Vetoryl

Written by Curtis Plowgian on 3 August 2022. Posted in Uncategorized

Adrenocortical suppressant for oral use in dogs only.

CAUTION:

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

DESCRIPTION:

VETORYL Capsules are available in 5 sizes (5, 10, 30, 60 and 120 mg) for oral administration based on body weight. Trilostane (4α,5α-epoxy- 17β-hydroxy-3-oxoandrostane-2α-carbonitrile) is an orally active synthetic steroid analogue that selectively inhibits 3 β-hydroxysteroid dehydrogenase in the adrenal cortex, thereby inhibiting the conversion of pregnenolone to progesterone. This inhibition blocks production of glucocorticoids and to a lesser extent, mineralocorticoids and sex hormones while steroid precursor levels increase. The structural formula is:

INDICATIONS:

VETORYL Capsules are indicated for the treatment of pituitary-dependent hyperadrenocorticism and adrenal-dependent hyperadrenocorticism in dogs.

DOSAGE AND ADMINISTRATION:

Always provide the Client Information Sheet with prescription (see INFORMATION FOR DOG OWNERS).
1. Starting dose. The starting dose for the treatment of hyperadrenocorticism in dogs is 1-3 mg/lb (2.2-6.7 mg/kg) once a day. Start with the lowest possible dose based on body weight and available combinations of capsule sizes. VETORYL Capsules should be administered with food.
2. Action at 10-14 day evaluation (Table 1). After approximately 10-14 days at this dose, re-examine the dog and conduct a 4-6 hour post-dosing ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). If physical examination is acceptable, take action according to Table 1. Owners should be instructed to stop therapy and contact their veterinarian immediately in the event of adverse reactions such as vomiting, diarrhea, lethargy, poor/reduced appetite, weakness, collapse or any other unusual developments. If these clinical signs are observed, conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function).

Table 1:

3. Individual dose adjustments and close monitoring are essential. Re-examine and conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function) 10-14 days after every dose alteration. Care must be taken during dose increases to monitor the dog’s clinical signs. Once daily administration is recommended. However, if clinical signs are not controlled for the full day, twice daily dosing may be needed. To switch from a once daily dose to a twice daily dose, the total daily dose should be divided into 2 portions given 12 hours apart. It is not necessary for the portions to be equal. If applicable, the larger dose should be administered in the morning and the smaller dose in the evening. For example, a dog receiving 90 mg would receive 60 mg in the morning, and 30 mg in evening.
4. Long term monitoring. Once an optimum dose of VETORYL Capsules has been reached, re-examine the dog at 30 days, 90 days and every 3 months thereafter. At a minimum, this monitoring should include:

• A thorough history and physical examination.
• An ACTH stimulation test (conducted 4-6 hours after VETORYL Capsule administration) – a post-ACTH stimulation test resulting in a cortisol of < 1.45 μg/dL (< 40 nmol/L), with or without electrolyte abnormalities, may precede the development of clinical signs of hypoadrenocorticism.
• Serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function).
Good control is indicated by favorable clinical signs as well as post-ACTH serum cortisol of 1.45-9.1 μg/dL (40-250 nmol/L).
If the ACTH stimulation test is < 1.45 μg/dL (< 40 nmol/L) and/or if electrolyte imbalances characteristic of hypoadrenocorticism (hyperkalemia and hyponatremia) are found, VETORYL Capsules should be temporarily discontinued until recurrence of clinical signs consistent with hyperadrenocorticism and ACTH stimulation test results return to normal (1.45-9.1 μg/dL or 40-250 nmol/L). VETORYL Capsules may then be re-introduced at a lower dose.

CONTRAINDICATIONS:

The use of VETORYL Capsules is contraindicated in dogs that have demonstrated hypersensitivity to trilostane. Do not use VETORYL Capsules in animals with primary hepatic disease or renal insufficiency (See WARNINGS and PRECAUTIONS). Do not use in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss.

WARNINGS:

Hypoadrenocorticism can develop at any dose of VETORYL Capsules. In some cases, it may take months for adrenal function to return and some dogs never regain adequate adrenal function. All dogs should undergo a thorough history and physical examination before initiation of therapy with VETORYL Capsules. Other conditions, such as primary hepatic and/or renal disease should be considered when the patient is exhibiting signs of illness in addition to signs of hyperadrenocorticism (e.g. vomiting, diarrhea, poor/reduced appetite, weight loss, and lethargy). Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of VETORYL Capsules should be considered. Owners should be advised to discontinue therapy immediately and contact their veterinarian if signs of potential drug toxicity are observed (see INFORMATION FOR DOG OWNERS, DOSAGE AND ADMINISTRATION, PRECAUTIONS, ADVERSE REACTIONS, ANIMAL SAFETY and POST-APPROVAL EXPERIENCE). In case of overdosage, symptomatic treatment of hypoadrenocorticism with corticosteroids, mineralocorticoids and intravenous fluids may be required.
Angiotensin converting enzyme (ACE) inhibitors should be used with caution with VETORYL Capsules, as both drugs have aldosterone-lowering effects which may be additive, impairing the patient’s ability to maintain normal electrolytes, blood volume and renal perfusion. Potassium sparing diuretics (e.g. spironolactone) should not be used with VETORYL Capsules as both drugs have the potential to inhibit aldosterone, increasing the likelihood of hyperkalemia.

HUMAN WARNINGS:

Keep out of reach of children. Not for human use. Wash hands after use. Do not empty capsule contents and do not attempt to divide the capsules. Do not handle the capsules if pregnant
or if trying to conceive. Trilostane is associated with teratogenic effects and early pregnancy loss in laboratory animals. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you.

PRECAUTIONS:

Mitotane (o,p’-DDD) treatment will reduce adrenal function. Experience in foreign markets suggests that when mitotane therapy is stopped, an interval of at least one month should elapse before the introduction of VETORYL Capsules. It is important to wait for both the recurrence of clinical signs consistent with hyperadrenocorticism, and a post-ACTH cortisol level of > 9.1 μg/dL (> 250 nmol/L) before treatment with VETORYL Capsules is initiated. Close monitoring of adrenal function is advised, as dogs previously treated with mitotane may be more responsive to the effects of VETORYL Capsules. The use of VETORYL Capsules will not affect the adrenal tumor itself. Adrenalectomy should be considered as an option for cases that are good surgical candidates. The safe use of this drug has not been evaluated in lactating dogs and males intended for breeding.

ADVERSE REACTIONS:

The most common adverse reactions reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea, and weakness. Occasionally, more serious reactions, including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis or adrenal necrosis/rupture may occur, and may result in death. In a US field study with 107 dogs, adrenal necrosis/rupture (two dogs) and hypoadrenocorticism (two dogs) were the most severe adverse reactions in the study. One dog died suddenly of adrenal necrosis, approximately one week after starting trilostane therapy. One dog
developed an adrenal rupture, believed to be secondary to adrenal necrosis, approximately six weeks after starting trilostane therapy. This dog responded to trilostane discontinuation and supportive care. Two dogs developed hypoadrenocorticism during the study. These two dogs had clinical signs consistent with hypoadrenocorticism (lethargy, anorexia, collapse) and post-ACTH cortisol levels ≤ 0.3 μg/dL. Both dogs responded to trilostane discontinuation and supportive care, and one dog required continued treatment for hypoadrenocorticism (glucocorticoids and mineralocorticoids) after the acute presentation.
Additional adverse reactions were observed in 93 dogs. The most common of these included diarrhea (31 dogs), lethargy (30 dogs), inappetence/anorexia (27 dogs), vomiting (28 dogs), musculoskeletal signs (lameness, worsening of degenerative joint disease) (25 dogs), urinary tract infection (UTI)/hematuria (17 dogs), shaking/shivering (10 dogs), otitis externa (8 dogs), respiratory signs (coughing, congestion) (7 dogs), and skin/coat abnormality (seborrhea, pruritus) (8 dogs). Five dogs died or were euthanized during the study (one dog secondary to adrenal necrosis, discussed above, two dogs due to progression of pre-existing congestive heart failure, one dog due to progressive central nervous system signs, and one dog due to cognitive decline leading to inappropriate elimination). In addition to the two dogs with adrenal necrosis/rupture and the two dogs with hypoadrenocorticism, an additional four dogs were removed from the study as a result of possible trilostane-related adverse reactions, including collapse, lethargy, inappetence, and trembling.
Complete blood counts conducted pre- and post-treatment revealed a statistically significant (p <0.005) reduction in red cell variables (HCT, HGB, and RBC), but the mean values remained within the normal range. Additionally, approximately 10% of the dogs had elevated BUN values (≥ 40 mg/dL) in the absence of concurrent creatinine elevations. In general, these dogs were clinically
normal at the time of the elevated BUN.
In a long term follow-up study of dogs in the US effectiveness study, the adverse reactions were similar to the short term study. Vomiting, diarrhea and general gastrointestinal signs were most commonly observed. Lethargy, inappetence/anorexia, heart murmur or cardiopulmonary signs, inappropriate urination/incontinence, urinary tract infections or genitourinary disease, and neurological signs were reported. Included in the US follow-up study were 14 deaths, three of which were possibly related to trilostane. Eleven dogs died or were euthanized during the study for a variety of conditions considered to be unrelated to or to have an unknown relationship with administration of trilostane.
In two UK field studies with 75 dogs, the most common adverse reactions seen were vomiting, lethargy, diarrhea/loose stools, and anorexia. Other adverse reactions included: nocturia, corneal ulcer, cough, persistent estrus, vaginal discharge and vulvar swelling in a spayed female, hypoadrenocorticism, electrolyte imbalance (elevated potassium with or without decreased sodium), collapse and
seizure, shaking, muscle tremors, constipation, scratching, weight gain, and weight loss. One dog died of congestive heart failure and another died of pulmonary thromboembolism. Three dogs were euthanized during the study. Two dogs had renal failure and another had worsening arthritis and deterioration of appetite.
In a long term follow-up of dogs included in the UK field studies, the following adverse reactions were seen: hypoadrenocortical episode (including syncope, tremor, weakness, and vomiting), hypoadrenocortical crisis or renal failure (including azotemia, vomiting, dehydration, and collapse), chronic intermittent vaginal discharge, hemorrhagic diarrhea, occasional vomiting, and distal limb edema. Signs of hypoadrenocorticism were usually reversible after withdrawal of the drug, but may be permanent. One dog discontinued VETORYL Capsules and continued to have hypoadrenocorticism when evaluated a year later. Included in the follow-up were reports of deaths, at least 5 of which were possibly related to use of VETORYL Capsules. These included dogs that died or were euthanized because of renal failure, hypoadrenocortical crisis, hemorrhagic diarrhea, and hemorrhagic gastroenteritis. Foreign Market Experience: The following events were reported voluntarily during post-approval use of VETORYL Capsules in foreign markets. The most serious adverse events were death, adrenal necrosis, hypoadrenocorticism (electrolyte alterations, weakness, collapse, anorexia, lethargy, vomiting, diarrhea, and azotemia), and corticosteroid withdrawal syndrome (weakness, lethargy, anorexia, and weight loss). Additional adverse events included: renal failure, diabetes mellitus, pancreatitis, autoimmune hemolytic anemia, vomiting, diarrhea, anorexia, skin reactions (rash, erythematous skin eruptions), hind limb paresis, seizures, neurological signs from growth of macroadenomas, oral ulceration, and muscle tremors.

POST-APPROVAL EXPERIENCE:

As of June 2013, the following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency: anorexia, lethargy/depression, vomiting, diarrhea, elevated liver enzymes, elevated potassium with or without decreased sodium, elevated BUN, decreased Na/K ratio, hypoadrenocorticism, weakness, elevated creatinine, shaking, renal insufficiency. In some cases, death has been reported as an outcome of the adverse events listed above.
For a cumulative listing of adverse reactions for trilostane reported to the CVM see: http://www.fda.gov/ADEreports
This listing includes Adverse Events reported to CVM for products, such as VETORYL Capsules, that contain the active ingredient trilostane. Listings by active ingredient may represent more than one brand name.
To report suspected adverse events and/or obtain a copy of the SDS or for technical assistance, call Dechra Veterinary Products at
(866) 933-2472.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at:
http://www.fda.gov/reportanimalae

INFORMATION FOR DOG OWNERS:

Owners should be aware that the most common adverse reactions may include: an unexpected decrease in appetite, vomiting, diarrhea, or lethargy and should receive the Client Information Sheet with the prescription. Owners should be informed that control of hyperadrenocorticism should result in resolution of polyphagia, polyuria and polydipsia. Serious adverse reactions associated with this drug can occur without warning and in some cases result in death (see ADVERSE REACTIONS and POST-APPROVAL EXPERIENCE). Owners should be advised to discontinue VETORYL Capsules and contact their veterinarian immediately if signs of intolerance such as vomiting, diarrhea, lethargy, poor/reduced appetite, weakness, or collapse are observed. Owners should be advised of the importance of periodic follow-up for all dogs during administration of VETORYL Capsules.

CLINICAL PHARMACOLOGY:

Trilostane absorption is enhanced by administration with food. In healthy dogs, maximal plasma levels of trilostane occur within 1.5 hours, returning to baseline levels within twelve hours, although large inter-dog variation occurs. There is no accumulation of trilostane or its metabolites over time.

EFFECTIVENESS:

Eighty-three dogs with hyperadrenocorticism were enrolled in a multi-center US field study. Additionally, 30 dogs with hyperadrenocorticism were enrolled in two UK field studies. Results from these studies demonstrated that treatment with VETORYL Capsules resulted in an improvement in clinical signs (decreased thirst, decreased frequency of urination, decreased panting, and improvement of appetite and activity). Improvement in post-ACTH cortisol levels occurred in most cases within 14 days of starting VETORYL Capsules therapy. In these three studies, there were a total of 10 dogs diagnosed with hyperadrenocorticism due to an adrenal tumor or due to concurrent pituitary and adrenal tumors. Evaluation of these cases failed to demonstrate a difference in clinical, endocrine, or biochemical response when compared to cases of pituitary-dependent hyperadrenocorticism.

ANIMAL SAFETY:

In a laboratory study, VETORYL Capsules were administered to 8 healthy 6 month old Beagles per group at 0X (empty capsules), 1X, 3X, and 5X the maximum starting dose of 6.7 mg/kg twice daily for 90 days. Three animals in the 3X group (receiving 20.1 mg/kg twice daily) and five animals in the 5X group (receiving 33.5 mg/kg twice daily) died between Days 23 and 46. They showed one or more of the following clinical signs: decreased appetite, decreased activity, weight loss, dehydration, soft stool, slight muscle tremors, diarrhea, lateral recumbency, and staggering gait. Bloodwork showed hyponatremia, hyperkalemia, and azotemia, consistent with hypoadrenocortical crisis. Post-mortem findings included epithelial necrosis or cystic dilation of duodenal mucosal crypts, gastric mucosal or thymic hemorrhage, atrial thrombosis, pyelitis and cystitis, and inflammation of the lungs. ACTH stimulated cortisol release was reduced in all dogs treated with VETORYL Capsules. The dogs in the 3X and 5X groups had decreased activity. The 5X dogs had less weight gain than the other groups. The 3X and 5X dogs had lower sodium, albumin, total protein, and cholesterol compared to the control dogs. The 5X dogs had lower mean corpuscular volume than the controls. There was a dose dependent increase in amylase. Post-mortem findings included dose dependent adrenal cortical hypertrophy.

STORAGE INFORMATION:

Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F)permitted.

HOW SUPPLIED:

VETORYL Capsules are available in 5, 10, 30, 60 and 120 mg strengths, packaged in aluminum foil blister cards of 10 capsules, with 3 cards per carton.
VETORYL Capsules 5 mg NDC 17033-105-30
VETORYL Capsules 10 mg NDC 17033-110-30
VETORYL Capsules 30 mg NDC 17033-130-30
VETORYL Capsules 60 mg NDC 17033-160-30
VETORYL Capsules 120 mg NDC 17033-112-30
Approved by FDA under NADA # 141-291

Manufactured for:

Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA
Method of use covered by US patent No. 9,283,235.
VETORYL is a trademark of Dechra Ltd
© 2019, Dechra Ltd

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Osurnia

Written by Curtis Plowgian on 1 August 2022. Posted in Uncategorized

Osurnia®
(florfenicol, terbinafine, betamethasone acetate)
Otic Gel

Antibacterial, antifungal, anti-inflammatory
For Otic Use in Dogs Only
Do not use in cats

CAUTION:

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

DESCRIPTION:

OSURNIA contains 10 mg florfenicol, 10 mg terbinafine and 1 mg betamethasone acetate per mL and the inactive ingredients propylene carbonate, glycerol formal, hypromellose, phospholipid, oleic acid and BHT in an off-white to slightly yellow translucent gel.

INDICATION:

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

DOSAGE AND ADMINISTRATION:

OSURNIA should be administered by a veterinary professional. Wear eye protection when administering Osurnia (see Human Safety Warnings, Precautions, Post-Approval Experience and Animal Safety). Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.
1. Clean and dry the external ear canal before administering the initial dose of the product.
2. Verify the tympanic membrane is intact prior to each administration (see Precautions, Contraindications, Animal Safety and Post-Approval Experience).
3. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
4. Open tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal(s) and squeeze entire tube contents into the external ear canal(s). After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal.
5. Restrain dog to minimize post-application head shaking to reduce potential for splatter of product, and accidental eye exposure in people and dogs (see Post-Approval Experience and Animal Safety).
6. Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness). If alternative otic therapies are required, it is recommended to clean the ear(s) before application.

CONTRAINDICATIONS:

Do not use in dogs with known tympanic perforation (see Precautions).
Do not use in dogs with a hypersensitivity to florfenicol, terbinafine or corticosteroids.

WARNINGS:

Human Safety Warnings:
OSURNIA may cause eye injury and irritation (see Precautions, Post-Approval Experience and Animal Safety). In case of accidental eye contact, flush thoroughly with water for at least 15 minutes. If symptoms develop, seek medical advice.

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. In case of accidental skin contact, wash area thoroughly with water.

PRECAUTIONS:

Wear eye protection when administering OSURNIA and restrain the dog to minimize post-application head shaking. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent ocular injury (see Human Safety Warnings, Post-Approval Experience and Animal Safety). The use of OSURNIA in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering this product. Reevaluate the dog if hearing loss or
signs of vestibular dysfunction are observed during treatment. Proper patient selection is important when considering the benefits and risks of using OSURNIA. The integrity of the
tympanic membrane should be confirmed before administering each dose of product. Changes to the middle ear, such as ulceration of the mucosal lining, have been associated with OSURNIA administration. (see Animal Safety). Signs of tympanic membrane rupture, internal ear disease such as head tilt, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have also been reported (see Post-Approval Experience). Do not administer orally. Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see Animal Safety). Use with caution in dogs with impaired hepatic function (see Animal Safety and Adverse Reactions). The safe use of OSURNIA in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

ADVERSE REACTIONS:

The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with OSURNIA with 1 tube per affected ear(s) and repeated after 7 days:

Post-Approval Experience (2020)
The following adverse events are based on post-approval adverse drug experience reporting for OSURNIA. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. In humans, accidental exposure leading to corneal ulcers and other ocular injuries such as eye irritation, burning, stinging, and itchiness have been reported to occur when the dog shook its head after application of OSURNIA. In dogs, the adverse events reported for OSURNIA are presented below in decreasing order of reporting frequency: Deafness, ear discharge, pinnal irritation and ear pain, emesis, head shaking, internal ear disorder (head tilt and vestibular), ataxia, vocalization, corneal ulcer, keratoconjunctivitis sicca, nystagmus, tympanic rupture, and cranial nerve disorder (facial paralysis).

OSURNIA is not approved for use in cats. The adverse events reported following extra-label use in cats are presented below in decreasing order of reporting frequency: Ataxia, anorexia, Horner’s syndrome (third eyelid prolapse and miosis), internal ear disorder (head tilt and vestibular), anisocoria, lethargy, head shake, emesis, nystagmus, deafness, and tympanic rupture.

CONTACT INFORMATION:

To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Dechra at 1-866-933-2472. For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

INFORMATION FOR DOG OWNERS:

Owners should be aware that adverse reactions may occur following administration of OSURNIA and should observe dog for signs such as deafness, ear pain and irritation, vomiting, head shaking, head tilt, incoordination, eye pain and ocular discharge (see Animal Safety and Post-Approval Experience). Owners should be advised to contact their veterinarian if any of the above signs are observed. Owners should also be informed that splatter may occur if the dog shakes its head following administration of OSURNIA which may lead to ocular exposure. As a result, eye injuries in humans and dogs have been reported including corneal ulcers. Owners should be careful to avoid ocular exposure (see Precautions and Post-Approval Experience).

CLINICAL PHARMACOLOGY:

OSURNIA is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. OSURNIA dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in OSURNIA. In a laboratory study conducted in healthy dogs (see Animal Safety), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1X dose, and during the first 2-7 days after administration of 5X dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1X to 5X.

MICROBIOLOGY:

The compatibility and additive effect of each of the components in OSURNIA was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa in dogs determined that florfenicol and terbinafine inhibit the growth of bacteria and yeast commonly associated with otitis externa in dogs. No consistent synergistic or antagonistic effect of the two antimicrobials was demonstrated. The addition of betamethasone acetate to the combination did not impair antimicrobial activity to any clinically
significant extent.

In a field study (see Effectiveness), the minimum of 10 isolates from successfully treated cases with OSURNIA was met for Staphylococcus pseudintermedius, Malassezia pachydermatis, and Pseudomonas aeruginosa. However, there were only three dogs where P. aeruginosa was the only pathogen cultured and they were all treatment failures. Therefore, OSURNIA may not be effective in treating otitis externa in which P. aeruginosa is the only pathogen present.

EFFECTIVENESS:

Effectiveness was evaluated in 235 dogs with otitis externa. The study was a double-masked field study with a placebo control (vehicle without the active ingredients). One hundred and fifty-nine dogs were treated with OSURNIA and seventy-six dogs were treated with the placebo control. All dogs were evaluated for safety. Treatment (1 mL) was administered to the affected ear(s) and repeated 7 days later. Prior to the first administration, the ear(s) were cleaned with saline but not prior to the Day 7 administration. Six clinical signs associated with otitis externa were evaluated:
pain, erythema, exudate, swelling, odor and ulceration. Total clinical scores were assigned for a dog based on the severity of each clinical sign on Days 0, 7, 14, 30 and 45. Success was determined by clinical improvement at Day 45. The success rates of the two groups were significantly different (p=0.0094); 64.78% of dogs administered OSURNIA were successfully treated, compared to 43.42% of the dogs in the placebo control group.

ANIMAL SAFETY:

In a target animal safety study, 24 mixed breed dogs (4 dogs/sex/group) were aurally administered 0X, 1X (1 mL/ear or 2 mL/dog with repeated administration in 7 days) or 5X (5 mL/ear or 10 mL/dog with repeated administration in 7 days) doses of OSURNIA for a total of 6 administrations in 5 weeks. All dogs remained in good health with normal hearing throughout the study. Decreased weight gain was noted in the 1X and 5X groups compared to the control group. Clinical findings included post-administration ear wetness in 1X and 5X groups and unilateral, transient
brown/red discharge from one ear each in two 5X dogs, with erythema in one dog after the 4th application. Local microscopic changes in ears (without clinical effects) included: slight or moderate unilateral vesicle formation within the epithelium of the tympanic membrane in two 1X and four 5X dogs, and unilateral mucosal ulceration in the lining of the middle ear cavity in three 5X dogs. Three 5X dogs had slightly elevated ALT activity, accompanied by minimal or mild microscopic hepatocellular vacuolation (in two dogs). Cortisol response to ACTH stimulation was decreased, but
within the normal reference range, in 1X dogs. The 5X dogs had a decrease in serum cortisol levels after ACTH stimulation (below normal reference range) accompanied by decreased adrenal gland and thymic weights with minimal adrenal cortical atrophy and slight (in three dogs) or moderate (in one dog also noted with slightly lower lymphocyte counts) lymphoid depletion of the thymus. The ACTH stimulation test results are consistent with systemic absorption of betamethasone resulting in a likely reversible suppression of the hypothalamic-pituitary-adrenal axis as seen with administration of exogenous corticosteroids.

STORAGE CONDITIONS:

OSURNIA should be stored under refrigerated conditions between 36° – 46° F (2° – 8° C). To facilitate comfort during administration, OSURNIA may be brought to room temperature and stored for up to three months.

HOW SUPPLIED:

OSURNIA is a gel in a single-use tube with a flexible soft tip, supplied in cartons containing 2 or 20 tubes.
Osurnia 2 tube carton NDC 17033-283-02
Osurnia 20 tube carton NDC 17033-283-20
Approved by FDA under NADA # 141-437

MANUFACTURED FOR:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA
Product of Great Britain

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Biomox

Written by Curtis Plowgian on 1 August 2022. Posted in Uncategorized

BIOMOX®
(amoxicillin)
Veterinary For Oral Suspension
For use in DOGS only.

Approved by FDA under NADA # 065-495

DESCRIPTION:

BIOMOX

® (amoxicillin) is a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.
Inactive Ingredients: Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benozate, Sodium Citrate, Sodium Saccharin, and Sucrose.

ACTION:

Amoxicillin has bactericidal activity against susceptible organisms

similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial wall mucopeptides. Most strains of the following gram-positive and gram- negative bacteria have demonstrated susceptibility to: amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta-hemolytic streptococci, Streptococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant
staphylococci. Most strains of Enterobacter and klebsiella and all strains of Pseudomonas are resistant. Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.

INDICATIONS:

BIOMOX

® (amoxicillin) for oral suspension is indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:
BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp.; Staphylococcus spp.; and E. coli.
SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp.; E. coli, Proteus mirabilis and Staphylococcus spp. As is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities
should be conducted prior to treatment.

CONTRAINDICATIONS:

Use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.

ADVERSE REACTIONS:

Amoxicillin is a semisynthetic penicillin and, therefore,has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.

WARNINGS:

 For use in dogs only.

PRECAUTIONS:

Until adequate reproductive studies are accomplished, Biomox (amoxicillin) for oral suspension should not be used in pregnant or breeding animals.

CAUTION:

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

DOSAGE AND ADMINISTRATION:

The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvment is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

DIRECTIONS FOR MIXING ORAL SUSPENSION:

Add sufficient water to the bottle as indicated in the table below and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.
Note: When stored at room temperature or in refrigerator, discard unused portion of reconstituted suspension after 14 days.

SUPPLY:

Bimox® (amoxicillin) for oral suspension is supplied in bottles containing 0.75 g of amoxicillin activity in bottles of 15 mL or 1.5 g of amoxicillin activity in bottles of 30 mL. After reconstitution with the required amount of water, each mL will contain 50 mg of amoxicillin as the trihydrate.

Manufactured for:

Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1 – 800 – 338 – 3659

BIOMOX®
(amoxicillin tablets)
For use in DOGS only.

Approved by FDA under NADA # 065-492

DESCRIPTION:

BIOMOX® (amoxicillin tablets) are a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.
Inactive Ingredients: Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

ACTION:

Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial cell wall mucopeptides. Most strains of the following gram- positive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta- hemolytic streptococci, Enterococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Enterobacter and Klebsiella and all strains of Pseudomonas are resistant. Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.

INDICATIONS:

BIOMOX® (amoxicillin tablets) are indicated for treatment of the following infections in dogs when caused by susceptible strains of organisms:
BACTERIAL DERMATITIS due to Staphylococcus aureus, Strepto-coccus spp., Staphylococcus spp., and Escherichia coli.
SOFT TISSUE INFECTIONS
(abscesses, wounds, lacerations) due to Staphylococcus aureus, Enterococcus faecalis, Escherichia coli, Proteus mirabilis, and Staphylococcus spp.

With all antibiotic therapy, appropriate in vitro cultures and sensitivities

should be conducted prior to treatment.

CONTRAINDICATIONS:

Use of amoxicillin is contraindicated in

animals with a history of an allergic reaction to penicillin.

ADVERSE REACTIONS:

Amoxicillin is a semisynthetic penicillin and, therefore, has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.

WARNINGS:

For use in dogs only.

PRECAUTIONS:

Until adequate reproductive studies are accomplished, Biomox® (amoxicillin tablets) should not be used in pregnant or breeding animals.

CAUTION:

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

DOSAGE AND ADMINISTRATION:

The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

SUPPLY:

Biomox® (amoxicillin tablets) are supplied in 50 mg, 100 mg and 200mg concentrations in bottles of 500 tablets.

Manufactured for:

Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1 – 800 – 338 – 3659

Printed in USA Rev. -06 05/19

©2019 Virbac Corporation. All Rights Reserved.
BIOMOX is a registered trademark of Virbac AH, Inc.

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Gentacalm Topical Spray

Written by Curtis Plowgian on 25 July 2022. Posted in Uncategorized

GENTACALM TOPICAL SPRAY
(Gentamicin Sulfate, USP With Betamethasone Valerate,
USP Topical Spray)
Veterinary
For Topical Use in Dogs Only
For Animal Use Only

CAUTION:

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

DESCRIPTION:

Each mL contains: gentamicin sulfate equivalent to 0.57 mg gentamicin base, betamethasone valerate equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, propylene glycol, methylparaben
and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

CHEMISTRY:

Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water. Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per milligram. Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY:

Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals. 1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and -negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp. and Streptococcus sp. Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie,3 et al. This human bioassay technique has been found reliable for evaluating vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy. Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

WARNING:

Clinical and experimental data have demonstrated that cortico- steroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have produced cleft palate. Other congenital anomalies, including deformed forelegs, phocomelia and anasarca, have been reported in offspring of dogs which received corticosteroids during pregnancy.

INDICATIONS:

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

CONTRAINDICATIONS:

 If hypersensitivity of any of the components occurs, discontinue treatment and institute appropriate therapy.

DOSAGE AND ADMINISTRATION:

Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of Gentamicin Sulfate With Betamethasone Valerate Topical Spray.

TOXICITY:

Gentamicin sulfate with betamethasone valerate topical spray was well-tolerated in an abraded skin study in dogs. No treatment-related toxicological changes in the skin were observed. Systemic effects directly related to treatment were confined to histological changes in the adrenals, liver and kidney and to organ-to-body weight ratios of adrenals. All were dose related, were typical for or not unexpected with corticosteroid therapy and were considered reversible with cessation of treatment.

SIDE EFFECTS:

Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs. Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

PRECAUTIONS:

Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Use of topical antibiotics may permit overgrowth of non-susceptible bacteria, fungi or
yeasts. If this occurs, treatment should be instituted with other appropriate agents as indicated. Administration of recommended dose beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on dose, duration and specific steroid may result in inhibition of endogenous steroid production following drug withdrawal.

In patients presently receiving or recently withdrawn from systemic cortico- steroids treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the usual signs of adrenocorticoid overdosage, which includes sodium retention, potassium loss, fluid retention, weight gains, polydipsia and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

HOW SUPPLIED:

Plastic spray bottles containing 60 mL, 120 mL and 240 mL of Gentamicin Sulfate With Betamethasone Valerate Topical Spray.
Store upright between 2°C and 30°C (36°F and 86°F).

REFERENCES:

1. Hennessy, PW, et al. In vitro activity of gentamicin against bacteria
isolated from domestic animals. Veterinary Medicine/Small Animal Clini-
cian. November 1971; 1118-1122.
2. Bachmann, HJ, et al. Comparative in vitro activity of gentamicin and
other antibiotics against bacteria isolated from clinical samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal Clini-
cian. October 1975; 1218-1222.
3. McKenzie, HW and Atkinson, RM. Topical activities of betametha-
sone esters in man. Arch Derm. May 1964; 741-746.
June, 2009

Manufactured for:
Dechra Veterinary Products
7015 College Blvd., Suite 525
Overland Park, KS 66211
Technical Services 866-933-2472

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Clavacillin

Written by Curtis Plowgian on 25 July 2022. Posted in Pharmacopée, Uncategorized

ClavacillinTM

(amoxicillin trihydrate/clavulanate potassium)

Veterinary Tablets

For use in dogs and cats

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

DESCRIPTION:

Clavacillin (amoxicillin trihydrate/clavulanate potassium) is an orallyadministered formulation comprised of the broad-spectrum antibiotic amoxicillin trihydrate and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).

Amoxicillin trihydrate is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative, aerobic and anaerobicmicroorganisms. It does not resist destruction by β-lactamases; therefore, it is not effective against β-lactamase-producing bacteria. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

Clavulanic acid, an inhibitor of β-lactamase enzymes, is produced by the fermentation of Streptomyces clavuligerus. Clavulanic acid by itself has only weak antibacterial activity. Chemically, clavulanate potassium is potassium z-(3R,5R)-2-β-hydroxyethylideneclavam-3-carboxylate.

ACTIONS:

Clavacillin is stable in the presence of gastric acid and are not significantlyinfluenced by gastric or intestinal contents. The 2 components are rapidly absorbedresulting in amoxicillin and clavulanic acid concentrations in serum, urine, and tissues similar to those produced when each is administered alone.

Amoxicillin and clavulanic acid diffuse readily into most body tissues and fluids with the exception of brain and spinal fluid, which amoxicillin penetrates adequately when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine. Clavulanic acid’s penetration into spinal fluid is unknown at this time. Approximately 15% of the administered dose of clavulanic acid is excreted in the urine within the first 6 hours.

Clavacillin combines the distinctive properties of a broad-spectrum antibiotic and aβ-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include β-lactamase-producing as well as non-β-lactamase-producing aerobic and anaerobic organisms.

MICROBIOLOGY:

Amoxicillin is bactericidal in action and acts through the inhibition ofbiosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other β-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide rangeof activity which includes β-lactamase-producing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including β-lactamase-producing strains, isolated from veterinary sources, were found to be susceptible to amoxicillin/clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these organisms in animals.

Aerobic bacteria, including Staphylococcus aureus*, β-lactamase-producing Staphylococcus aureus* (penicillin resistant), Staphylococcus species*, Staphylococcus epidermidis,Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species*,Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli*, Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella haemolytica, Pasteurella species*.

* The susceptibility of these organisms has also been demonstrated in in vivo studies.

Studies have demonstrated that both aerobic and anaerobic flora are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both gram-positive and gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.

SUSCEPTIBILITY TEST:

The recommended quantitative disc susceptibility method(FEDERAL REGISTER 37:20527-29; Bauer AW, Kirby WMM, Sherris JC, et al: Antibioticsusceptibility testing by standardized single disc method. Am J Clin Path 45:493, 1966) utilized 30 mcg Augmentin^® (AMC) discs for estimating the susceptibility of bacteria to amoxicillin trihydrate and clavulanate potassium.

INDICATIONS:

Clavacillin is indicated in the treatment of:

Dogs: Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms:β-lactamase-producing Staphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli.

Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Clavacillin has been shown to be clinically effective for treating cases of canine periodontal disease.

Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producingStaphylococcus aureus, non-β-lactamase-producing Staphylococcus aureus,Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Urinary tractinfections (cystitis) due to susceptible strains of E. coli.

Therapy may be initiated with Clavacillin prior to obtaining results from bacteriologicaland susceptibility studies. A culture should be obtained prior to treatment to determinesusceptibility of the organisms to Clavacillin. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.

CONTRAINDICATIONS:

The use of this drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins or cephalosporins.

WARNINGS: Safety of use in pregnant or breeding animals has not been determined.Store at controlled room temperature, 68-77°F (20-25°C).

Do not remove from foil strip until ready to use.

ADVERSE REACTIONS:

Clavacillin contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

Post-Approval Experience (July, 2017) The following adverse events are based on post-approval adverse drug experiencereporting. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

The following adverse events reported for dogs and cats are listed in decreasing order of reporting frequency for amoxicillin and clavulanate potassium tablets: Anorexia, lethargy, vomiting and diarrhea.

To report suspected adverse events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Dechra at (866) 933-2472.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at http://www.fda.gov/reportanimalae

DOSAGE AND ADMINISTRATION:

Dogs: The recommended dosage is 6.25 mg/lb of body weight twice a day.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5-7 days or for 48 hours after all symptoms have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.

Cats: The recommended dosage is 62.5 mg twice a day.

Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5-7 days or for 48 hours after all symptoms have subsided, not to exceed 30 days.If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated.

Urinary tract infections may require treatment for 10-14 days or longer. The maximum duration of treatment should not exceed 30 days.

HOW SUPPLIED:

Clavacillin Tablets in the following strengths are supplied in strip packs.

Each carton can hold 5 strips with 14 tablets (70 tablets per carton) or 15 strips with 14 tablets (210 tablets per carton).

Each 62.5-mg tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillinactivity and 12.5 mg of clavulanic acid as the potassium salt. For use in dogs and cats.

Each 125-mg tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic acid as the potassium salt. For use in dogs only.

Each 250-mg tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and 50 mg of clavulanic acid as the potassium salt. For use in dogs only.

Each 375-mg tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic acid as the potassium salt. For use in dogs only.

Dispense according to recommendations outlined in Dosage and Administration section.

Approved by FDA under ANADA # 200-592

Augmentin is a trademark owned by GlaxoSmithKline.

Manufactured for:

Dechra Veterinary Products , 7015 College Boulevard, Suite 525 Overland Park, KS 66211 USA

Made in Austria.

Rev. June 2021

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Enroquin

Written by William Bordeau on 5 July 2022. Posted in Uncategorized, Pharmacopée

Enroquin^TM Flavored Tablets (enrofloxacin)

CAUTION:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
3Federal law prohibits the extralabel use of this drug in food-producing animals.7

DESCRIPTION:

Enrofloxacin is a synthetic chemotherapeutic agent from the class of the quinolone carboxylic acid derivatives. It has antibacterial activity against a broad spectrum of Gram negative and Gram positive bacteria (see Tables I and II). It is rapidly absorbed from the digestive tract, penetrating into all measured body tissues and fluids (See Table III). Tablets are available in three sizes (22.7, 68 and 136 mg enrofloxacin).

CHEMICAL NOMENCLATURE AND STRUCTURAL FORMULA:

ACTIONS:

Microbiology: Quinolone carboxylic acid derivatives are classified as DNA gyrase inhibitors. The mechanism of action of these compounds is very complex and not yet fully understood. The site of action is bacterial gyrase, a synthesis promoting enzyme. The effect on Escherichia coli is the inhibition of DNA synthesis through prevention of DNA supercoiling. Among other things, such compounds lead to the cessation of cell respiration and division. They may also interrupt bacterial membrane integrity.1

Enrofloxacin is bactericidal, with activity against both Gram negative and Gram positive bacteria. The minimum inhibitory concentrations (MICs) were determined for a series of 39 isolates representing 9 genera of bacteria from natural infections in dogs and cats, selected principally because of resistance to one or more of the following antibiotics: ampicillin, cephalothin, colistin, chloramphenicol, erythromycin, gentamicin, kanamycin, penicillin, streptomycin, tetracycline, triple sulfa and sulfa/trimethoprim. The MIC values for enrofloxacin against these isolates are presented in Table I. Most strains of these organisms were found to be susceptible to enrofloxacin in vitro but the clinical significance has not been determined for some of the
isolates. The susceptibility of organisms to enrofloxacin should be determined using enrofloxacin 5 mcg disks. Specimens for susceptibility testing should be collected prior to the initiation of enrofloxacin therapy.

*Includes feline isolates. The inhibitory activity on 120 isolates of seven canine urinary pathogens was also investigated and is listed in Table II.

Distribution in the Body:

Enrofloxacin penetrates into all canine and feline tissues and body fluids. Concentrations of drug equal to or greater than the MIC for many pathogens (See Tables I, II and III) are reached in most tissues by two hours after dosing at 2.5 mg/kg and are maintained for 8-12 hours after dosing. Particularly high levels of enrofloxacin are found in urine. A summary of the body fluid/tissue drug levels at 2 to 12 hours after dosing at 2.5 mg/kg is given in Table III.

Pharmacokinetics:

In dogs, the absorption and elimination characteristics of the oral formulation are linear (plasma concentrations increase proportionally with dose) when enrofloxacin is administered at up to 11.5 mg/kg, twice daily.2 Approximately 80% of the orally administered dose enters the systemic circulation unchanged. The eliminating organs, based on the drug’s body clearance time, can readily remove the drug with no indication that the eliminating mechanisms are saturated. The primary route of excretion is via the urine. The absorption and elimination characteristics beyond this point are unknown. In cats, no oral absorption information is available at other than 2.5 mg/kg, administered orally as a single dose. Saturable absorption and/or elimination processes may occur at greater doses. When saturation of the absorption process occurs, the plasma concentration of the active moiety will be less than predicted, based on the concept of dose proportionality. Following an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb), enrofloxacin reached 50% of its maximum serum concentration in 15 minutes and peak serum level was reached in one hour. The elimination half-life in dogs is approximately 2½-3 hours at that dose, while in cats it is greater than 4 hours. In a study comparing dogs and cats, the peak concentration and the time to peak concentration were not different. A graph indicating the mean serum levels following a dose of 2.5 mg/kg (1.13 mg/lb) in dogs (oral and intramuscular) and cats (oral) is shown in Figure 1.

Figure 1: Serum Concentrations of Enrofloxacin Following a Single Oral or Intramuscular Dose
at 2.5 mg/kg in Dogs and a Single Oral Dose at 2.5 mg/kg in Cats.

Breakpoint:

Based on pharmacokinetic studies of enrofloxacin in dogs and cats after a single oral administration of 2.5 mg enrofloxacin/kg BW (i.e. half of the lowest-end single daily dose range for dogs and half the single daily dose for cats) and the data listed in Tables I and II, the following breakpoints are recommended for canine and feline isolates:

A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable plasma levels. A report of “Intermediate” is a technical buffer and isolates falling into this category should be retested. Alternatively the organism may be successfully treated if the infection is in a body site where drug is physiologically concentrated. A report of “Resistant” indicates that the achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected. Standardized procedures require the use of laboratory control organisms for both standardized
disk diffusion assays and standardized dilution assays. The 5 μg enrofloxacin disk should give the following zone diameters and enrofloxacin powder should provide the following MIC values for reference strains:

INDICATIONS:

Enroquin Flavored Tablets (enrofloxacin) are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enroquin Flavored Tablets are indicated for use in dogs and cats.

EFFICACY CONFIRMATION:

 Dogs: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Escherichia coli, Klebsiella
pneumoniae, Proteus mirabilis, and Staphylococcus intermedius; respiratory infections (pneumonia, tonsillitis, rhinitis) associated with susceptible strains of Escherichia coli and Staphylococcus aureus; and urinary cystitis associated with susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus aureus. Cats: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Pasteurella multocida, Staphylococcus aureus, and Staphylococcus epidermidis.

CONTRAINDICATIONS:

Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones. Dogs: Based on the studies discussed under the section on ANIMAL SAFETY SUMMARY, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.

ADVERSE REACTIONS:

Dogs: Two of the 270 (0.7%) dogs treated with enrofloxacin at 5.0 mg/kg per day in the clinical field studies exhibited side effects, which were apparently drug-related. These two cases of vomition were self-limiting.

Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system.

Gastrointestinal: anorexia, diarrhea, vomiting, elevated liver enzymes
Neurologic: ataxia, seizures
Behavioral: depression, lethargy, nervousness
Cats: No drug-related side effects were reported in 124 cats treated with enrofloxacin at
5.0 mg/kg per day for 10 days in clinical field studies. Post-Approval Experience: The
following adverse experiences, although rare, are based on voluntary post-approval adverse drug
experience reporting. The categories of reactions are listed in decreasing order of frequency
by body system.
Ocular: mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and
hyperreflective tapeta have been reported), loss of vision. Mydriasis may be an indication of
impending or existing retinal changes.
Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea
Neurologic: ataxia, seizures
Behavioral: depression, lethargy, vocalization, aggression

To report suspected adverse events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Dechra at (866) 933-2472.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary/SafetyHealth

ANIMAL SAFETY SUMMARY:

 Dogs: Adult dogs receiving enrofloxacin orally at a daily dosage rate of 52 mg/kg for 13 weeks had only isolated incidences of vomition and inappetence. Adult dogs receiving the tablet formulation for 30 consecutive days at a daily treatment of 25 mg/kg did not exhibit significant clinical signs nor were there effects upon the clinical chemistry, hematological or histological parameters. Daily doses of 125 mg/kg for up to 11 days induced vomition, inappetence, depression, difficult locomotion and death while adult dogs receiving 50 mg/kg/day for 14 days had clinical signs of vomition and inappetence. Adult dogs dosed intramuscularly for three treatments at 12.5 mg/kg followed by 57 oral treatments at 12.5 mg/kg, all at 12 hour intervals, did not exhibit either significant clinical signs or effects upon the clinical chemistry, hematological or histological parameters. Oral treatment of 15 to 28 week old growing puppies with daily dosage rates of 25 mg/kg has induced abnormal carriage of the carpal joint and weakness in the hindquarters. Significant improvement of clinical signs is observed following drug withdrawal. Microscopic studies have identified lesions of the articular cartilage following 30 day treatments at either 5, 15 or 25 mg/kg in this age group. Clinical signs of difficult ambulation or associated cartilage lesions have not been observed in 29 to 34 week old puppies following daily treatments of 25 mg/kg for 30 consecutive days nor in 2 week old puppies with the same treatment schedule. Tests indicated no effect on circulating microfilariae or adult heartworms (Dirofilaria immitis) when dogs were treated at a daily dosage rate of 15 mg/kg for 30 days. No effect on cholinesterase values was observed. No adverse effects were observed on reproductive parameters when male dogs received 10 consecutive daily treatments of 15 mg/kg/day at 3 intervals (90, 45 and 14 days) prior to breeding or when female dogs received 10 consecutive daily treatments of 15 mg/kg/day at 4 intervals: between 30 and 0 days prior to breeding, early pregnancy (between 10th & 30^th days), late pregnancy (between 40th & 60th days), and during lactation (the first 28 days).

Cats: Cats in age ranges of 3 to 4 months and 7 to 10 months received daily treatments of 25 mg/kg for 30 consecutive days with no adverse effects upon the clinical chemistry, hematological or histological parameters. In cats 7-10 months of age treated daily for 30 consecutive days, 2 of 4 receiving 5 mg/kg, 3 of 4 receiving 15 mg/kg, 2 of 4 receiving 25 mg/kg and 1 of 4 nontreated controls experienced occasional vomition. Five to 7 month old cats had no side effects with daily treatments of 15 mg/kg for 30 days, but 2 of 4 animals had articular cartilage lesions when administered 25 mg/kg per day for 30 days. Doses of 125 mg/kg for 5 consecutive days to adult cats induced vomition, depression, incoordination and death while those receiving 50 mg/kg for 6 days had clinical signs of vomition, inappetence, incoordination and convulsions, but they returned to normal. Enrofloxacin was administered to thirty-two (8 per group), six- to eight-month-old cats at doses of 0, 5, 20, and 50 mg/kg of body weight once a day for 21 consecutive days. There were no adverse effects observed in cats that received 5 mg/kg body weight of enrofloxacin. The administration of enrofloxacin at 20 mg/kg body weight or greater caused salivation, vomition, and depression. Additionally, dosing at 20 mg/kg body weight or greater resulted in mild to
severe fundic lesions on ophthalmologic examination (change in color of the fundus, central or generalized retinal degeneration), abnormal electroretinograms (including blindness), and diffuse light microscopic changes in the retina.

DRUG INTERACTIONS:

Compounds that contain metal cations (e.g., aluminum, calcium, iron, magnesium) may reduce the absorption of some quinolone-class drugs from the intestinal tract. Concomitant therapy with other drugs that are metabolized in the liver may reduce the clearance rates of the quinolone and the other drug. Dogs: Enrofloxacin has been administered to dogs at a daily dosage rate of 10 mg/kg concurrently with a wide variety of other health products including anthelmintics (praziquantel, febantel, sodium disophenol), insecticides (fenthion, pyrethrins), heartworm preventatives (diethylcarbamazine) and other antibiotics (ampicillin, gentamicin sulfate, penicillin, dihydrostreptomycin). No incompatibilities with other drugs are known at this time.
Cats: Enrofloxacin was administered at a daily dosage rate of 5 mg/kg concurrently with anthelmintics (praziquantel, febantel), an insecticide (propoxur) and another antibacterial (ampicillin). No incompatibilities with other drugs are known at this time.

WARNINGS:

 For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. 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 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. For customer service or to obtain product information, including Safety Data Sheet, call Dechra at (866) 933-2472.

PRECAUTIONS:

Quinolone-class drugs 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. Quinolone-class drugs have been associated with cartilage erosions in weight-bearing joints and other forms 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.

DOSAGE AND ADMINISTRATION:

 Dogs: Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on
clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. If dogs do not consume Enroquin Flavored Tablets willingly when offered by hand, then alternatively the tablet(s) may be offered in the food or hand-administered (pilled) as with other oral tablet medications.

All tablet sizes are double scored for accurate dosing.

Cats: Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. In cats, Enroquin Flavored Tablets should be pilled. After administration, watch the animal closely to be certain the entire dose has been consumed.

All tablet sizes are double scored for accurate dosing.

Dogs & Cats: The duration of treatment should be selected based on clinical evidence. Generally, administration of Enroquin Flavored Tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be reevaluated and a different course of therapy considered.
The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.

STORAGE:

Dispense tablets in tight containers only. Store at controlled room temperature, 68-77°F (20-25°C).

HOW SUPPLIED:

Flavored Tablets NDC Number Tablet Size Tablets/Bottle
17033-302-10 22.7 mg 100 Double Scored
17033-302-50 22.7 mg 500 Double Scored
17033-306-05 68 mg 50 Double Scored
17033-306-25 68 mg 250 Double Scored
17033-313-05 136 mg 50 Double Scored
17033-313-20 136 mg 200 Double Scored
ANADA 200-551, Approved by FDA

REFERENCES:

1 Doughherty, T.J., & Saukkonen, J.J. (1985). Membrane permeability changes associated with
DNA gyrase inhibitors in Escherichia Coli. Antimicrob Agents Chemother, 28 (2), 200-206.
2 Walker, R.D., Stein, G.E., Hauptmam, J.G., McDonald, K.H. (1992). Pharmacokinetic evaluation of
enrofloxacin administered orally to healthy dogs. Am J Vet Res, 53 (12): 2315-2319.

Manufactured for:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA
Made in India.
Neutral Code No.: UK/DRUGS/58/UA/2007
Rev. September 2017

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P.O. BOX 162059, FORT WORTH, TX, 76161

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