxoSmithKline UK Stockley Park West Uxbridge
Middlesex UB11 1BT
8. MARKETING AUTHORISATION NUMBER(S)
PL 00003/5108R.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
December 2003.
10 DATE OF REVISION OF THE TEXT
27/01/2014