Adspec Sterile Solution

Figure 1. Chemical structure of spectinomycin sulfate tetrahydrate

The chemical name of spectinomycin sulfate tetrahydrate is:

Decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)-4H-pyrano[2,3-b] [1,4] benzodioxin-4 -one sulfate, tetrahydrate.

Microbiology

Spectinomycin is bacteriostatic and exerts its antibacterial effect by binding to the 30S ribosome and inhibiting bacterial protein synthesis. Spectinomycin has activity against a variety of gram-negative bacteria, some mycoplasma, and a limited number of gram-positive bacteria. Generally, it is not active against anaerobic bacteria.

Spectinomycin has demonstrated in vitro and in vivo activity against the three major pathogenic bacteria (Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus) associated with bovine respiratory disease (pneumonia).

Spectinomycin has also demonstrated in vitro activity against Actinomyces pyogenes, Mycoplasma bovis, and Mycoplasma dispar. The clinical significance of this in vitro activity in cattle has not been demonstrated.

Adspec Sterile Solution Indications

ADSPEC Sterile Solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus.

Contraindications

As with all drugs, the use of ADSPEC Sterile Solution is contraindicated in animals previously found to be hypersensitive to the drug.

Residue Warnings

Treated Cattle Must Not Be Slaughtered For 11 Days Following Last Treatment. Dosages Administered Either In Excess Of The Approved Maximum Dose Or By Unapproved Routes May Result In Illegal Residues In Edible Tissues.

A Withdrawal Period Has Not Been Established For This Product In Pre-ruminating Calves. Do Not Use In Calves To Be Processed For Veal.

A Milk Discard Period Has Not Been Established For This Product In Lactating Dairy Cattle. Do Not Use In Female Dairy Cattle 20 Months Of Age Or Older. Use Of Spectinomycin In This Class Of Cattle May Cause Drug Residues In Milk.

Human Warnings

Not For Human Use. Keep Out Of Reach Of Children.

As with other antibiotics, allergic reactions may occur in previously sensitized individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact with skin, eyes, mouth, and clothing. Persons with a known hypersensitivity to spectinomycin should avoid exposure to this product.

In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Seek medical attention if allergic reactions occur.

The material safety data sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information or obtain a material safety data sheet, call 1-800-253-8600.

Precautions

The safety of ADSPEC Sterile Solution has not been determined for cattle intended for breeding.

Discoloration at the injection site may persist beyond 11 days after injection. This may necessitate trimming of the injection site and surrounding tissues at slaughter.

Adverse Reactions

The use of ADSPEC Sterile Solution may result in mild swelling at the injection site. Anaphylactic reactions may occur in animals previously sensitized.

Animal Safety

Cattle

When spectinomycin sulfate sterile solution was administered at doses of 15, 45, or 75 mg/kg/day (1X, 3X, or 5X the maximum daily recommended therapeutic dose) for 15 days, treatment-related effects included decreased urinary pH and mild swelling at injection sites. At necropsy, labeled injection sites examined at 1 day and 8 days after injection of 30 mL of spectinomycin sulfate sterile solution had dark red, tan, brown, and/or dark brown areas, often with some expansion (thickening) of the subcutis. Only mild discoloration was observed on gross examination of injection sites at 15 days after injection.

When spectinomycin sulfate sterile solution was administered subcutaneously at a dose of 15 mg/kg/day to 152 crossbred beef calves with naturally occurring BRD in clinical field trials, one calf died following the second daily injection. The cause of death following a gross necropsy was reported as an anaphylactic reaction.

Adspec Sterile Solution Dosage And Administration

ADSPEC Sterile Solution is to be administered to cattle at a daily dose of 10 to 15 mg spectinomycin per kg of body weight (4.5 to 6.8 mL per 100 lb body weight). Treatment should be administered at 24-hour intervals for 3 to 5 consecutive days. Selection of dose (10 to 15 mg/kg/day) and duration of treatment (3 to 5 days) should be based on an assessment of the severity of disease, pathogen susceptibility, and clinical response. Do not inject more than 50 mL per site.

ADSPEC Sterile Solution is to be administered to cattle by subcutaneous injection in the neck.

Storage Conditions

Store at controlled room temperature 20° to 25°C (68° to 77°F) [for additional information see USP]. Protect from freezing.

How Supplied

ADSPEC Sterile Solution is available in the following package size:

Nada #141-077, Approved By Fda

Made in Mexico for: Pharmacia & Upjohn Company, Kalamazoo, MI 49001, USA

By: Pharmacia & Upjohn, S.A. de C.V., Calzada de Tlalpan #2962, 04870 Mexico, D.F.

801 760 002

August 2000

Nac No.