TRIPLE MAX- gentamicin sulfate, mometasone furoate anhydrous, and clotrimazole suspension

Triple max by

Drug Labeling and Warnings

Triple max by is a Animal medication manufactured, distributed, or labeled by Covetrus North America, Med-Pharmex, Inc, FUJIAN FUKANG PHARMACEUTICAL CO., LTD., Erregierre SpA, Crystal Pharma SAU. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

ANADA #200-536, Approved by FDA
VETERINARY
For Otic Use in Dogs Only

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Keep this and all drugs out of the reach of children.

DESCRIPTION: Each gram of Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate anhydrous, USP equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oil-based system containing a plasticized hydrocarbon gel.

CLINICAL PHARMACOLOGY

PHARMACOLOGY:
Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive bacteria.  In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms.  In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: Pseudomonas spp. (including P. aeruginosa), coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.

Mometasone: Mometasone furoate anhydrous is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.

Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin.  Inflammation can increase percutaneous absorption.  Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast.  The primary action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis.  Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses.  In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor and swelling.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux.  These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Gentamicin-Mometasone-Clotrimazole:By virtue of its three active ingredients, gentamicin, mometasone, and clotrimazole otic suspension has antibacterial, anti-inflammatory, and antifungal activity.  In clinical field trials, gentamicin, mometasone, and clotrimazole otic suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis.  Gentamicin, mometasone, and clotrimazole otic suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS & USAGE

INDICATIONS: Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided.  Do not use in dogs with known perforation of eardrums.

WARNINGS AND PRECAUTIONS

WARNINGS: The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g, geriatric).  The hearing deficit is usually temporary.  If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension immediately and flush the ear canal thoroughly with a non-toxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring.  Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.  Field and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. 

Administration of recommended doses of Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous,USP; and Clotrimazole, USP, Otic Suspension beyond 7 days may result in delayed wound healing.

If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

TOXICOLOGY Field and safety studies with gentamicin, mometasone, and clotrimazole otic suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS).

ADVERSE REACTIONS

ADVERSE REACTIONS

Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency.  All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension: In field studies following once-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs.  In a field study following twice-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

The external ear canal should be thoroughly cleaned and dried before treatment.  Verify that the eardrum is intact.  For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g bottles, 15 g bottles, and 30 g bottles (2 drops from the 215 g bottle) of Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension once daily into the ear canal.  For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g bottles, 15 g bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal.  Therapy should continue for 7 consecutive days.

HOW SUPPLIED

HOW SUPPLIED: Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous, USP; and Clotrimazole, USP, Otic Suspension is available in 7.5 g plastic bottles, 15 g plastic bottles, 30 g plastic bottles, and 215 g plastic bottles.

STORAGE AND HANDLING

Do not store above 25°C (77°F).  Shake the bottles well before use.

Manufactured by
Med-Pharmex, Inc.
Pomona, CA 91767-1861

For additional information about adverse drug experience reporting for animal contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth

Questions?
(855) 724 -3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE MAX 
gentamicin sulfate, mometasone furoate anhydrous, and clotrimazole suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4856
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)	GENTAMICIN	3 mg  in 1 g
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)	MOMETASONE FUROATE	1 mg  in 1 g
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4856-7	7.5 g in 1 BOTTLE, PLASTIC
2	NDC: 11695-4856-1	15 g in 1 BOTTLE, PLASTIC
3	NDC: 11695-4856-3	30 g in 1 BOTTLE, PLASTIC
4	NDC: 11695-4856-2	215 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200536	11/20/2019

Labeler - Covetrus North America (603750329)

Registrant - Med-Pharmex, Inc (025353699)

Establishment
Name	Address	ID/FEI	Business Operations
Med-Pharmex, Inc		025353699	manufacture