Propylene Glycol

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Propylene Glycol Recall

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Side Effects & Adverse Reactions

SEALED FOR YOUR PROTECTION
FOR ANIMAL USE ONLY

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

An aid in the prevention and treatment of ketosis in dairy cattle.

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History

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Sources

Propylene Glycol Manufacturers

Radix Laboratories, Inc.

Propylene Glycol | Radix Laboratories, Inc.

In adult dairy cattle, feed at a rate of 4 fl. oz. (120ml) per head per day, starting 4 days before calving and continuing for 4-6 days. use as a drench, or mix with feed.

No Recall
Agri Laboratories Ltd

Propylene Glycol | Agri Laboratories Ltd

DOSAGE: Cows, orally, 8 ounces twice daily for four days.

KEEP OUT OF REACH OF CHILDREN

No Recall
Vedco

Propylene Glycol | Vedco

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Phoenix Pharmaceutical Inc./clipper Distributing, Inc.

Propylene Glycol | Phoenix Pharmaceutical Inc./clipper Distributing, Inc.

For use mixed with feed or as a drench.

PREVENTION:

Dairy Cattle.....................6-8 fl oz/head/day

Begin 2 weeks before calving and continue for 6 weeks after calving.

TREATMENT:

Dairy Cattle....................6-16 fl oz/head/day

Dosage dependant upon severity, to be given for 10 days.

No Recall
United Agricultural & Veterinary Products, Inc/centaur, Inc.

Propylene Glycol | United Agricultural & Veterinary Products, Inc/centaur, Inc.

PREVENTION: As aid in prevention of Acetonemia (Ketosis) in dairy cattle, give 6 to 8 fluid ounces per head per day beginning 2 weeks before calving and continuing for 6 weeks after calving.

TREATMENT: As aid in treatment of Acetonemia (Ketosis) in dairy cattle, give 6 to 16 fluid ounces (dependent of severity) per head per day for 10 days.

Use as drench or mix with feed.

No Recall
Mwi/vet One

Propylene Glycol | Mwi/vet One

Oral

Ketosis Treatment for Dairy Cattle

Not for human use

Keep out of reach of children

ADMINISTRATION

For use mixed with feed or as a drench.

DOSAGE

In dairy cattle, administer 6-16 ounces per head, per day for 10 days. Severe cases of ketosis may require larger doses. Before administering Propylene Glycol to cows suffering from milk fever, mastitis or metritis consult a veterinarian.

PREVENTION

In dairy cattle, administer 6-8 fluid ounces per day beginning 2 weeks before calving and continuing 6 weeks after calving.

No Recall
Aspen Veterinary Resources, Ltd

Propylene Glycol | Auxilium Pharmaceuticals, Inc.

edex® in the Treatment of Erectile Dysfunction
The dosage range of edex® for the treatment of erectile dysfunction is 1 to 40 mcg. The intracavernous injection should be given over a 5 to 10 second interval. In a study with a dose range of 1 to 20 mcg of edex®, the mean dose was 10.7 mcg at the end of the dose titration period. In two studies with a dose range of 1 to 40 mcg of edex®, the mean dose was 21.9 mcg at the end of the dose titration period. Doses greater than 40 mcg have not been studied. A ½ inch, 27 to 30 gauge needle is generally recommended for the intracavernous injection. The patient is advised not to exceed the optimum edex® dose which was determined in the doctor's office. The lowest possible effective dose should always be used.
Initial Titration in Physician's Office Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology
Dosage titration should be initiated at 2.5 micrograms of alprostadil. If there is a partial response, the dose may be increased by 2.5 micrograms to a dose of 5 micrograms and then in increments of 5 to 10 micrograms, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. If there is no response to the initial 2.5-microgram dose, the second dose may be increased to 7.5 micrograms, followed by increments of 5 to 10 micrograms. The patient must stay in the physician's office until complete detumescence occurs. It there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.
Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury)
Dosage titration should be initiated at 1.25 micrograms of alprostadil. The dose may be increased by 1.25 micrograms to a dose of 2.5 micrograms, followed by an increment of 2.5 micrograms to a dose of 5 micrograms, and then in 5-microgram increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.
At-Home (Maintenance Therapy) Dosing Instructions
The first injections of edex® must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The physician should instruct the patient to discard any needles which become bent during the self-injection procedure as these needles may break. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. The intracavernous injection must be done under sterile conditions. The site of injection is usually along the lateral aspect of the proximal third of the penis. Visible veins should be avoided. The side of the penis that is injected and the site of injection must be alternated. The injection site must be cleansed with an alcohol swab before injection.

The dose of edex® that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse and that is maintained for no longer than 1 hour. If the duration of erection is longer than 1 hour, the dose of edex® should be reduced. The lowest effective dose should be used at home. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. Dose adjustment may be required and should be made only after consultation with the physician.

Careful and continuous follow-up of the patient while in the self-injection program must be exercised. This is especially true for the initial self-injections, since adjustments in the dose of edex® may be needed. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. The reconstituted edex® cartridge and needle are intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the needles and cartridges.

While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of edex® should be adjusted, if needed.

The patient is instructed to follow the enclosed patient information pamphlet.
Preparation of Solution
The edex® injection device is used to reconstitute the single-dose, dual-chamber cartridge. The plunger is used to force the sterile 0.9% sodium chloride (1.075 mL) in one chamber into the chamber containing alprostadil. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. The reusable edex® injection device is for use only with the cartridges and needles included in the edex® Cartridge Packs.

Prepare the edex® solution immediately before use. Do not administer unless solution is clear. Do not add any drugs or solutions to the edex® solution. Discard any unused solution remaining in the cartridge. The reconstituted solution should not be stored.

The edex® cartridge contains a solid layer or lyophilized cake of dry white powder approximately 3/8" in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored.

CAUTION: Do not reuse any solution remaining in the cartridge due to the possibility of bacterial contamination.
Administration
edex® is given as an intracavernous injection over a 5 to 10 second interval. See patient information for edex®.
Stability
The single-dose, dual-chamber cartridge should be reconstituted only when it is certain that the patient is ready to administer the drug. The reconstituted drug solution should be used immediately after reconstitution. Any solution remaining in the cartridge should be discarded.

No Recall
Durvet, Inc.

Propylene Glycol | Durvet, Inc.

For use mixed with feed or as a drench.

Prevent: Dairy Cattle: 6-8 fl oz/.head/day

Begin 2 weeks before calving and continue for 6 weeks after calving.

Treatment: Dairy Cattle: 6-16 fl oz/head/day

Dosage dependent upon severity, to be give for 10 days.

TAKE TIME OBSERVE LABEL DIRECTIONS

No Recall