Orbax® Suspension

ORBAX Oral Suspension is indicated for the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli and Enterococcus faecalis. ORBAX Oral Suspension is also indicated for skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, coagulase positive staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas spp., Klebsiella pneumoniae, Escherichia coli, Enterobacter spp., Citrobacter spp., Enterococcus faecalis, β-hemolytic streptococci (Group G) and Streptococcus equisimilis.

ORBAX Oral Suspension is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Pasteurella multocida.

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 dogs and cats known to be hypersensitive to quinolones. 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. The use of fluoroquinolones in cats has been reported to adversely affect the retina and should be used with caution in cats. Blindness has also been reported post-approval in cats. In some cases, blindness has been temporary.

See Package Insert for full information including side effects, precautions, warnings, and contraindications.

1. Data on file. Multi-clinic, randomized, controlled field trail evaluating the use of ORBAX^® (orbifloxacin) Oral Suspension and Synulox^® (amoxicillin/clavulanate) in the treatment of cats with skin and soft tissue infections (primarily post-traumatic wounds and absesses) in France, Belgium, and Germany in 2001. Madison, NJ: Intervet Inc.

2. Prescribing information for ORBAX^® Oral Suspension for Oral Use in Cats. Madison, NJ: Intervet Inc. 2011.

3. Prescribing information for ORBAX^® Oral Suspension for Oral Use in Dogs. Madison, NJ: Intervet Inc. 2011.

Dogs and Cats

Fluoroquinolone antibiotic

Active ingredient(s): Orbifloxacin

Orbax Oral Suspension is malt flavored.

Orbax Oral Suspension contains 30 mg of orbifloxacin per mL of oral suspension. Each 20 mL bottle includes a mess-free dispensing system with a calibrated, press-in oral dosing syringe for easy and accurate dosing (3 mL with 0.25 markings).

Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian. For current availability, please refer to the product selection above.

Orbax Oral Suspension should be administered as directed by your veterinarian. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule.

Complete the full course of treatment as prescribed, even if your pet's condition improves. Incomplete treatment may result in recurrence or worsening of the infection. Contact your veterinarian ahead of time if your pet needs a refill.

If a dose is missed, administer it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not give more medication than prescribed or two doses at once. If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), please contact your veterinarian.

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.

Dogs: 1.1 - 3.4 mg/lb (2.5 - 7.5 mg/kg) once daily.

Cats: 3.4 mg/lb (7.5 mg/kg) once daily. DO NOT EXCEED THIS DOSE IN CATS.

Store upright in a cool, dry place at a controlled temperature between 36°F and 77°F. ORBAX Oral Suspension does not require refrigeration. Use within 30 days of first use.

Keep this and all other medications in a secure location out of the reach of children and animals. Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly, as outlined on the product label.

Side effects appear to be uncommon when this medication is given at the labeled dosage(s). Reported side effects in dogs include vomiting, convulsions, depression/lethargy, and anorexia (decreased/lack of appetite). Reported side effects in cats include blindness, mydriasis (dilated pupils), anorexia, ataxia (decreased coordination), depression/lethargy, vomiting, convulsions, abnormal retina, and hypersalivation (excessive drooling). In some cases, blindness has been temporary.

This medication may increase sensitivity to sunlight, especially in animals with thin or light-colored hair coats. Monitor for sunburn (particularly in hairless areas) and ensure your pet avoids direct or prolonged sun exposure while taking this medication.

Contact your veterinarian immediately if your pet has a seizure or experiences joint pain, trouble walking, enlarged pupils, vision loss/blindness, complete loss of appetite, or if any signs of an allergic reaction (e.g., facial or throat swelling, rash, difficulty breathing) occur.

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

For oral use in dogs and cats only. Keep this and all other medications out of reach of children and animals.

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

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.

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.

Do NOT use orbifloxacin 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).

The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats. Blindness has also been reported post-approval in cats. In some cases, blindness has been temporary. DO NOT EXCEED 3.4 mg/lb (7.5 mg/kg) BODY WEIGHT PER DAY IN CATS.

Administer orbifloxacin with caution in the presence of hepatic insufficiency/impairment.

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.

Discuss the risks of using this medication with your veterinarian prior to use if your pet falls into any of the categories above.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to any fluoroquinolone antibiotic, including orbifloxacin, or to any other ingredient in the formulation. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

Compounds (e.g., sucralfate, antacids, and multivitamins) containing divalent and trivalent cations (e.g., 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.

The dosage of theophylline should be reduced when used concurrently with fluoroquinolones. Cimetidine has been shown to interfere with the metabolism of fluoroquinolones and should be used with care when used concurrently. Concurrent use of fluoroquinolones with oral cyclosporine is contraindicated. Concurrent administration of fluoroquinolones may increase the action of oral anticoagulants.

Additionally, the following drugs* may also have potential interactions with this medication: antidiabetic agents (including insulins), corticosteroids (e.g., dexamethasone, prednisone), methotrexate, nitrofurantoin, NSAIDs, and tramadol.

*NOTE: This may not be a comprehensive list. Please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Merck Animal Health at 1-800-224-5318 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental ingestion or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.