SUROLAN- miconazole nitrate, polymyxin b sulfate, and prednisolone acetate suspension/ 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:

Vetoquinol USA Inc

INN (International Name):

miconazole nitrate

Composition:

miconazole nitrate 23 mg in 1 mL

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. Store at or below 25 °C (77 °F).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUROLAN- MICONAZOLE NITRATE, POLYMYXIN B SULFATE, AND PREDNISOLONE
ACETATE SUSPENSION/
DROPS
VETOQUINOL USA INC
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SUROLAN
otic suspension
(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)
RX
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 evalua