2010 ‫ אוקטובר‬:‫ עלון מאושר‬."‫"פורמט עלון זה נקבע ע"י משרד הבריאות ותוכנו נבדק ואושר‬
“This leaflet format has been determined by the Ministry of Health and the content thereof has
been checked and approved.” Date of approval: October 2010.
DEX-OTIC®
EAR DROPS
Composition
Each ml contains:
Active Ingredients
Dexamethasone sodium phosphate
Neomycin sulfate
Polymyxin B sulfate
1 mg
5 mg
10,000 units
Other Ingredients
Propylene glycol, sodium acetate anhydrous, phenyl mercuric acetate, purified
water.
Action
Dexamethasone phosphate provides effective anti-inflammatory, anti-allergic and
antipruritic activity to relieve local discomfort, erythema, swelling and exudation.
Neomycin and polymyxin B are especially effective when applied locally against a
wide variety of both Gram-positive and Gram-negative bacteria. Polymyxin B sulfate is
especially effective against Pseudomonas, one of the most common causes of ear
infections.
Indications
Inflammatory conditions and superficial bacterial infections of the external auditory
canal, caused by staphylococci, Pseudomonas, Proteus and other Gram-positive and
Gram-negative bacteria susceptible to these antibiotics.
Contraindications
Known hypersensitivity to any ingredient of the preparation.
Patients who have demonstrated hypersensitivity to cross-sensitizing substances
such as aminoglycosides and other related antibiotics.
Topical corticosteroids are contraindicated in fungal infections, tuberculosis of the
skin, vaccinia, varicella and herpes simplex.
This preparation should not be applied in the external auditory canal of patients with
known or suspected perforated eardrums because of the possibility of ototoxicity
caused by neomycin.
This preparation is not intended for ophthalmic use.
Warnings
Ototoxicity and nephrotoxicity have been reported with the topical use of neomycin.
The likelihood of their occurrence may be increased if the patient is being
concurrently treated with an aminoglycoside antibiotic.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, use of this
preparation in large quantities or large areas for prolonged periods of time is not
recommended in instances where significant systemic absorption may occur.
Polymyxin B sulfate has also neurotoxic and nephrotoxic potential.
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Use in Pregnancy
There are no adequate and well-controlled studies in pregnant women on
teratogenic effects from topically applied corticosteroids. Therefore, topical
corticosteroids should be used during pregnancy only if the potential benefit to the
mother justifies the potential risk to the embryo or fetus. Infants born to mothers who
have been treated with large amounts of corticosteroids or for prolonged periods of
time, should be observed carefully for signs of hypoadrenalism.
Neomycin present in maternal blood can cross the placenta and may give rise to a
theoretical risk of fetal toxicity, thus, use of this preparation is not usually
recommended during pregnancy.
Use in Breastfeeding
It is not known whether topical application of corticosteroids can result in sufficient
systemic absorption to produce detectable quantities in breast milk.
Therefore, caution should be exercised when topical corticosteroids are applied to
nursing women.
There is little information to demonstrate the possible effect of topically applied
neomycin in lactation.
Use in the Elderly
Caution should be exercised in cases where a decrease in renal function exists and
significant absorption of neomycin may occur.
Adverse Reactions
This preparation is usually well tolerated. Stinging and burning may occur if the
preparation gains access to the middle ear.
Signs of a sensitivity reaction to neomycin may also appear, usually as a low-grade
reddening with swelling, dry scaling or itching, or simply as a failure to heal. During
long-term use of neomycin-containing preparations, periodic examination for such
signs is recommended. If they occur, patients should be advised to discontinue
treatment. These symptoms regress quickly on withdrawing the medication.
Neomycin-containing applications should be avoided for the patient thereafter.
Allergic cross-reactions may occur which could prevent the future use of any or all
the following antibiotics for the treatment of infections: kanamycin, paromomycin,
streptomycin, gentamicin.
The following local adverse reactions have been reported with topical corticosteroids,
especially under occlusive dressings: burning, itching , irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic
contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae
and miliaria.
Infections may be masked or enhanced and new infections may appears during
corticosteroid use due to suppression of the immune response .
Precautions
If sensitization or irritation occurs, discontinue use.
If the sensitivity is attributed to the antibiotic component, neomycin-containing
preparations should be avoided by the patient in the future.
Allergic cross-reactions may occur which could prevent use of any or all of the
aminoglycoside antibiotics for the treatment of future infections.
When using neomycin-containing preparations to control secondary infection in
chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be
borne in mind that the skin is more liable to become sensitive to other substances,
including neomycin.
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If local infection should continue or become severe, or in the presence of systemic
infection, appropriate antimicrobial therapy should be instituted. If a favorable
response is not obtained, the use of this preparation should be temporarily
discontinued, until the infection has been controlled.
If extensive areas are treated or if the occlusive technique is used, the possibility
exists of increased systemic absorption and suitable precautions will be required in
patients with electrolyte imbalance, gastrointestinal disturbances, diabetes, myopathy,
cataract, renal or hepatic impairment, osteoporosis and hemorrhage.
As with other antibiotic-containing topical preparations, prolonged use may result in
an overgrowth of non-susceptible fungi. The possibility of persistent fungal infections
of the ear should be considered after prolonged steroid dosing. Appropriate measures
should be taken if this occurs.
All topically active corticosteroids possess the potential to suppress the pituitaryadrenal axis following absorption. Development of adverse systemic effects due to the
cortisone component is considered to be unlikely, but the recommended dosage
should not be exceeded.
Drug Interactions
Following significant systemic absorption , both neomycin and polymyxin B sulfate
can intensify and prolong the respiratory depressant effects of neuromuscular
blocking agents. However, the neuromuscular blocking activity of neomycin sulfate
and polymyxin B sulfate is unlikely to present a hazard during use of this preparation.
Laboratory Tests
Systemic effects of excessive levels of the cortisone component may include a
reduction in the number of circulating eosinophils and a decrease in urinary excretion
of 17-hydroxycorticosteroids.
Directions for Use
Note:
Use of this preparation should not be continued for more than 7 days without medical
supervision. If the infection is not improved after 1 week, cultures and susceptibility
tests should be repeated to verify the identity of organism and to determine whether
therapy should be changed.
The patient should lie with the affected ear upward and in such a position as to be
able to retain the drops in the ear. Following instillation of the drops, the patient
should maintain this reclining position for 5 minutes, to facilitate penetration of the
drops into the ear canal.
Repeat the procedure for the other ear, if necessary.
If preferred, a cotton wick may be inserted into the ear canal, and then saturated
with the solution. This wick should be kept moist by adding further solution every 4
hours. The wick should be replaced at least once every 24 hours.
Adults
2-3 drops into the affected ear, 3-4 times daily.
Children
1-2 drops into the affected ear, 3-4 times daily.
The product can be used within 3 months from first opening of the bottle.
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Registration Number: 012 77 24202 00
Storage
Store in a cool and dark place. Do not refrigerate.
Manufacturer
Teva Pharmaceutical Industries Ltd
P.O.Box 3190, Petach Tikva 49131.
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27. 10. 2010, RH