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AMINOPENICILLINS (Veterinary—Systemic)

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AMINOPENICILLINS (Veterinary—Systemic) AMINOPENICILLINS (Veterinary—Systemic) This monograph includes information on the following: Amoxicillin; organisms.{R-3; 12} Ampicillin. Cattle: Ampicillin for injectable suspension is indicated for the treatment of respiratory tract infections caused by susceptible Some commonly used brand names are: organisms, including some bacterial pneumonias associated For veterinary-labeled products— with shipping fever complex.{R-3; 5} ELUS,CANHorsesEL: Ampicillin for injection is used for the treatment Amoxi-Drop [Amoxicillin] Moxilean-50 Suspension of pneumonia caused by susceptible organisms.{R-1} [Amoxicillin] Skin and soft tissue infections (treatment)— Amoxil Tablets Polyflex [Ampicillin] Cats and dogs: Amoxicillin for oral suspension, amoxicillin [Amoxicillin] tablets, and ampicillin for injectable suspension are indicated Amoxi-Tabs [Amoxicillin] and ELUS,CANampicillin for injectionEL is used in the treatment of soft tissue infections and wounds caused by susceptible For human-labeled products— organisms.{R-3; 5; 6; 14; 29} Apo-Ampi [Ampicillin] Nu-Ampi [Ampicillin] ELUS,CANHorsesEL: Ampicillin for injection is used in the treatment Novo-Ampicillin of skin and soft tissue infections, including abscesses and [Ampicillin] wounds, caused by susceptible organisms.{R-1} ELUS,CANStrangles (treatment)EL—Horses: Ampicillin for injection may be used in the treatment of strangles caused by susceptible Category: Antibacterial (systemic). {R-1} Streptococcus equi. Tonsillitis, bacterial (treatment); or Indications ELCANTracheobronchitis, bacterial (treatment)EL; or ELUS EL Note: The text between and describes uses that are not included Upper respiratory tract infections (treatment)—Cats and dogs: ELCAN EL in U.S. product labeling. Text between and describes uses Amoxicillin for oral suspension, amoxicillin tablets, and that are not included in Canadian product labeling. ampicillin for injectable suspension are indicated and The ELUS or ELCAN designation can signify a lack of product ELUS,CANampicillin for injectionEL is used in the treatment of availability in the country indicated. See the Dosage Forms tonsillitis and upper respiratory tract infections caused by section of this monograph to confirm availability. susceptible organisms.{R-3; 5; 6; 14; 29} ELCANAmoxicillin for oral suspension and amoxicillin tablets are indicated in the treatment General considerations of tracheobronchitis in dogs, caused by susceptible organisms.EL{R- The aminopenicillins have activity against penicillin-sensitive gram- 6; 14} positive bacteria as well as some gram-negative bacteria. Urinary tract infections, bacterial (treatment)—Cats and dogs: Ampicillin is effective against alpha- and beta-hemolytic Amoxicillin for oral suspension, amoxicillin tablets, and streptococci, including Streptococcus equi,{R-1} non–penicillinase- ampicillin for injectable suspension are indicated while producing Staphylococcus species, some Bacillus anthracis, and ELUS,CANampicillin for injection and ampicillin capsulesEL are used most strains of Clostridia.{R-3} Ampicillin is also effective against in the treatment of urinary tract infections, including cystitis and gram-negative bacteria, including many strains of Escherichia coli urethritis, caused by susceptible organisms.{R-3; 5; 6; 14; 15; 24; 29} (E. coli), Salmonella, and Pasteurella multocida.{R-3} Amoxicillin has the same spectrum of activity as ampicillin, but has slightly Potentially effective better activity against some gram-negative bacteria, including E. ELUS,CANBacterial infections (treatment)EL—Calves, nonruminating: At coli, and Salmonella species.{R-4} Most anaerobic bacteria, except one time, amoxicillin tablets were labeled in the United States for beta-lactamase–producing strains of Bacteroides, are sensitive to use in the treatment of infections in calves caused by susceptible amoxicillin.{R-78} The aminopenicillins are subject to destruction E. coli.{R-8} Although the labeled product is no longer available, by beta-lactamases and therefore are not effective against some oral amoxicillin may be used in the treatment of susceptible bacteria that produce these enzymes.{R-1; 3} Most strains of infections in calves. Klebsiella, Proteus, and Pseudomonas are resistant.{R-1; 23} ELUS,CANLeptospirosis (treatment)EL—Dogs: Although the efficacy has not been established, amoxicillin is used in therapy of Accepted leptospirosis in dogs. Penicillin and penicillin derivatives ELCANDermatitis, bacterial (treatment)EL—Dogs: Amoxicillin for oral (including amoxicillin) are considered to be effective for suspension and amoxicillin tablets are indicated in the treatment eliminating leptospiremia, but it is not known if they are effective of bacterial dermatitis caused by susceptible organisms; however, in terminating the carrier state.{R-13; 30; 31} amoxicillin is not the treatment of choice because bacteria that cause dermatitis are often resistant to this medication.{R-6; 14; 68-70} Regulatory Considerations Gastroenteritis, bacterial (treatment)—Cats and dogs: Amoxicillin for U.S. and Canada— ELCAN oral suspension, amoxicillin tablets, and ampicillin for Withdrawal times have been established for ampicillin for EL ELUS,CAN injectable suspension are indicated and ampicillin for injectable suspension. See the Dosage Forms section.{R-3; 5; 8} EL injection is used in the treatment of bacterial gastrointestinal tract infections caused by susceptible organisms.{R-3; 5; 6; 14; 29} Pneumonia, bacterial (treatment)— Chemistry ELCANCalves, nonruminatingEL: Ampicillin for injectable Source: {R-14} suspension is indicated for the treatment of respiratory tract Amoxicillin—Semisynthetic derivative of ampicillin. {R-1} infections caused by susceptible organisms, including some Ampicillin—Semisynthetic penicillin. bacterial pneumonias associated with shipping fever Chemical name: complex.{R-3} Amoxicillin—4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Cats and dogs: ELCANAmpicillin for injectable suspensionEL is acid, 6-[[amino(4-hydroxyphenyl)acetyl]amino]-3,3- indicated and ELUS,CAN amoxicillin for oral suspension, dimethyl-7-oxo-, trihydrate[2S-[2 alpha,5 alpha,6 beta(S*)]]- {R-16} amoxicillin tablets, and ampicillin for injectionEL are used in . the treatment of pneumonia caused by susceptible Ampicillin—4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic © 2007 The United States Pharmacopeial Convention All rights reserved 1 acid, 6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-, 86} Ampicillin trihydrate administered intramuscularly produces [2S-[2 alpha,5 alpha,6 beta(S*)]]-.{R-16} lower ampicillin blood concentrations that extend over a longer Ampicillin sodium—4-Thia-1-azabicyclo[3.2.0]heptane-2- period of time than does ampicillin sodium.{R-27; 49} carboxylic acid, 6-[(aminophenylacetyl)amino]-3,3-dimethyl- Note: There is evidence that giving amoxicillin and clavulanate 7-oxo-, mono-sodium salt, [2S-[2 alpha,5 alpha,6 beta(S*)]]- concurrently has little effect on the pharmacokinetics of .{R-16} either medication;{R-82} therefore, the following information Molecular formula: based on dosing with amoxicillin and clavulanate {R-16} Amoxicillin—C16H19N3O5S⋅3H2O. combination may be useful in predicting the absorption of {R-16} Ampicillin—C16H19N3O4S. amoxicillin alone. {R-16} {R-82} Ampicillin sodium—C16H18N3NaO4S. Calves— Molecular weight: Preruminant calves (2 weeks old): Absorption of Amoxicillin—419.45.{R-16} amoxicillin when administered orally in Ampicillin—349.40.{R-16} combination with clavulanate at doses of 10 to 20 Ampicillin sodium—371.39.{R-16} mg per kg of body weight (mg/kg) is 34 to 36%. Description: Early ruminant calves (6 weeks old): Absorption of Amoxicillin USP—White, practically odorless, crystalline amoxicillin and clavulanate combination is much powder.{R-17} poorer than in preruminant calves given the same Ampicillin USP—White, practically odorless, crystalline oral dose; therapeutic serum amoxicillin powder.{R-17} concentrations are not achieved in early ruminant Ampicillin Sodium USP—White to off-white, odorless or calves. practically odorless, crystalline powder. Is hygroscopic.{R-17} pKa:{R-22} Distribution: The aminopenicillins are rapidly and widely {R-6; 8; 23; 39} Amoxicillin—2.8 and 7.2. distributed into most body fluids with the exception of {R-69} Ampicillin—2.7 and 7.3. fluids of the eye and the prostate gland; also, distribution into {R-8} Solubility: cerebrospinal fluid is low unless the meninges are inflamed. {R-21; 34; 75} Amoxicillin USP—Slightly soluble in water and in methanol; Penetration into synovial fluid is high. insoluble in carbon tetrachloride and in chloroform.{R-17} Volume of distribution— Ampicillin USP—Slightly soluble in water and in methanol; Amoxicillin: Horses— insoluble in carbon tetrachloride and in chloroform.{R-17} Adults: {R-42} Ampicillin Sodium USP—Very soluble in water and in isotonic Area—0.33 liter per kg of body weight (L/kg). {R-86} sodium chloride and dextrose solutions.{R-17} Steady state—0.19 L/kg. Foals (6 to 7 days of age): Area—0.37 L/kg.{R-41} Pharmacology/Pharmacokinetics Steady state—0.27 L/kg.{R-41} Note: Unless otherwise noted, pharmacokinetic data in this section are Ampicillin: based on intravenous administration of ampicillin or amoxicillin. Cats—Area: 0.12 L/kg.{R-40} There is evidence that administering ampicillin concurrently Horses—Steady state: 0.18 L/kg;{R-23; 86} 0.26 L/kg.{R-85} with either gentamicin or kanamycin does not alter the {R-34; 84} pharmacokinetics of either of the medications in horses. Protein binding: Amoxicillin—Horses:
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