DURAMYCIN 72-200- oxytetracycline injection, solution

Duramycin 72-200 by

Drug Labeling and Warnings

Duramycin 72-200 by is a Animal medication manufactured, distributed, or labeled by Durvet, Inc. , Norbrook Laboratories Limited, Chifeng Pharmaceutical Co. Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Duramycin 72-200 can also be administered by intravenous, subcutaneous, or intramuscular injection at a level of 3-5 mg of oxytetracycline per lb of body weight per day. In the treatment of severe foot rot and advanced cases of other indicated diseases, a dosage level of 5 mg/lb of body weight per day is recommended. Treatment should be continued 24-48 hours following remission of disease signs; however, not to exceed a total of 4 consecutive days. Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning of treatment.

Swine: A single dosage of 9 mg of Duramycin 72-200 per lb of body weight 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.

Duramycin 72-200 can also be administered by intramuscular injection at a level of 3-5 mg of oxytetracycline per lb of body weight per day. Treatment should be continued 24-48 hours following remission of disease signs; however, not to exceed a total of 4 consecutive days. Consult your veterinarian if improvement is not noted within 24-48 hours of the beginning of treatment.

For sows, administer once intramuscularly in the neck region 3 mg of oxytetracycline per lb of body weight approximately 8 hours before farrowing or immediately after completion of farrowing.

For swine weighing 25 lb of body weight and under, Duramycin 72-200 should be administered undiluted for treatment at 9 mg/lb but should be administered diluted for treatment at 3 or 5 mg/lb.

* To prepare dilutions, add one part of Duramycin 72-200 to 3, 5, or 7 parts of sterile water, or 5% dextrose solution as indicated; the diluted product should be used immediately.

9 mg/lb Dosage Volume of Undiluted Duramycin 72-2003 or 5 mg/lb Dosage Volume of Diluted Duramycin 72-200
Body weight9 mg/lb3 mg/lbDilution*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
  • DIRECTIONS FOR USE:

    Duramycin 72-200 is intended for use in the treatment of disease due to oxytetracycline-susceptible organisms in beef cattle; dairy cattle; calves, including preruminating (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, Duramycin 72-200 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% alcohol. The injection site should be similarly cleaned with the disinfectant. Needles of 16-18 gauge and 1-1½ inches long are adequate for intramuscular and subcutaneous injections. Needles 2-3 inches are recommended for intravenous use.

    Intramuscular Administration:

    Intramuscular injections in swine should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle in the neck region; avoid 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 and dairy cattle, and not more than 5 mL should be injected at any one 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 1-2 mL per site is injected in small calves.

    Subcutaneous Administration:

    Subcutaneous injections in beef cattle, dairy cattle, and calves, including preruminating (veal) calves, should be made by directing the needle of suitable gauge and length through the loose folds of the neck skin in front of the shoulder. Care should be taken to ensure that the tip of the needle has penetrated the skin but is not lodged in muscle. 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. The solution should be injected slowly into the area between the skin and muscles. No more than 10 mL should be injected subcutaneously at any one site in adult beef and dairy cattle; rotate injection sites for each succeeding treatment. The volume administered per injection site should be reduced according to age and body size so that 1-2 mL per site is injected in small calves.

    Intravenous Administration:

    Duramycin 72-200 may be administered intravenously to beef and dairy cattle. As with all highly concentrated materials, Duramycin 72-200 should be administered slowly by the intravenous route.

    Preparation of the Animal for Injection:

    1. Approximate the 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: 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.

    3. 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.

      Figure IFigure I
Figure IIFigure II

    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 3 distinct steps. First, insert the needle through the hide. Second, insert the needle into the vein. This may require 2 or 3 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. Continuous steady flow of blood through the needle indicates that the needle is still in 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. 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 Duramycin 72-200 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 indicate 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 needle with straight pull. Then apply pressure over area of injection momentarily to control any bleeding through needle puncture, using cotton soaked in alcohol or other suitable antiseptic.

    Not for Human Use.

    Restricted Drug - California. Use Only as Directed.

    MANUFACTURED FOR:
    DURVET INC.
    Blue Springs, Missouri 64014
    www.durvet.com

    MADE IN THE UK

    MANUFACTURED BY:
    Norbrook Laboratories Limited,
    Newry, BT35 6PU, Co. Down, Northern Ireland.

    Rev. 09-11
    025215I04

  • Principal Display Panel - Duramycin 72-200 200 mg/mL Carton Label

    NDC 30798-237-17

    durvet

    Duramycin 72-200

    (Oxytetracycline)
    200 mg/mL
    Antibiotic

    Each mL contains 200 mg of
    oxytetracycline base as amphoteric
    oxytetracycline.

    For the treatment of disease in beef
    cattle; dairy cattle; calves, including
    preruminating (veal) calves;
    and swine.

    ANADA 200-306, Approved by FDA

    Net Contents: 500 mL

    Principal Display Panel - Duramycin 72-200 200 mg/mL Carton Label
  • Principal Display Panel - Duramycin 72-200 200 mg/mL Label

    NDC 30798-237-17

    durvet

    Duramycin 72-200

    (Oxytetracycline)
    200 mg/mL
    Antibiotic

    Each mL contains 200 mg of oxytetracycline base
    as amphoteric oxytetracycline.

    For the treatment of disease in beef cattle; dairy cattle;
    calves, including preruminating (veal) calves; and swine.

    ANADA 200-306, Approved by FDA

    Net Contents: 500 mL

    Principal Display Panel - Duramycin 72-200 200 mg/mL Label
  • INGREDIENTS AND APPEARANCE
    DURAMYCIN 72-200 
    oxytetracycline injection, solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC: 30798-237
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    oxytetracycline (UNII: X20I9EN955) (oxytetracycline anhydrous - UNII:SLF0D9077S) oxytetracycline200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    pyrrolidone (UNII: KKL5D39EOL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 30798-237-101 in 1 CARTON
    1100 mL in 1 VIAL, GLASS
    2NDC: 30798-237-131 in 1 CARTON
    2250 mL in 1 VIAL, GLASS
    3NDC: 30798-237-171 in 1 CARTON
    3500 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20030607/07/2008
    Labeler - Durvet, Inc. (056387798)
    Registrant - Norbrook Laboratories Limited (214580029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Norbrook Laboratories Limited232880554API MANUFACTURE, MANUFACTURE, ANALYSIS

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