Orbax 5.7 mg Tablets (Canada)

Manufacturer: Schering-Plough

Orbifloxacin 5.7 Mg, 22.7 Mg, 68 Mg Tablets

Antibiotic

DIN 02237712, 02237713, 02237714

Veterinary Use Only

Description

Each yellow tablet contains: orbifloxacin 5.7 mg

Each green scored tablet contains: orbifloxacin 22.7 mg

Each blue scored tablet contains: orbifloxacin 68 mg

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

Organism	N	Mic50	mic90
staphylococcus Intermedius	81	0.195	0.39
staphylococcus Aureus	15	0.195	0.39
e. Coli	78	0.048	0.39
pasteurella Multocida	52	0.012	0.048
proteus Mirabilis	24	0.39-0.78	0.78-1.56
pseudomonas Aeruginosa	17	1.56-3.125	6.25-12.5
pseudomonas Spp.	29	1.56	6.25
klebsiella Pneumoniae	12	0.195	0.195
enterobacter Spp.	42	0.0975	0.39
enterococcus Spp.	35	1.56-3.125	12.5-25
group G β-haemolytic Streptococci	36	0.39	0.78-1.56
streptococcus Spp.	50	0.39	0.78-1.56
acinetobacter Spp.	39	0.0975	1.56

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.

Orbax 5.7 mg Tablets Dosage And Administration

Dogs and Cats: 2.5 mg/kg body weight 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.

# of tablets to be administered	Weight Of Animal
	lbs	5	10	20	30	40	50	60	90	120
	kg	2.3	4.5	9	13.6	18.2	22.7	27.3	41	54.5
# of 5.7 mg tablets		1	2
# of 22.7 mg tablets			1/2	1	1 1/2	2	2 1/2
# of 68 mg tablets					1/2			1	1 1/2	2

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.

Precautions

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).

Orbax^® is not recommended for use in breeding dogs and cats as effects on fertility and reproductive function have not been evaluated.

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.

Side Effects

No adverse reactions or side effects attributable to the administration of Orbax^® Tablets were reported in clinical trials conducted in the United States and Canada. Mild and self-limiting vomiting, with an uncertain relationship to Orbax^® administration, was observed in less than 2% of treated cases (4/241).

Warning

To limit the potential development of antimicrobial resistance:

- Fluoroquinolone drugs such as Orbax^® should not be used indiscriminately.

- Orbax^® should not be used in food producing animals.

Keep out of reach of children.

Storage Conditions

Store between 2° and 30°C (36° and 86°F).

How Supplied

Orbax^® Tablets are colour-coded for easy identification of tablet strength:

5.7 mg: Bottles containing 250 yellow tablets;

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.

^® Registered trademark of Schering-Plough Canada Inc.

Schering-Plough Animal Health (Schering-Plough Canada Inc.), Pointe-Claire, Quebec H9R 1B4

71-470332

Nac No.

12080702