Linco-Spectin Sterile Solution (Canada)

Company: Zoetis

lincomycin hydrochloride and spectinomycin sulfate sterile solution

DIN 00813893

Veterinary Use Only

Antibiotic

MEDICINAL INGREDIENTS: Lincomycin (as lincomycin hydrochloride), 50 mg/mL and spectinomycin (as spectinomycin sulfate), 100 mg/mL

PRESERVATIVE: Benzyl alcohol, 9 mg/mL

Description

Lincomycin is an antibiotic produced by Streptomyces lincolnensis and is chemically distinct from all other clinically available antibiotics. It is readily soluble in water. It is effective in vitro against most of the common gram-positive pathogens.

Spectinomycin is an antibiotic produced by Streptomyces flavopersicus. Spectinomycin free base is weakly basic and readily soluble in water. It has in vivo and in vitro activity against many gram-positive and gram-negative organisms but, like lincomycin, is inactive against yeasts, molds, and viruses.

Linco-Spectin Sterile Solution Indications

For the treatment of infections in dogs and cats caused by Staphylococcus aureus, Pasteurella multocida, Streptococcus spp. and Mycoplasma spp.

Dogs: Linco-Spectin Sterile Solution has demonstrated efficacy in the treatment of respiratory infections, skin diseases and urinary tract infections. Specifically, infections successfully treated with Linco-Spectin Sterile Solution include pneumonia, pharyngitis, tonsillitis, bronchitis, pyogenic dermatitis, pustular dermatitis, abscesses, cystitis and metritis.

Cats: Linco-Spectin Sterile Solution has demonstrated efficacy in the treatment of urinary tract and upper respiratory tract infections and localized infections. Infections successfully treated with Linco-Spectin Sterile Solution in cats include cystitis, upper respiratory tract infections, and infected fight wounds and abscesses.

Dosage and Administration

Linco-Spectin Sterile Solution is for intramuscular injection only. Dosage may be calculated on the basis of spectinomycin content so as to provide 20 mg spectinomycin per kg body weight, or 1.0 mL Linco-Spectin Sterile Solution per 5 kg body weight.

The dose may be repeated at 12 - 24 hour intervals for up to 21 days. Monitoring of patients should be carried out to assure safety and efficacy of Linco-Spectin Sterile Solution when treating conditions that require prolonged therapy. As with all antibiotics, it is recommended that in vitro sensitivity studies be conducted as a basis for selection of Linco-Spectin Sterile Solution.

Pharmacology

When Linco-Spectin Sterile Solution (100 mg spectinomycin and 50 mg lincomycin) was administered intramuscularly to dogs, peak levels of both antibiotics were obtained in one hour. At doses of 15 mg spectinomycin and 7.5 mg lincomycin/kg, peak serum levels for spectinomycin were 42.0 mcg/mL and for lincomycin, 4.50 mcg/mL. These levels are in excess of the minimum inhibitory concentrations of the two antibiotics for many bacteria. Studies indicate that bile is an important route of excretion of lincomycin. Significant levels of lincomycin have been demonstrated in the majority of body tissues. After a single oral administration of lincomycin to a dog, fecal excretion amounted to 77% of the dose; urinary excretion to 14%. After a single intramuscular injection, fecal excretion equalled 38% of the dose; and urinary excretion, 49%. Urinary excretion was essentially complete in less than 24 hours and fecal excretion by 48 hours after either route of administration. Lincomycin has also been shown to be excreted in the milk of lactating cows, goats, rats, and women.

Following intramuscular administration, spectinomycin is rapidly excreted in the urine.

MICROBIOLOGY: In vitro studies have demonstrated microbiostatic activity of Linco-Spectin Sterile Solution against ten microbial agents, including three strains of canine Mycoplasma spp., two strains of Staphylococcus aureus, three strains of Pasteurella multocida, and two strains of haemolytic streptococci.

Linco-Spectin Sterile Solution has been demonstrated to be effective in vivo against such organisms as Mycoplasma spp., Staphylococcus aureus, Streptococcus spp., and Pasteurella multocida.

SAFETY:

Lincomycin: The acute LD₅₀ intraperitoneally in mice is 1000 mg/kg and orally in rats is 15,645 mg/kg. It was well tolerated when administered orally to rats and dogs at doses up to 300 mg/kg/day for up to one year. Parenteral administration of 60 mg/kg/day for 30 days produced no evidence of toxicosis detectable at necropsy.

Administration of lincomycin parenterally to pregnant rats and dogs in sustained parenteral dosage did not produce a teratogenic effect upon the embryos.

Spectinomycin: The oral LD₅₀ for spectinomycin in the rat was found to be 13,685 mg/kg. The dog has tolerated single oral doses of 1000 mg/kg and single intravenous doses of 500 and 1000 mg/kg. An intravenous dose of 2000 mg/kg in the dog produces transient collapse. Continuous oral doses of up to 500 mg/kg for four weeks did not produce signs of toxicosis in the dog.

Linco-Spectin Sterile Solution: Studies conducted in rats demonstrated that there was no potentiation or antagonistic effect shown by the equitoxic mixture of the two compounds administered orally. Linco-Spectin Sterile Solution was administered intramuscularly to dogs twice daily for 21 days at a dose of 15, 50, or 150 mg/kg spectinomycin and 7.5, 25, or 75 mg/kg lincomycin.

No evidence of toxicosis was detected either grossly or by clinical chemistry during treatment or at necropsy. Only moderate irritation was noted at the injection sites and only two dogs on the higher levels showed transient signs of pain following injection.

In a similar study, Linco-Spectin Sterile Solution was administered intramuscularly to cats for 21 days to provide 5 or 25 mg lincomycin/kg and 10 or 50 mg spectinomycin/kg twice daily. All injections were well tolerated. No signs of toxicosis were detected clinically during administration or by gross examination at necropsy.

Only mild to moderate signs of muscular and subcutaneous irritation were observed at necropsy.

Adverse Reactions

Diarrhea was reported to have occurred in two cats treated with Linco-Spectin Sterile Solution. Neither case required adjunctive therapy to correct the diarrhea following drug withdrawal.

Some decrease in appetite was observed in one dog treated for ten days with Linco-Spectin Sterile Solution. Several investigators reported observing signs of pain upon injection, but serious inflammatory reactions following injection have not been reported.

Contraindications

(1) As with all drugs, the administration of Linco-Spectin Sterile Solution is contraindicated in animals previously found to be hypersensitive to either lincomycin or spectinomycin or to the combination. (2) Lincomycin has been demonstrated to be toxic for rabbits, guinea pigs, hamsters and chinchillas. Linco-Spectin Sterile Solution is, therefore, contraindicated in these species.

Warnings

For intramuscular use in dogs and cats only. Keep out of reach of children.

CAUTIONS: Linco-Spectin Sterile Solution, like any drug, should be used with caution in animals with a history of significant allergies.

The use of antibiotics occasionally results in overgrowth of non susceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken.

Storage

Store between 15 and 30°C. The appearance of a slight haze in an unopened vial of Linco-Spectin Sterile Solution may occur, but does not affect the potency or therapeutic efficacy of the product.

PRESENTATION: Linco-Spectin Sterile Solution is available in 50 mL vials.

Zoetis is a trademark and Linco-Spectin is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9H 4M7

40024050

1632-11-2

CPN: 1198295.5