ALBON® (sulfadimethoxine) Tablets

ALBON- sulfadimethoxine tablet 
Pfizer Animal Health

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

CAUTION

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

DESCRIPTION

Albon is a low-dosage, rapidly absorbed, longacting 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

Action

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.

INDICATIONS AND USAGE

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

tonsillitispustular dermatitis
pharyngitisanal gland infections
bronchitisabscesses
pneumoniawound infections
cystitisbacterial enteritis
nephritiscanine salmonellosis
metritisbacterial enteritis associated
pyometrawith 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.

WARNING

Not for human use.

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.

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.

For ease of administration in animals of varying weights, 3 tablet sizes are provided. The following table indicates how dosage may be adjusted depending on tablet size and body weight. Subsequent doses should be given at 24-hour intervals.

Tablet SizeApproximate Animal WeightInitial Dose
25 mg/lb
(55 mg/kg)
Subsequent Daily Doses
12.5 mg/lb
(27.5 mg/kg)
125 mg5 lb (2.2 kg)1 tablet1/2 tablet
250 mg10 lb (4.5 kg)1 tablet1/2 tablet
500 mg20 lb (9.1 kg)1 tablet1/2 tablet

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.

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.

STORAGE

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

HOW SUPPLIED

Albon Tablets are available in the following strengths for dogs and cats: 125 mg, 250 mg, or 500 mg sulfadimethoxine per tablet.

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.

NADA #15-102, Approved by FDA for Tablets

MADE IN INDIA

Logo

75-8430-11IN.OO
MAR 2008

PRINCIPAL DISPLAY PANEL - 125 mg Tablet Bottle Label

ALBON®
(sulfadimethoxine)

Not for Human Use

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

125 mg

200 Tablets

NADA #15-102, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 125 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

ALBON®
(sulfadimethoxine)

Not for Human Use

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

250 mg

500 Tablets

NADA #15-102, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

ALBON®
(sulfadimethoxine)

Not for Human Use

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

500 mg

100 Tablets

NADA #15-102, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label
ALBON 
sulfadimethoxine tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61106-8430
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfadimethoxine (sulfadimethoxine) sulfadimethoxine125 mg
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Bi-convex, cylindrical) Size8mm
FlavorImprint Code ALBON;125
Contains    
Packaging
#Item CodePackage Description
1NDC:61106-8430-1200 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01510212/14/1964
ALBON 
sulfadimethoxine tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61106-8431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfadimethoxine (sulfadimethoxine) sulfadimethoxine250 mg
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (Flat faced, cylindrical with beveled edges) Size10mm
FlavorImprint Code ALBON;250
Contains    
Packaging
#Item CodePackage Description
1NDC:61106-8431-1500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01510212/14/1964
ALBON 
sulfadimethoxine tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61106-8432
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfadimethoxine (sulfadimethoxine) sulfadimethoxine500 mg
Product Characteristics
ColorWHITEScore4 pieces
ShapeROUND (Flat faced, cylindrical with beveled edges) Size13mm
FlavorImprint Code ALBON;500
Contains    
Packaging
#Item CodePackage Description
1NDC:61106-8432-1100 in 1 BOTTLE, PLASTIC
2NDC:61106-8432-2500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA01510212/14/1964
Labeler - Pfizer Animal Health (039055157)
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals LTD862602830MANUFACTURE

Revised: 07/2012
 
Pfizer Animal Health