Delta Albaplex / Delta Albaplex 3X

NDC 0009-0593-02

NDC 0009-3357-01

Brand of Tetracycline Hydrochloride, Novobiocin Sodium and Prednisolone Tablets

For Use in Animals Only

Important Note

The prednisolone component of DELTA ALBAPLEX Tablets containing tetracycline hydrochloride, novobiocin sodium and prednisolone has been shown to contribute to clinical response if administered only for the first 48 hours of treatment. Subsequent antibacterial treatment is to be continued with ALBAPLEX^® Tablets containing tetracycline hydrochloride and novobiocin sodium. See INDICATIONS and DOSAGE Sections following.

Description

DELTA ALBAPLEX Tablets contain prednisolone, which provides a faster clinical response in the indicated conditions and a combination of two antibiotics-tetracycline hydrochloride and novobiocin sodium-which supplies additive antibacterial effect against certain bacterial pathogens.

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Tetracycline Hydrochloride

Tetracycline hydrochloride is an odorless, yellow, fine crystalline powder which is freely soluble in water and gastric juice. It is absorbed readily from the gastrointestinal tract. Following oral administration to dogs, peak blood concentrations are obtained within two to four hours, significant levels are found at twelve hours, and detectable amounts remain in the serum for at least 24 hours. The antibiotic is excreted principally through the kidney.

The in vitro spectrum of antimicrobial activity of tetracycline hydrochloride includes a broad range of gram-positive and gram-negative bacteria such as alpha and beta streptococci, some strains of staphylococci, Klebsiella pneumoniae, certain clostridia, Shigella, Aerobacter aerogenes, and some strains of Salmonella. The clinical significance of this has not been determined.

In an in vivo study, it was shown that tetracycline hydrochloride is significantly more effective than novobiocin sodium in eliminating pathogenic streptococci organisms from the throats of dogs suffering from upper respiratory infections. However, it was also shown that tetracycline hydrochloride was significantly less effective than novobiocin sodium in eliminating pathogenic staphylococci.

Studies conducted in laboratory animals show that tetracycline hydrochloride has a low order of toxicity comparable to that of the other tetracyclines.

Novobiocin Sodium

Novobiocin sodium is an antibiotic produced by Streptomyces niveus and was developed in the Research Laboratories of The Upjohn Company. The crystalline antibiotic has a light yellow to white color, depending upon the state of subdivision. In contrast to most antibiotics produced by actinomycetes, novobiocin sodium, like penicillin, is acidic in nature and is stable to the degree of acidity or alkalinity present in the gastrointestinal tract. Following oral administration of 10 mg per lb to dogs, peak blood concentrations are obtained within one to two hours and significant levels remain at twelve hours. When an appreciable amount of novobiocin sodium is present in the serum, the drug diffuses into the pleural and ascitic fluids. Novobiocin sodium does not diffuse into the cerebrospinal fluid. The antibiotic is concentrated in the liver and bile and is excreted in the feces and urine. As determined by tests in animals, novobiocin sodium has a relatively low order of toxicity.

In vitro studies show that novobiocin sodium is active against both gram-positive and gram-negative bacteria, including some strains of Staphylococcus aureus, Streptococcus hemolyticus, Diplococcus pneumoniae, and some strains of Proteus vulgaris. The clinical significance of this has not been determined. Novobiocin sodium shows no cross-resistance with penicillin against resistant strains of Staphylococcus aureus. However, in vitro studies indicate that Staphylococcus aureus may develop resistance to novobiocin sodium as with other antibiotics.

Prednisolone

Prednisolone, a derivative of hydrocortisone, has greater glucocorticoid activity, greater anti-inflammatory activity, less sodium-retaining effect, and less potassium-losing effect than the parent compound. The glucocorticoid activity of prednisolone is approximately three times that of hydrocortisone, and the dose required to produce a given anti-inflammatory effect in dogs is of the order of one-fourth to one-third the required dose of hydrocortisone (or about one-fifth the required dose of cortisone).

Prednisolone exerts an inhibitory influence on the cellular, fibrous, and amorphous components of connective tissue and thereby suppresses the basic processes of inflammation. Vascular permeability is decreased, exudation diminished and migration of inflammatory cells markedly impaired. In infections characterized by stress and/or toxicity, prednisolone therapy, in conjunction with properly indicated antibacterial therapy, is helpful in reducing the clinical signs and in speeding the recovery of the animal being treated.

Combined Antibiotic-adrenocortical Therapy

DELTA ALBAPLEX Tablets have been formulated to provide for the use of tetracycline hydrochloride, novobiocin sodium, and prednisolone. It provides a broad antibacterial effect from the combined antibiotics plus the anti-inflammatory effects of prednisolone.

Combined antibiotic therapy offers a wider range of antibacterial activity than therapy with either of the single antibiotics. In vitro studies with tetracycline hydrochloride and novobiocin sodium have indicated that this antibiotic combination is effective against such organism as Staphylococcus aureus, Streptococcus fecalis and Proteus rettgeri. Moreover, in vitro studies have shown that the development of resistance by Staphylococcus aureus to a combination of tetracycline hydrochloride and novobiocin sodium occurs at a markedly slower rate than to either antibiotic alone. Studies in mice infected with Staphylococcus aureus have indicated that tetracycline hydrochloride and novobiocin sodium are compatible in vivo against the strains tested.

An in vivo clinical study in dogs has shown that the combination of novobiocin sodium and tetracycline hydrochloride is significantly more effective than either single antibiotic in eliminating pathogenic Staphylococcus spp. and E. coli from the throats of dogs suffering from upper respiratory disease. This study also showed that the incidence of treatment failure is significantly reduced when novobiocin sodium and tetracycline hydrochloride are administered concurrently.

In dogs with upper respiratory infections, the prednisolone component of DELTA ALBAPLEX results in a significantly faster reduction in the clinical signs of illness in the first 48 hours of treatment than is achievable by therapy with novobiocin sodium and tetracycline hydrochloride, either singly or in combination. After 48 hours, treatment is to be continued for 3 days with ALBAPLEX Tablets containing tetracycline hydrochloride and novobiocin sodium.

Delta Albaplex / Delta Albaplex 3X Indications

DELTA ALBAPLEX Tablets are indicated in the treatment of acute or chronic upper respiratory conditions, ie, tonsillitis, bronchitis, and tracheobronchitis, when it is necessary to initially reduce the severity of associated clinical signs and when caused by pathogens susceptible to novobiocin sodium and tetracycline hydrochloride such as Staphylococcus spp. and E. coli.

The product has been shown to be of maximum benefit when used during the first 48 hours of treatment. Subsequent therapy should be continued with ALBAPLEX Tablets containing novobiocin sodium and tetracycline hydrochloride for an additional 3 days or longer as needed.

As with all antibiotics, appropriate in vitro culturing and susceptibility tests should be conducted on samples taken before treatment is started.

Contraindications

As with other adrenocortical steroids, this product is contraindicated in animals with tuberculosis, hyperadrenocorticism and peptic ulcers.

Warning

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca.

Delta Albaplex / Delta Albaplex 3X Caution

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

Precautions

In the following conditions this product should be used with caution; diabetes mellitus, osteoporosis, predisposition to thrombophlebitis, hypertension, congestive heart failure, and renal insufficiency.

All necessary procedures for establishment of a bacterial diagnosis should be carried out whenever possible before institution of therapy. Combined antibiotic corticosteroid therapy does not obviate the need for indicated surgical procedures.

Side Effects

Because of the wide antibacterial effect of this antibiotic combination on intestinal flora, a change in the character of the stools may be anticipated in certain animals; however, administration of novobiocin sodium and tetracycline hydrochloride, combined, to dogs at exaggerated doses for six months caused no significant toxicity. If allergic reactions develop during treatment with this product, use of it should be discontinued.

Since the use of any broad spectrum antibiotic may result in overgrowth of nonsusceptible organisms, constant observation of the animal patient is essential. If new infections appear during therapy, appropriate measures should be taken.

Injudicious use of adrenal hormones in animals with infections can be hazardous. It is, therefore, essential that effective antibacterial agents be administered concurrently. Alteration of the inflammatory reaction by corticosteroid therapy may be beneficial; however, it may also mask signs of infection and facilitate spread of micro-organisms. In addition, systemic manifestations, such as fever and signs of toxemia, may be suppressed. Aretardant effect on wound healing has not been encountered with prednisolone, but such a possibility should be considered if it is used in conjunction with surgery.

While the use of DELTA ALBAPLEX Tablets in the recommended doses is not likely to induce the side effects commonly associated with prolonged or intensive adrenocorticoid therapy, overdosage may give rise to the following; hyperglycemia and glycosuria; nitrogen loss; and suppression of endogenous adrenocortical activity. The most commonly observed symptoms of overdosage in the dog are polydipsia and polyuria.

Dosage

The dosage for dogs is 10 mg of each antibiotic and 0.25 mg prednisolone per lb of body weight repeated at 12 hour intervals for 48 hours. This dose can be given as follows:

DELTA ALBAPLEX Tablets (one tablet for each 6 lbs of body weight)

DELTA ALBAPLEX 3X Tablets (one tablet for each 18 lbs of body weight)

Antibacterial treatment is to be continued with ALBAPLEX Tablets containing novobiocin sodium and tetracycline hydrochloride at the same dose schedule for an additional 3 days.

How Supplied

DELTA ALBAPLEX Tablets are available in bottles of 500.

DELTA ALBAPLEX 3X Tablets are available in bottles of 250.

NADA #65-090, Approved by FDA

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Made in Canada for Pharmacia & Upjohn Company, Kalamazoo, Michigan 49001, USA

By Patheon YM Inc., Toronto, Ontario M3B 1Y5, Canada

Revised October 2002

811 242 108

811 242 208

NAC No.: 3690470.0