SUROLAN- miconazole nitrate, polymyxin b sulfate, prednisolone acetate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Available from:

Elanco US Inc.

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION

Therapeutic indications:

SUROLAN is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius ). SUROLAN is contraindicated in dogs with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity.

Product summary:

SUROLAN is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUROLAN- MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE
ACETATE SOLUTION/ DROPS
ELANCO US INC.
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SUROLAN™
RX OTIC SUSPENSION
(MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE)
Antifungal, antibacterial and anti-inflammatory
_For otic use in dogs only_
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
SUROLAN contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B
sulfate
and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal
silicon dioxide and
liquid paraffin.
INDICATIONS
SUROLAN is indicated for the treatment of canine otitis externa
associated with
susceptible strains of yeast (_Malassezia pachydermatis)_ and bacteria
(_Staphylococcus_
_pseudintermedius_).
DOSAGE AND ADMINISTRATION
Shake well before use.
The external ear should be thoroughly cleaned and dried before the
initiation of
treatment. Verify that the eardrum is intact. Instill 5 drops of
SUROLAN in the ear canal
twice daily and massage the ear. Therapy should continue for 7
consecutive days.
CONTRAINDICATIONS
SUROLAN is contraindicated in dogs with suspected or known
hypersensitivity to
miconazole nitrate, polymyxin B sulfate, or prednisolone acetate.
Do not use in dogs with known perforated tympanum. Do not use with
drugs known to
induce ototoxicity.
WARNINGS
Not for use in humans. Keep this and all drugs out of reach of
children.
ANIMAL WARNINGS
Do not administer orally.
For otic use only.
PRECAUTIONS
Before instilling any medication into the ear, examine the external
ear canal thoroughly
to be certain the tympanic membranes are not ruptured.
If overgrowth of non-susceptible bacteria or fungi occurs, treatment
should be
discontinued and appropriate therapy instituted.
Long-term use of topical otic corticosteroids has been associated with
adrenocortical
suppression and iatrogenic hypoadrenalcorticism in dogs.
The safe use of SUROLAN in dogs used for breeding purposes, during
pregnancy, or in
lactating bitches, has not been evaluated.
ADV