muricin warnings: trizchlortm products › animalhealth... · ducing strains), neisseria...

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TRIZCHLOR TM Products Shampoo and Spray Conditioner are indicated for use in dogs, cats and horses Flush and Wipes are indicated for dogs and cats Antibacterial, Antiseptic Effective against multi-drug-resistant Staphylococcal infections Contains no alcohol; is non-irritating to ulcerated or abraded skin or ears. Use in conjunction with Muricin ® (mupirocin 2% ointment) on focal areas of infection 1 Recent in vitro study of chlorhexidine shampoos (2%, 3%, 4%) demonstrated equivalent and excellent minimum bactericidal activity against S. pseudintermedius (methicillin-susceptible and methicillin-resistant) at 10 min incubation time. 2 Patented, USP Tris EDTA composition Indications: For support of healthy skin for animals with conditions responsive to chlorhexidine. Active Ingredients: Chlorhexidine Gluconate: Adjunctive therapy for bacterial skin infections caused by Gram-positive and Gram-negative bacteria. 3 Residual effects; shown to remain active on skin after rinsing. 3 Bacteria do not tend to develop resistance towards chlorhexidine gluconate. TrizEDTA (tromethamine USP, disodium EDTA dihydrate): 3 Antimicrobial and antibiotic potentiating activity. Alkalinizing (pH 8). Blocks the Pseudomonas efflux pump. Potentiates chlorhexidine and antibiotics. Disrupts the bacterial cell wall by chelating metal ions making the cell wall more porous. Inhibits the effects of ulcerating bacterial enzymes. References 1 Methicillin-Resistant Staphylococcal Infections, Karen A. Moriello, DVM, DACVD University of Wisconsin–Madison, Clinician’s Brief, February 25, 2012 (Vol. 10 No. 2), pp. 23-24 2 Challenges & New Developments in Canine Pyoderma: Topical & Systemic Treatment, Kimberly S. Coyner, DVM, Diplomate ACVD, Today’s Veterinary Practice, Mar/Apr 2012 (Vol. 2, No. 2) 3 Koch, S.N. (2012). Canine and Feline Dermatology Drug Handbook. Ames: Wiley-Blackwell MURICIN is not for ophthalmic use. Safety in pregnant or breeding animals has not been determined. Due to a potential hazard for nephrotoxicity due to polyethylene glycol content of the product base, exercise care in use for extensive deep lesions where absorption of large quantities of polyethylene glycol is possible. Multidrug-resistant staphylococcal infections require intensive daily bathing (eg, 4% chlorhexidine gluconate, 4% chlorhexidine gluconate with tris-EDTA). 1 02PB-TRI50019-0213 MURICIN ® (mupirocin 2% ointment) For dermatologic use on dogs. Keep Out of Reach of Children. Store between 15° and 30°C (59° and 86°F). CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Each gram of MURICIN contains 20 mg of mupirocin in a bland, water-washable ointment base con- sisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment, NF). Mupirocin is a naturally-occurring, broadspectrum antibiotic. The chemical name is (E)-(2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5- hydroxy-4- methylhexyl]tetrahydro-3,4-dihydroxy-ß-meth- yl-2H-pyran-2-crotonic acid, ester with 9- hydroxynonanoic acid. The chemical structure is: CLINICAL PHARMACOLOGY: Mupirocin is a chemical entity produced by fermentation of the organism Pseudomo- nas fluorescens. Mupirocin inhibits bacterial protein synthe- sis by reversibly and specifically binding to bacterial iso- leucyl transfer-RNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobio- cin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram- positive and gram-negative bacteria. Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and ß-lactamase-producing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, a-hemolytic Strepto- cocci, ß group A Streptococci (including S. pyogenes), other ß Streptococci (including S. agalactiae), group D Strepto- cocci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacte- rium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobac- ter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including ß-lactamase-producing strains), Neisseria gonorrheae (including ß-lactamase-pro- ducing strains), Neisseria meningitidis, Branhamella catarrh- alis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes. Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylo- coccus aureus and Staphylococcus intermedius. INDICATIONS FOR USE: MURICIN is indicated for the topi- cal treatment of canine bacterial infections of the skin, in- cluding superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius. CONTRAINDICATIONS: This drug is contraindicated in animals with a history of sensitivity reactions to any of its components. WARNINGS: Because of the potential hazard of nephro- toxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible. Safety of use in pregnant or breeding animals has not been determined. MURICIN is not for ophthalmic use. ADVERSE REACTIONS: No adverse reactions have been reported with this product. If a skin reaction such as irrita- tion should occur, treatment should be discontinued and appropriate therapy instituted. DOSAGE AND ADMINISTRATION: Prior to treatment, the lesion should be cleansed. MURICIN should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days. 1. Remove entire Applicator Assembly, puncture tube with white portion of the cap. 2. Replace entire Applicator Assembly. 3. To dispense, remove the white portion of the cap. 4. After use replace white cap to close. IMPORTANT: The opening of this product is covered by a metal tamper-resistant seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase. HOW SUPPLIED: MURICIN is supplied in 15-gram tubes. ANADA # 200-418. Approved by FDA. NDC 17033-420-15. I420 DECHRA R1/08 #131 NAC No.: 12920021 Manufactured for: Dechra Veterinary Products 7015 College Blvd., Suite 525 Overland Park, KS 66211 U.S. Patent 6,538,155

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Page 1: MUriCiN WARNINGS: TrizCHLOrTM Products › animalhealth... · ducing strains), Neisseria meningitidis, Branhamella catarrh-alis and Pasteurella multocida, and the anaerobic isolates

TrizCHLOrTM Products• Shampoo and Spray Conditioner are indicated for use in dogs,

cats and horses

• Flush and Wipes are indicated for dogs and cats

• Antibacterial, Antiseptic

• Effective against multi-drug-resistant Staphylococcal infections

• Contains no alcohol; is non-irritating to ulcerated or abraded skin or ears.

• Use in conjunction with Muricin® (mupirocin 2% ointment) on focal areas of infection1

• recent in vitro study of chlorhexidine shampoos (2%, 3%, 4%) demonstrated equivalent and excellent minimum bactericidal activity against S. pseudintermedius (methicillin-susceptible and methicillin-resistant) at 10 min incubation time.2

• Patented, USP Tris EDTA composition

Indications:For support of healthy skin for animals with conditions responsive to chlorhexidine.

Active Ingredients:Chlorhexidine Gluconate: • Adjunctive therapy for bacterial skin infections caused by

Gram-positive and Gram-negative bacteria.3

• residual effects; shown to remain active on skin after rinsing.3

• Bacteria do not tend to develop resistance towards chlorhexidine gluconate.

TrizEDTA (tromethamine USP, disodium EDTA dihydrate): 3

• Antimicrobial and antibiotic potentiating activity.• Alkalinizing (pH 8).• Blocks the Pseudomonas efflux pump.• Potentiates chlorhexidine and antibiotics.• Disrupts the bacterial cell wall by chelating metal ions

making the cell wall more porous.• inhibits the effects of ulcerating bacterial enzymes.

references

1 Methicillin-resistant Staphylococcal infections, Karen A. Moriello, DVM, DACVD University of Wisconsin–Madison, Clinician’s Brief, February 25, 2012 (Vol. 10 No. 2), pp. 23-242 Challenges & New Developments in Canine Pyoderma: Topical & Systemic Treatment, Kimberly S. Coyner, DVM, Diplomate ACVD, Today’s Veterinary Practice, Mar/Apr 2012 (Vol. 2, No. 2)3 Koch, S.N. (2012). Canine and Feline Dermatology Drug Handbook. Ames: Wiley-Blackwell

MUriCiN is not for ophthalmic use. Safety in pregnant or breeding animals has not been determined. Due to a potential hazard for nephrotoxicity due to polyethylene glycol content of the product base, exercise care in use for extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.

Multidrug-resistant staphylococcal infections require intensive daily bathing (eg, 4% chlorhexidine gluconate, 4% chlorhexidine gluconate with tris-EDTA).1

02PB-Tri50019-0213

MUriCiN®

(mupirocin 2% ointment)For dermatologic use on dogs.Keep Out of Reach of Children.

Store between 15° and 30°C (59° and 86°F).

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

DESCRIPTION: Each gram of MUriCiN contains 20 mg of mupirocin in a bland, water-washable ointment base con-sisting of polyethylene glycol 400 and polyethylene glycol 3350 (polyethylene glycol ointment, NF). Mupirocin is a naturally-occurring, broadspectrum antibiotic. The chemical name is (E)-(2S,3r,4r,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4- methylhexyl]tetrahydro-3,4-dihydroxy-ß-meth-yl-2H-pyran-2-crotonic acid, ester with 9- hydroxynonanoic acid. The chemical structure is:

CLINICAL PHARMACOLOGY: Mupirocin is a chemical entity produced by fermentation of the organism Pseudomo-nas fluorescens. Mupirocin inhibits bacterial protein synthe-sis by reversibly and specifically binding to bacterial iso-leucyl transfer-rNA synthetase. Due to this mode of action, mupirocin shows no cross resistance with chloramphenicol, erythromycin, gentamicin, lincomycin, neomycin, novobio-cin, penicillin, streptomycin, and tetracycline. Mupirocin is an antimicrobial agent that inhibits the growth of gram-positive and gram-negative bacteria. Bacteria susceptible to the action of mupirocin in vitro include the aerobic isolates of Staphylococcus aureus (including methicillin-resistant strains and ß-lactamase-producing strains), Staphylococcus intermedius, Staphylococcus epidermidis, other coagulase positive or negative Staphylococci, a-hemolytic Strepto-cocci, ß group A Streptococci (including S. pyogenes), other ß Streptococci (including S. agalactiae), group D Strepto-cocci (including S. faecalis and S. faecium), group Viridans Streptococci, Streptococcus pneumoniae, Corynebacte-rium hofmanii, Bacillus subtilis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Enterobac-ter cloacae, Enterobacter aerogenes, Citrobacter freundii, Hemophilus influenzae (including ß-lactamase-producing strains), Neisseria gonorrheae (including ß-lactamase-pro-ducing strains), Neisseria meningitidis, Branhamella catarrh-alis and Pasteurella multocida, and the anaerobic isolates of Peptostreptococcus anaerobius, Clostridium difficile, and Clostridium sporogenes. Clinical significance of the in vitro data is unknown except for susceptible strains of Staphylo-coccus aureus and Staphylococcus intermedius.

INDICATIONS FOR USE: MUriCiN is indicated for the topi-cal treatment of canine bacterial infections of the skin, in-cluding superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.

CONTRAINDICATIONS: This drug is contraindicated in animals with a history of sensitivity reactions to any of its components.

WARNINGS: Because of the potential hazard of nephro-toxicity due to the polyethylene glycol content of the base, care should be exercised when using this product in treating extensive deep lesions where absorption of large quantities of polyethylene glycol is possible. Safety of use in pregnant or breeding animals has not been determined. MUriCiN is not for ophthalmic use.

ADVERSE REACTIONS: No adverse reactions have been reported with this product. if a skin reaction such as irrita-tion should occur, treatment should be discontinued and appropriate therapy instituted.

DOSAGE AND ADMINISTRATION: Prior to treatment, the lesion should be cleansed. MUriCiN should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.1. remove entire Applicator Assembly, puncture tube with white portion of the cap.2. replace entire Applicator Assembly.3. To dispense, remove the white portion of the cap.4. After use replace white cap to close.

IMPORTANT: The opening of this product is covered by a metal tamper-resistant seal. if this seal has been punctured or is not visible, do not use and return product to place of purchase.

HOW SUPPLIED: MUriCiN is supplied in 15-gram tubes.

ANADA # 200-418. Approved by FDA.NDC 17033-420-15.

i420 DECHrA r1/08#131NAC No.: 12920021

Manufactured for: Dechra Veterinary Products7015 College Blvd., Suite 525Overland Park, KS 66211

U.S. Patent 6,538,155

Page 2: MUriCiN WARNINGS: TrizCHLOrTM Products › animalhealth... · ducing strains), Neisseria meningitidis, Branhamella catarrh-alis and Pasteurella multocida, and the anaerobic isolates

TrizCHLOrTM 4 ProductsTrizCHLORTM 4 Shampoo, Spray, Wipes

Active Ingredients: 4% Chlorhexidine Gluconate, Tris-EDTA, USP

Indications: For support of healthy skin for animals with conditions responsive to chlorhexidine. These conditions include: superficial bacterial and fungal skin infections, acute moist dermatitis (hot spots).

TrizCHLOr 4

Product No. Size

TCSW 8 oz Shampoo

GTCSW 1 gallon Shampoo

TCCW 8 oz Conditioner

TCW 50 ct Wipes

TrizCHLORTM FlushActive Ingredients: 0.15% Chlorhexidine Gluconate, Tris-EDTA, USP

Indications: For support of healthy skin for animals with conditions responsive to chlorhexidine. Effective for wound irrigation and cleansing to inhibit bacterial infection.

Note: Ear cleaning in cats should be done with caution.

TrizCHLOr Flush

Product No. Size

TPW 4 oz

TrizCHLOrTM 4HC Products TrizCHLORTM 4 HC Shampoo, ConditionerActive Ingredients: 4% Chlorhexidine Gluconate, 1% Hydrocortisone, Tris-EDTA, USP

For support of healthy skin for animals with conditions responsive to chlorhexidine. These conditions include: superficial, pruritic bacterial and fungal skin infections, acute moist dermatitis (hot spots), pododermatitis and methicillin resistant Staphylococcus infections. The addition of hydrocortisone aids in relief of inflammation and pruritus.

TrizCHLOr 4 HC

Product No. Size

TCSHW 8 oz Shampoo

TCCHW 8 oz Conditioner

For Technical Support or information, contact:Dechra Veterinary Products at 866-933-2472 or www.dechra-us.com

MURICIN® (mupirocin ointment 2%) is an FDA approved, water-removable topical treatment indicated for canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.

MUriCiN

Product No. Size

520-15 5 gram tube

references

3 Loeffler et al. Comparison of a chlorhexidine and benzoyl peroxide shampoo as sole treatment in canine superficial pyodermas. Veterinary Record 2011 169: 249

“In select cases, chlorhexidine may be used as sole therapy to resolve cases of superficial pyodermas, possibly eliminating the need for oral antibiotics.” 3

MUriCiN is not for ophthalmic use. Safety in pregnant or breeding animals has not been determined. Due to a potential hazard for nephrotoxicity due to polyethylene glycol content of the product base, exercise care in use for extensive deep lesions where absorption of large quantities of polyethylene glycol is possible.