Tetradure

T

Dosage Form: FOR ANIMAL USE ONLY
Tetradure™
300
(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of oxytetracycline base as amphoteric oxytetracycline.

For Use in Beef Cattle, Non-lactating Dairy Cattle, Calves, Including Pre-ruminating (Veal) Calves and Swine.

READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INTRODUCTION

Tetradure™ 300 (Oxytetracycline) Injection is a sterile, ready to use solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Oxytetracycline is an antimicrobial agent that is effective in treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

Tetradure™ 300 should be stored at room temperature 59°-86°F (15°-30°C). The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

INGREDIENTS

Tetradure™ 300 (oxytetracycline) Injection is a sterile, pre-constituted solution of the broad-spectrum antibiotic oxytetracycline dihydrate. Each mL contains 300 mg oxytetracycline as base, 40% (v/v) glycerol formal, 10% (v/v) polyethylene glycol 200, 2.7% (w/v) magnesium oxide, 0.4% (w/v) sodium formaldehyde sulphoxylate (as a preservative) and monoethanolamine (as required to adjust pH).

INDICATIONS

Tetradure™ 300 is intended for use in treatment for the following disease when due to oxytetracycline-susceptible organisms:

Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

Tetradure™ 300 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. Tetradure™ 300 is indicated for the treatment of the infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis, foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

Swine

Tetradure™ 300 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona.

In sows Tetradure™ 300 is indicated as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.

PHARMACOLOGY

Oxytetracycline is derived from the metabolic activity of the actinomycete, Streptomyces rimosus. Oxytetracycline is an antimicrobial agent that is effective in the treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria.

The antibiotic activity of oxytetracycline is not appreciably diminished in the presence of body fluids, serum or exudates.

Studies have shown that the half-life of oxytetracycline in blood following intramuscular treatment with Tetradure™ 300 at 5 mg per pound of bodyweight is approximately 23 hours in cattle and 18 hours in swine.

Studies have shown when Tetradure™ 300 is administered once intramuscularly to cattle or swine at 9 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for 3 to 4 days.

Studies have shown when Tetradure™ 300 is administered once intramuscularly or subcutaneously to cattle at 13.6 mg per pound of bodyweight, blood oxytetracycline concentration of greater than 0.2 mcg/mL have been observed for at least 7 to 8 days.

Tetradure Dosage and Administration Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves

A single intramuscular or subcutaneous dosage of 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

At a single intramuscular or subcutaneous dose range of 9 to 13.6 mg of oxytetracycline per pound of bodyweight, Tetradure™ 300 is recommended in the treatment of the following conditions:

(1) Bacterial pneumonia caused by Pasteurella spp (shipping fever) in calves and yearlings where retreatment is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable. (2) Infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis.

For other indications Tetradure™ 300 is to be administered intramuscularly, subcutaneously or intravenously at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. In treatment of foot-rot and advanced cases of other indicated diseases, a dosage level of 5 mg per pound of bodyweight per day is recommended. Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

Do not administer intramuscularly in the neck of small calves due to lack of sufficient muscle mass.

Use extreme care when administering this product by intravenous injection. Perivascular injection or leakage from an intravenous injection may cause severe swelling at the injection site.

Swine

A single dosage of 9 mg of oxytetracycline per pound of bodyweight administered intramuscularly is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Tetradure™ 300 can also be administered by intramuscular injection at a level of 3 to 5 mg of oxytetracycline per pound of bodyweight per day. Treatment should be continued 24 to 48 hours following remission of disease signs; however, not to exceed a total of four (4) consecutive days. If improvement is not noted within 24 to 48 hours of the beginning of treatment, diagnosis and therapy should be re-evaluated.

For sows, administer once intramuscularly 3 mg of oxytetracycline per pound of bodyweight approximately eight (8) hours before farrowing or immediately after completion of farrowing as an aid in the control of infectious enteritis in baby pigs.

For swine weighing 25 lbs of bodyweight and under, Tetradure™ 300 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

9 mg dosage of undiluted Tetradure™ 300 3 or 5 mg/lb dosage volume of diluted Tetradure™ 300 Bodyweight 9 mg/lb 3 mg/lb Dilution* 5 mg/lb * To prepare dilutions, add one part of Tetradure™ 300 to three (3), five (5) or seven (7) parts of the sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately. 5 lb 0.15 mL 0.4 mL 37.5 mg/mL 0.7 mL 10 lb 0.30 mL 0.6 mL 50 mg/mL 1.0 mL 25 lb 0.75 mL 1.0 mL 75 mg/mL 1.7 mL Precautions

Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site in adult beef cattle and non-lactating dairy cattle and 5 mL intramuscularly per injection site in adult swine, may result in antibiotic residues beyond the withdrawal time.

Consult with your veterinarian prior to administering this product in order to determine to proper treatment required in the event of an adverse reaction. At the first sign of any adverse reaction, discontinue use of the product and seek the advice of your veterinarian. Some of the reactions may be attributable either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

Shortly after injection treated animals may have transient hemoglobinuria resulting in darkened urine.

As with all antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. The absence of a favourable response following treatment, or the development of new signs or symptoms may suggest an overgrowth of non-susceptible organisms. If superinfections occur, the use of this product should be discontinued and appropriate specific therapy should be instituted.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Tetradure™ 300 in conjunction with penicillin.

STORAGE

Store at room temperature, 59°-86°F (15°-30°C). Keep from freezing.

Warnings

WARNINGS: Discontinue treatment at least 28 days prior to slaughter of cattle and swine. Not for use in lactating dairy animals. Rapid intravenous administration may result in animal collapse. Oxytetracycline should be administered intravenous slowly over a period of at least 5 minutes.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Merial at 1-888-637-4251.

CAUTION

Intramuscular or subcutaneous injection may result in local tissue reactions which persist beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Intramuscular injection in the rump area may cause mild temporary lameness associated with swelling at the injection site. Subcutaneous injection in the neck area may cause swelling at the injection site.

Adverse Reactions

Reports of adverse reactions associated with oxytetracycline administration include injection site swelling, restlessness, ataxia, trembling, swelling of eyelids, ears, muzzle, anus and vulva (or scrotum and sheath in males), respiratory abnormalities (labored breathing), frothing at the mouth, collapse and possibly death. Some of these reactions may be attributed either to anaphylaxis (an allergic reaction) or to cardiovascular collapse of unknown cause.

PRESENTATION

Tetradure™ 300 is available in 100 mL, 250 mL and 500 mL vials.

Livestock Drug - Not for Human Use.
Restricted Drug(s) California. Use Only as Directed.

DISTRIBUTED BY:
Merial Limited
Duluth, GA 30096-4640, USA

™Tetradure is a trademark and Cattle Head Logo is a registered trademark of Merial Limited.
MADE IN THE UK

U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053

Rev. 06-2003

008630109

NADA 141-143, APPROVED BY THE FDA

PRINCIPAL DISPLAY PANEL - 100 mL Carton

Tetradure™
300

(OXYTETRACYCLINE) INJECTION

ANTIBIOTIC

Each mL contains 300 mg of Oxytetracycline
base as amphoteric oxytetracycline.

For the treatment of diseases in beef cattle,
non-lactating dairy cattle, calves, including
pre-ruminating (veal) calves and swine.

Caution: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.

NADA 141-143, Approved By FDA

U.S. Patent No. 6,110,905
U.S. Patent No. 6,310,053

Net Contents:
100 mL

MERIAL

Tetradure 300 
oxytetracycline  injection, solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-0415 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength oxytetracycline (oxytetracycline) oxytetracycline 300 mg  in 1 mL Inactive Ingredients Ingredient Name Strength glycerol formal   polyethylene glycol   magnesium oxide   sodium formaldehyde sulfoxylate   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50604-0415-1 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 100 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-1) 2 50604-0415-2 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 2 250 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-2) 3 50604-0415-3 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 3 500 mL In 1 BOTTLE, GLASS This package is contained within the CARTON (50604-0415-3)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141143 07/31/1993
Labeler - Merial Limited (034393582) Revised: 09/2010Merial Limited

Tetradure

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