Label: ALBON- sulfadimethoxine liquid 

  • Label RSS
  • NDC Code(s): 61106-8435-5, 61106-8435-6
  • Packager: Pfizer Animal Health
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated 09/12

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  • SPL UNCLASSIFIED SECTION

    Oral Suspension 5%

    For the treatment of sulfadimethoxine-sensitive bacterial infections in dogs and cats and bacterial enteritis associated with coccidiosis in dogs.

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  • CAUTION

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

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  • DESCRIPTION

    Albon is a low-dosage, rapidly absorbed, long-acting sulfonamide, effective for the treatment of a wide range of bacterial infections commonly encountered in dogs and cats.

    Sulfadimethoxine is a white, almost tasteless and odorless compound. Chemically, it is N1-(2,6-dimethoxy-4-pyrimidinyl) sulfanilamide. The structural formula is:

    Chemical Structure
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  • CLINICAL PHARMACOLOGY

    Sulfadimethoxine has been demonstrated clinically or in the laboratory to be effective against a variety of organisms, such as streptococci, klebsiella, proteus, shigella, staphylococci, escherichia, and salmonella.1,2 These organisms have been demonstrated in respiratory, genitourinary, enteric, and soft tissue infections of dogs and cats.

    The systemic sulfonamides which include sulfadimethoxine are bacteriostatic agents. Sulfonamides competitively inhibit bacterial synthesis of folic acid (pteroylglutamic acid) from para-aminobenzoic acid. Mammalian cells are capable of utilizing folic acid in the presence of sulfonamides.

    The tissue distribution of sulfadimethoxine, as with all sulfonamides, is a function of plasma levels, degree of plasma protein binding, and subsequent passive distribution in the tissues of the lipid-soluble un-ionized form. The relative amounts are determined by both its pKa and by the pH of each tissue. Therefore, levels tend to be higher in less acid tissue and body fluids or those diseased tissues having high concentrations of leucocytes.2

    In the dog, sulfadimethoxine is not acetylated as in most other animals, and it is excreted predominantly as the unchanged drug.3 Sulfadimethoxine has a relatively high solubility at the pH normally occurring in the kidney, precluding the possibility of precipitation and crystalluria. Slow renal excretion results from a high degree of tubular reabsorption,4 and plasma protein binding is very high, providing a blood reservoir of the drug. Thus, sulfadimethoxine maintains higher blood levels than most other long-acting sulfonamides. Single, comparatively low doses of Albon give rapid and sustained therapeutic blood levels.1

    To assure successful sulfonamide therapy (1) the drug must be given early in the course of the disease, and it must produce a high sulfonamide level in the body rapidly after administration, (2) therapeutically effective sulfonamide levels must be maintained in the body throughout the treatment period, (3) treatment should continue for a short period of time after the clinical signs have disappeared, and (4) the causative organisms must be sensitive to this class of drugs.

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  • INDICATIONS AND USAGE

    Albon is indicated for the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections in dogs and cats:

    tonsillitis pustular dermatitis
    pharyngitis anal gland infections
    bronchitis abscesses
    pneumonia wound infections
    cystitis bacterial enteritis
    nephritis canine salmonellosis
    metritis bacterial enteritis associated
    pyometra with coccidiosis in dogs

    when caused by streptococci, staphylococci, escherichia, salmonella, klebsiella, proteus or shigella organisms sensitive to sulfadimethoxine.

    Limitations

    Sulfadimethoxine is not effective in viral or rickettsial infections, and as with any antibacterial agent, occasional failures in therapy may occur due to resistant microorganisms. The usual precautions in sulfonamide therapy should be observed.

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  • WARNING

    Not for human use.

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  • PRECAUTION

    During treatment period, make certain that animals maintain adequate water intake.

    If animals show no improvement within 2 or 3 days, reevaluate your diagnosis.

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  • DOSAGE AND ADMINISTRATION

    Initial Dose: 25 mg/lb (55 mg/kg) of animal body weight.

    Subsequent Daily Doses: 12.5 mg/lb (27.5 mg/kg) of animal body weight.

    Dogs and cats should receive 1 teaspoonful of Albon Oral Suspension 5% per 10 lb of body weight (25 mg/lb or 55 mg/kg) as an initial dose, followed by 1/2 teaspoonful per 10 lb of body weight (12.5 mg/lb or 27.5 mg/kg) every 24 hours thereafter. Representative weights and doses are indicated in the following table:

    Animal Weight Initial Dose
    25 mg/lb
    (55 mg/kg)
    Subsequent Daily Doses
    12.5 mg/lb
    (27.5 mg/kg)
    5 lb (2.2 kg) 1/2 tsp (2 1/2 mL) 1/4 tsp (1 1/4 mL)
    10 lb (4.5 kg) 1 tsp (5 mL) 1/2 tsp (2 1/2 mL)
    20 lb (9.1 kg) 2 tsp (10 mL) 1 tsp (5 mL)
    40 lb (18.2 kg) 4 tsp (20 mL) 2 tsp (10 mL)
    80 lb (36.4 kg) 8 tsp (40 mL) 4 tsp (20 mL)

    Treatment may be initiated with Albon Injection 40% to obtain effective blood levels almost immediately or to facilitate treatment of the fractious animal.

    Length of treatment depends on the clinical response. In most cases treatment for 3–5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

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  • TOXICITY AND SAFETY

    Data regarding acute and chronic toxicities of sulfadimethoxine indicate the drug is very safe. The LD50 in mice is greater than 2 g/kg of body weight when administered intraperitoneally and greater than 16 g/kg when administered orally. In dogs receiving massive single oral doses of 3.2 g/kg of body weight, diarrhea was the only adverse effect observed. Dogs given 160 mg/kg of body weight orally daily for 13 weeks showed no signs of toxicity.

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  • STORAGE

    Store at controlled room temperature 15°–30°C (59°–86°F).

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  • HOW SUPPLIED

    Albon Oral Suspension is available in 60- and 473-mL bottles; each tsp (5 mL) contains 250 mg sulfadimethoxine in a custard-flavored carrier.

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  • REFERENCES

    1. Data on file, Pfizer Animal Health.

    2. Stowe CM: The sulfonamides. In Jones LM (ed), Veterinary Pharmacology and Therapeutics, Ames, Iowa, Iowa State University Press, chapter 33, 1965.

    3. Bridges JW, Kirby MR, Walker SR, et al: Species differences in the metabolism of sulfadimethoxine. Biochem J 109:851, 1968.

    4. Baggot JD: Some aspects of drug persistence in domestic animals. Res Vet Sci 11(2):130, 1970.

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  • SPL UNCLASSIFIED SECTION

    NADA #43-785, Approved by FDA

    Distributed by:
    Pfizer Animal Health
    Div. of Pfizer Inc
    NY, NY 10017

    805 373 000

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  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    ALBON®
    (sulfadimethoxine)

    Oral Suspension 5%

    For oral use in dogs and cats

    For the treatment of
    sulfadimethoxine-sensitive
    bacterial infections in dogs and
    cats and bacterial enteritis
    associated with coccidiosis in dogs.

    does not meet USP for pH

    Not for Human Use

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

    250 mg/5 mL

    60 mL
    NADA #43-785, Approved by FDA

    Pfizer

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ALBON®
    (sulfadimethoxine)

    Oral Suspension 5%

    For oral use in dogs and cats

    For the treatment of
    sulfadimethoxine-sensitive
    bacterial infections in dogs and
    cats and bacterial enteritis
    associated with coccidiosis in dogs.

    does not meet USP for pH

    Not for Human Use

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

    250 mg/5 mL

    473 mL
    NADA #43-785, Approved by FDA

    Pfizer

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    ALBON 
    sulfadimethoxine liquid
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:61106-8435
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sulfadimethoxine (sulfadimethoxine) sulfadimethoxine 250 mg  in 5 mL
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CUSTARD Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-8435-5 60 mL in 1 BOTTLE, GLASS
    2 NDC:61106-8435-6 473 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA043785 07/02/1971
    Labeler - Pfizer Animal Health (039055157)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmacia and Upjohn Company 829076566 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Animal Health, Lincoln, NE 039055157 MANUFACTURE
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