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Lutalyse Injection (dinoprost tromethamine injection) is the most "veterinarian recommended" and "producer used" prostaglandin in the market.1 Artificial insemination synchronization programs with Lutalyse can improve breeding success. Producers and veterinarians today have more options for using Lutalyse in reproduction programs than ever before. FACTREL Injection (gonadorelin injection) is now approved for use with Lutalyse to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows.
Lutalyse is the only prostaglandin approved to be used with EAZI-BREED CIDR Cattle Inserts in dairy heifers and dairy cows.
This product uses dinoprost tromethamine to:
Cattle: Lutalyse Injection is indicated as a luteolytic agent. Lutalyse Injection is effective only in those cattle having a corpus luteum, i.e., those which ovulated at least five days prior to treatment.
Future reproductive performance of animals that are not cycling will be unaffected by injection of Lutalyse Injection.
View Lutalyse Drug Facts Sheet.
As with any multi-dose vial, practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the vial stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.
No vial stopper should be entered more than 20 times. For this reason, the 100 mL bottle should only be used for cattle. The 30 mL bottle may be used for cattle, swine, or mares.
Below are three examples of treatment regimens for FTAI that fit within the dosage regimen framework described immediately above:
Example 1 | Example 2 | Example 3 | |
---|---|---|---|
Day 0 (Monday) | 1st Factrel | 1st Factrel | 1st Factrel |
Day 7 (the following Monday) | Lutalyse | Lutalyse | Lutalyse |
Day 9 (Wednesday) | 2nd Factrel + FTAI at 48 hours after Lutalyse | 2nd Factrel + FTAI at 48 hours after Lutalyse | 2nd Factrel + FTAI at 48 hours after Lutalyse |
Day 10 (Thursday) | FTAI 24 hours after 2nd Factrel | FTAI 24 hours after 2nd Factrel |
Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.
No milk discard or preslaughter drug withdrawal period is required for labeled uses in cattle. No preslaughter drug withdrawal period is required for labeled uses in swine. Use of this product in excess of the approved dose may result in drug residues. Do not use in horses intended for human consumption.
Severe localized clostridial infections associated with injection of LUTALYSE Injection have been reported. In rare instances, such infections have resulted in death.
Aggressive antibiotic therapy should be employed at the first sign of infection at the injection site whether localized or diffuse. Do not administer intravenously (IV) as this route may potentiate adverse reactions. Non-steroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently. Do not administer to pregnant cattle, unless abortion is desired. Cattle administered a progestin would be expected to have a reduced response to LUTALYSE Injection. Do not administer to sows and/or gilts prior to 3 days of normal predicted farrowing as an increased number of stillbirths and postnatal mortality may result. In mares, LUTALYSE Injection is ineffective when administered prior to day-5 after ovulation.
For Treatment of Pyometra (chronic endometritis) in Cattle: In studies conducted with LUTALYSE Injection, pyometra was defined as presence of a corpus luteum in the ovary and uterine horns containing fluid but not a conceptus based on palpation per rectum. Return to normal was defined as evacuation of fluid and return of the uterine horn size to 40mm or less based on palpation per rectum at 14 and 28 days. Most cattle that recovered in response to LUTALYSE Injection recovered within 14 days after injection. After 14 days, recovery rate of treated cattle was no different than that of non-treated cattle.
For Abortion in Beef Cows, Beef Heifers and Replacement Dairy Heifers: Commercial cattle were palpated per rectum for pregnancy in six feedlots. The percent of pregnant cattle in each feedlot less than 100 days of gestation ranged between 26 and 84; 80% or more of the pregnant cattle were less than 150 days of gestation. The abortion rates following injection of LUTALYSE Injection increased with increasing doses up to about 25 mg. As examples, the abortion rates, over 7 feedlots on the dose titration study, were 22%, 50%, 71%, 90% and 78% for cattle up to 100 days of gestation when injected IM with LUTALYSE Injection doses of 0,1 (5 mg), 2 (10 mg), 4 (20 mg) and 8 (40 mg) mL, respectively. The statistical predicted relative abortion rate based on the dose titration data, was about 93% for the 5 mL (25 mg) LUTALYSE Injection dose for cattle injected up to 100 days of gestation.
For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: For a full description of the studies conducted for the use of FACTREL Injection and LUTALYSE Injection, please refer to the labeling for FACTREL Injection.
This product uses dinoprost tromethamine to:
Potential side effects include:
These effects are transient and are not detrimental.
Other potential reactions include:
These reactions typically occur within 15 minutes of injection and resolve within an hour. Even while experiencing a reaction, mares typically continue eating. In a study of several hundred mares on Lutalyse, a single anaphylactic reaction was reported, but was not substantiated.
These reactions are typically short-term (10 minutes to 3 hours) and non-detrimental.