Lutalyse (Dinoprost Tromethamine) Sterile Solution
Dinoprost tromethamine sterile solution, used as a luteolytic agent in cattle, parturition induction in swine, and luteolytic effect in mares.
LUTALYSE� STERILE SOLUTION
Zoetis
dinoprost tromethamine injection
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
For intramuscular use for estrus synchronization, 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; and for controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
DESCRIPTION
This product contains the naturally occurring prostaglandin F2 alpha (dinoprost) as the tromethamine salt. Each mL contains dinoprost tromethamine equivalent to 5 mg dinoprost: also, benzyl alcohol, 16.5 mg added as preservative. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Dinoprost tromethamine is a white or slightly off-white crystalline powder that is readily soluble in water at room temperature in concentrations to at least 200 mg/mL.
INDICATIONS AND USAGE
Cattle: LUTALYSE Sterile Solution is indicated as a luteolytic agent.
LUTALYSE 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.
1. For Intramuscular Use for Estrus Synchronization in Beef Cattle and Non-Lactating Dairy Heifers. LUTALYSE is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum.
Inject a dose of 5 mL LUTALYSE (25 mg PGF2α) intramuscularly either once or twice at a 10 to 12 day interval.
With the single injection, cattle should be bred at the usual time relative to estrus.
With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE.
Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.
2. For Intramuscular Use for Unobserved (Silent) Estrus in Lactating Dairy Cows with a Corpus Luteum. Inject a dose of 5 mL LUTALYSE (25 mg PGF2α) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus breed at the usual time relative to estrus.
Management Considerations: Many factors contribute to success and failure of reproduction management, and these factors are important also when time of breeding is to be regulated with LUTALYSE Sterile Solution. Some of these factors are:
a. Cattle must be ready to breed - they must have a corpus luteum and be healthy;
b. Nutritional status must be adequate as this has a direct effect on conception and the initiation of estrus in heifers or return of estrous cycles in cows following calving;
c. Physical facilities must be adequate to allow cattle handling without being detrimental to the animal;
d. Estrus must be detected accurately if timed AI is not employed;
e. Semen of high fertility must be used;
f. Semen must be inseminated properly.
A successful breeding program can employ LUTALYSE effectively, but a poorly managed breeding program will continue to be poor when LUTALYSE is employed unless other management deficiencies are remedied first.
Cattle expressing estrus following LUTALYSE are receptive to breeding by a bull. Using bulls to breed large numbers of cattle in heat following LUTALYSE will require proper management of bulls and cattle.
3. For Intramuscular Use for Treatment of Pyometra (chronic endometritis) in Cattle. Inject a dose of 5 mL LUTALYSE (25 mg PGF2α) intramuscularly. In studies conducted with LUTALYSE, 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 recovered within 14 days after injection. After 14 days, recovery rate of treated cattle was no different than that of nontreated cattle.
4. For Intramuscular Use for Abortion of Feedlot and Other Non-Lactating Cattle. LUTALYSE is indicated for its abortifacient effect in feedlot and other non-lactating cattle during the first 100 days of gestation. Inject a dose of 25 mg intramuscularly. Cattle that abort will abort within 35 days of injection.
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 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 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 dose for cattle injected up to 100 days of gestation.
Swine: For intramuscular use for parturition induction in swine. LUTALYSE Sterile Solution is indicated for parturition induction in swine when injected within 3 days of normal predicted farrowing.
The response to treatment varies by individual animals with a mean interval from administration of 2 mL LUTALYSE (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of farrowing in sows and gilts in late gestation.
Management Considerations: Several factors must be considered for the successful use of LUTALYSE Sterile Solution for parturition induction in swine. The product must be administered at a relatively specific time (treatment earlier than 3 days prior to normal predicted farrowing may result in increased piglet mortality). It is important that adequate records be maintained on (1) the average length of gestation period for the animals on a specific location, and (2) the breeding and projected farrowing dates for each animal. This information is essential to determine the appropriate time for administration of LUTALYSE.
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 "barren", 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 "pseudopregnancy", 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 "anestrous" mares which abort subsequent to 36 days of pregnancy may not result in return to estrus due to presence of functional endometrial cups.
WARNINGS
User Safety: Not for human use. 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. Accidental spillage on the skin should be washed off immediately with soap and water.
Residue Warnings: 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.
PRECAUTIONS
- Do not administer intravenously (I.V.) as this route might potentiate adverse reactions.
- 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.
- As with all parenteral products careful aseptic techniques should be used to decrease the possibility of post-injection bacterial infections. The vial stopper should be cleaned and disinfected prior to needle entry. Only sterile needles should be used and the same needle should not be used more than once.
- Nonsteroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently.
Cattle: Do not administer to pregnant cattle, unless abortion is desired. Cattle administered a progestin would be expected to have a reduced response to LUTALYSE Sterile Solution.
Swine: 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.
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.
ADVERSE REACTIONS
Cattle: Limited salivation has been reported in some instances.
Swine: The most frequently observed side effects were erythema and pruritus, slight incoordination, nesting behavior, itching, urination, defecation, abdominal muscle spasms, tail movements, hyperpnea or dyspnea, increased vocalization, salivation, and at the 100 mg (10X) dose only, vomiting. These side effects are transitory, lasting from 10 minutes to 3 hours, and were not detrimental to the health of the animal.
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 reported but was not confirmed.
To report adverse reactions call Pfizer Animal Health at 1-800-366-5288.
HOW SUPPLIED
LUTALYSE Sterile Solution is available in 30 and 100 mL vials.
STORAGE CONDITIONS
Store at controlled room temperature 20� to 25� C (68� to 77� F). Protect from freezing
