Indobiotic

Gentamicin Sulfate:

• Indobiotic (Gentamicin Sulfate) reviews

F-27078915

NADA #141-177, Approved by FDA.

PRODUCT

INFORMATION

VETERINARY

For Otic Use in Dogs Only

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

Keep this and all drugs out of the reach of children.

DESCRIPTION Each gram of Indobiotic (Gentamicin Sulfate) Otic Suspension contains Indobiotic (Gentamicin Sulfate) sulfate, USP equivalent to 3 mg Indobiotic (Gentamicin Sulfate) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.

PHARMACOLOGY

Indobiotic (Gentamicin Sulfate): Indobiotic (Gentamicin Sulfate) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Indobiotic (Gentamicin Sulfate) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Indobiotic (Gentamicin Sulfate) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:

Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.

Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.

Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Indobiotic (Gentamicin Sulfate) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Indobiotic (Gentamicin Sulfate) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Indobiotic (Gentamicin Sulfate) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS Indobiotic (Gentamicin Sulfate) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Indobiotic (Gentamicin Sulfate) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

Administration of recommended doses of Indobiotic (Gentamicin Sulfate) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

TOXICOLOGY Field and safety studies with Indobiotic (Gentamicin Sulfate) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).

ADVERSE REACTIONS

Indobiotic (Gentamicin Sulfate): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Indobiotic (Gentamicin Sulfate) Otic Suspension: In field studies following once daily teatment with Indobiotic (Gentamicin Sulfate) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Indobiotic (Gentamicin Sulfate) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE AND ADMINISTRATION

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Indobiotic (Gentamicin Sulfate) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

HOW SUPPLIED Indobiotic (Gentamicin Sulfate) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.

Store between 2° and 25°C (36° and 77°F). Shake well before use.

U.S. Patent No. 6,127,353.

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Indometacin:

• Indobiotic information
• Indobiotic indications
• Indobiotic warnings
• Indobiotic intake guidelines
• Indobiotic dosage
• Indobiotic overdose
• Indobiotic missed dose
• Indobiotic side effects
• Indobiotic drug reactions
• Indobiotic (Indometacin) reviews

Indobiotic information

Indobiotic (Indometacin) is a non-steroidal anti-inflammatory drug, typically prescribed in order to manage symptoms such as pain, fever, swelling and stiffness. This medication acts as an inhibitor of prostaglandin production - prostaglandins are the agents that are known to induce these symptoms.

Indobiotic indications

There are several medical conditions for which Indobiotic (Indometacin) may be prescribed, including rheumatoid arthritis, ankylosing spondylitis, arthritic gout, juvenile arthritis, osteoarthritis and psoriatic arthritis. Apart from these, this drug has shown positive results when prescribed for the treatment of Reiter's syndrome, Bartter syndrome and Paget's disease. Indobiotic (Indometacin) may also be prescribed for patients that are suffering from pseudogout, pericarditis, dysmenorrheal, bursitis or tendonitis. This drug is also effective for the management of such affections as nephrogenic diabetes insipidus, hemicrania continua, paroxysmal hemicrania and migraine, but it may also be used in the management of symptoms such as pain and fever associated with malignancies (bony metastases, tumors or lymphogranulomatosis). There may be other uses for this medication as well.

Indobiotic warnings

The intake of Indobiotic (Indometacin) is not suitable in the case of patients that are suffering from an allergy to this drug, to any of its components, to Aspirin or to other non-steroidal anti-inflammatory medications. Also, this drug should not be employed in the treatment of patients with concurrent peptic ulcers or with severe preexisting liver or kidney damage. In the case of neonates with patent ductus arteriosus, Indobiotic (Indometacin) should not be employed in the treatment of children of less than 2 years of age.

Caution should be employed in the treatment of patients suffering from Parkinson's disease, psychotic disorders or epilepsy as Indobiotic (Indometacin) may worsen the symptoms of these conditions. Therapy with this medication may require special consideration when employed in the treatment of patients suffering from bleeding tendencies as Indobiotic (Indometacin) may inhibit the aggregation of platelets. Frequent blood cell counts clinical evaluations are recommended in the case of patients with preexisting bone marrow damage.

Indobiotic intake guidelines

It is highly recommended that the patient closely follows the Indobiotic (Indometacin) intake guidelines that he or she has been given by the prescribing doctor. In many cases, regular physical examination of the patient may be required, in order to detect early signs of oedema or any possible side effects affecting the central nervous system. Blood pressure should be measured in order to check for hypertension. As part of the regular testing, blood cell counts, serum electrolyte measurements of the sodium, chloride and potassium and assessment of renal and liver functions should be performed, especially in the case of patients that are being administered Indobiotic (Indometacin) in combination with a potassium-sparing diuretic or an ACE inhibitor; this is useful in order to detect or prevent development of kidney failure or hyperkalemia.

Indobiotic dosage

The exact Indobiotic (Indometacin) dosage depends on the medical condition that the individual is being treated for. Apart from that, the examining health care professional will decide the appropriate dosage based on several factors such as the patient's medical history, his or her age as well as general health condition. The Indobiotic (Indometacin) dosage may vary greatly from one patient to another, so it is highly recommended that you use the exact dosage that has been prescribed in your case.

Indobiotic overdose

Indobiotic (Indometacin) has a high factor of acute toxicity in humans, and in some cases an overdose with this drug resulted in the death of the patient. As such, it is highly advised to take the medication dosage that has been prescribed for your case, and never take a higher dose.

Typical symptoms of a Indobiotic (Indometacin) overdose include dizziness, drowsiness, mental confusion, severe headache, paraesthesia, nausea, vomiting and numbness of limbs. In some cases, severe gastrointestinal bleeding as well as cardiac arrest or cerebral oedema are possible.

Indobiotic missed dose

It is highly advised that you set up a regular intake schedule in order to lower the risks of missing a dose of your medication. In the case of Indobiotic (Indometacin), if you happen to miss a dose it is advised to take it as soon as you remember, unless it is almost time for another dose of the medication. If this is the case, you should completely skip the missed dose and continue with your regular intake schedule; you should bring the matter to the attention of your personal health care provider as soon as possible. He or she will assess the situation and decide on the appropriate course of action to take, if needed.

Indobiotic side effects

There are several side effects associated with a Indobiotic (Indometacin) treatment. Treatment with this drug may lead to the appearance of peptic ulcers or other less severe gastrointestinal disturbances such as mild diarrhea, dyspepsia or heartburn. Due to the retention of lithium, patients following a treatment with Indobiotic (Indometacin) have a higher risk of lithium toxicity. Hypertension, hyperkalemia and hypernatremia as well as oedema are also possible side effects of a therapy with this drug. In up to 20% of the cases, the patients may experience headaches, sometimes together with tinnitus, vertigo, dizziness, hearing loss or blurred vision. Photosensitivity and skin reactions have been reported. In rare cases, Indobiotic (Indometacin) may cause severe damage to the bone marrow, severe or even lethal hepatitis or potentially fatal shock.

Indobiotic drug reactions

At this time, there is no exact information regarding the possible interactions between Indobiotic (Indometacin) and other medications. It is advised that you consult with your personal health care professional and inform him or her about any other medication you are currently taking before starting a treatment with this drug.