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Date: Thursday, December 2, 2021 16:15

Description: MSD-AH
Telephone: 01908 685685 (Customer Support Centre)
Release 2.50
Otomax® Ear Drops Suspension
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Ear/eye/nose
Active ingredient: Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate
Product:Otomax® Ear Drops Suspension
Product index: Otomax® Ear Drops
Qualitative and quantitative composition
Each ml of the veterinary medicinal product contains:
Active substance:
Gentamicin base (as sulfate) 2640 IU
Betamethasone (as valerate) 0.88 mg
Clotrimazole 8.80 mg
Excipient(s):
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Ear drops suspension. A smooth, uniform, white to off-white viscous suspension
Clinical particulars
Target Species
Dogs
Indications for use
Treatment of acute external otitis. Also for treatment of short term exacerbation of the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as Staphylococcus intermedius, and fungi susceptible to clotrimazole, in particular Malassezia pachydermatis.
Contraindications
Do not administer to dogs with a perforated eardrum.
Do not administer in the case of known hypersensitivity to any of the ingredients.
Do not administer to pregnant or lactating bitches.
Do not administer the product concurrently with other substances known to cause ototoxicity.
Special warnings for each target species
Contact with eyes should be avoided. In case of accidental contact, flush with plenty of water. Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.
Special precautions for use
Before the product is applied, the external auditory canal must be examined thoroughly to ensure that the eardrum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut.
Use of the product should be based on susceptibility of isolated bacteria and/or other appropriate diagnostic tests. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to gentamicin and may decrease the effectiveness of treatment with other aminoglycosides, due to the potential for cross resistance.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.
Operator warnings
Avoid contact with the product.
Wash hands carefully after applying the product. In case of accidental contact with the eyes, rinse with copious amounts of water.
Do not handle the product if you have known hypersensitivity against compounds in the product.
Adverse Reactions
Erythematous papules may appear locally; these lesions regress when treatment is discontinued.
Temporary impairment of hearing and extremely rare cases of irreversible loss of hearing have been observed, especially in elderly animals.
In the event of auditory or vestibular dysfunction, treatment must be discontinued immediately and the auditory canal cleaned carefully using a non-ototoxic solution.
Prolonged and extensive use of topical corticosteroid preparations have been known to induce local and systemic side-effects. These include suppression of adrenal function, epidermal thinning, and delayed wound healing.
If you notice any serious effects or other effects not mentioned in this datasheet, please inform your veterinary surgeon.
Use during pregnancy or lactation
Do not administer to pregnant or lactating bitches.
Interactions
Do not administer the product concurrently with other substances known to cause ototoxicity.
Amounts to be administered and administration route
For otic use only.
Shake the product well before administration.
Dogs weighing less than 15 kg: Apply 4 drops to the ear twice a day.
Dogs weighing more than 15 kg: Apply 8 drops to the ear twice a day.
The duration of treatment is 7 days.
After application the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
1 drop of the product corresponds to 66.9 IU gentamicin, 22.3 µg betamethasone and 223 µg clotrimazole.
Overdose
Local and transient eruptions of papules have been observed at 5 times the recommended dosage.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATC Vet Code: QS02CA90
Pharmacotherapeutic group
Otologicals corticosteroids and antiinfectives in combination
Pharmacodynamic properties
Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, coagulase-positive Staphylococcus spp. and Proteus mirabilis.
Betamethasone valerate is a synthetic dexamethasone-analogue corticosteroid with an anti-inflammatory, anti-pruritic activity when applied topically. It has mild mineralocorticoid properties. Betamethasone valerate is absorbed after topical application. Absorption may be increased if there is inflammation of the skin.
Clotrimazole is an antifungal agent which acts by causing changes in the cell membrane, which lead to a loss of intracellular components and consequently to a cessation of molecular synthesis. Clotrimazole has a broad spectrum of activity and is used in the treatment of skin conditions caused by various species of pathogenic dermatophytes and by moulds, in particular Malassezia pachydermatis.
Pharmaceutical particulars
Excipients
Paraffin Liquid
Plasticized Hydrocarbon Gel Ointment Base
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 14 days
Do not use after the expiry date stated on the bottle or carton (EXP end of: MM/YY).
When the container is broached (opened) for the first time, using the in-use shelf life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.
Special precautions for storage
Do not store above 25 °C. Keep the container in the outer carton.
Immediate packaging
Containers and closures:
Bottles:
High density polyethylene (HDPE) bottle with filling volumes of 14 mL or 34 mL with a
low density polyethylene (LDPE) cap and LDPE applicator/cap.
Tubes:
8.5 mL and 17 mL lined aluminium tubes with HDPE white screw cap and LDPE applicator/cap.
Package sizes:
Box containing 1 tube of 8.5 mL
Box containing 1 tube of 17 mL
Box containing 1 plastic bottle of 14 mL
Box containing 1 plastic bottle of 34 mL
Box containing 6 tubes of 8.5 mL
Box containing 6 tubes of 17 mL
Box containing 12 tubes of 8.5 mL
Box containing 12 tubes of 17 mL
Not all pack sizes may be marketed.
Disposal
Any unused product or waste materials should be disposed of in accordance with
national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4588
Significant changes
Date of the first authorisation or date of renewal
22 July 1999.
Date of revision of the text
August 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Otomax® 1x14ml:
GTIN:08713184092861
GTIN description:Otomax® 1x34ml:
GTIN:08713184092854