Description
TYLOSIN INJECTION B.P. (Vet.) 20% W/V
NOT FOR HUMAN USE FOR ANIMAL TREATMENT ONLY
COMPOSITION:
Each ml contains:
Tylosin Tartrate B.P.
equivalent to Tylosin base 200 mg
Benzyl alcohol B.P. 2% v/v
Propylene glycol B.P. and
Water for Injection B.P. (1:1) q.s.
DESCRIPTION:
A pale yellow to amber color solution.
INDICATIONS:
Cattle: Tylosin Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Actinomyces pyogenes: foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Actinomyces pyogenes.
Sheep: Pneumonia, arthritis, contagious and acute agalactia due to Mycoplasma agalactiae, mastitis
Goats: Contagious pleuropneumonia due to Mycoplasma mycoides.
CONTRAINDICATION:
Do not administer to animals hypersensitive to Tylosin, or cross-hypersensitivity to macrolides.
DOSAGE AND ADMINISTRATION:
Cattle:
Inject 5-10 mg/kg of body weight daily Intramuscularly.
Do not inject more than 10 ml per injection site.
Duration of treatment: The treatment should be continued every 24 hours, not exceeding 5 days.
Sheep and Goats:
Inject 10 mg/kg of body weight daily Intramuscularly.
Do not inject more than 5 ml per injection site.
Duration of treatment: The treatment should be continued every 24 hours, not exceeding 3 days.
SIDE EFFECTS:
Temporary swelling at the injection site. Allergic reactions – erythema, itch, respiratory reactions- slight edema, prolapse of rectum, which disappears quickly after some time.
DRUG INTERACTION:
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.
Drug interactions with tylosin are not well established, although it has been suggested that it should be used cautiously with digoxin. Other possible drug interactions based on information from erythromycin include the following: azole antifungals, cisapride, chloramphenicol, clindamycin, lincomycin, digoxin, diltiazem, verapamil, omeprazole, sucralfate, warfarin, alfentanil, bromocriptine, buspirone, carbamazepine, chemotherapy agents, cyclosporine, disopyramide, methylprednisolone, midazolam, alprazolam, triazolam, quinidine, sildenafil, tacrolimus, and theophylline.
PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES:
Pharmaco-therapeutic group: Antibacterials for systemic use, Macrolides group of antibiotics.
PHARMACOLOGY:
MECHANISM OF ACTION:
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. For more specific information on organisms that Tylosin is usually active against, refer to the erythromycin monograph just before this one. Cross-resistance with erythromycin occurs.
PHARMACOLOGICAL EFFECTS:
Tylosin is a macrolide antibiotic and bacteriostatic feed additive used in veterinary medicine. It has a broad spectrum of activity against Gram-positive organisms and a limited range of Gram-negative organisms. It is found naturally as a fermentation product of Streptomyces fradiae. Tylosin is used in veterinary medicine to treat bacterial infections in a wide range of species and has a high margin of safety. It has also been used as a growth promotant in some species and as a treatment of colitis in companion animals.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS):
In very rare cases, the following adverse reactions have been observed in animals administered Tylosin at the recommended rate:
Injection site reaction, Valvular swelling in cattle.
Oedema of the rectal mucosa, partial anal protrusion (rose budding), erythema and pruritus in Pigs, Anaphylactic shock and death, where repeat injections are to be administered, use different sites for each injection.
CAUTION:
Do not mix Flasin 20% Injection with other parenteral solutions as this may cause precipitation of the active ingredient.
Do not slaughter treated animals within 21 days of treatment.
Do not administer to Horses or other equines. Injection of Tylosin in equines has been fatal.
WITHDRAWAL PERIOD:
Cattle:
Meat and Offals: 28 days
Milk: 5 days
Sheep, Goats:
Edible tissue: 42 days
Milk: 5 days
NATURE AND COMPOSITION OF IMMEDIATE PACKAGING:
Carton containing 100 ml amber type I glass vials, each of which is sealed with a grey butyl rubber bung with aluminum overseal, packed in a carton.
STORAGE:
Store below 30°C, Protect from direct sunlight.
Once broached, use it within 28 days.
PRESENTATION:
30 ml and 100 ml Vial.
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