SPECTINOMYCIN
SPECTINOMYCIN
SPECTINOMYCIN
SPECTINOMYCIN VeterinarySystemic
Some commonly used brand names for veterinary-labeled products are: Paratyphoid (treatment)1Chicks, newly hatched: Spectinomycin hydro-
Adspec Sterile Solution; AmTech Spectam Scour-Halt; Bovispec Sterile chloride injection is indicated in the control of mortality and to lessen
Solution; Spectam; Spectam Injectable; Spectam Oral Solution; Spectam severity of infections caused by Salmonella typhimurium{R-17}.
Scour-Halt; Spectam Soluble Powder; and Spectam Water Soluble. Pneumonia, bacterial (treatment)Cattle: Spectinomycin sulfate injec-
Note: For a listing of dosage forms and brand names by country tion is indicated in the treatment of pneumonia (bovine respiratory
availability, see the Dosage Forms section(s). disease) associated with M. haemolytica, P. multocida, and H. somnus in
cattle{R-21; 25}.
CATEGORY: Salmonella infantis infection (treatment)1Chicks, newly hatched: Spec-
Antimicrobial (systemic). tinomycin hydrochloride injection is indicated in the control of
mortality and to lessen severity of infections caused by S. infantis{R-17};
INDICATIONS: however, S. infantis is not considered to be a major pathogen in the
Note: Bracketed information in the Indications section refers to uses that poultry industry.
either are not included in U.S. product labeling or are for products not Synovitis (prophylaxis)Chickens, broiler: Spectinomycin powder for oral
commercially available in the U.S. solution is indicated to aid in the prevention of mortality associated
with infectious synovitis due to susceptible Mycoplasma synoviae{R-2;
18}
.
GENERAL CONSIDERATIONS Synovitis (treatment)
Spectinomycin is an antibiotic that is active against a variety of Chickens, broiler1: Spectinomycin powder for oral solution is indicated
aerobic gram-negative and gram-positive organisms{R-3; 4} as well to aid in the control of mortality associated with infectious synovitis
as Mycoplasma species{R-7}. Spectinomycin is used clinically, due to susceptible M. synoviae{R-18}.
primarily for its activity against gram-negative organisms; some Chicks, newly hatched1: Spectinomycin hydrochloride injection is
gram-positive organisms may also be susceptible to this agent. It indicated in the control of mortality and to lessen severity of
has in vitro and in vivo activity against Mannheimia (Pasteurella) infections caused by susceptible M. synoviae{R-17}.
haemolytica, Pasteurella multocida, and Haemophilus somnus{R-25}. [Fowl cholera (treatment)]Turkeys: Spectinomycin hydrochloride injec-
Anaerobic organisms are generally resistant{R-7}. Spectinomycin is tion is indicated to reduce mortality due to fowl cholera caused by
usually bacteriostatic at therapeutic doses{R-5}. As an aminocyclitol sensitive strains of Pasteurella multocida{R-1}.
antibiotic, spectinomycin is structurally and functionally similar to
the aminoglycoside antibiotics, which are also aminocyclitols.
ACCEPTANCE NOT ESTABLISHED
Spectinomycin lacks the toxic effects of the aminoglycoside antibi-
Colibacillosis (treatment)1[Ducklings]: There are insufficient data to
otics; however, its use is limited by the ready development of
establish the safety and efficacy of spectinomycin in the treatment of
bacterial resistance{R-5}.
colibacillosis in ducklings; however, in one study, subcutaneous admin-
istration of spectinomycin reduced the mortality and improved weight
gain in 1-day-old ducklings experimentally infected with E. coli{R-10}.
ACCEPTED
Infections, bacterial (treatment), including
Air sacculitis (treatment)1Turkey poults, 1- to 3-day-old: Spectinomycin
Respiratory tract infections (treatment)[Pigs]1: There are insufficient
hydrochloride injection is indicated to aid in the control of air sacculitis
data to establish the safety and efficacy of spectinomycin injection in
associated with Mycoplasma meleagridis sensitive to spectinomycin
{R-17} the treatment of respiratory infections and systemic infections due to
.
susceptible organisms in pigs; however, the parenteral administra-
Chronic respiratory disease (CRD) (prophylaxis)Chickens, broiler:
tion of spectinomycin to pigs has been used in clinical practice to
Spectinomycin powder for oral solution is indicated to aid in the
treat these infections{R-5}.
prevention of mortality due to CRD associated with susceptible
Mycoplasma gallisepticum{R-2; 18}. 1
Not included in Canadian product labeling or product not commercially
Chronic respiratory disease (CRD) (treatment)
available in Canada.
Turkey poults, 1- to 3-day-old1: Spectinomycin hydrochloride injection
is indicated to aid in the control of CRD associated with Escherichia
coli{R-17}. REGULATORY CONSIDERATIONS
Chickens, broiler: Spectinomycin powder for oral solution is indicated to U.S.
aid in the control of mortality due to CRD associated with susceptible Spectinomycin oral solution is labeled for use in piglets younger than 4
Mycoplasma gallisepticum{R-2; 18}. weeks of age or weighing < 6.8 kg{R-3; 4}.
Colibacillosis (treatment)1Chicks, newly hatched: Spectinomycin Spectinomycin injection is labeled for use only in newly hatched chicks
hydrochloride injection is indicated in the control of mortality and to and in 1- to 3-day-old turkey poults{R-17}.
lessen severity of infections caused by E. coli{R-17}. Spectinomycin is not labeled for use in birds producing eggs for human
Enteritis, bacterial (treatment)Piglets: Spectinomycin oral solution is consumption{R-18}.
indicated in the treatment of bacterial enteritis (white scours) Withdrawal times have been established for the use of spectinomy-
associated with E. coli in piglets younger than 4 weeks of age{R-3; 4}. cin in newly hatched chicks{R-17}, broiler chickens{R-18}, 1- to
3-day-old turkey poults{R-17}, and piglets{R-4}(see the Dosage Forms administration of spectinomycin{R-7}. Tissue/serum ratios of spectino-
section). mycin usually do not exceed 0.25 to 0.5 and are much lower in brain,
Canada aqueous humor, and bone{R-22}.
Spectinomycin is not labeled for use in birds producing eggs for human Volume of distribution (VolD):
consumption{R-1}. Cows0.295 Liter per kg (L/kg){R-13}.
Spectinomycin injection is not labeled for use in turkeys weighing Ewes0.307 L/kg{R-13}.
< 0.5 kg{R-1}.
Withdrawal times have been established for the use of spectinomycin Protein binding: CowsLow (approximately 10%){R-13}.
in broiler chickens{R-2}, piglets{R-3}, and turkeys{R-1}(see the Dosage
Forms section). Biotransformation: Spectinomycin does not appear to undergo any
significant metabolism. In swine, it is excreted unchanged in the urine
CHEMISTRY following intramuscular administration{R-7}.
Source: Spectinomycin is a product of Streptomyces spectabilis{R-5; 25}.
Chemical group: Aminocyclitol{R-5}. Half-life: Elimination
Chemical name: Cows: 1.01{R-13} to 1.2 hours{R-7}.
Spectinomycin hydrochloride4H-Pyrano[2,3-b][1,4]benzodioxin-4-one, Ewes: 1.01 hours{R-13}.
decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)-, dihy- Pigs: 0.98 hour{R-7}.
drochloride, pentahydrate{R-6}.
Spectinomycin sulfate tetrahydrateDecahydro-4a,7,9-trihydroxy- Peak serum concentration/Time to peak serum concentration:
2-methyl-6,8-bis(methylamino)-4H-pyrano[2,3-b][1,4]benzodioxin- Calves, preruminating20 mcg/mL between 0.33 and 0.67 hours
4-one sulfate, tetrahydrate{R-25}. following an intramuscular dose of 10 mg/mL{R-7}.
Molecular formula: Spectinomycin hydrochlorideC14H24N2O7 CowsApproximately 55 micrograms per mL (mcg/mL) at 1 hour
2HCl 5H2O{R-6}. following an intramuscular dose of 20 mg per kg of body weight
Molecular weight: Spectinomycin hydrochloride495.35{R-6}. (mg/kg){R-13}.
Description: Spectinomycin Hydrochloride USPWhite to pale-buff Dogs
crystalline powder{R-16}. Intramuscular: 78 mcg/mL 40 minutes following an intramuscular
pKa: 6.95 and 8.70{R-23}. dose of 40 mg/kg.
Solubility: Spectinomycin Hydrochloride USPFreely soluble in Oral{R-7}:
water; practically insoluble in alcohol, in chloroform, and in 22 mcg/mL approximately 4 hours following a dose of
ether{R-16}. 100 mg/kg.
80 mcg/mL approximately 4 hours following a dose of 500 mg/kg.
PHARMACOLOGY/PHARMACOKINETICS EwesApproximately 53 mcg/mL at 1 hour following an intramuscular
Note: Unless otherwise noted, pharmacokinetic data in this section are dose of 20 mg/kg{R-13}.
based on a single intravenous injection of spectinomycin.
The pharmacokinetics and detection of spectinomycin do not appear to Elimination:
be influenced by administration in combination with lincomycin{R-7}; Following intramuscular administrationSpectinomycin is rapidly
some of the pharmacokinetic data in this section are derived from absorbed, then quickly eliminated from plasma and tissues
studies in which lincomycin and spectinomycin were administered through renal excretion{R-7}. Because of this rapid excretion, drug
concomitantly{R-7}. accumulation is not observed following repeated administra-
tion{R-7}. Renal impairment may cause accumulation of the active
Mechanism of action/effect: Spectinomycin binds to the 30S ribo- drug{R-22}.
somal subunit of the microorganism and inhibits protein synthesis by Following oral administrationBecause spectinomycin is poorly
preventing elongation of the polypeptide chain at the translocation absorbed from the gastrointestinal tract, it is excreted mostly in the
step{R-5}. feces{R-7}.
CLINICAL EFFECTS OF OVERDOSE Auxiliary labeling: When not in use, the plastic doser should be
Note: The following effects have been selected on the basis of their removed and the original cap replaced on bottle{R-3; 4}. The plastic
potential clinical significance (possible signs in parentheses where doser should be rinsed with water after each use.
appropriate)not necessarily inclusive ( = major clinical signifi-
cance): USP requirements: Not in USP{R-16}.
Acute effects
Turkey poults{R-1} SPECTINOMYCIN HYDROCHLORIDE POWDER FOR
Ataxia{R-1}; coma{R-1} ORAL SOLUTION
Note: Clinical signs of ataxia and coma following a single, subcuta-
neous dose of 90 mg per poult were transient, resolving after 4 Usual dose:
hours{R-1}; a single, subcutaneous injection of up to 50 mg per Chronic respiratory disease (prophylaxis and treatment)Chickens,
poult caused no detectable ill effects{R-1}. broiler: Oral, administered as the sole source of drinking water at a
concentration of 0.5 mg (base) per mL (2 grams [base] per gallon) of Chronic respiratory disease (treatment)1Turkey poults, 1- to 3-day-
water for the first three days of life and for one day following each old: Subcutaneous in cervical area, 5 mg (base) as a single, total dose
vaccination{R-2; 18; 24}. per poult{R-17}. Dilution with sterile physiologic saline is recom-
Synovitis (prophylaxis and treatment1)Chickens, broiler: Oral, admin- mended to facilitate accurate dosing{R-17}.
istered as the sole source of drinking water at a concentration of 0.26 Colibacillosis (treatment)1;
mg (base) per mL (1 gram [base] per gallon) of water for the first three Paratyphoid (treatment)1;
to five days of life{R-18; 24}. Salmonella infantis infection (treatment)1; or
Note: Canadian labeling lists a dose of 0.5 mg (base) per mL (2 grams Synovitis (treatment)1Chicks, newly hatched: Subcutaneous in
[base] per gallon) of water for this indication{R-2}. cervical area, 2.5 to 5 mg (base) as a single, total dose per chick{R-17}.
Dilution with sterile physiologic saline is recommended so that the total
Strength(s) usually available: volume administered is 0.2 mL{R-17}.
U.S. [Fowl cholera (treatment)]Turkeys: Subcutaneous in dorsal cervical
Veterinary-labeled product(s): area, 11 to 22 mg (base) per kg of body weight as a single injection.
500 mg (base) per gram of water-soluble powder (OTC) [Spectam The entire flock should be treated as soon as symptoms of fowl
Water Soluble]. cholera are observed{R-1}. Treatment must not be repeated within
Canada five days of the initial treatment{R-1}.
Veterinary-labeled product(s): Note: [Ducklings]1For use in animals not to be used in food production:
500 mg (base) per gram of water-soluble powder (OTC) [Spectam Although there are insufficient data to establish safety and efficacy, a
Soluble Powder]. single, subcutaneous, total dose of 5 mg (base) per duckling has been
shown to reduce mortality and improve weight gain in one-day-old
Withdrawal times: ducklings experimentally infected with E. coli{R-10}.
U.S. and Canada{R-2; 18; 24}
[Pigs]1Although there are insufficient data to establish safety and
efficacy, the intramuscular administration of spectinomycin to pigs,
Withdrawal time at doses ranging from 6.6 to 22 mg (base) per kg of body weight
Species Meat (days)
every twelve to twenty-four hours{R-11}, has been used in clinical
practice to treat respiratory infections and systemic infections caused by
Chickens 5 organisms sensitive to spectinomycin{R-5}.
Strength(s) usually available{R-22}:
Note: The above withdrawal time applies when medication is adminis-
U.S.
tered in the drinking water up to a maximum concentration of 0.5 mg
Veterinary-labeled product(s):
(base) per mL for up to a maximum duration of 5 days{R-2; 18}.
100 mg (base) per mL (OTC) [GENERIC]{R-17}.
Products are not labeled for use in poultry laying eggs for human
Canada
consumption{R-24}.
Veterinary-labeled product(s):
100 mg (base) per mL (OTC) [Spectam; Spectam Injectable]{R-1}.
Packaging and storage: Store below 40 C (104 F), preferably
between 15 and 30 C (59 and 86 F), unless otherwise specified by Withdrawal times:
manufacturer. Note: PigsBecause injectable spectinomycin is not labeled for use in pigs,
there are no established withdrawal times in the U.S. or Canada. If
Preparation of dosage form: Water-soluble powder should be mixed spectinomycin is administered intramuscularly at a dose of 20 mg per kg
with drinking water according to the manufacturers directions. of body weight, evidence has been compiled by the Food Animal Residue
Avoidance Databank (FARAD) that suggests a meat withdrawal time of
USP requirements: Not in USP{R-16}. thirty days would be sufficient to avoid violative residues{R-7; 14}.
U.S.{R-17}
1
Not included in Canadian product labeling or product not commercially
available in Canada. Withdrawal time
Note: The above withdrawal time applies when medication is adminis- Package and storage: Store at 20 to 25 C (68 to 77 F), unless
tered up to a maximum dose of 22 mg per kg of body weight as a single otherwise specified by the manufacturer{R-25}. Protect from freezing.
injection.{R-1} USP requirements: Not in USP{R-16}.