Indobiotic Unidose

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Indobiotic Unidose uses

Indobiotic Unidose consists of Gentamicin Sulfate, Indometacin.

Gentamicin Sulfate:



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 Unidose (Gentamicin Sulfate) Otic Suspension contains Indobiotic Unidose (Gentamicin Sulfate) sulfate, USP equivalent to 3 mg Indobiotic Unidose (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 Unidose (Gentamicin Sulfate): Indobiotic Unidose (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 Unidose (Gentamicin Sulfate) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Indobiotic Unidose (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 Unidose (Gentamicin Sulfate) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Indobiotic Unidose (Gentamicin Sulfate) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Indobiotic Unidose (Gentamicin Sulfate) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS Indobiotic Unidose (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 Unidose (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 Unidose (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 Unidose (Gentamicin Sulfate) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).

ADVERSE REACTIONS

Indobiotic Unidose (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 Unidose (Gentamicin Sulfate) Otic Suspension: In field studies following once daily teatment with Indobiotic Unidose (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 Unidose (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 Unidose (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 Unidose (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.

Distributed by

PATTERSON VETERINARY

137 Barnum Road, Devens, MA 01434

www.pattersonvet.com

Made in Canada.

9/15

85239791

Indometacin:


Indobiotic Unidose information

Indobiotic Unidose (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 Unidose indications

There are several medical conditions for which Indobiotic Unidose (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 Unidose (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 Unidose warnings

The intake of Indobiotic Unidose (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 Unidose (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 Unidose (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 Unidose (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.

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Indobiotic Unidose intake guidelines

It is highly recommended that the patient closely follows the Indobiotic Unidose (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 Unidose (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 Unidose dosage

The exact Indobiotic Unidose (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 Unidose (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 Unidose overdose

Indobiotic Unidose (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 Unidose (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.

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Indobiotic Unidose 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 Unidose (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 Unidose side effects

There are several side effects associated with a Indobiotic Unidose (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 Unidose (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 Unidose (Indometacin) may cause severe damage to the bone marrow, severe or even lethal hepatitis or potentially fatal shock.

Indobiotic Unidose drug reactions

At this time, there is no exact information regarding the possible interactions between Indobiotic Unidose (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.

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Indobiotic Unidose 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.


Indobiotic Unidose 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.


Indobiotic Unidose 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.


Indobiotic Unidose 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.


Indobiotic Unidose 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."GENTAMICIN PIGLET (GENTAMICIN SULFATE) INJECTION [SPARHAWK LABORATORIES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."GENTAMICIN SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "gentamicin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Indobiotic Unidose?

Depending on the reaction of the Indobiotic Unidose after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Indobiotic Unidose 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 Indobiotic Unidose 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 Indobiotic Unidose, 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 Indobiotic Unidose 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. Arunabha Ray, MD Pharmacology

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