Tetroxy-LA

Generic Name: oxytetracycline injection
Dosage Form: FOR ANIMAL USE ONLY

CAUTION

When administered to cattle, muscle discoloration may necessitate trimming of the injection site(s) and surrounding tissues during the dressing procedure.

WARNING:  Discontinue treatment at least 28 days prior to slaughter of cattle and swine.  Rapid intravenous administration may result in animal collapse.  Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes.

PRECAUTIONS

Exceeding the highest recommended dosage level of drug per pound of body weight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly 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 period.

Consult with your veterinarian prior to administering this product in order to determine the 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 attributed 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 nonsusceptible organisms, including fungi.  A lack of response by the treated animal, or the develpment of new signs, may suggest that an overgrowth of nonsusceptible organisms has occurred.  If any of these conditions occur, consult your veterinarian.  Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Tetroxy-LA in conjunction with penicillin.


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.


STORAGE

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


CARE OF SICK ANIMALS

The use of antibiotics in the management of diseases is based on an accurate diagnosis and an adequate course of treatment.  When properly used in the treatment of diseases caused by oxytetracycline susceptible organisms, most animals that have been treated with oxytetracycline injection show a noticeable improvement within 24 to 48 hours.  It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian.  Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs and needless losses.  Good housing, sanitation and nutrition are important in the maintenance of healthy animals, and are essential in the treatment of diseased animals.


INDICATIONS

Tetroxy-LA is intended for use in the treatment of the following diseases in beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves, and swine when due to oxytetracycline susceptible organisms:

Cattle:
In cattle, Tetroxy-LA is indicated int he treatment of pneumonia and shipping fever complex associated withPasteurella spp. andHemophilus spp.; infectious bovine keratoconjuctivitis (pinkeye) caused byMoraxella bovis; foot rot and diptheria caused byFusobacterium necrophorum; bacterial enteritis (scours) caused byEscherichia coli; wooden tongue caused byActinobacillus lignieresii; leptospirosis caused byLeptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.

Swine:
In swine, Tetroxy-LA is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospria pomona.  In sows, Tetroxy-LA is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.


DOSAGE:

Cattle: Tetroxy-LA is to be administered by intramuscular or intravenous injection to beef cattle, non-lactating dairy cattle and calves, including pre-ruminating (veal) calves.  In accordance with Beef Quality Assurance Guidelines, administration by subcutaneous or intravenous injection is preferred.

A single dosage of 9 milligrams of Tetroxy-LA per pound of body weight (4.5 mL/100 lb) administered intramuscularly is recommended in the treatment of the following conditions:  1)  bacterial pnuemonia caused by Pasteurella spp. (shipping fever) in calves and yearlings, where re-treatment is impractical due to husbandry conditions, such as cattle on range, or where repeated restraint is inadvisable; 2)  infectious bovine keratoconjuctivitis (pinkeye) caused by Moraxella bovis.

Tetroxy-LA can also be administered by intravenous or intramuscular injection at a level of 3 to 5 milligrams of oxytetracycline per pound of body weight per day.  In the treatment of severe foot rot and advanced cases of other indicated diseases, a dosage level of 5 milligrams per pound of body weight per day is recommended.  Treatment should continue 24 to 48 hours following remission of disease signs, however, not to exceed a total of four consecutive days.  Consult your veterinarian if improvement is not noted within 24 to 48 hours of the beginning of treatment.

Swine:  A single dosage of 9 milligrams of Tetroxy-LA per pound of body weight (4.5 mL/100 lb) administered intramuscularly in the neck region is recommended in the treatment of bacterial pneumonia caused by Pasteurella multocida in swine, where re-treatment is impractical due to husbandry conditions or where repeated restraint is inadvisable.

Tetroxy-LA can also be administered by intramuscular injection at a level of 3 to 5 milligrams of oxytetracycline per pound of body weight per day.  Treatment should be continued 24 to 48 hours following remission of disease signs, however, not to exceed a total of four consecutive days.  Consult your veterinarian if improvement is not noted within 24 to 48 hours of the beginning of treatment.

For sows, administer once intramuscularly 3 milligrams of oxytetracycline per pound of body weight approximately 8 hours before farrowing or immediately after completion of farrowing.

For swine weighing 25 lb of body weight and under, Tetroxy-LA should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 to 5 mg/lb.

Body Weight                              9 mg/lb Dosage (Volume of UNDILUTED) Tetroxy - LA                           3 or 5 mg/lb Dosage (Volume of DILUTED) Tetroxy-LA
                                                                          9 mg/lb                                                                     3 mg/lb                Dilution*                5 mg / lb                      
5 lb                                                                      0.2 mL                                                                       0.6 mL                  1 : 7                    1.0 mL  
10 lb                                                                    0.5 mL                                                                       0.9 mL                  1 : 5                    1.5 mL
25 lb                                                                    1.1 mL                                                                       1.5 mL                  1 : 3                    2.5 mL
*  To prepare dilutions, add one part Tetroxy-LA to three, five or seven parts of sterile water or 5 percent dextrose solution as indicated; the diluted product should be used immediately.


CATTLE DOSAGE GUIDE - Single Dose 9 mg/lb Bodyweight
At the first signs of pneumonia or pinkeye, administer a single dose of Tetroxy-LA by deep intramuscular injection according to the following weight categories.1

Animal weight (lb)         Number of mL or cc                            Animal weight (lb)         Number of mL or cc                 Animal weight (lb)          Number of mL or cc
100                              4.5                                                    500                             22.5                                        900                              40.5
200                              9.0                                                    600                             27.0                                        1000                            45.0
300                             13.5                                                   700                             31.5                                        1100                             49.5
400                             18.0                                                   800                             36.0                                        1200                             54.0
1 Do not administer more than 10mL at any one injection site (1 to 2 mL per site in small calves).  Discontinue treatment 28 days prior to slaughter.


SWINE DOSAGE GUIDE - Single Dose 9 mg/lb Bodyweight

At the first signs of pneumonia administer Tetroxy-LA by deep intramuscular injection according to the following weight categories.1    

Animal weight (lb)         Number of mL or cc                            Animal weight (lb)         Number of mL or cc                 Animal weight (lb)          Number of mL or cc
10                               0.5                                                    125                              5.6                                         250                               11.3
25                               1.1                                                    150                              6.8                                         275                               12.4
50                               2.3                                                    175                              7.9                                         300                               13.5
75                               3.4                                                    200                              9.0                                         325                               14.6
100                             4.5                                                    225                              10.1
1 Do not administer more than 5 mL at any one injection site.  Discontinue treatment 28 days prior to slaughter.    


DIRECTIONS FOR USE:  Tetroxy-LA is intended for use in the treatment of disease due to oxytetracycline susceptible organisms in beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves and swine.  A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized by boiling in water for 15 minutes).  In cold weather, Tetroxy-LA should be warmed to room temperature before administration to animals.  Before withdrawing the solution from the bottle, disinfect the rubber cap on the bottle with suitable disinfectant, such as 70 percent alcohol.  The injection site should be similarly cleaned with the disinfectant.  Needles of 16 or 18 gauge and 1 to 1 1/2 inches long are adequate for intramuscular and subcutaneous injections.  Needles 2 to 3 inches are recommended for intravenous use.

INTRAMUSCULAR ADMINISTRATION:  Intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle; such as in the rump, hip or thigh regions, avoiding blood vessels and major nerves.  Before injecting the solution pull back gently on the plunger.  If blood appears in the syringe, a blood vessel has been entered: withdraw the needle and select a different site.  No more than 10 mL should be injected intramuscularly at any one site in adult beef cattle and non-lactating dairy cattle, and not more than 5 mL per site in adult swine; rotate injection sites for each succeeding treatment.  The volume administered per injection site should be reduced according to age and body size so that 1 to 2 mL per site is injected in small calves.

INTRAVENOUS ADMINISTRATION:  Tetroxy-LA may be administered intravenously to beef cattle and non-lactating dairy cattle.  As with all highly concentrated materials, Tetroxy-LA should be administered slowly by the intravenous route.

Preparation of the Animal for Injection:  1.  Approximate location of vein.  The jugular vein runs in the jugular groove on each side of the neck from the angle of the jaw to just above the brisket and slightly above and to the side of the windpipe.  (See Fig I).

2.  Restraint.  A stanchion or chute is ideal for restraining the animal.  With a halter, rope, or cattle leader (nose tongs), pull the animal's head around the side of the stanchion, cattle chute, or post in such a manner to form a bow in the neck (See Fig. II), then snub the head securely to prevent movement.  By forming the bow in the neck, the outside curvature of the bow tends to expose the jugular vein and make it easily accessible.  Caution:

3.  Avoid restraining the animal with a tight rope or halter around the throat or upper neck, which might impede blood flow.  Animals that are down present no problem so far as restraint is concerned.  Clip hair in area where injection is to be made (over the vein in the upper third of the neck).  Clean and disinfect the skin with alcohol or other suitable antiseptic.

Entering the Vein and Making the Injection:  1.  Raise the vein.  This is accomplished by tying the choke rope tightly around the neck close to the shoulder.  The rope should be tied in such a way that it will not come loose and so that it can be untied quickly by pulling the loose end.  (See Fig. II).  In thick necked animals, a block of wood placed in the jugular groove between the rope and the hide will help considerably in applying the desired pressure at the right point.  The vein is a soft flexible tube through which blood flows back to the heart.  Under ordinary conditions it cannot be seen or felt with the fingers.  When the flow of blood is blocked at the base of the neck by the choke rope, the vein becomes enlarged and rigid because of the back pressure.  If the choke rope is sufficiently tight, the vein stands out and can be easily seen and felt in thin-necked animals.  As a further check in identifying the vein, tap it with the fingers in front of the choke rope.  Pulsations that can be seen or felt with the fingers in front of the point being tapped will confirm the fact that the vein is properly distended.  It is impossible to put the needle into the vein unless it is distended.  Experienced operators are able to raise the vein simply by hand pressure, but the use of a choke rope is more certain.

2.  Inserting the needle.  This involves three distinct steps.  First, insert the needle through the hide.  Second, insert the needle into the vein.  This may require two or three attempts before the vein is entered.  The vein has a tendency to roll away from the point of the needle, especially if the needle is not sharp.  The vein can be steadied with the thumb and finger of one hand.  With the other hand, the needle point is placed directly over the vein, slanting it so that its direction is along the length of the vein, either toward the head or toward the heart.  Properly positioned this way, a quick thrust of the needle will be followed by a spurt of blood through the needle, which indicates that the vein has been entered.  Third, once in the vein, the needle should be inserted along the length of the vein all the way to the hub, exercising caution to see that the needle does not penetrate the opposite side of the vein.  If blood does not flow continuously, the needle is out of the vein (or clogged) and another attempt must be made.  If difficulty is encountered, it may be advisable to use the vein on the other side of the neck.

3.  Medication.  While the needle is being placed in proper position in the vein, an assistant should get the medication ready so that the injection can be started without delay after the vein has been entered.

4.  Making the injection.  With the needle in position as indicated by continuous flow of blood, release the choke rope by a quick pull on the free end.  This is essential; the medication cannot flow into the vein while it is blocked.  Immediately connect the syringe containing Tetroxy-LA to the needle and slowly depress the plunger.  If there is resistance to depression of the plunger, this indicates that the needle has slipped out of the vein (or is clogged) and the procedure will have to be repeated.  Watch for any swelling under the skin near the needle, which would indicated that the medication is not going into the vein.  Should this occur, it is best to try the vein on the opposite side of the neck.

5.  Removing the needle. When injection is complete, remove the needle with straight pull.  Then apply pressure over area of injection momentarily, to control any bleeding through the needle puncture, using cotton soaked in alcohol or other suitable antiseptic.




LIVESTOCK DRUG.

RESTRICTED DRUG (California), USE ONLY AS DIRECTED.

Tetroxy-LA

(oxytetracycline injection)

ANTIBIOTIC

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

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

Each mL contains 200 mg of oxytetracycline base as oxytetracyline dihydrate.

ANADA 200-117, Approved by FDA

Net Contents:  250 mL

Tetroxy-LA 
oxytetracycline injection
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-6008
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxytetracycline (oxytetracycline) oxytetracycline 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Povidone  
Magnesium Oxide  
Sodium Formaldehyde Sulfoxylate  
Hydrochloric Acid  
Packaging
# Item Code Package Description
1 NDC:61133-6008-3 250 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200117 04/13/1995
Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)
Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)
Establishment
Name Address ID/FEI Operations
Bimeda-MTC Animal Health 256232216 manufacture
Revised: 09/2010
 
Bimeda, Inc. Division of Cross Vetpharm Group



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