Marbofloxacin

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.

Otiserene®

For the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

Zeniquin®

For the treatment of infections in cats associated with bacteria susceptible to marbofloxacin.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

Zeniquin®

Dogs and cats

For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin.

Marboquin™

Zeniquin (marbofloxacin) tablets are indicated for the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin.

Zeniquin® (marbofloxacin)

Marbofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract following oral administration to fasted animals. Divalent cations are generally known to diminish the absorption of fluoroquinolones. The effects of concomitant feeding on the absorption of marbofloxacin have not been determined. (See Drug Interactions.) In the dog, approximately 40% of an oral dose of marbofloxacin is excreted unchanged in the urine1. Excretion in the feces, also as unchanged drug, is the other major route of elimination in dogs. Ten to 15% of marbofloxacin is metabolized by the liver in dogs. In vitro plasma protein binding of marbofloxacin in dogs was 9.1% and in cats was 7.3%. In the cat, approximately 70% of an oral dose is excreted in the urine as marbofloxacin and metabolites with approximately 85% of the excreted material as unchanged drug. Pharmacokinetic parameters related to intravenous dosing were estimated in a study of 6 healthy adult beagle dogs, and are summarized in Table 1. The absolute bioavailability following dosing of oral tablets to the same animals was 94%. Marbofloxacin plasma concentrations were determined over time in healthy adult beagle dogs (6 dogs per dosage group) following single oral doses of 1.25 mg/lb or 2.5 mg/lb. Absorption of orally administered marbofloxacin increases proportionally over the dose range of 1.25 to 2.5 mg/lb. Marbofloxacin plasma concentrations were determined over time in 7 healthy adult male cats following a single oral dose of 2.5 mg/lb. Plasma pharmacokinetic parameters following oral dosing of dogs and cats are summarized in Figures 2 and 3 and in Table 2. Based on the terminal elimination half-life and the dosing interval, steady-state levels are reached after the third dose and are expected to be approximately 25% greater in dogs and 35% greater in cats than those achieved after a single dose. Marbofloxacin is widely distributed in canine tissues. Tissue concentrations of marbofloxacin were determined in healthy male beagle dogs (4 dogs per time period) at 2, 18 and 24 hours after a single oral dose (1.25 or 2.5 mg/lb) and are summarized in Tables 3a and 3b. Table 1: Mean pharmacokinetic parameters following intravenous administration of marbofloxacin to 6 adult beagle dogs at a dosage of 2.5 mg/lb. Parameter Estimate ± SD* n=6 Total body clearance, (mL/h•kg) 94 ± 8 Volume of distribution at steady state, Vss, (L/kg) 1.19 ± 0.08 AUC0-inf (μg•h/mL) 59 ± 5 Terminal plasma elimination half-life, t1/2(h) 9.5 ± 0.7 * SD = standard deviation Table 2: Mean pharmacokinetic parameters following oral administration of marbofloxacin tablets to adult beagle dogs at a nominal dosage of 1.25 mg/lb or 2.5 mg/lb and to cats at 2.5 mg/lb.† Parameters Dog Estimate ± SD* (1.25 mg/lb) n=6 Dog Estimate ± SD* (2.5 mg/lb) n=6 Cat Estimate ± SD* (2.5 mg/lb) n=7 Time of maximum concentration, Tmax(h) 1.5 ± 0.3 1.8 ± 0.3 1.2 ± 0.6 Maximum concentration, Cmax, (μg/mL) 2.0 ± 0.2 4.2 ± 0.5 4.8 ± 0.7 AUC0-inf (μg•h/mL) 31.2 ± 1.6 64 ± 8 70 ± 6 Terminal plasma elimination half-life, t1/2(h) 10.7 ± 1.6 10.9 ± 0.6 12.7 ± 1.1 † mean actual dosages administered to dogs were 1.22 mg/lb and 2.56 mg/lb, respectively, and the mean actual dosage administered to cats was 2.82 mg/lb. * SD = standard deviation Figure 2: Mean plasma concentrations (µg/mL) following single oral administration of marbofloxacin to adult beagle dogs at dosages of 1.25 mg/lb or 2.5 mg/lb. * See Table 4 in Microbiology section for MIC data. Figure 3: Mean plasma concentrations (µg/mL) following single oral administration of marbofloxacin to adult cats at a dosage of 2.5 mg/lb. * See Table 5 in Microbiology section for MIC data. Table 3a: Tissue distribution following a single oral administration of marbofloxacin tablets to adult beagle dogs at a dosage of 1.25 mg/lb*. Tissue Marbofloxacin 2 hours (n=4) Concentrations 18 hours (n=4) (μg/g ± SD) 24 hours (n=4) bladder 4.8 ± 1.1 2.6 ± 1.5 1.11 ± 0.19 bone marrow 3.1 ± 0.5 1.5 ± 1.5 0.7 ± 0.2 feces 15 ± 9 48 ± 40 26 ± 11 jejunum 3.6 ± 0.5 1.3 ± 1.0 0.7 ± 0.3 kidney 7.1 ±1.7 1.4 ± 0.5 0.9 ± 0.3 lung 3.0 ± 0.5 0.8 ± 0.2 0.57 ± 0.19 lymph node 5.5 ± 1.1 1.3 ± 0.3 1.0 ± 0.3 muscle 4.1 ± 0.3 1.0 ± 0.3 0.7 ± 0.2 prostate 5.6 ± 1.4 1.8 ± 0.6 1.1 ± 0.4 skin 1.9 ± 0.6 0.41 ± 0.13 0.32 ± 0.08 * SD = standard deviation Table 3b: Tissue distribution following a single oral administration of marbofloxacin tablets to adult beagle dogs at a dosage of 2.5 mg/lb. Tissue Marbofloxacin 2 hours (n=4) Concentrations 18 hours (n=4) (μg/g ± SD*) 24 hours (n=4) bladder 12 ± 4 6 ± 7 1.8 ± 0.4 bone marrow 4.6 ± 1.5 1.28 ± 0.13 0.9 ± 0.3 feces 18 ± 3 52 ± 17 47 ± 28 jejunum 7.8 ± 1.1 2.0 ± 0.3 1.1 ± 0.3 kidney 12.7 ±1.7 2.7 ± 0.3 1.6 ± 0.2 lung 5.48 ± 0.17 1.45 ± 0.19 1.0 ± 0.2 lymph node 8.3 ± 0.7 2.3 ± 0.5 2.03 ± 0.06 muscle 7.5 ± 0.5 1.8 ± 0.3 1.20 ± 0.12 prostate 11 ± 3 2.7 ± 1.0 2.0 ± 0.5 skin 3.20 ± 0.33 0.705 ± 0.013 0.46 ± 0.09 * SD = standard deviation

Zeniquin® (marbofloxacin)

Marbofloxacin 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. Marbofloxacin is contraindicated in immature dogs during the rapid growth phase (small and medium breeds up to 8 months of age, large breeds up to 12 months of age and giant breeds up to 18 months of age). Marbofloxacin is contraindicated in cats under 12 months of age. Marbofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

Zeniquin® (marbofloxacin)

For use in animals only. Keep out of 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 fluoroquinolones 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. Keep Marbofloxacin in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Marbofloxacin Tablets For oral use in dogs and cats only

For use in animals only. Keep out of 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 fluoroquinolones 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.

Zeniquin® (marbofloxacin)

The following clinical signs were reported during the course of clinical field studies in dogs receiving marbofloxacin at dosages up to 2.5 mg/lb daily: decreased or loss of appetite (5.4%), decreased activity (4.4%), and vomiting (2.9%). The following signs were reported in less than 1% of cases in dogs: increased thirst, soft stool/diarrhea, behavioral changes, shivering/shaking/tremors, and ataxia. One dog which had a seizure the day before study enrollment experienced a seizure while on marbofloxacin therapy. The following clinical signs were reported during clinical field studies in cats receiving 1.25 mg/lb/day: diarrhea (2.1%) and soft stool (1.4%). Vomiting was reported in less than 1% of cases in cats.

Zeniquin® (marbofloxacin)

1.25 milligrams per pound of body weight once daily, but may be increased to 2.5 milligrams per pound of body weight once daily.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

Zeniquin®

Administer one dose (1 tube) per affected ear once.

Otic

Otiserene®

Dogs and cats

The recommended dosage for oral administration to dogs and cats is 1.25 mg marbofloxacin per lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb. For the treatment of skin and soft tissue infections, Marbofloxacin Chewable Tablets should be given for 2-3 days beyond the cessation of clinical signs for a maximum of 30 days. For the treatment of urinary tract infections, Marbofloxacin Chewable Tablets should be administered for at least 10 days. If no improvement is noted within 5 days, the diagnosis should be re-evaluated and a different course of therapy considered.

Oral

Marbofloxacin Chewable Tablets

Dogs and cats

1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/lb of body weight once daily.

Oral

Cronoquin™ Tablets

1.25 milligrams per pound of body weight once daily, but may be increased to 2.5 milligrams per pound of body weight once daily.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

Zeniquin®

The recommended dosage for oral administration to dogs and cats is 1.25 mg marbofloxacin per lb of body weight once daily, but the dosage may be safely increased to 2.5 mg/lb. For the treatment of skin and soft tissue infections, Marbofloxacin Chewable Tablets should be given for 2–3 days beyond the cessation of clinical signs for a maximum of 30 days. For the treatment of urinary tract infections, Marbofloxacin Chewable Tablets should be administered for at least 10 days. If no improvement is noted within 5 days, the diagnosis should be re-evaluated and a different course of therapy considered.

ORAL

Marbofloxacin Chewable Tablets For oral use in dogs and cats only