PEN-AQUEOUS- penicillin g procaine injection, suspension

Pen-Aqueous by

Drug Labeling and Warnings

Pen-Aqueous by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Bimeda Inc., Constant Irwindale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Pen-Aqueous®

(penicillin G procaine Injectable Suspension)

FOR CATTLE, SWINE, SHEEP & HORSES

Aqueous Suspension

Antibiotic

300,000 units per mL

Restricted Drug (California) - Use Only as Directed

NADA 065-505, Approved by FDA

For Intramuscular Use Only

Sterile, Multiple Dose Vial

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

DESCRIPTION: Pen-Aqueous® Alternative Method is available in 100 mL, 250 mL and 500 mL multiple-dose vials. Each mL contains: Active Ingredients: Penicillin G potassium 300,000 units*, Procaine hydrochloride 130.8 mg*. Inactive Ingredients: 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.

MECHANISM OF ACTION

ACTIONS: Penicillin G is an effective bactericide in the treatment of infections caused primarily by penicillin-sensitive organisms, such as Streptococcus equi and Erysipelothrix thusiopathiae, as well as the gram negative organism Pasteurella multocida.

INDICATIONS & USAGE

INDICATIONS: Pen-Aqueous® is indicated for the treatment of:

1. Cattle and sheep - bacterial pneumonia (shipping fever) caused by Pasteurella multocida.

2. Swine - erysipelas caused by Erysipelothrix rhusiopathiae.

2. Horses - strangles caused by Streptococcus equi.

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE: The suspension should be administered by deep intra- muscular 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. Use this product within 28 days of the first puncture and puncture a maximum of 15 times. Consider using automatic injection equipment or a repeater syringe if necessary to avoid exceeding 15 punctures. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use.

The injection site should be washed with soap and water and painted with a germicide such astincture 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 Pen-Aqueous® should show noticeable improvement within 36 to 48 hours.

DOSAGE: The dosage for 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 non-lactating dairy and beef cattle, sheep, and swine, or 5 days in lactating dairy cattle. If no improvement is observed within 48 hours, consult your veterinarian.

RESIDUE WARNING

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.

PRECAUTIONS

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.

HOW SUPPLIED

HOW SUPPLIED: Pen-Aqueous® is supplied in 100 mL, 250 mL, and 500 mL multiple-dose vials.

STORAGE AND HANDLING

STORE BETWEEN 2°C -8°C (36°F - 46°F). PROTECT FROM FREEZING. WARM TO ROOM TEMPERATURE AND SHAKE WELL BEFORE USING.

GENERAL PRECAUTIONS

RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED.

DISPOSE OF CONTAINERS IN AN APPROVED LANDFILL OR BY INCINERATION.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEN-AQUEOUS 
penicillin g procaine injection, suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-151
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C)	PENICILLIN G	300000 [USP'U]  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-151-01	250 mL in 1 VIAL, MULTI-DOSE
2	NDC: 46066-151-02	500 mL in 1 VIAL, MULTI-DOSE
3	NDC: 46066-151-03	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA065505	09/22/2003

Labeler - Aspen Veterinary Resources (627265361)

Registrant - Bimeda Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Constant Irwindale		010569463	manufacture