ALBON ® Tablets

Manufacturer
Zoetis Inc.
Effective date
2019-11-07
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:40:34

Label at a glance#

ProductAlbon
Active ingredientSULFADIMETHOXINE
Label structure15 sections

Indications and uses

 Albon is indicated for the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections in dogs and cats:    tonsillitis pharyngitis bronchitis pneumonia cystitis nephritis metritis pyometra  pustular dermatitis anal gland infections abscesses wound infections bacterial enteritis canine salmonellosis bacterial enteritis associated with coccidiosis in dogs when caused by streptococci, staphyl...

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 Size Approximate Animal Weight Initial Do...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ALBON®
(sulfadimethoxine tablets)
Tablets

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

CAUTION

SAFE HANDLING WARNING SECTION

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

Description

DESCRIPTION SECTION

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
Chemical Structure

Action

SPL UNCLASSIFIED SECTION

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

VETERINARY INDICATIONS SECTION

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

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

WARNING

WARNINGS SECTION

 Not for human use.

PRECAUTION

PRECAUTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 Size Approximate Animal Weight Initial Dose 25 mg/lb (55 mg/kg) Subsequent Daily Doses 12.5 mg/lb (27.5 mg/kg)
 125 mg 5 lb (2.2 kg) 1 tablet 1/2 tablet
 250 mg 10 lb (4.5 kg) 1 tablet 1/2 tablet
 500 mg 20 lb (9.1 kg) 1 tablet 1/2 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

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION

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

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

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

REFERENCES

REFERENCES SECTION

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.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 015-102

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40028552
Revised: August 2019

PRINCIPAL DISPLAY PANEL - 125 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

125 mg bottle label
125 mg bottle label

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 mg bottle label
250 mg bottle label

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mg bottle label
500 mg bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
897083Albon 125 MG Oral TabletPSN4
897087Albon 250 MG Oral TabletPSN4
897089Albon 500 MG Oral TabletPSN4
897079sulfadimethoxine 125 MG Oral TabletPSN4
897085sulfadimethoxine 250 MG Oral TabletPSN4
102797sulfadimethoxine 500 MG Oral TabletPSN4
897083sulfadimethoxine 125 MG Oral Tablet [Albon]SBD4
897087sulfadimethoxine 250 MG Oral Tablet [Albon]SBD4
897089sulfadimethoxine 500 MG Oral Tablet [Albon]SBD4
897079sulfadimethoxine 125 MG Oral TabletSCD4
897085sulfadimethoxine 250 MG Oral TabletSCD4
102797sulfadimethoxine 500 MG Oral TabletSCD4
897083Albon 125 MG Oral TabletSY4
897087Albon 250 MG Oral TabletSY4
897089Albon 500 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-8431-1Albon200 in 1 BOTTLE, PLASTICTABLET2004
54771-8432-1Albon500 in 1 BOTTLE, PLASTICTABLET5004
54771-8433-1Albon100 in 1 BOTTLE, PLASTICTABLET1004
54771-8433-2Albon500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-8431ALBON (SULFADIMETHOXINE) TABLET [ZOETIS INC.]41 package rows20191108_71a27a8a-038b-4b6d-8237-d6b58ddf9dc8.zip
54771-8432ALBON (SULFADIMETHOXINE) TABLET [ZOETIS INC.]41 package rows20191108_71a27a8a-038b-4b6d-8237-d6b58ddf9dc8.zip
54771-8433ALBON (SULFADIMETHOXINE) TABLET [ZOETIS INC.]42 package rows20191108_71a27a8a-038b-4b6d-8237-d6b58ddf9dc8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
sulfadimethoxineACTIVE INGREDIENT30CPC5LDEX1
sulfadimethoxineACTIVE MOIETY30CPC5LDEX1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-843154771-8431-1
54771-843254771-8432-1
54771-843354771-8433-1, 54771-8433-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.