Tylosin Injection: 50 mg/mL, 200 mg/mL

By | 2016-03-15

MACROLIDE ANTIBIOTIC

Highlights of Prescribing Information

  • Macrolide antibiotic related to erythromycin, used primarily in cattle & swine; sometimes used orally in cats/dogs for chronic colitis
  • Contraindications: hypersensitivity to it or other macrolide antibiotics; probably contraindicated in horses
  • Adverse Effects: Pain & local reactions after IM injection, GI upset (anorexia, & diarrhea). May cause severe diarrheas if administered PO to ruminants or by any route to horses. SWINE: edema of rectal mucosa & mild anal protrusion with pruritus, erythema, & diarrhea

What Is Drug Used For?

Although the injectable form of tylosin is approved for use in dogs and cats, it is rarely used parenterally in those species. Oral tylosin is sometimes recommended for the treatment of chronic colitis in small animals (see Doses), but controlled studies documenting its efficacy have not been performed.

Tylosin is also used clinically in cattle and swine for infections caused by susceptible organisms.

Pharmacology / Actions

Tylosin is thought to have the same mechanism of action as erythromycin (binds to 50S ribosome and inhibits protein synthesis) and exhibits a similar spectrum of activity. It is a bacteriostatic antibiotic. Tylosin may also have immunomodulatory effects on cell-mediated immunity. In dogs, tylosin increases concentrations of enterococci (Enterococcus fecalis) in the jejunum. Enterococci are thought to have probiotic effects.

For more specific information on organisms where tylosin is usually active, refer to the erythromycin monograph; cross-resistance with erythromycin occurs.

Pharmacokinetics

Tylosin tartrate is well absorbed from the GI tract, primarily from the intestine. The phosphate salt is less well absorbed after oral administration. Tylosin base injected SC or IM is reportedly rapidly absorbed.

Like erythromycin, tylosin is well distributed in the body after systemic absorption, with the exception of penetration into the CSE The volume of distribution of tylosin is reportedly 1.7 L/kg in small animals and 1-2.3 L/kg in cattle. In lactating dairy cattle, the milk to plasma ratio is reported to be between 1 – 5.4.

Tylosin is eliminated in the urine and bile apparently as unchanged drug. The elimination half-life of tylosin is reportedly 54 minutes in small animals, 139 minutes in newborn calves, and 64 minutes in calves 2 months of age or older.

Before you take Drug

Contraindications / Precautions / Warnings

Tylosin is contraindicated in patients hypersensitive to it or other macrolide antibiotics (e.g., erythromycin). Most clinicians feel that tylosin is contraindicated in horses, as severe and sometimes fatal diarrheas may result from its use in that species.

Adverse Effects

Most likely adverse effects with tylosin are pain and local reactions at intramuscular injection sites, and mild GI upset (anorexia and diarrhea). Tylosin may induce severe diarrheas if administered orally to ruminants or by any route to horses. In swine, adverse effects reported include edema of rectal mucosa and mild anal protrusion with pruritus, erythema, and diarrhea.

Reproductive / Nursing Safety

In a system evaluating the safety of drugs in canine and feline pregnancy (), this drug is categorized as in class: B (Safe for use if used cautiously. Studies in laboratory animals may have uncovered some risk, but these drugs appear to be safe in dogs and cats or these drugs are safe if they are not administered when the animal is near term.)

Overdosage / Acute Toxicity

Tylosin is relatively safe in most overdose situations. The LD50 in pigs is greater than 5 g/kg orally, and approximately 1 g/kg IM. Dogs are reported to tolerate oral doses of 800 mg/kg. Long-term (2 year) oral administration of up to 400 mg/kg produced no organ toxicity in dogs. Shock and death have been reported in baby pigs overdosed with tylosin, however.

Drug Interactions

Drug interactions with tylosin have not been well documented. It has been suggested that tylosin may increase digoxin blood levels with resultant toxicity. It is suggested to refer to the erythromycin monograph for more information on potential interactions.

Laboratory Considerations

■ Macrolide antibiotics may cause falsely elevated values of AST (SGOT), and ALT (SGPT) when using colorimetric assays.

■ Fluorometric determinations of urinary catecholamines can be altered by concomitant macrolide administration.

How to use Drug

Drug dosage for dogs:

When using Tylan Soluble (100 grams per bottle) powder: Using volumetric containers to measure powders is not necessarily accurate, but 1 level teaspoonful (5 mL) of powder contains approximately 2.5-2.7 grams of tylosin; l/8th of a teaspoonful contains approximately 325 mg tylosin.

  1. a) For small intestinal bacterial overgrowth: 10-20 mg/kg PO q12h; recommended for chronic cases, may require therapy for as long as 6 weeks. ()
  2. b) For adjunctive treatment of IBD: 10 mg/kg PO three times daily. Therapeutic trial for 21 days to evaluate efficacy. ()
  3. c) For clostridial colitis: 10-40 mg/kg PO twice daily. Practically (using the wettable powder): Vi6th of teaspoon 2-3 times daily for dogs (<7kg); Vfcth of a teaspoon 2-3 times a day for medium dogs (7-15 kg); and 1/4 teaspoon 2-3 times a day for larger dogs (>15 kg). Mix with food to hide unpleasant taste or put into capsules. Animals with chronic clostridial colitis can often be controlled with one treatment every 2-3 days. ()
  4. d) For IBD and antibiotic responsive diarrhea: 20-40 mg/kg PO q12h ()

Drug dosage for cats:

When using Tylan Soluble (100 grams per bottle) powder: Using volumetric containers to measure powders is not necessarily accurate, but 1 level teaspoonful (5 mL) of powder contains approximately 2.5-2.7 grams of tylosin; l/8th of a teaspoonful contains approximately 325 mg tylosin.

  1. a) For adjunctive treatment of IBD: 10 mg/kg PO three times daily. Therapeutic trial for 21 days to evaluate efficacy. ()
  2. b) For treatment of IBD or diarrheas caused by perfringens: 20-40 mg/kg PO twice daily ()
  3. c) For IBD: 40 mg/kg PO q12h ()
  4. d) For clostridial colitis: 10-40 mg/kg PO twice daily. Practically (using the wettable powder): Vi6th of teaspoon 2-3 times daily. Mix with food to hide unpleasant taste or put into capsules. Animals with chronic clostridial colitis can often be controlled with one treatment every 2-3 days. ()

Drug dosage for ferrets:

For susceptible infections:

  1. a) 10 mg/kg PO once to twice daily ()

Drug dosage for rabbits, rodents, small mammals:

  1. a) Rabbits: 10 mg/kg PO, SC, IM ql2-24h ()
  2. b) Gerbils, Hamsters, Rats: 10 mg/kg SC q24h ()

Drug dosage for cattle:

For susceptible infections:

  1. a) 17.6 mg/kg IM once daily. Continue treatment for 24 hours after symptoms have stopped, not to exceed 5 days. Do not inject more than 10 mL per site. Use the 50 mg/mL formulation in calves weighing less than 200 pounds. (Package insert; Tylosin Injection — TechAmerica)
  2. b) For bronchopneumonia and fibrinous pneumonia in cattle associated with penicillin G-refractory pyogenes infections or other bacteria sensitive to tylosin and resistant to sulfas, penicillin G and tetracyclines: using Tylosin 200 mg/mL: 44 mg/kg IM q24h. Recommend a 21-day slaughter withdrawal at this dosage. ()
  3. c) 5-10 mg/kg IM or slow IV once daily; not to exceed 5 days ()
  4. d) Tylosin base injectable: 10 mg/kg IM initially, then 6 mg/kg IM q8h (q8- 12h in calves) ()

Drug dosage for swine:

For susceptible infections:

  1. a) 8.8 mg/kg IM twice daily. Continue treatment for 24 hours after symptoms have stopped, not to exceed 3 days. Do not inject more than 5 mL per site. (Package insert; Tylosin Injection — TechAmerica)
  2. b) 5-10 mg/kg until 24 hours after remission of disease signs; not to exceed 3 days therapy ()
  3. c) Tylosin base injectable: 12.5 mg/kg IM q12h ()

Drug dosage for sheep and goats:

For susceptible infections:

  1. a) 10 mg/kg, treatment not to exceed 5 days ()

Drug dosage for birds:

For susceptible infections:

  1. a) For initial therapy in caged birds for upper respiratory infections (especially if mycoplasma suspected).

Using 200 mg/mL injectable: 40 mg/kg IM. Used in combination with aminoglycosides. ()

  1. b) For initial therapy of upper respiratory infections and air sacculitis. Using 50 mg/mL or 200 mg/mL injectable: 10-40 mg/kg IM twice daily or three times daily ()
  2. c) 30 mg/kg IM q12h ()

Drug dosage for reptiles:

For susceptible infections:

  1. a) For tortoises: 5 mg/kg IM once daily for at least 10 days. Used primarily for chronic respiratory infections or when Mycoplasma is suspected ()
  2. b) All species: 5 mg/kg IM once daily ()

Monitoring

■ Clinical efficacy

■ Adverse effects

Chemistry / Synonyms

A macrolide antibiotic related structurally to erythromycin, tylosin is produced from Streptomyces fradiae. It occurs as an almost white to buff-colored powder with a pKa of 7.1. It is slightly soluble in water and soluble in alcohol. Tylosin is considered highly lipid soluble. The tartrate salt is soluble in water. The injectable form of the drug (as the base) is in a 50% propylene glycol solution.

Tylosin may also be known as Desmycosin, tilosina, tylozin, tylosiini, tylosinum, tylozyna or Tylan.

Storage / Stability / Compatibility

Unless otherwise instructed by the manufacturer, injectable tylosin should be stored in well-closed containers at room temperature. Tylosin, like erythromycin, is unstable in acidic (pH <4) media. It is not recommended to mix the parenteral injection with other drugs.

Dosage Forms / Regulatory Status

Veterinary-Labeled Products:

Note: The product Tylan Plus Vitamins was used extensively orally in companion animals, but has been withdrawn from the market. Tylan Soluble may be substituted, but is significantly more concentrated than Tylan Plus Vitamins and dosage sizes (teaspoons are not equivalent) will be different.

Tylosin Injection: 50 mg/mL, 200 mg/mL; Tylan (Elanco); generic; (OTC). Approved for use in nonlactating dairy cattle, beef cattle, swine, dogs, and cats. Slaughter withdrawal (at labeled doses): cattle = 21 days; swine = 14 days. Note: Although this author (Plumb) was unable to locate parenteral products approved for use in lactating dairy animals, one source states that tylosin has a 72 hour milk withdrawal for dairy cattle, and 48 hour milk withdrawal in dairy goats and sheep. Contact FARAD for more information before using in lactating dairy animals.

Tylosin Tartrate Powder: (approximately 2.5-2.7 grams/level tea-spoonsful) in 100 g bottles; Tylan Soluble (Elanco); (OTC). Approved for use in turkeys (not layers), chickens (not layers) and swine. Slaughter withdrawal swine = 2 days; chickens = 1 day; turkeys = 5 days.

There are many approved tylosin products for addition to feed or water for use in beef cattle, swine, and poultry. Many of these products have other active ingredients included in their formulations.

Human-Labeled Products: None.

 

Plumb’s Veterinary Drug Handbook. 2008