Lutalyse is used as a luteolytic agent in cattle, parturition induction in swine, and luteolytic effect in mares.
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* For intramuscular use for estrus synchronization in cattle
* Treatment of unobserved silent estrus and pyometra chronic endometritis in cattle
* For abortion of feedlot and other non-lactating cattle
* For parturition induction in swine
* For controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
Mares: LUTALYSE Sterile Solution is indicated for its luteolytic effect in mares. This luteolytic effect can be utilized to control the timing of estrus in estrous cycling and clinically anestrous mares that have a corpus luteum in the following circumstances:
1. Controlling Time of Estrus of Estrous Cycling Mares: Mares treated with LUTALYSE during diestrus 4 or more days after ovulation will return to estrus within 2 to 4 days in most cases and ovulate 8 to 12 days after treatment. This procedure may be utilized as an aid to scheduling the use of stallions.
2. Difficult-to-Breed Mares: In extended diestrus there is failure to exhibit regular estrous cycles which is different from true anestrus. Many mares described as anestrus during the breeding season have serum progesterone levels consistent with the presence of a functional corpus luteum.
A proportion of &ldquobarren&rdquo, maiden, and lactating mares do not exhibit regular estrous cycles and may be in extended diestrus. Following abortion, early fetal death and resorption, or as a result of &ldquopseudopregnancy&rdquo, there may be serum progesterone levels consistent with a functional corpus luteum.
Treatment of such mares with LUTALYSE usually results in regression of the corpus luteum followed by estrus and/or ovulation. In one study with 122 Standardbred and Thoroughbred mares in clinical anestrus for an average of 58 days and treated during the breeding season, behavioral estrus was detected in 81 percent at an average time of 3.7 days after injection with 5 mg LUTALYSE ovulation occurred an average of 7.0 days after treatment. Of those mares bred, 59% were pregnant following an average of 1.4 services during that estrus.
Treatment of &ldquoanestrous&rdquo mares which abort subsequent to 36 days of pregnancy may not result in return to estrus due to presence of functional endometrial cups.
Dosage and Administration:
Mares: Not for use in horses intended for food
1. Evaluate the reproductive status of the mare.
2. Administer a single intramuscular injection of 1 mg per 100 lbs 45.5 kg body weight which is usually 1 mL to 2 mL LUTALYSE Sterile Solution.
3. Observe for signs of estrus by means of daily teasing with a stallion, and evaluate follicular changes on the ovary by palpation of the ovary per rectum.
4. Some clinically anestrous mares will not express estrus but will develop a follicle which will ovulate. These mares may become pregnant if inseminated at the appropriate time relative to rupture of the follicle.
5. Breed mares in estrus in a manner consistent with normal management.
Dinoprost tromethamine is administered once as a single intramuscular injection of 1 mg per 100 lbs 45.5 kg body weight which is usually 1 mL to 2 mL of LUTALYSE containing 5 mg dinoprost as the tromethamine salt per milliliter.
Not for human use.
Women of child-bearing 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. Direct contact with the skin should, therefore, be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
Use of this product in excess of the approved dose may result in drug residues.
Mares: LUTALYSE Sterile Solution is ineffective when administered prior to day-5 after ovulation.
Pregnancy status should be determined prior to treatment, since LUTALYSE has been reported to induce abortion and parturition when sufficient doses were administered.
Mares should not be treated if they suffer from either acute or subacute disorders of the vascular system, gastrointestinal tract, respiratory system, or reproductive tract.
Do not administer by intravenous route.
Nonsteroidal anti-inflammatory drugs i.e., indomethacin may inhibit prostaglandin synthesis, therefore these drugs should not be administered concurrently.
Mares: The most frequently observed side effects are sweating and decreased rectal temperature. However, these have been transient in all cases observed and have not been detrimental to the animal. Other reactions seen have been increase in heart rate, increase in respiration rate, some abdominal discomfort, locomotor incoordination, and lying down. These effects are usually seen within 15 minutes of injection and disappear within one hour. Mares usually continue to eat during the period of expression of side effects. One anaphylactic reaction of several hundred mares treated with LUTALYSE Sterile Solution was