BIMASONE- flumethasone injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FLUMETHASONE (UNII: LR3CD8SX89) (FLUMETHASONE - UNII:LR3CD8SX89)

Dostopno od:

Bimeda, Inc.

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION

Terapevtske indikacije:

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. 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.

Povzetek izdelek:

Bimasone is supplied in 100 mL vials.

Status dovoljenje:

Abbreviated New Animal Drug Application

Lastnosti izdelka

BIMASONE- FLUMETHASONE INJECTION, SOLUTION
BIMEDA, INC.
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BIMASONE
(FLUMETHASONE) 0.5 MG/ML
STERILE INJECTION FOR HORSES, DOGS, & CATS
GLUCOCORTICOID
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
GENERAL
Flumethasone is a chemical modification of prednisolone which
possesses greater anti-
inflammatory and gluconeogenic properties than the parent compound
when compared
on an equivalent basis. Due to the potency of Bimasone, dosage
recommendations
should be consulted prior to drug administration. Chemically, it is
6α, 9α-difluoro-16α
methylprednisolone.
The structural formula is as follows:
DESCRIPTION
The active ingredient of Bimasone is flumethasone which occurs as a
white to creamy
white, odorless,
crystalline powder. The appearance of Bimasone is a clear colorless to
slightly yellowish
mobile liquid.
Each mL of the injectable preparation contains 0.5 mg flumethasone,
420 mg
polyethylene glycol 400, 9 mg benzyl alcohol as a preservative, 8 mg
sodium chloride,
0.1 mg citric acid, sodium hydroxide and/or hydrochloric acid for pH
adjustment when
necessary, and water for injection USP, q.s.
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 corti