Orbax 68 mg Tablets (Canada)

Company: Merck Animal Health

ORBIFLOXACIN TABLETS USP

22.7 mg and 68 mg

ANTIBIOTIC

DIN 02237713

DIN 02237714

Veterinary Use Only

Description

Active Ingredients

Each green scored tablet contains: orbifloxacin 22.7 mg.

Each blue scored tablet contains: orbifloxacin 68 mg.

NON-MEDICINAL INGREDIENTS:

Lactose Monohydrate, Povidone, Sodium Starch Glycolate, Opadry green or blue, Magnesium Stearate, Silicon Dioxide and Carnauba Wax.

Orbax 68 mg Tablets Indications

ORBAX (orbifloxacin) is indicated for the treatment of infections caused by susceptible bacterial pathogens located in tissues where effective MIC levels of the drug are attained. Clinical field evaluations indicated the effectiveness of orbifloxacin in the treatment of the following infections in dogs and cats:

• urinary tract infections in dogs caused by susceptible strains of Escherichia coli and Proteus mirabilis.

• skin and soft tissue infections (wounds, abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius, Escherichia coli, Enterobacter spp., Enterococcus faecalis, and group G β-haemolytic streptococci.

• skin and soft tissue infections (wounds, abscesses) in cats caused by susceptible strains of Pasteurella multocida, Staphylococcus intermedius, Enterococcus spp., Acinetobacter spp. and group G β-haemolytic streptococci.

Dosage and Administration

Dogs and Cats: 2.5 mg/kg body weight given orally once daily. For skin and soft tissue infections, administer for 2 to 3 days after the complete resolution of clinical signs, from a minimum of 5 to a maximum of 10 consecutive days. For urinary tract infections in dogs, administer for 10 consecutive days. If no improvement is observed within 5 days, the diagnosis and/or the susceptibility of the organism should be re-evaluated and an alternate course of therapy considered. The following table is a useful guide to dosing.

Contraindications

Fluoroquinolone antibiotics, including orbifloxacin, have been associated with arthropathy of weight-bearing joints in immature animals of several species, notably dogs. Thus, orbifloxacin is contraindicated in young dogs during the rapid growth phase: between 2 and 8 months of age in small and medium sized breeds, and up to 18 months of age in large and giant breeds.

CAUTIONS: Ideally, antibiotic susceptibility should be determined prior to the use of any antibiotic. Where this is not practical, culture and sensitivity results obtained after the initiation of ORBAX therapy should be reviewed to confirm susceptibility of the pathogen(s).

Safety has not been established in breeding, pregnant or lactating dogs and cats. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

Concurrent administration of preparations containing metal cations (e.g. magnesium hydroxide or aluminum hydroxide antacids, or multivitamins containing iron or zinc) has been reported to dramatically decrease the absorption of the fluoroquinolone antibiotics from the gastrointestinal tract.

Warnings

To limit the potential development of antimicrobial resistance, ORBAX should not be used in food producing animals. Keep out of reach of children.

Adverse Reactions

The adverse events listed below are based on post-approval adverse drug experience reporting with ORBAX Tablets. Since not all adverse reactions are reported, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are grouped by system organ class and listed in decreasing order of reporting frequency:

Cat:

Eye: blindness, mydriasis, abnormal retina

Digestive Tract: vomiting, anorexia, hypersalivation, diarrhea

Neurological: depression/lethargy, ataxia, convulsions

Dog:

Neurological: convulsions, depression/lethargy, ataxia

Digestive Tract: vomiting, anorexia, diarrhea

Allergic type reactions: swelling of head/face, urticaria

Eye: blindness

Pharmacology

Orbifloxacin [1 - cyclopropyl - 5,6,8 - trifluoro - 1,4 - dihydro - 7 - (cis - 3,5 - dimethyl - 1 - piperazinyl) - 4 - oxoquinolone - 3 - carboxylic acid], is a synthetic broad spectrum antibiotic belonging to the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is bactericidal against a wide range of gram-negative and gram-positive bacteria, and exerts its effect by interfering with bacterial DNA gyrase, an enzyme essential to bacterial DNA synthesis and maintenance.

Orbifloxacin is rapidly and virtually completely absorbed following oral administration in dogs and cats. Peak plasma concentrations in the order of 2.5 µg/mL are attained within one hour after an oral dose. Orbifloxacin has a large volume of distribution, consistent with good penetration into body tissues and fluids. The plasma half-life is approximately 6 and 4 hours in dogs and cats, respectively.

MICROBIOLOGY: The in vitro susceptibility of pathogens encountered in North American clinical trials conducted between 1994 and 1996 is summarized in the table below. For most susceptible microorganisms the MIC is less than 1 µg/mL. Minimal inhibitory concentrations were determined according to the guidelines established by the National Committee for Clinical Laboratory Standards.

Summary of Orbifloxacin MICs from All Clinical Isolates (Dogs and Cats) in North American Trials

STORAGE CONDITIONS: Store between 2 and 30 °C (36 and 86 °F). Protect from excessive moisture.

How Supplied

ORBAX Tablets are colour-coded for easy identification of tablet strength:

22.7 mg: Bottles containing 250 green, E-Z Break, single-scored tablets;

68 mg: Bottles containing 100 blue, E-Z Break, single-scored tablets.

INTERVET CANADA CORP., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866 683-7838

^® Registered trademark of Intervet Canada Corp.

Version: 10 July 2014

CPN: 1208069.6