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Orbax Suspension


Orbax Suspension - 20ml


Orbax Suspension - 20ml

20ml, for dogs and cats
The once-a-day antibiotic cats actually like.
  • Bound to a taste-masking agent, orbifloxacin passes taste buds undetected.
  • Cats taste the malt flavor, not the antibiotic.
SKU: 293620-RX
Price: $32.95

Quantity:
RX required for this item.
Click here for our full Prescription Policy and Form

Intervet/Schering-Plough Animal Health has launched a once-a-day, malt-flavored oral antibiotic for cats and small dogs. The product, Orbax (orbifloxacin) Oral Suspension, is designed to make it easier and more convenient for pet owners to administer the medicine to their dog or cat.

“We are constantly seeking ways to keep pets healthy, safe and happy and make the job easier for their care providers,” said Steve Shell, head of the Companion Animal Business Unit.

“Orbax Oral Suspension’s innovative technology in both formulation and dispensing can make all the difference in supporting recovery from serious infection.”

Why Orbax Oral Suspension?

  • Administered once-a-day
  • Unique press-in dispensing system (3 mL syringe with 0.25 mL markings)
  • Makes dosing easy and accurate, administration mess-free
  • No refrigeration needed
  • Ready to use, no need to reconstitute, simply shake well

New! Taste-Masking Technology

  • Orbifloxacin is bound to a patented taste-masking agent so it passes taste buds undetected, then is released in the low pH environment of the stomach. Cats and dogs taste the malt flavor, not the antibiotic.

The product, as the company described it, features a patented, taste-masking ion exchange agent that enables the orbifloxacin to pass by an animal’s taste buds undetected and then be released in the low pH environment of the stomach.

The malt-flavored oral suspension is readily accepted by 95 percent of cats and 96 percent of dogs, according to Intervet/Schering-Plough Animal Health.

The product, which does not require refrigeration, also features a ready-to-use “press-in” dispensing system to ensure accurate, “neat” dosing, according to the company. The medication can be detected throughout the body within a few hours after administration.

Orbax Oral Suspension has rapid, broad-spectrum bactericidal activity against a wide range of gram-negative and gram-positive organisms, according to the company. The product is indicated for skin infections (wound and abscesses) in cats and skin, soft tissue and urinary tract infections (cystitis) in dogs.

The company noted that Orbax Oral Suspension is in the quinolone family of antibiotics, which have been shown to cause arthropathy (joint disease) in immature animals. In animals with known or suspected CNS disorders, quinolones have been associated with CNS stimulation, which may lead to convulsive seizures. The use of fluoroquniolones in cats has been reported to adversely affect the retina and should be used with caution in cats, according to the company.

DOSAGE AND ADMINISTRATION: Shake Well Before Use. BEFORE INITIAL USE, remove the cap and insert the syringe adaptor by pressing firmly into top of bottle. Insert the syringe tip into the adaptor opening and invert the bottle. Withdraw the required amount of medication with the calibrated syringe. After use, replace cap, leaving adaptor in the bottle, and rinse the syringe with water.

The dose of ORBAX® Oral Suspension in the dog is 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight administered once daily (See Drug interactions and Animal Safety). The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient’s host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® Oral Suspension may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy.

For the treatment of skin infections, ORBAX® Oral Suspension should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX® Oral Suspension should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.


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ORBAX® TABLETS

Intervet/Merck Animal Health

(orbifloxacin)

For Oral Use in Dogs and Cats Only

NADA #141-081, Approved by FDA.

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

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

DESCRIPTION: Orbifloxacin is a synthetic broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is the international nonproprietary name for 1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(cis-3,5-dimethyl-1-piperazinyl)-4-oxoquinoline-3-carboxylic acid. The chemical formula for orbifloxacin is C19H20F3N3O3 and its molecular weight is 395.38.

The compound is slightly soluble in water; however, solubility increases in both acidic and alkaline conditions. The compound has two dissociation constants (pKa’s): 5.95 and 9.01.

FIGURE 1. Chemical structure of orbifloxacin.

INDICATIONS: ORBAX® (orbifloxacin) Tablets are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin.

EFFICACY CONFIRMATION: Clinical efficacy was established in skin and soft tissue infections (wounds and abscesses) in the dog and cat, and urinary tract infections (cystitis) in the dog, associated with bacteria susceptible to orbifloxacin. Specific bacterial pathogens isolated in clinical field trials are listed in the MICROBIOLOGY section.

DOSAGE AND ADMINISTRATION: For routine out-patient treatment of infection caused by a susceptible organism, in an otherwise healthy dog or cat, the dose of ORBAX® (orbifloxacin) Tablets is 2.5 to 7.5 mg/kg of body weight administered once daily. (See DRUG INTERACTIONS and TARGET ANIMAL SAFETY.) The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient’s host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® (orbifloxacin) Tablets may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy.

For the treatment of skin and associated soft tissue infections, ORBAX® Tablets should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX® Tablets should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.

To administer a total daily dose of 2.5 mg/kg, ORBAX® Tablets may be dispensed as indicated in Table 1.

Table 1: Dose Table for ORBAX® Tablets (2.5 mg/kg total daily dose)

 

WEIGHT OF DOG/CAT (lbs)

5

10

20

30

40

50

60

90

120

No. of
5.7 mg tablets

1

2

 

 

 

 

 

 

 

No. of
22.7 mg tablets

 

1/2

1

1 1/2

2

2 1/2

 

 

 

No. of
68 mg tablets

 

 

 

1/2

 

 

1

1 1/2

2

CLINICAL PHARMACOLOGY: Pharmacokinetics in healthy adult beagle dogs and healthy adult cats: In fasted animals, orbifloxacin is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration. Absorption of orally administered orbifloxacin increases proportionately with dose (exhibits linear pharmacokinetics) up to 37.5 mg/kg when given daily for 30 days. The absolute bioavailability (F) of an oral dose is approximately 100%. Peak plasma concentrations are usually attained within 1 hour of administration. The effects of concomitant feeding on the absorption of orbifloxacin has not been studied. Divalent cations are generally known to diminish the absorption of fluoroquinolones. (See DRUG INTERACTIONS.)

The relatively large volume of distribution at steady state (Vss) is indicative of a widespread distribution and penetration into body tissues. Within 24 hours of administration, approximately 40% of an oral dose was excreted into the urine unchanged in dogs with normal renal function. This supports the efficacy of orbifloxacin in the treatment of urinary tract infections. Based on the plasma elimination half-life and the dosing interval, negligible drug accumulation is expected with multiple dosing.

Pharmacokinetic parameters estimated in a randomized two-period, two-sequence crossover study using single intravenous and oral doses are summarized in Tables 2 and 3 and Figures 2 and 3.

Table 2: Mean Pharmocokinetic Parameters Estimated in 12 Adult Beagle Dogs and 12 Adult Cats After a Single IV Bolus of Orbifloxacin at 2.5 mg/kg

Pharmacokinetic Parameter

Dog Estimate (SD)

Cat Estimate (SD)

Total body clearance, mL/min/kg

2.9 ± 0.2

4.09 ± 0.7

Volume of distribution at steady state, Vss (L/kg)

1.2 ± 0.2

1.3 ± 0.13

AUC0-∞ (µg•h/mL)

14.3 ± 0.9

10.6 ± 2.4

Terminal plasma elimination half-life, t1/2 (hrs)

5.4 ± 1.1

4.5 ± 1.8

Table 3: Mean Pharmacokinetic Parameters Estimated in 12 Adult Beagle Dogs and 12 Adult Cats After a Single Oral Dose of Orbifloxacin at 2.5 mg/kg

Pharmacokinetic Parameter

Dog Estimate (SD)

Cat Estimate (SD)

Total body clearance/F, mL/min/kg

3.0 ± 0.2

3.98 ± 0.8

Maximum concentration, Cmax (µg/mL)

2.3 ± 0.3

2.06 ± 0.6

Time of maximum concentration, Tmax (minutes)

46 ± 27

60 ± 27

AUC0-∞ (µg•h/mL)

14.3 ± 1.4

10.82 ± 2.6

Terminal plasma elimination half-life, t1/2 (hrs)

5.6 ± 1.1

5.52 ± 2.66

Plasma Concentration of Orbifloxacin vs. Time in Dogs

FIGURE 2. Mean plasma concentration of orbifloxacin vs. time in dogs (2.5 mg/kg = observed values, 7.5 mg/kg = extrapolated values).

Plasma Concentration of Orbifloxacin vs. Time in Cats

FIGURE 3. Mean plasma concentration of orbifloxacin vs. time in cats (2.5 mg/kg = normalized from an actual mean dose of 3.32 mg/kg; 7.5 mg/kg = extrapolated values).

MICROBIOLOGY: Orbifloxacin is bactericidal against a wide range of gram-negative and gram-positive organisms and exerts its antibacterial effect through interference with the bacterial enzyme DNA gyrase which is needed for the maintenance and synthesis of bacterial DNA. The minimum inhibitory concentrations (MICs) of pathogens isolated in multicentered clinical field trials performed in the United States was determined using National Committee for Clinical Laboratory Standards (NCCLS), and is shown in Tables 4, 5, and 6.

Table 4: MIC Values* (µg/mL) of Orbifloxacin Against Urinary Pathogens Isolated Between 1994 and 1996 From Clinical Infections in Dogs

Bacteria Name

Number of Isolates

MIC50

MIC90

MIC Range

Staphylococcus intermedius

5

**

**

0.0975 - 0.39

Proteus mirabilis

19

0.78

1.56

0.048 - 1.56

Escherichia coli

35

0.0975

0.39

0.024 - ≥25

Enterococcus faecalis

5

**

**

0.003 - 3.12

*The correlation between the in vitro susceptibility data (MIC Values) and clinical response has not been determined.

**There were an insufficient number of isolates to calculate the MIC50 or MIC90.

Table 5: MIC Values* (µg/mL) of Orbifloxacin Against Dermal Pathogens Isolated Between 1994 and 1996 From Clinical Infections of Dogs

Bacteria Name

Number of Isolates

MIC50

MIC90

MIC Range

Staphylococcus intermedius

51

0.195

0.39

0.003 - 1.56

Staphylococcus aureus

8

**

**

0.195 - ≥25

Coagulase +ve staphylococci

59

0.195

0.39

0.003 - ≥25

Pasteurella multocida

5

**

0

0.003 - 0.78

Proteus mirabilis

7

**

**

0.39 - 1.56

Pseudomonas aeruginosa

14

3.125

12.5

0.39 - ≥25

Pseudomonas spp.

18

3.125

12.5

0.02 - ≥25

Klebsiella pneumoniae

9

**

**

0.0975 - 0.195

Escherichia coli

28

0.0975

0.39

0.012 - 6.25

Enterobacter spp.

24

0.0975

0.39

0.012 - 6.25

Citrobacter spp.

4

**

**

0.024 - 0.0975

Enterococcus faecalis

11

**

**

0.3 - ≥25

Streptococcus β-hemolytic (Grp G)

22

0.39

1.56

0.006 - 3.12

Streptococcus equisimilis

10

**

**

0.003 - 0.78

*The correlation between the in vitro susceptibility data (MIC Values) and clinical response has not been determined.

**There were an insufficient number of isolates to calculate the MIC50 or MIC90.

Table 6: MIC Values* (µg/mL) of Orbifloxacin Against Dermal Pathogens Isolated Between 1994 and 1996 From Clinical Infections of Cats

Bacteria Name

Number of Isolates

MIC50

MIC90

MIC Range

Staphylococcus intermedius

25

0.39

0.39

0.024 - 3.125

Staphylococcus aureus

7

**

**

0.195 - 0.39

Coagulase +ve staphylococci

32

0.39

0.39

0.024 - 3.125

Pasteurella multocida

47

0.012

0.048

0.003 - 0.195

Pseudomonas aeruginosa

3

**

**

0.39 - 3.125

Pseudomonas spp.

10

**

**

0.195 - 6.25

Escherichia coli

17

0.048

0.195

0.024 - 25

Enterobacter spp.

12

**

**

0.024 - 0.78

Enterococcus faecalis

10

**

**

1.56 - 3.125

Streptococcus β-hemolytic (Grp G)

14

**

**

0.006 - 1.56

*The correlation between the in vitro susceptibility data (MIC Values) and clinical response has not been determined.

**There were an insufficient number of isolates to calculate the MIC50 or MIC90.

DRUG INTERACTIONS: Compounds (eg, sucralfate, antacids, and multivitamins) containing divalent and trivalent cations (eg, iron, aluminum, calcium, magnesium, and zinc) may substantially interfere with the absorption of quinolones resulting in a decrease in product bioavailability. Therefore, the concomitant oral administration of quinolones with foods, supplements, or other preparations containing these compounds should be avoided.

CONTRAINDICATIONS: Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Orbifloxacin is contraindicated in immature 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).

Orbifloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

PRECAUTIONS: The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in 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. Quinolones have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.

The safety of orbifloxacin in animals that are used for breeding or that are pregnant and/or lactating has not been demonstrated.

WARNING: For use in animals only. Do not exceed 7.5 mg/kg body weight per day in cats. Keep out of the reach of children.

Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposure. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.

TARGET ANIMAL SAFETY: Orbifloxacin administered to young, clinically healthy, adult dogs and cats at doses of 7.5 mg/kg, 22.5 mg/kg, and 37.5 mg/kg for 30 consecutive days was well tolerated. At the exaggerated doses of 22.5 and 37.5 mg/kg/day, orbifloxacin caused mild gastrointestinal effects (soft feces) in both male and female cats. Emesis (males only), diarrhea (males only), reduced food consumption with subsequent reduced body weight were evident in cats administered ORBAX® at 75 mg/kg/day for 10 days. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. In 8- to 10-week-old beagle puppies dosed daily with orbifloxacin for 30 days, microscopic lesions consistent with fluoroquinolone-induced arthropathy of the articular cartilage was seen in only one of eight dogs dosed at 12.5 mg/kg, and in all eight dogs dosed at 25 mg/kg. (See CONTRAINDICATIONS.) No arthropathy was noted in 12-week-old kittens administered orbifloxacin at doses as high as 25 mg/kg for 1 month.

ADVERSE REACTIONS: In clinical trials, when the drug was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported.

Post Approval Experience: The following adverse reactions, although rare, are based upon voluntary post-approval reporting:

Hypersensitivity: facial edema, anaphylaxis/anaphylactoid reactions

Neurologic: seizures, ataxia

Behavioral: depression, lethargy

Gastrointestinal: vomiting, anorexia

HOW SUPPLIED: ORBAX® (orbifloxacin) Tablets are available in the following presentations:

5.7 mg: Bottles of 250 yellow tablets NDC 0061-1171-01

22.7 mg: Bottles of 250 green, E-Z Break, single-scored tablets NDC 0061-1141-01

68 mg: Bottles of 100 blue, E-Z Break, single-scored tablets NDC 0061-1174-01

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

To report suspected adverse reactions, contact Schering-Plough Animal Health at 1-800-932-0473.

September 2004

F-19335658

B-19335658

81-497245

Made in Canada.

Schering-Plough Animal Health Corp., Union, NJ 07083

Copyright © 1997, 2004, 2005, Schering-Plough Animal Health Corp.

All rights reserved.

NAC No.: 1047142.2

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