Elephant specific information, if available, is in blue.

Chemistry – An antibiotic obtained from Streptomyces niveus or spheroides, novobiocin sodium occurs as white to light yellow, crystalline powder and is very soluble in water.

 

Storage/Stability/Compatibility – Novobiocin should be stored in tight containers and at room temperature unless otherwise directed.

 

Pharmacology – Novobiocin is believed to act in several ways in a bactericidal manner. It inhibits bacterial DNA gyrase, thereby interfering with protein and nucleic acid synthesis. It also interferes with bacterial cell wall synthesis. Activity of the drug is enhanced in an alkaline medium.

 

The spectrum of activity of novobiocin includes some gram positive cocci (Staphs, Streptococcus pneumonia, and some group A streps). Activity is variable against other Streptococci and weak against the Enterococci. Most gram negative organisms are resis­tant to the drug, but some Haemophilus sp., Neisseria sp., and Proteus sp. may be suscep­tible.

 

Uses/Indications – As a single agent, novobiocin is approved for use in dry dairy cattle as a mastitis tube and as a premix for chickens, turkeys, ducks, and mink. It is available in combination with procaine penicillin G to treat mastitis in lactating dairy cattle. Novobiocin is available in combination with tetracycline ± prednisolone for oral use in dogs.

 

Pharmacokinetics – After oral administration, novobiocin is well absorbed from the GI tract. Peak levels occur within 1-4 hours. The presence of food can decrease peak concen­trations of the drug.

 

Novobiocin is only poorly distributed to body fluids with concentrations in synovial, pleural and ascitic fluids less than those found in the plasma. Only minimal quantities of the drug cross the blood-brain barrier, even when meninges are inflamed. Highest concen­trations of novobiocin are found in the small intestine and liver. The drug is approximately 90% protein bound and is distributed into milk.

 

Novobiocin is primarily eliminated in the bile and feces. Approximately 3% is excreted into the urine and urine levels are usually less than those found in serum.

 

Contraindications/Precautions/Reproductive Safety – Novobiocin is contraindicated in patients hypersensitive to it. Additionally, the drug should be used with extreme caution in patients with preexisting hepatic or hematopoietic dysfunction. Safety during pregnancy has not been established; use only when clearly indicated.

 

Adverse Effects/Warnings – Adverse effects reported with the systemic use of this drug include fever, GI disturbances (nausea, vomiting, diarrhea), rashes and blood dyscrasias. In humans, occurrances of hypersensitivity reactions, hepatotoxicity and blood dyscrasias have significantly limited the use of this drug.

 

Overdosage/Acute Toxicity – Little information is available regarding overdoses of this drug. It is suggested that large oral overdoses be handled by emptying the gut following standard protocols; monitor and treat adverse effects symptomatically if necessary.

 

Drug Interactions – Novobiocin reportedly acts similarly to probenecid by blocking the tubular transport of drugs. Although the clinical significance of this is unclear, the elimi­nation rates of drugs excreted in this manner (e.g.,penicillins, cephalosporins) could be decreased and half-lives prolonged.

 

Drug/Laboratory Interactions – Novobiocin can be metabolized into a yellow-colored product that can interfere with serum bilirubin determinations. It may also interfere with the determination BSP (bromosulfophthalein, sulfobromophthaelein) uptake tests by alter­ing BSP uptake or biliary excretion.

 

Doses –

Dogs:

For susceptible infections:

a)   10 mg/kg q8h PO (Greene 1984)

 

For susceptible infections using the combination product (with tetracycline):

a)   22 mg/kg of each antibiotic PO q12h (Package insert; Albaplex®—Upjohn)

 

Cattle:

For treatment of mastitis in dry cows:

a)   Infuse contents of one syringe into each quarter at the time of drying off; not later than 30 days prior to calving. (Package directions; Drygard® Suspension —Upjohn)

For treatment of mastitis in lactating cows:

a)   Using the penicillin/novobiocin product (Special Formula 17900-Forte®): Infuse contents of one syringe in each infected quarter. Repeat once in 24 hours. (Package Directions; Special Formula 17900-Forte®—Upjohn)

 

 

Client Information: Shake mastitis tubes well before using.

 

Monitoring Parameters –

1)   Clinical efficacy

2)   Adverse effects

3    Periodic liver function tests and CBC’s are recommended if using long-term sys­temically.

 

Dosage Forms/Preparations/FDA Approval Status/Withholding Times –

 

Veterinary-Approved Products:

Novobiocin (as the sodium) Oil Suspension 400 mg per 10 ml Mastitis tube; Drygard® Suspension (Upjohn); (OTC)  Approved for use in dry cows. Not to be used within 30 days of calving. Slaughter withdrawal = 30 days.

 

Novobiocin Premix 17.5 g/lb, and 25 g/lb; Albamix® Premix  (Upjohn); (OTC)  Approved for use in chickens (not layers), turkeys (not layers for human consump­tion), ducks, and mink. Slaughter withdrawal = chickens and turkeys (4 days), ducks (3 days), and mink (none).

 

Novobiocin Combination Products:

Novobiocin (as the sodium salt) 150 mg and Penicillin G Procaine 100,000 IU per 10 ml Mastitis Syringe; Special Formula 17900-Forte®  (Upjohn); (OTC)  Approved for use in lactating dairy cattle. Milk withdrawal = 72 hours. Slaughter withdrawal = 15 days.

 

Novobiocin Sodium 60 mg and Tetracycline HCl 60 mg tablets; Novobiocin Sodium 180 mg and Tetracycline HCl 180 mg tablets; Albaplex®  and Albaplex® 3X (Upjohn); (Rx)  Approved for use in dogs.

 

Novobiocin Sodium 60 mg, Tetracycline HCl 60 mg & Prednisolone 1.5 mg tablets; Novobiocin Sodium 180 mg, Tetracycline HCl 180 mg & Prednisolone 4.5 mg tablets; Delta Albaplex®  and Delta Albaplex® 3X (Upjohn); (Rx)  Approved for use in dogs.

 

Human-Approved Products:

Novobiocin (as the sodium) 250 mg Capsules; Albamycin®  (Upjohn); (Rx)