SPECTOGARD- spectinomycin sulfate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SPECTINOMYCIN SULFATE (UNII: BZ0H4TLF9X) (SPECTINOMYCIN - UNII:93AKI1U6QF)

Available from:

Bimeda, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS AND USAGE SpectoGard Sterile Solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. CONTRAINDICATIONS AS with all drugs, the use of SpectoGard Sterile Solution is contraindicated in animals previously found to be hypersensitive to the drug.

Product summary:

HOW SUPPLIED SpectoGard Sterile Solution is available in the following package size: 500 mL Multi-Dose vial. Approved by FDA under ANADA # 200-694 Restricted Drug (California) – Use Only as Directed Manufactured for: Bimeda, Inc. Le Sueur, MN 56058 www.bimeda.com

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

SPECTOGARD- SPECTINOMYCIN SULFATE INJECTION, SOLUTION
BIMEDA, INC.
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SPECTOGARD®
(SPECTINOMYCIN) SULFATE
STERILE SOLUTION
FOR SUBCUTANEOUS INJECTION IN CATTLE
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION
SpectoGard Sterile Solution contains the sulfate salt of
spectinomycin, an aminocyclitol
antibiotic produced by _Streptomyces spectabilis_.
Each mL of SpectoGard Sterile Solution contains spectinomycin sulfate
tetrahydrate
equivalent to 100 mg spectinomycin; and 9.45 mg benzyl alcohol, added
as preservative.
The pH was adjusted with hydrochloric acid or sodium hydroxide.
Figure 1. Chemical structure of spectinomycin sulfate tetrahydrate
The chemical name of spectinomycin sulfate tetrahydrate is:
Decahydro-4a,7,9-
trihydroxy-2-methyl-6,8-bis (methylamino)-4H-pyrano [2,3-b] [1,4]
benzodioxin-4-one
sulfate, tetrahydrate.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Spectinomycin is bacteriostatic and exerts its antibacterial effect by
binding to the 30S
ribosome and inhibiting bacterial protein synthesis.
Spectinomycin has activity against a variety of gram-negative
bacteria, some
mycoplasma, and a limited number of gram-positive bacteria. Generally,
it is not active
against anaerobic bacteria.
Spectinomycin has demonstrated _in vitro_ and _in vivo_ activity
against the three major
pathogenic bacteria (_Mannheimia haemolytica, Pasteurella multocida,
_and_ Histophilus_
_somni_) associated with bovine respiratory disease (pneumonia).
Spectinomycin has also demonstrated _in vitro_ activity against
_Actinomyces pyogenes,_
_Mycoplasma bovis, _and_ Mycoplasma dispar_. The clinical significance
of this_ in vitro_ activity
in cattle has not been demonstrated.
INDICATIONS AND USAGE
SpectoGard Sterile Solution is indicated for the treatment of bovine
respiratory disease
(pneumonia) associated with _Mannheimia haemolytica, Pasteurella
multocida, _and
_Histophilus somni._
CONTRAINDICATIONS
AS with all drugs, the use of SpectoGard Sterile Solution is
contraindicated i