Marbocyl

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Marbocyl uses



Tablets

For oral use in dogs and cats only

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

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

DESCRIPTION: Marbocyl is a synthetic broad-spectrum antibacterial agent from the fluoroquinolone class of chemotherapeutic agents. Marbocyl is the non-proprietary designation for 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[3,2,1-ij][4,1,2] benzoxadiazine-6-carboxylic acid. The empirical formula is C17H19FN4O4 and the molecular weight is 362.36. The compound is soluble in water; however, solubility decreases in alkaline conditions. The N-octanol/water partition coefficient (Kow) is 0.835 measured at pH 7 and 25°C.

Figure 1: Chemical structure of Marbocyl

Chemical Structure

CLINICAL

Pharmacology: Marbocyl 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 Marbocyl have not been determined. (See Drug Interactions.) In the dog, approximately 40% of an oral dose of Marbocyl 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 Marbocyl is metabolized by the liver in dogs.

In vitro plasma protein binding of Marbocyl 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 Marbocyl 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%.

Marbocyl 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 Marbocyl increases proportionally over the dose range of 1.25 to 2.5 mg/lb. Marbocyl 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. Marbocyl is widely distributed in canine tissues. Tissue concentrations of Marbocyl 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.

Parameter Estimate ± SDSD = standard deviation

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
Parameter Dog

Estimate ± SDSD = standard deviation

(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

Figure 2: Mean plasma concentrations (µg/mL) following single oral administration of Marbocyl 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 Marbocyl to adult cats at a dosage of 2.5 mg/lb.

* See Table 5 in Microbiology section for MIC data.

Marbocyl Concentrations (µg/g ± SD)
Tissue 2 hours

(n=4)

18 hours

(n=4)

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
Marbocyl Concentrations (µg/g ± SDSD = standard deviation)
Tissue 2 hours

(n=4)

18 hours

(n=4)

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
Figure 2 Figure 3

Microbiology: The primary action of fluoroquinolones is to inhibit the bacterial enzyme, DNA gyrase. In susceptible organisms, fluoroquinolones are rapidly bactericidal at relatively low concentrations. Marbocyl is bactericidal against a broad range of gram-negative and gram-positive organisms. The minimum inhibitory concentrations (MICs) of pathogens isolated in clinical field studies performed in the United States were determined using National Committee for Clinical Laboratory Standards (NCCLS) standards, and are shown in Tables 4 and 5.

Organism No. of Isolates MIC50 MIC90 MIC Range
Staphylococcus intermedius 135 0.25 0.25 0.125–2
Escherichia coli 61 0.03 0.06 0.015–2
Proteus mirabilis 35 0.06 0.125 0.03–0.25
Beta-hemolytic Streptococcus , (not Group A or Group B) 25 1 2 0.5–16
Streptococcus, Group D enterococcus 16 1 4 0.008–4
Pasteurella multocida 13 0.015 0.06 ≤0.008–0.5
Staphylococcus aureus 12 0.25 0.25 0.25–0.5
Enterococcus faecalis 11 2 2 1–4
Klebsiella pneumoniae 11 0.06 0.06 0.01–0.06
Pseudomonas spp. 9 MIC50 and MIC90 not calculated due to insufficient number of isolates. 0.06–1
Pseudomonas aeruginosa 7 0.25–1
Organism No. of Isolates MIC50 MIC90 MIC Range
Pasteurella multocida 135 0.03 0.06 ≤0.008–0.25
Beta-hemolytic Streptococcus 22 1 1 0.06–1
Staphylococcus aureus 21 0.25 0.5 0.125–1
Corynebacterium spp. 14 0.5 1 0.25–2
Staphylococcus intermedius 11 0.25 0.5 0.03–0.5
Enterococcus faecalis 10 2.0 2.0 1.0–2.0
Escherichia coli 10 0.03 0.03 0.015–0.03
Bacillus spp. 10 0.25 0.25 0.125–0.25

INDICATIONS AND USAGE: Marbocyl (marbofloxacin) tablets are indicated for the treatment of infections in dogs and cats associated with bacteria susceptible to Marbocyl.

CONTRAINDICATIONS: Marbocyl 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. Marbocyl 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). Marbocyl is contraindicated in cats under 12 months of age. Marbocyl is contraindicated in dogs and cats known to be hypersensitive to quinolones.

WARNING: 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.

PRECAUTIONS: 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 use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats. The safety of Marbocyl in animals used for breeding purposes, pregnant, or lactating has not been demonstrated.

ADVERSE REACTIONS: The following clinical signs were reported during the course of clinical field studies in dogs receiving Marbocyl 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 Marbocyl 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.

DOSAGE AND ADMINISTRATION: The recommended dosage for oral administration to dogs and cats is 1.25 mg Marbocyl 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, Marbocyl 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, Marbocyl 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.

Drug Interactions: Compounds (e.g., sucralfate, antacids, and mineral supplements) containing divalent and trivalent cations (e.g., iron, aluminum, calcium, magnesium, and zinc) can interfere with the absorption of quinolones which may result 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.

EFFECTIVENESS CONFIRMATION: Clinical effectiveness was confirmed in bacterial skin and soft tissue infections in dogs and cats and urinary tract infections (cystitis) in dogs associated with bacteria susceptible to Marbocyl. Bacterial pathogens isolated in clinical field studies are provided in the Microbiology section.

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TARGET ANIMAL SAFETY:

Dogs: The toxicity of Marbocyl was assessed in 12- to 14-month-old beagle dogs administered Marbocyl at 2.5, 7.5 and 12.5 mg/lb/day for 42 days. Vomiting, reddened skin (usually involving the ears) and reddened mucous membranes were occasionally observed in all groups, including controls, but were noted most frequently in the 12.5 mg/lb group. Decreased food consumption and weight loss were significant in the 7.5 mg/lb and 12.5 mg/lb groups. No clinical lameness was noted in any of the treated animals. Minimal to slight lesions in the articular cartilage were observed in 1/8 placebo-treated animals and in 3/8 animals given 12.5 mg marbofloxacin/lb. Macroscopically, these lesions were vesicles, raised areas, or depressed, light-colored areas. Microscopically, these lesions were characterized by the presence of one or more of the following: fissuring, erosion, chondrocyte proliferation, fibrillation, or vertical splitting of the articular cartilage. These cartilage lesions in treated dogs were similar to those in control dogs, and were not typical of those produced by fluoroquinolones. In addition to the above pathologic alterations, red areas of articular cartilage were noted macroscopically in 0/8 placebo-treated dogs and in 2/8 dogs from each of the three marbofloxacin-treated groups. These areas usually correlated microscopically with areas of vascularity of the articular surface, but could not be confirmed microscopically in all animals. They consisted of large blood vessels in mature fibrous connective tissue, with no indication of active vascularization due to drug-induced damage. They were considered most likely to be developmental anomalies or normal variations of the joint surface and were not considered to be related to drug treatment.

Marbocyl was administered to 12- to 14-month-old beagle dogs at a dosage of 25 mg/lb/day for 12 days. Decreased food consumption, vomiting, dehydration, excessive salivation, tremors, reddened skin, facial swelling, decreased activity and weight loss were seen in treated dogs. No clinical lameness was noted. As in the 42 day study, grossly visible, focal, red areas of articular cartilage were seen. These findings were noted in 2/6 placebo-treated dogs and in 4/6 marbofloxacintreated dogs. The foci were areas of fibrocartilage with prominent vascularization or increased vascularization of subchondral bone. Due to the appearance microscopically and macroscopically, these red foci were described as likely to be developmental anomalies or normal variations in articular cartilage.

Marbocyl administered to 3- to 4-month-old, large breed, purpose-bred mongrel dogs at a dosage of 5 mg/lb/day for 14 days resulted in marked lameness in all dogs due to articular cartilage lesions. Lameness was accompanied by decreased appetite and activity.

Cats: Marbocyl was administered for 42 consecutive days to 24 cats approximately 8 months old (8 cats per treatment group) at the dosages of 2.5, 7.5 and 12.5 mg/lb/day (5.5, 16.5 and 27.5 mg/kg/day). Treatment with Marbocyl did not produce adverse effects on body weights, food consumption, serum chemistry, urinalysis or organ weight parameters. Decreased segmented neutrophil counts were observed in some cats in all treatment groups, including the placebo group, but mean counts were significantly lower in the marbofloxacin-treated groups. In some cats, absolute neutrophil counts were below normal reference values (as low as 615 neutrophils/μL in a marbofloxacin-treated cat and as low as 882 neutrophils/μL in a placebo-treated cat). Other hematological observations were not adversely affected. Clinical signs were occasionally noted in cats in the highest dosage group: excessive salivation in 4/8 cats and redness of ear pinnae in 2/8 cats. Macroscopic changes in the articular cartilage of femurs were seen in one cat receiving 7.5 mg/lb and in 3 cats receiving 12.5 mg/lb. Microscopically, these gross lesions were related to a focal or multifocal chondropathy. Microscopic chondropathy not associated with macroscopic observations was also present in one cat treated with 2.5 mg/lb daily (1X the upper end of the dose range) and one additional cat treated with 7.5 mg/lb daily. There was no evidence of lameness during the course of the study. A perivascular to diffuse dermatitis was seen microscopically in one mid-dose cat and 4 high-dose cats. Funduscopic exam by a board-certified ophthalmologist and histologic examination of retina and optic nerve by ocular pathologists revealed no lesions in any of the treatment groups.

Marbocyl was also administered orally to 6 cats approximately 8 months of age for 14 consecutive days at a dosage of 25 mg/lb/day (55 mg/kg/day). Clinical signs associated with drug intolerance were excessive salivation in 5/6 cats and redness of ear pinnae in all cats after 8 days of treatment. Emesis was noted occasionally in several cats and diminished activity was noted in one cat. Decreased food intake was noted in some animals, primarily males, when compared to controls. Perivascular to diffuse dermatitis was seen microscopically in the pinnae of all treated animals and in the standard skin samples of several animals. There was focal or multifocal articular chondropathy in 2/6 treated animals. One treated cat had a duodenal mucosal erosion and one treated cat had a pyloric ulcer. There were no observations of lameness and no adverse effects on hematology, clinical chemistry, urinalysis, or organ weight parameters. Funduscopic examination by a board-certified ophthalmologist and histologic examination of retina and optic nerve by ocular pathologists revealed no lesions.

A study was conducted to investigate the effect of Marbocyl on articular cartilage of skeletally mature cats 12–14 months of age. Forty cats were randomly assigned to 4 groups of 10 cats each. Groups received placebo or Marbocyl at dosages of 1.25, 3.75 or 7.5 mg/lb/day (2.75, 8.25 or 16.5 mg/kg/day) for 42 consecutive days. There were no treatment-related pathological changes in the joints or other tissues. Emesis and soft stools was noted in all treatment groups, including placebo, and increased in frequency with increasing dose and duration of treatment. Emesis was more apparent in the high-dose males.

STORAGE CONDITIONS: Store below 30°C (86°F).

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HOW SUPPLIED:

Marbocyl tablets are available in the following strengths of Marbocyl and bottle sizes:

25 mg scored tablets supplied in bottles that contain 100 or 250 tablets

50 mg scored tablets supplied in bottles that contain 100 or 250 tablets

100 mg scored tablets supplied in a 50 tablet bottle

200 mg scored tablets supplied in a 50 tablet bottle

REFERENCES:

1. Schneider M, et al: Pharmacokinetics of Marbocyl in dogs after oral and parenteral administration. J Vet Pharmacol Therap 19:56–61, 1996.

To report suspected adverse effects, and/or obtain a copy of the MSDS, call 1-888-963-8471.

NADA #141-151, Approved by FDA

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

13910600

Revised: January 2013

Marbocyl®

(marbofloxacin)

Tablets

For oral use in dogs and cats only

Antibacterial

Caution: Federal law restricts

this drug to use by or on the

order of a licensed veterinarian.

Federal law prohibits the

extralabel use of this drug

in food-producing animals.

25 mg

100 Tablets

NADA #141-151, Approved by FDA

zoetis

Marbocyl®

(marbofloxacin)

Tablets

For oral use in dogs only

Antibacterial

Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Federal law prohibits the extralabel use

of this drug in food-producing animals.

50 mg

100 Tablets

NADA #141-151, Approved by FDA

zoetis

Marbocyl®

(marbofloxacin)

Tablets

For oral use in dogs only

Antibacterial

Caution: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Federal law prohibits the extralabel use

of this drug in food-producing animals.

100 mg

50 Tablets

NADA #141-151, Approved by FDA

zoetis

Marbocyl®

(marbofloxacin)

Tablets

For oral use in dogs only

Antibacterial

Caution: Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

Federal law prohibits the

extralabel use of this drug

in food-producing animals.

200 mg

50 Tablets

NADA #141-151, Approved by FDA

zoetis

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Marbocyl pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Marbocyl available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Marbocyl destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Marbocyl Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Marbocyl pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ZENIQUIN (MARBOFLOXACIN) TABLET [ZOETIS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Marbocyl?

Depending on the reaction of the Marbocyl after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Marbocyl not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Marbocyl addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Marbocyl, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Marbocyl consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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