Meds A-Z
Dinoprost Tromethamine
Detailed information about Dinoprost Tromethamine
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.
What it does:
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for...
When it's needed:
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory prob...
Call your vet sooner if you notice:
- Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. 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. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Dinoprost Tromethamine
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Zoetis Inc.
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200253 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141442 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. 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. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
- High: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. 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. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 0 | |
| 1 | Cat | 0 | |
| 0 | Dog | 0 |
Species coverage: Dog (10) Cat (4)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2016-US-058187
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 7 • Secondary summaries: 0
- Updated ANADA 200-253 FOI Summar.pdf · FOI
- ucm061681.pdf · FOI
- ProstaMate® · SPL
- UCM471254.pdf · FOI
- UCM461152.pdf · FOI
- LUTALYSE® HighCon Injection · SPL
- Prostin F2 Alpha® Sterile Solution · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/11891 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/977 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/114/ProstaMate%C2%AE · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/933 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/932 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2335/LUTALYSE%C2%AE%20HighCon%20Injection · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1967/Prostin%20F2%20Alpha%C2%AE%20Sterile%20Solution · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
At a Glance
Quick facts and links to official labeling and safety signals.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:14 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. 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. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 54771-1327-1 | 54771 | - | |
| 54771-1327-2 | 54771 | - | |
| 54771-1327-3 | 54771 | - | |
| 54771-1328-1 | 54771 | - | |
| 54771-1328-2 | 54771 | - | |
| 54771-1328-3 | 54771 | - | |
| 61133-4001-1 | 61133 | - | |
| 82231-105-00 | 82231 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
ucm061681.pdf
• FOI summary • Official
• Jan. 21, 2022
FDA FOI summary for application 200253
-
Updated ANADA 200-253 FOI Summar.pdf
• FOI summary • Official
• Jan. 21, 2022
FDA FOI summary for application 200253
-
UCM461152.pdf
• FOI summary • Official
• March 17, 2019
FDA FOI summary for application 141442
-
UCM471254.pdf
• FOI summary • Official
• March 17, 2019
FDA FOI summary for application 141442
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asth… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Vomiting, Drooling, Itching, Lack of efficacy - NOS, Tachypnoea, Constricted pupils. (Official, 2026-02-12)
- usage: For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BR… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
ProstaMate®
RX
Dinoprost Tromethamine
Injectable Solution
• Intramuscular
|
Bimeda Animal Health Limited | ANADA 200-253 | Approved | Jan 21, 2022 |
|
LUTALYSE® HighCon Injection
RX
Dinoprost Tromethamine
Injectable Solution
• Intramuscular, Subcutaneous
|
Zoetis Inc. | NADA 141-442 | Approved | Mar 17, 2019 |
|
Prostin F2 Alpha® Sterile Solution
RX
Dinoprost Tromethamine
Liquid (Solution)
• Intramuscular
|
Zoetis Inc. | NADA 100-202 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
What It's For (FDA Label Highlights)
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Composition / specifications
For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.
ProstaMate 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 ProstaMate (25 mg dinoprost) 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 ProstaMate. 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.
For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.
Inject a dose of 5 mL ProstaMate (25 mg dinoprost) 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.
For use with gonadorelin injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
Administer 2 to 4 mL gonadorelin injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:
- Administer the first dose of gonadorelin injection (2-4 mL) at Day 0
- Administer ProstaMate® (25 mg dinoprost, as dinoprost tromethamine) by intramuscular injection 6-8 days after the first dose of gonadorelin injection.
- Administer a second dose of gonadorelin injection (2-4 mL) 30 to 72 hours after the ProstaMate® injection.
- Perform FTAI 0 to 24 hours after the second dose of gonadorelin injection, or inseminate cows on detected estrus using standard herd practices.
For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.
- Administer one EAZI-BREED™ CIDR® Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).
- Administer 5 mL ProstaMate® at the time of removal of the EAZI-BREED™ CIDR® Cattle Insert.
- Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals found in estrus following normal herd practices.
For treatment of pyometra (chronic endometritis) in cattle.
Inject a dose of 5 mL ProstaMate (25 mg dinoprost) intramuscularly.
For abortion in beef cows, beef heifers and replacement dairy heifers.
ProstaMate® is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Inject a dose of 25 mg dinoprost (5 mL) intramuscularly. Cattle that abort will abort within 35 days of injection.
For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.
- Administer one EAZI-BREED™ CIDR® Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
- Inject 5 mL ProstaMate (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED™ CIDR® Cattle Insert removal, on Day 6 of the 7 day administration period.
- Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED™ CIDR® Cattle Insert and inseminate animals about 12 hours after onset of estrus.
For parturition induction in swine.
For intramuscular use for parturition induction in swine. ProstaMate 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 ProstaMate (10 mg dinoprost) to parturition of approximately 30 hours. This can be employed to control the time of arrowing in sows and gilts in late gestation.
For controlling the timing of estrus in estrous cycling mares and for difficult-to-breed mares (clinically anestrous mares that have a corpus luteum).
Administer a single intramuscular injection of 1 mg per 100 lbs (45.5 kg) body weight which is usually 1 mL to 2 mL ProstaMate.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.
Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
For abortion in beef cows, beef heifers and replacement dairy heifers.
Inject a dose of 25 mg (2 mL) by intramuscular or subcutaneous injection.
LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
For estrus synchronization in beef cows, beef heifers and replacement dairy heifers.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) intramuscularly or subcutaneously either once or twice at a 10 to 12 day interval.
LUTALYSE HighCon Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. 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 HighCon Injection. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.
For treatment of pyometra (chronic endometritis) in cattle.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.
For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.
Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example, if administered on a Monday remove the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection at the time of removal of the EAZI-BREED CIDR Cattle Insert. Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
For unobserved (silent) estrus in lactating dairy cows with a corpus luteum.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.
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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.
For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
Inject a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection.
Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:Administer the first dose of FACTREL Injection (2 – 4 mL) at Day 0Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 6 – 8 days after the first dose of FACTREL Injection.Administer a second dose of FACTREL Injection (2 – 4 mL) 30 to 72 hours after LUTALYSE HighCon InjectionPerform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
Specifications:
Each milliliter of sterile solution contains the equivalent of 5 milligrams of dinoprost.
Conditions of use:
Horses (mares)
Amount:
Equivalent of 1 milligram of dinoprost per 100 pounds of body weight. For use once as a single intramuscular injection.
Indications:
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum.
Limitations:
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. Use of this
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
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Summary
This supplement provides for the addition of the following indications and corresponding dosage regimens: for use with gonadorelin injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows; for use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows; for use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. In addition, this supplement provides for labeling revisions to align the labels with those of the RLNAD.
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FOI ucm061681.pdf
Summary
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 in swine; and for controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
- ProstaMate® (ZIP)
FDA page: Open in Animal Drugs @ FDA
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FOI UCM471254.pdf
Summary
This supplement provides for the addition of the subcutaneous route of administration. -
FOI UCM461152.pdf
Summary
For estrus synchronization in beef cows, beef heifers and replacement dairy heifers; for unobserved (silent) estrus in lactating dairy cows with a corpus luteum; for treatment of pyometra (chronic endometritis) in cattle; for abortion of beef cows, beef heifers and replacement dairy heifers; for use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows; for use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows; and for use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
Usage
For its luteolytic effect to control timing of estrus in estrus cycling mares and in clinically anestrous mares that have a corpus luteum. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. For abortion in beef cows, beef heifers and replacement dairy heifers.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and bronchiospasms. 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. Do not administer intravenously; this may potentiate adverse reactions. Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday). Administer a dose of 2 mL LUTALYSE HighCon Injection (25 mg dinoprost) by intramuscular or subcutaneous injection 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 Day administration period. Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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. LUTALYSE HighCon Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Cattle that abort will abort within 35 days of injection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, or 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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 5 and Cat 2 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Retriever - Labrador, Female, 27.216 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 10 Milligram per animal • Reactions: Drooling, Vomiting, Tachypnoea, Itching • Outcome: Ongoing
- Report ID: USA-USFDACVM-2024-US-007094
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Weight: 27.216 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Solution
- Dose: 10 Milligram per animal
Dog, Mastiff, Female, 46.448 kilogram • Drug: MSK, Solution, Unknown • Reactions: Vomiting • Outcome: Ongoing
- Report ID: USA-USFDACVM-2023-US-006391
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Weight: 46.448 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Cat, Rex - Devon, Female, 3 year, 2.495 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 0.10 mL per animal • Reactions: Vaginal discharge • Outcome: Ongoing
- Report ID: USA-USFDACVM-2018-US-006177
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 3.00 Year
- Weight: 2.495 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Solution
- Dose: 0.10 mL per animal
Dog, Poodle - Miniature, Female, 16 year, 9.072 kilogram • Drug: MSK, Solution, Unknown, Dose: 0.10 Milligram per kilogram, Frequency: 1 per day • Reactions: Lack of efficacy - NOS • Outcome: Ongoing
- Report ID: USA-USFDACVM-2017-US-028747
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 16.00 Year
- Weight: 9.072 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
- Dose: 0.10 Milligram per kilogram
- Frequency: 1 per day
Cat, Cat (other), Female • Drug: MSK, Solution, Unknown • Reactions: Constricted pupils • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2016-US-058187
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
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