Label: PENICILLIN INJECTABLE - penicillin g procaine injection, suspension
- NDC Code(s): 30798-213-13, 30798-213-17
- Packager: Durvet
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Description: Penicillin G Procaine Injectable Suspension is available in 100-mL, 250-mL and 500-mL multiple dose vials. Each mL contains: penicillin G potassium 300,000 units*, procaine hydrochloride 130.8 mg*, methylparaben 1.3 mg, propylparaben 0.2 mg, sodium citrate 10 mg, sodium carboxymethylcellulose 1 mg, povidone 5 mg, lecithin 6 mg, sodium formaldehyde sulfoxylate 0.2 mg, procaine hydrochloride 20 mg, and Water for Injection, q.s.
*Penicillin G Potassium and Procaine Hydrochloride react to form Penicillin G Procaine.
ACTIONS: Penicillin G is an effective bactericide in the treatment of infections caused primarily by penicillin-sensitive organisms, such as Streptococcus equi and Erysipelothrix insidiosa, as well as the gram negative organism Pasteurella multocida.
INDICATIONS: Penicillin G Procaine is indicated for the treatment of:
1. Cattle and sheep - bacterial pneumonia (shipping fever) caused by Pasteurella multocida.
2. Swine - erysipelas caused by Erysipelothrix insidiosa.
3. Horses - strangles caused by Streptococcus equi.
DIRECTIONS FOR USE: Restricted Drug (California) - Use Only as Directed.
The suspension should be administered by deep intramuscular injection within the fleshy muscles of the hip, rump, round or thigh, or into the neck, changing the site for each injection. Do not inject subcutaneously, into a blood vessel, or near a major nerve.
Use a 16 or 18 gauge needle, 1.5 inches long. The needle and syringe should be washed thoroughly before use. The needle and syringe should then be sterilized by placing in boiling water for 15 to 20 minutes.
The injection site should be washed with soap and water and painted with a germicide such as tincture of iodine or 70% alcohol. The product should then be administered by using the following procedure:
1. Warm the vial to room temperature and shake thoroughly to ensure uniform suspension.
2. Wipe the rubber stopper on top of the vial with a piece of absorbent cotton soaked in 70% alcohol.
3. Inject air into the vial for easier withdrawal.
4. After filling the syringe, make sure the needle is empty by pulling back the plunger of the syringe until a small air bubble appears. Then detach the needle from the syringe.
5. Insert the needle deep into the muscle, attach the syringe and withdraw the plunger slightly. If blood appears, withdraw the needle and insert it into a different location.
6. Inject the dose slowly. Do not massage the site of injection.
7. Not more than 10 mL should be injected into one location.
Daily treatment should be continued for at least 48 hours after temperature has returned to normal and all other signs of infection have subsided. Animals treated with Penicillin G Procaine Injectable Suspension should show noticeable improvement within 26 to 48 hours.
DOSAGE: The dosage of cattle, sheep, swine, and horses is 3000 units per pound of body weight, or 1.0 mL for each 100 pounds of body weight once daily. Treatment should not exceed 7 days in on-lactating dairy and beef cattle, sheep, swine, or 5 days in lactating dairy cattle. If no improvement is observed within 48 hours, consult your veterinarian.Close
- Residue Warnings
1. Not for use in horses intended for food.
2. Milk that has been taken from animals during treatment and for 48 hours after the last treatment must not be used for food. The daily treatment schedule should not exceed 7 days of treatment in non-lactating dairy and beef cattle, sheep and swine, or 5 days in lactating dairy cattle.
3. The drug should be discontinued for the following time periods before treated animals are slaughtered for food: cattle - 4 days; sheep - 8 days swine - 6 days; non-ruminating calves - 7 days.Close
PRECAUTIONS Sensitivity reactions to penicillin and procaine, such as hives or respiratory distress, may occur in some animals. If such signs of sensitivity occur, stop medication and call your veterinarian. In some instances, particularly if respiratory distress is severe, immediate injection of epinephrine or antihistamine may be necessary.
As with any antibiotic preparation, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If this condition is suspected, stop medication and consult your veterinarian.
STORAGE: Penicillin G Procaine Injectable Suspension should be stored in a cold room at a temperature between 2 degrees and 8 degrees C (36 degrees - 46 degrees F). Avoid freezing the product.Close
- How Supplied
HOW SUPPLIED: Penicillin G Procaine Injectable Suspension is supplied in 100-mL, 250-mL and 500-mL multiple-dose vials.Close
- Package Label Display Panel
(Penicillin G Procaine Injectable Suspension)
300,000 units per mL
FOR INTRAMUSCULAR USE ONLY
Sterile, Multiple Dose Vial
Restricted Drug (California) - Use Only as Directed
NADA 065-505, Approved by FDA
NET CONTENTS: 500 mL
- INGREDIENTS AND APPEARANCE
penicillin g procaine injection, suspension
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:30798-213 Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Penicillin G Procaine (UNII: 17R794ESYN) (Penicillin G - UNII:Q42T66VG0C) Penicillin G Procaine 3000 [USP'U] in 500 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30798-213-17 500 mL in 1 VIAL, MULTI-DOSE 2 NDC:30798-213-13 250 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA065505 08/06/2009 Labeler - Durvet (056387798)