Surolan 23 mg/ml ear drops and cutaneous suspension for cats and dogs 15 ml
Treatment of otitis externa and skin infections in cats and dogs
Surolan Ear Drops and Cutaneous Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Surolan
Miconazole Nitrate 23
Prednisolone Acetate 5
Polymyxin B Sulfate 0.5293
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF Surolan
Ear drops suspension and cutaneous suspension.
4. CLINICAL PARTICULARS OF Surolan
4.1 Target species
Dogs and cats
4.2. Indications for use, specifying the target species
For the topical treatment of otitis externa and skin infections caused by Gram-positive bacteria e.g. Staphylococcus aureus and Streptococcus spp. and Gram-negative bacteria Escherichia coli and Pseudomonas aeruginosa.
For the topical treatment of otitis externa and skin infections caused by fungi and yeasts: Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.
For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis.
The product also has anti-inflammatory and anti-pruritic activity.
Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent.
4.4 Special warnings for each target species
As the product is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner.
4.5. Special precautions for use
i. Special precautions for use in animals
For external use only.
Due to likely variability (time, geographical) in the occurrence of resistance of bacteria for Polymyxin B, bacteriological sampling and susceptibility testing are recommended.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not handle the product if you are allergic to the ingredients in the product.
Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after use.
Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy. Always wear single use disposable gloves when applying the product to animals.
4.6. Adverse reactions (frequency and seriousness)
Long-term use of topical steroids may cause skin thinning and delay wound healing.
4.7 Use during pregnancy, lactation or lay
Corticosteroids are not recommended for use in pregnant animals.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
This product is for topical administration. Shake the bottle vigorously and ensure the product is fully resuspended before use.
At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if necessary.
Ears: Clean the auditory canal and place a few drops of the product into the ear twice daily. For infections caused by Otodectes cynotis, instill five drops twice daily for 14 days.
Massage the ear and the auditory canal gently but thoroughly to ensure proper distribution.
Skin: Having ensured the area to be treated is clean, apply a few drops of the product (depending on lesion size) twice a day and rub well.
Treatment should be continued until a few days after complete disappearance of the clinical symptoms. In some obstinate cases, treatment may be required for 2 to 3 weeks (see also 4.6).
Where ear mite infestation is present, consideration should be given to treating both ears even if infestation is only apparent in one ear.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
The product is applied topically. No toxic side effects have been observed after accidental intake by licking.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL OF Surolan
ATC vet code: QS02CA01
Pharmacotherapeutic group: Otologicals, Corticosteriods and antiinfectives in combination
5.1. Pharmacodynamic properties
Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity and a potent activity against Gram-positive bacteria. Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi.
Polymyxin B sulfate is a polypeptide antibiotic with bactericidal activity against Gram-negative bacteria. It binds to phospholipids in the cytoplasmic membrane, whereby the membrane permeability is disturbed. This results in lysis of the bacteria.
Prednisolone acetate is a glucocorticoid with strong anti-inflammatory activity which results from its reduction of the permeability of capillaries and vascular proliferation and from the inhibition of fibroblast action.
5.2 Pharmacokinetic particulars
After topical application of miconazole nitrate, virtually no systemic absorption takes place through the skin or mucus membranes.
Systemic absorption of prednisolone on normal or abraded skin is minimal. Absorption of polymyxin B via the skin is also negligible. Excretion is almost completely via the kidneys.
6. PHARMACEUTICAL PARTICULARS OF Surolan
6.1. List of excipients
Silica colloidal anhydrous
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years:
Shelf life after first opening the immediate packaging: 3 months.
6.4. Special precautions for storage
Do not store above 25 °C