flumethasone

Musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, osteoarthritis, the disc syndrome and myositis. In septic arthritis appropriate antibacterial therapy should be concurrently administered. In certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation and inflammation associated with these conditions. The drug has proven useful in otitis externa in conjunction with topical medication for similar reasons. In allergic states such as hives, urticaria and insect bites. Shock and shock-like states, by intravenous administration.

Bimasone™

It is used for the treatment of musculoskeletal conditions due to inflammation of muscles or joints and accessory structures where permanent structural changes do not exist, e.g., arthritis, osteoarthritis disc syndrome, and myositis (in septic arthritis, appropriate antibacterial therapy should be concurrently administered); certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation; otitis externa in conjunction with topical medication; allergic states, e.g., hives, urticaria, and insect bites; and shock and shock-like states by intravenous administration.

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A protein-rich diet is useful in dogs and cats on long-term therapy to counteract nitrogen loss if it should occur. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome and myositis. It is also used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Tablets

Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

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

Anaprime® Ophthalmic Solution

For the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, and blepharitis.

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

Anaprime® Opthakote Ophthalmic

It is recommended in certain acute and chronic canine dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 milligram per animal. For use only by or on the order of a licensed veterinarian.

Fluosmin Suspension

Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

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

Anaprime® Ophthalmic Solution

It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.

Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Tablets

It is used for the treatment of certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation.

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A protein-rich diet is useful in dogs and cats on long-term therapy to counteract nitrogen loss if it should occur. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

Musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, such as bursitis, carpitis, osselets and myositis. Following therapy an appropriate period of rest should be instituted to allow a more normal return to function of the affected part. In allergic states such as hives, urticaria and insect bites.

Bimasone™

It is recommended in the various disease states involving synovial structures (joints) of horses where excessive synovial fluid of inflammatory origin is present and where permanent structural changes do not exist. Such conditions include arthritis, carpitis, and osselitis.

Clinical and experimental data have demonstrated that corticosteroids 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. The drug is not to be used in horses intended for slaughter for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Anaprime® Suspension

It is used for the treatment of musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, e.g., bursitis, carpitis, osselets, and myositis; and allergic states, e.g., hives, urticaria, and insect bites.

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. The drug is not to be used in horses intended for slaughter for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

INDICATIONS Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states which are known to be responsive to the anti-inflammatory corticoids. Equine Indications 1. Musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, such as bursitis, carpitis, osselets and myositis. Following therapy an appropriate period of rest should be instituted to allow a more normal return to function of the affected part. 2. In allergic states such as hives, urticaria and insect bites. Canine Indications 1. Musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, osteoarthritis, the disc syndrome and myositis. In septic arthritis appropriate antibacterial therapy should be concurrently administered. 2. In certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation and inflammation associated with these conditions. The drug has proven useful in otitis externa in conjunction with topical medication for similar reasons. 3. In allergic states such as hives, urticaria and insect bites. 4. Shock and shock-like states, (4) by intravenous administration. Feline Indications 1. In certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation and inflammation associated with these conditions.

FDA application 200-612

CLINICAL PHARMACOLOGY Flumethasone has been reported (1) to possess 700 times the glucocorticoid activity of cortisol (hydrocortisone) as measured in the liver glycogen deposition assay in the rat; 120 times that of cortisol in the cotton pellet assay in the rat; and also in the same animal, shows a net excretion of sodium. In similar tests in rats, another report (2) showed flumethasone 730 times more potent than cortisol in the granuloma inhibition assay and 165 times the activity of cortisol in the glycogen deposition assay. The same report showed that in man, the compound possessed 7.8 times the potency of prednisolone. An additional report (3) indicated that flumethasone possessed 677 times the potency of cortisol in the liver glycogen deposition test in the rat, and 30, 25, and 31 times respectively, the eosinopenic, hyperglycemic and antirheumatic potency of cortisol, as measured in man. Veterinary experimental studies utilizing the eosinophil depression test in normal dogs and blood glucose elevation and eosinophil depression in normal cattle as parameters of drug activity, in comparison tests involving prednisone and dexamethasone, indicate that flumethasone possesses greater anti-inflammatory and gluconeogenic activity than these compounds, on an equivalent basis. Clinical evidence of drug potency obtained during evaluation of the compound and based upon effective drug dosage levels further substantiates the above experimental findings. General Effects of Adrenocorticoids The adrenocorticoids are divided into two main classes: mineralocorticoids and glucocorticoids, based on their major physiologic and pharmacologic actions. Mineralocorticoids such as the naturally occurring desoxycorticosterone and aldosterone are mainly concerned with hydration, sodium and potassium regulation and the normal renal glomerular filtration of these two electrolytes. The mineralocorticoids have little if any effect as anti-inflammatory agents, and are not widely used in medicine. Glucocorticoids include the naturally occurring compounds, cortisone and hydrocortisone. Their major effects are as follows: 1. Increase protein catabolism and gluconeogenesis. 2. Depressionof lymphoid tissues, fibroblasts and eosinophils. 3. Increase the sense of well being and tolerance to pain. 4. Depress thyroid function and anterior pitutiary function through reciprocal influences. 5. Influence vasoconstrictive response of the circulatory system to norepinephrine, helping to maintain blood pressure. 6. Increase renal flow. 7. Influence gastric HCl and pepsin production. 8. Reduces the secretion of mucus from respiratory and enteric mucosa. 9. Affect to some degree sodium retention and potassium excretion. 10. Stimulate erythropoiesis and myelopoiesis. Synthetic analogues of cortisone and hydrocortisone containing a double bond between carbon 1 and 2 of the corticosteroid nucleus, resulted in compounds with a greatly decreased effect on electrolyte metabolism. Additional molecular changes present in other synthetic corticoids presently used in medicine such as methylation at carbons 6 or 16 and hydroxylation at carbon 16, have led to a further decrease in electrolyte imbalance noted with the naturally occurring glucocorticoids. Fluorination at carbon 6 and/or 9 have led to a marked increase in anti-inflammatory activity. The synthetic glucocorticoids exhibit a marked increase in potency in that a smaller amount of drug is required to elicit the same effects seen only with large amounts of the natural glucocorticoids. It is also noted that the synthetic analogues persist for a longer period of time in the body which is believed due to their slower metabolism and excretion.

FDA application 200-612

CONTRAINDICATIONS Do not use in viral infections. Except for emergency therapy, do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome and peptic ulcers. Existence of congestive heart failure, diabetes and osteoporosis are relative contraindications.

FDA application 200-612

WARNINGS Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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 resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia and anasarca.

FDA application 200-612

0.0625 to 0.25 mg daily by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated. With chronic conditions, the preceding doses may be used and oral maintenance therapy with flumethasone tablets instituted at a daily dose of 0.0625 to 0.25 mg. lntralesional dosages in the dog have ranged from 0.125 to 1 mg depending on the size and location of the lesion under treatment. Intra-articular dosages in the dog have ranged from 0.166 to 1 mg depending on the severity of the condition under treatment and the size of the involved joint.

Intra-Articular, Subcutaneous, Intralesional, Intravenous, Intramuscular

Bimasone™

0.0625 to 0.25 milligram daily, intravenously, intramuscularly, or subcutaneously; 0.125 to 1.0 milligram daily, intralesionally depending on the size and location of the lesion; 0.166 to 1.0 milligram daily, intra-articularly, depending on the severity of the condition and the size of the involved joint.

Intravenous, Subcutaneous, Intramuscular, Intralesional, Intra-Articular

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A protein-rich diet is useful in dogs and cats on long-term therapy to counteract nitrogen loss if it should occur. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

Up to 10 pounds body weight-1.0 milligrams intramuscularly daily. 10 to 25 pounds body weight-2.0 milligrams intramuscularly daily. 25 and over pounds body weight-4.0 milligrams intramuscularly daily.

Intramuscular

Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 milligram per animal. For use only by or on the order of a licensed veterinarian.

Fluosmin Suspension

Administer orally from 0.0625 to 0.25 milligram daily in divided doses.

Oral

Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Tablets

Instill 1 to 2 drops per eye every 6 hours.

Ophthalmic

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

Anaprime® Opthakote Ophthalmic

Apply 2 to 3 drops per eye, every 4 hours.

Ophthalmic

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

Anaprime® Ophthalmic Solution

0.03125 to 0.125 mg by intravenous intramuscular or subcutaneous injection. If necessary, the dose may be repeated. With chronic conditions, the preceding injectable doses may be used and oral maintenance therapy with flumethasone tablets instituted at a daily dosage of 0.03125 to 0.125 mg.

Intra-Articular, Subcutaneous, Intralesional, Intravenous, Intramuscular

Bimasone™

0.03125 to 0.125 milligram daily intravenously, intramuscularly, or subcutaneously.

Intravenous, Subcutaneous, Intramuscular, Intralesional, Intra-Articular

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A protein-rich diet is useful in dogs and cats on long-term therapy to counteract nitrogen loss if it should occur. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

Administer orally from 0.03125 to 0.125 milligram daily in divided doses.

Oral

Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or where peptic ulcers occur, except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during last trimester of pregnancy and may precipitate premature parturition fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Tablets

Apply 2 to 3 drops per eye, every 4 hours.

Ophthalmic

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

Anaprime® Ophthalmic Solution

The drug is administered intra-articularly at a dosage level of 6 to 10 milligrams per injection. The dosage level is dependent on the size of the involved synovial structure and the degree of severity of the condition under treatment. The dosage is limited to a single injection per week in any one synovial structure.

Intra-Articular

Clinical and experimental data have demonstrated that corticosteroids 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. The drug is not to be used in horses intended for slaughter for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Anaprime® Suspension

1.25 to 2.5 mg daily by intravenous, intramuscular or intra-articular injection. If necessary, the dose may be repeated.

Intra-Articular, Subcutaneous, Intralesional, Intravenous, Intramuscular

Bimasone™

1.25 to 2.5 milligrams daily, intravenously, intramuscularly, or intra-articularly.

Intravenous, Subcutaneous, Intramuscular, Intralesional, Intra-Articular

Clinical and experimental data have demonstrated that corticosteroids 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. When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present. It has been demonstrated that corticosteroids especially at high dose levels, may result in delayed wound and fracture healing. Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously. The drug is not to be used in horses intended for slaughter for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Flucort® Solution

ADMINISTRATION AND DOSAGE Bimasone is recommended for administration by injection using various routes depending on the animal species and conditions under treatment. Injection should be accomplished slowly, with the drug at or near body temperature. The following recommended dosages should be used as therapeutic guides. Each animal should be treated on an individual basis and dosage adjusted according to the response noted. Dosage of Bimasone: Equine: 1.25 to 2.5 mg daily by intravenous, intramuscular or intra-articular injection. If necessary, the dose may be repeated. Canine: 0.0625 to 0.25 mg daily by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated. With chronic conditions, the preceding doses may be used and oral maintenance therapy with flumethasone tablets instituted at a daily dose of 0.0625 to 0.25 mg. lntralesional dosages in the dog have ranged from 0.125 to 1 mg depending on the size and location of the lesion under treatment. Intra-articular dosages in the dog have ranged from 0.166 to 1 mg depending on the severity of the condition under treatment and the size of the involved joint. Feline: 0.03125 to 0.125 mg by intravenous, intramuscular or subcutaneous injection. If necessary, the dose may be repeated. With chronic conditions, the preceding injectable doses may be used and oral maintenance therapy with flumethasone tablets instituted at a daily dosage of 0.03125 to 0.125 mg. NOTE: The use of a microsyringe or standard tuberculin syringe may facilitate the accurate administration of small amounts of the drug. If desired, therapy with Bimasone may be substituted for other corticoids by the appropriate adjustment of dose levels.

INTRAVENOUS, INTRAMUSCULAR, INTRA-ARTICULAR, SUBCUTANEOUS, INTRALESIONAL

FDA application 200-612