POSATEX- orbifloxacin, mometasone furoate, and posaconazole

POSATEX- orbifloxacin, mometasone furoate, and posaconazole suspension

Merck Sharp & Dohme Corp.

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Posatex Otic Suspension

(Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole,

Suspension)

Antibacterial, anti-inflammatory, antifungal

For Otic Use in Dogs Only

CAUTION: Federal law restricts this drug to use by or on the order of a

licensed veterinarian.

Federal law prohibits the extralabel use of this drug in food-producing

animals.

DESCRIPTION: Each gram of POSATEX Otic Suspension contains 10 mg of

orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone

furoate; and 1 mg of posaconazole in a mineral oil based system containing a plasticized

hydrocarbon gel.

Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg orbifloxacin,

0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.

INDICATIONS: POSATEX Otic Suspension is indicated for the treatment of otitis

externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis)

and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and

Enterococcus faecalis).

DOSAGE AND ADMINISTRATION: Shake well before use. For dogs weighing less than

30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For

dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy

should continue for 7 consecutive days.

CONTRAINDICATIONS: POSATEX Otic Suspension is contraindicated in dogs with

known or suspected hypersensitivity to quinolones, mometasone furoate monohydrate,

or posaconazole. Do not use in dogs with known tympanic perforation (see

PRECAUTIONS).

WARNINGS:

Human Warnings: Not for use in humans. Keep out of reach of children.

Animal Warnings: Do not administer orally. Immediately discontinue use of POSATEX

Otic Suspension if hearing loss is observed during treatment (see ADVERSE

REACTIONS).

PRECAUTIONS: The use of POSATEX Otic Suspension in dogs with perforated

tympanic membranes has not been evaluated. The integrity of the tympanic membranes

should be confirmed before administering this product.

Avoid prolonged or repeated use of POSATEX Otic Suspension. Long-term use of

topical otic corticosteroids has been associated with adrenocortical suppression and

iatrogenic hyperadrenocorticism in dogs (see ANIMAL SAFETY).

The safe use of POSATEX Otic Suspension in dogs used for breeding purposes, during

pregnancy or in lactating bitches, has not been evaluated. The systemic administration

of quinolones has been shown to produce cartilage erosions of weight bearing joints and

other signs of arthropathy in immature animals of various species.

ADVERSE REACTIONS: In the field study, 143 dogs were treated with POSATEX Otic

Suspension. Of those, 1 dog with bilateral otitis externa developed hearing loss.

POSATEX Otic Suspension treatment was discontinued and the condition resolved

after one week.

To report suspected adverse reactions, call 1-800-224-5318.

For a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.

CLINICAL PHARMACOLOGY:

Orbifloxacin: Orbifloxacin is a synthetic fluoroquinolone antibacterial agent. The

bactericidal action of fluoroquinolones is concentration-dependent and results from

interference with bacterial DNA gyrase and topoisomerase IV. Since these enzymes are

needed for bacterial DNA synthesis and transcription, fluoroquinolones disrupt bacterial

replication and lead to bacterial cell death.

Mometasone: Mometasone furoate monohydrate is a topical corticosteroid

characterized by a (2') furoate 17-ester having chlorine at the 9 and 21 positions.

Posaconazole: Posaconazole is a broad-spectrum triazole antifungal agent. The

mechanism by which triazoles exert fungicidal action involves the selective inhibition of

the enzyme lanosterol a C14 demethylase (a microsomal cytochrome P-450- dependent

enzyme) involved in ergosterol biosynthesis in yeasts and filamentous fungi.

Systemic absorption of the active ingredients was determined in single-dose radiolabelled

studies with C-orbifloxacin, H-mometasone furoate, and C-posaconazole contained

within the POSATEX Otic Suspension formulation and placed into the ear canals of

normal beagle dogs. Most of the absorption occurred in the first few days after

administration. The extent of percutaneous absorption of topical medications is

influenced by many factors including the integrity of the epidermal barrier. Inflammation

can increase the percutaneous absorption of drugs.

EFFECTIVENESS: The effectiveness of POSATEX Otic Suspension was evaluated in a

placebo-controlled, double-blind, multi-site field study. One hundred and ninety one dogs

with naturally occurring clinical otitis externa associated with both yeast and bacteria

were randomly allocated to either POSATEX Otic Suspension or placebo ointment. Of

the 160 dogs evaluated for effectiveness, 122 were treated with POSATEX Otic

Suspension and 38 were treated with placebo ointment. Treatments were administered

once daily for 7 consecutive days. Assessment of effectiveness was based on

improvement in clinical signs at re-evaluation 2-7 days following administration of the last

dose.

Compared to the placebo, a significant percent of dogs treated with POSATEX Otic

Suspension showed improvement in clinical signs (discomfort, erythema, and swelling)

caused by otitis externa associated with one or more of the following organisms:

Malassezia pachydermatis, coagulase positive staphylococci, Pseudomonas aeruginosa,

14 3 14

and Enterococcus faecalis.

Percent of Dogs Showing Improvement in Clinical Signs of

Otitis Externa

Clinical Sign

POSATEX

Otic

Suspension

Group

Placebo

Group

Significance

Discomfort 88% 45% p<0.0001

External Ear

Canal Erythema

81% 39% p<0.0001

External Ear

Canal Swelling

83% 49% p=0.0001

ANIMAL SAFETY: POSATEX Otic Suspension was administered at 1,3, and 5 times the

recommended dosage for 21 consecutive days. The control group received the vehicle

in both ears at the clinical dose given five times per day. There was a slight decrease in

serum cortisol concentration after ACTH stimulation on Day 21 in the 5× group.

Erythema was noted in all groups. Aural pain, swelling, or heat were each noted in 3

separate dogs in the 5× group.

STORAGE INFORMATION: Store at temperatures between 2°-30°C (35.6°-86°F).

Shake well before use.

HOW SUPPLIED: POSATEX Otic Suspension is available in 7.5 g, 15 g, and 30 g plastic

bottles.

Approved by FDA under NADA # 141-266

Madison, NJ 07940 USA

Made in Germany

Rev. 02/2019

PRINCIPAL DISPLAY PANEL - 30 g Bottle Label

Posatex

Otic Suspension

(orbifloxacin, mometasone

furoate monohydrate and

posaconazole suspension)

Antibacterial,

Anti-inflammatory,

Antifungal

Caution: Federal law

restricts this drug to use by

or on the order of a licensed

veterinarian.

Federal law prohibits the

extralabel use of this drug

in food-producing animals.

KEEP OUT OF REACH

OF CHILDREN.

Approved by FDA under NADA # 141-266

NDC 0061-0089-03

30g

MERCK

Animal Health

POSATEX

orbifloxacin, mometasone furoate, and posaconazole suspension

Product Information

Product Type

PRESCRIPTION ANIMAL DRUG

Item Code (Source)

NDC:0061-0089

Route of Administration

AURICULAR (OTIC)

Active Ingredient/Active Moiety

Merck Sharp & Dohme Corp.

Ingredient Name Basis of Strength Strength

Orbifloxacin (UNII: 660932TPY6) (Orbifloxacin - UNII:660932TPY6) Orbifloxacin 10 mg in 1 g

Mometasone Furoate (UNII: 04201GDN4R) (Mometasone - UNII:8HR4QJ6DW8) Mometas one Furoate 1 mg in 1 g

posaconazole (UNII: 6TK1G07BHZ ) (pos aconazole - UNII:6TK1G07BHZ ) pos aconazole 1 mg in 1 g

Inactive Ingredients

Ingredient Name Strength

Mineral Oil (UNII: T5L8T28FGP)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date

1 NDC:0061-0089-01 1 in 1 CARTON

1 7.5 g in 1 BOTTLE, PLASTIC

2 NDC:0061-0089-02 1 in 1 CARTON

2 15 g in 1 BOTTLE, PLASTIC

3 NDC:0061-0089-03 1 in 1 CARTON

3 30 g in 1 BOTTLE, PLASTIC

Marketing Information

Marketing